66
Abstracts
study of 100 adult asthmatics. RESULTS: The table reports outcomes over a 10-year period. Results were driven
by the impact of ICS on quality of life, rather than on
mortality. Findings were stable over most input data
ranges. However, at efficacy levels below 3% and toxicity rates greater than 2.9%, the cost-effectiveness estimate exceeded $100,000/QALY. CONCLUSION: Results
suggest that inhaled steroids deliver good comparative
value in mild-to-moderate adult asthma. More research is
needed, however, on the impact of ICS toxicity on patient
preferences.
Strategy
Quick Relievers alone
1ICS in moderate disease
1ICS in mild disease
1ICS in mild/mod. disease
Cost
QALY
$QALY
$5,185
$5,961
$7,616
$8,392
6.77
6.84
6.93
7.00
—
$10,300
dominated
$15,000
CONTRIBUTED POSTER
PRESENTATIONS
ARTHRITIS, OSTEOPOROSIS &
MUSCULOSKELETAL DISORDERS
PAM1
JOINT COUNTS IN PATIENTS WITH NEW
ONSET RHEUMATOID ARTHRITIS: PATIENT VS.
PHYSICIAN ASSESSMENT
Kim SS, Drabinski AM, Williams GR, Formica CA
Knoll Pharmaceutical Company, Mount Olive, NJ, USA
BACKGROUND: Both physician-assessed and patient
self-reported joint counts have been used in the assessment of disease activity in rheumatoid arthritis. The objective of this study was to compare patient vs. physician
reported joint counts in patients with new onset RA.
METHODS: Baseline data was analyzed from the Study
of New Onset Rheumatoid Arthritis (S.O.N.O.R.A.SM),
a five-year prospective, longitudinal, inception cohort
study to document long-term functional, clinical, and humanistic outcomes and patterns of treatment in patients
with new onset RA. Baseline data collection consisted of
physician and patient surveys. Physicians assessed swollen (SJ) and tender/painful joints (TJ) while patients reported painful joint (PJ). Physician’s SJ and TJ consisted
of examination in 64 and 66 joints, respectively. Patient’s
PJ was assessed in 16 joint areas with use of a mannequin. The Pearson product moment correlation coefficient was calculated for SJ, TJ, and PJ counts. RESULTS:
One hundred and seven patients completed the baseline
survey. Mean age of the sample was 55 6 15 years; 79%
were female; 80% were Caucasian. Mean joint counts were
12.6 (SE 5 0.9) SJ, 14.0 (SE 5 1.3) TJ, and 6.6 (SE 5
0.4) PJ. Patient-reported PJ correlated with physician-
reported SJ (r 5 0.22, p 5 0.023) and TJ (r 5 0.55, p ,
0.001). CONCLUSION: Higher correlation was observed
between PJ and TJ compared to SJ. Patient, self-reported
joint counts may be a useful surrogate of joint activity in
the absence of physician assessment. However, caution
should be taken given that the accuracy of patient, selfreported joint counts still needs further evaluation. Fiveyear follow-up of this population will provide further insight on the sensitivity to change for both patient and
physician reported joint counts as it relates to disease activity.
PAM2
AN ECONOMIC EVALUATION OF
OSTEOPOROSIS MEDICATION USE PATTERNS
IN A MANAGED CARE ORGANIZATION: A TIME
TO FRACTURE ANALYSIS
Chen KS1, White TJ2, Chang E2
1
University of Southern California, Los Angeles, CA, USA;
2
Prescription Solutions, Costa Mesa, CA, USA
Osteoporosis affects approximately 24 million Americans
and accounts for an estimated annual direct medical costs
of over $13.8 billion. An economic analysis that evaluates the effectiveness of osteoporosis medications for prevention of bone fractures in a naturalistic setting has not
been formally conducted. OBJECTIVES: To compare
differences among four therapeutic alternatives [estrogen
replacement therapy (ERT), raloxifene, nasal calcitonin,
and alendronate] with respect to health care costs (pharmacy, medical, and total), and time to fracture. METHODS: Retrospective pharmacy and medical claims data
from a large managed care organization were analyzed.
Patients were included if they were diagnosed with osteoporosis and newly initiated on medication between
1/1/98–12/31/98. All patients were followed for exactly 1
year. Cost data was log-transformed to correct for skewness. ANCOVA was conducted to compare total health
care costs; Cox Proportional Hazard Model was performed to compare the risk of fracture. Total health care
costs was defined as all osteoporosis-related services covered. RESULTS: There were 12,757 female patients identified for the analysis and the average age was 70(S.D. 5
10). A total of 1,721(13.5%) patients had a fracture after
initiation of drug therapy. After adjusting for age, prior
medication costs, prior fracture event, and comorbidities,
adjusted means (95%CI) of log-transformed total health
care costs was lowest for ERT 5.87(5.84–5.90), compared to raloxifene 6.32(6.19–6.46), alendronate
6.55(6.51–6.59) and calcitonin 7.20(6.61–7.80). Compared to calcitonin, the adjusted hazard ratios (95%CI)
for a fracture were 0.174(0.078–0.39) for ERT,
0.175(0.078–0.39) for alendronate, and 0.160(0.068–
0.377) for raloxifene. CONCLUSIONS: In this population, ERT was associated with statistically significant
lower total health care costs compared to raloxifene, alendronate, and calcitonin. Raloxifene was associated
with statistically significant lower total health care costs
67
Abstracts
compared to calcitonin and alendronate. Furthermore,
hazard ratios showed that patients taking ERT, raloxifene, or alendronate were approximately 83% less likely
to experience fracture at any point in time compared to
calcitonin.
PAM3
THE COST OF OSTEOPOROTIC FRACTURES IN
THE UNITED KINGDOM
Burge RT1, Worley D1, Johansen A2, Bose U3
1
Procter & Gamble Pharmaceuticals, Mason, OH, USA;
2
University of Wales, Cardiff, UK; 3Procter & Gamble
Pharmaceuticals, Middlesex, UK
BACKGROUND: The UK has more than 19 million people aged over 50, including about 9.4 million aged over
65. Demographic changes will lead to increases in the
over-50 population of 10% and 25% by 2010 and 2020,
respectively. There are already 3 million UK residents
with osteoporosis, but the prevalence of osteoporosis increases with age, and the public health impact of osteoporosis will increase substantially over the next 20
years. OBJECTIVE: To predict fracture numbers and
corresponding costs for men and women aged 50–99
years in the UK for the years 2000 to 2020. METHODS:
A Markov model was designed to simulate the natural
history of osteoporosis within the UK population. Inputs
to the model included age/sex specific fracture incidence
rates, published unit costs for different fracture types
(hip, vertebral, forearm/wrist, other), age/sex specific
mortality rates, and age/sex specific population totals.
Total fracture numbers were adjusted using published
site-specific attribution figures to identify the number
that were a consequence of osteoporosis. Iteration techniques were employed across ages 50–99 in men and
women, to generate the distribution of prevalence-based
estimates of fractures and costs for the base year 2000.
Osteoporosis costs and fracture numbers were then projected into future years by applying growth rates in age/
sex specific population totals to these year 2000 estimates. RESULTS: In 2000 there were 190,000 osteoporosis-related fractures at a cost of £1.8 billion. Men
accounted for 32,000 fractures and £330 million. By
2020, annual osteoporotic fracture numbers increased by
over 21% to 230,000, with costs growing by 20% to
over £2.1 billion. Cumulative totals for 2000–2010 were
2.2 million fractures and £20.3 billion. CONCLUSIONS:
Osteoporotic fractures will have substantial and increasing impacts on UK health services unless highly effective
preventative interventions achieve widespread use.
PAM4
USE OF COX 2 NSAIDS IN SUBJECTS WITHOUT
RISK OF GASTROINTESTINAL SIDE EFFECTS
Harley CR
Ingenix Pharmaceutical Services, Eden Prairie, MN, USA
OBJECTIVE: While Cox 2 inhibitors have a theoretical
advantage over other nonsteroidal anti-inflammatory
drugs (NSAIDS) by reducing gastrointestinal (GI) side effects, not all individuals are at increased risk of GI complications and therefore may benefit equally from nonCox 2 specific NSAIDS. This study determined the use of
Cox 2 inhibitors by subjects with no identifiable GI risk.
The cost of this “inappropriate use” was estimated.
METHODS: This was a longitudinal claims data analysis
using 1999 medical, pharmacy and enrollment data from
a large national health plan. Subjects were identified as
either Cox 2 users (n 5 23,190) or other NSAID users
(n 5 192,079) from pharmacy claims, and total NSAID
costs were calculated for a six-month period. RESULTS:
Cox 2 users were more likely to have a GI risk factor,
(prior GI events, age over 60 years, chronic NSAID use of
two or more prescriptions in the six months prior to the
first Cox 2 claim, and prior corticosteroid use) compared
to other NSAID users. Because individuals with arthritis
may require on-going NSAID use, a diagnosis of arthritis
(OA or RA) was also considered a risk factor for GI complications. Having an arthritis diagnosis was more likely
among Cox 2 users compared to other NSAID users
(44.1% and 13.0% respectively). Twenty-six percent of
Cox 2 users had neither a discernable GI risk nor an arthritis diagnosis. An unadjusted cost comparison between
Cox 2 subjects with no GI risk and no arthritis and similar other NSAID subjects found a significant mean difference of $131 per person in NSAID costs for six months.
CONCLUSIONS: Despite health plan policies to manage
the use of Cox 2 inhibitors, a quarter of Cox 2 users appeared to be inappropriate. The total health system cost
of this potentially inappropriate use was $775,000 for six
months.
PAM5
INVESTIGATING THE CONSTRUCT VALIDITY
OF A DISEASE SPECIFIC AND A GENERAL
QUALITY OF LIFE INSTRUMENTS OF PATIENTS
WITH RHEUMATOID ARTHRITIS
Lovas K1, Szende A2, Bàlint G3, Szebenyi B3, Héjj G3
1
Semmelweis University, Budapest, Hungary; 2AstraZeneca,
Torokbalint, Hungary; 3National Institute of Rheumatology and
Physiotherapy, Budapest, Hungary
OBJECTIVES: Quality of life is a key parameter in describing the health status patients of rheumatoid arthritis.
Construct validity of a generic (EQ-5D) and a disease
specific (RAQoL) quality of life instrument was tested
with the intention of further use in clinical and health
economic trials and burden of disease studies in Hungary. METHODS: RAQoL and EQ-5D have been recently adapted into Hungarian. Authors analysed the demographic and QoL data from a cross-sectional postal
survey of patient with rheumatoid arthritis. The convergent validity of EQ-5D, RAQoL scores has been compared to functional measurement scores from the Health
Assessment Questioner (HAQ). Pearson correlation coef-
68
Abstracts
ficients were used to assess the level of association. RESULTS: 81 patients participated in the study. Mean age
of the sample was 57.3 (SD 5 10.1) years, 89% (n 5 72)
were female. The average disease duration among patients was 14.5 (SD 5 10.6) years. RAQoL scores were
relatively strongly correlated (Pearson coefficient 5 0.662)
with HAQ scores. The EQ-5D index scores showed higher
correlation (0.627) with HAQ than the Visual Analogue
Scale of EQ-5D (0.463). The Pearson Correlation Coefficient between RAQoL and EQ-5D index scores was
0.515, and between RAQoL and EQ-5D VAS scores was
0.396. CONCLUSIONS: Results suggest that the Hungarian RAQoL is a valid instrument of measuring QoL of
rheumatoid arthritis patients. The EQ-5D index provides
also appropriate results, and can be proposed for costutility analyses. However EQ-5D VAS scores are not recommended to describe the QoL of patients with rheumatoid arthritis.
PAM6
COST-EFFECTIVENESS OF ROFECOXIB VERSUS
NSAIDS IN THE TREATMENT OF
OSTEOARTHRITIS
Sullivan P, Hay J
University of Southern California, Los Angeles, CA, USA
OBJECTIVES: The purpose of this study is to examine
the cost-effectiveness (CE) of rofecoxib versus NSAIDs in
the treatment of osteoarthritis. METHODS: The authors
used decision-analysis from a societal perspective to
model a hypothetical cohort of osteoarthritis patients on
long-term NSAID therapy. Incremental cost per QALY
(C/QALY) estimates were calculated for a hypothetical
trial population and for patients at high risk of G.I. adverse events. High-risk patients were defined in the literature as having four risk factors combined: history of G.I.
bleeds, history of peptic ulcer, cardiovascular disease and
age 75 years or greater. All costs were expressed in 1997
prices. Utility estimates were obtained from a separate
analysis of pharmacy claims data including the Health
Utilities Index Mark 2 from a large HMO. Confidence
intervals were assessed using the maximum and minimum values from the literature. Univariate sensitivity and
threshold analysis were conducted. RESULTS: The C/
QALY range is $5,658 to $108,831 for osteoarthritis patients; base case C/QALY is $103,597 for all osteoarthritis patients, 2$9,374 for high-risk patients. Rofecoxib is
cost-effective (C/QALY ,5$50,000) if the incidence of
perforations, ulcers and bleeds (PUB) is 0.098 per year or
greater. Sensitivity: the most sensitive parameters were:
symptomatic dyspepsia utility; rofecoxib price; symptomatic peptic ulcer utility; incidence of G.I. symptoms;
NSAID price and incidence of PUBs. However, the parameters with greatest uncertainty and variability in the
literature are incidence of PUBs and G.I. symptoms.
CONCLUSION: The point estimate C/QALY of rofecoxib for all osteoarthritis patients varies from very costeffective to not cost-effective depending on assumptions
for the probability of PUBs and G.I. symptoms. Rofecoxib is cost saving for patients at high risk of developing
G.I. complications.
PAM7
THE CORRELATION BETWEEN ARTHRITIS
SPECIFIC MEASURES AND SF-36 SCALES IN
RHEUMATOID ARTHRITIS PATIENTS
Lubeck DP1, Yelin E1, Katz P1, Roepke L1, Wanke LA2, Buatti M3
1
University of California-San Francisco, San Francisco, CA, USA;
2
Immunex Corporation, Seattle, WA, USA; 3Wyeth-Ayerst
Research, Philadelphia, PA, USA
OBJECTIVE: To evaluate the correlation between general measures of function and well-being, as measured by
the 8 domains of the SF-36, with arthritis specific measures of function and symptom frequency. METHODS:
We identified 606 patients from a longitudinal, observational study of RA (RAPOLO). Patients completed telephone interviews about arthritis specific function (HAQ,
RA Status and Symptoms), the SF-36 domains, Physical
and Mental Summary Scores (PCS, MCS) and the Arthritis Specific Health Index (ASHI). We present correlations
between the SF-36 domains, PCS, MCS and ASHI with
selected arthritis measures. All correlations are presented
as absolute values. RESULTS: All correlations were in
the anticipated direction. A correlation .0.6 5 good–excellent, and ,0.4 5 below average. The HAQ was highly
correlated with the SF-36 physical scales, and had weak
correlations with the emotional function scales and the
ASHI. Other arthritis specific scales (joint swelling, joint
pain, morning stiffness, RA fatigue and RA pain) were
strongly correlated with the ASHI, the SF-36 pain, physical function, role function-physical and energy/fatigue
scales; and had weak correlations with the emotional
functioning and general health scales. CONCLUSIONS:
In RA patients, the SF-36 measures aspects of functioning
and well-being not covered by the arthritis specific measures, especially in the areas of emotional functioning.
This is indicated by the moderate to weak correlations
between the arthritis specific measures and the domains
of emotional function, role emotional function, and mental health and the MCS.
PAM8
COST COMPARISON OF TREATING
OSTEOPOROSIS PATIENTS WITH ESTROGENS
OR SELECTIVE ESTROGEN RECEPTOR
MODULATOR IN A MANAGED CARE
POPULATION
Liao E, Sweazy L, Huse D
PharMetrics, Inc, Watertown, MA, USA
OBJECTIVE: To compare osteoporosis treatment charges
among patients treated with an estrogen versus a selective
estrogen receptor modulator (SERM) in a managed care
population. METHODS: Patients 40 years of age with a
69
Abstracts
diagnosis of osteoporosis between January 1 and June
30, 1999 and 2 pharmacy claims for an estrogen or
SERM were selected from the PharMetrics Integrated
Outcomes Database. Patients were excluded if they had
less than 6 months of continuous enrollment following
the first (index) prescription claim for an estrogen or
SERM or received other drugs for osteoporosis, such as
bisphosphonates or calcitonin-salmon. The frequency of
of hip, vertebral, forearm/wrist or other fracture and/or
related surgical procedures and osteoporosis-specific
charges were assessed over the 6-month period following
the index prescription. RESULTS: 252,892 patients met
the selection criteria, including 245,650 treated with estrogen and 7,242 with SERMs. The estrogen cohort was
significantly younger than the SERM cohort (mean age:
54.3 vs. 59.0 years, p , 0.001) and had less frequent
fractures/surgical procedures (1.0% vs. 1.6%, p , 0.001).
The SERM group had higher mean osteoporosis-related
pharmacy ($309 vs. $106) and medical charges ($73 vs.
$29) resulting in a total charge difference of $247 (p ,
0.001). Stratified analyses indicated that the SERM cohort had consistently higher mean charges across all age
ranges compared to the estrogen cohort. CONCLUSION:
In this initial cost comparison between SERM and estrogen therapy for osteoporosis, short-term (6-month) osteoporosis-related charges were significantly higher in the
SERM group primarily due to the difference in drug
costs. Longer-term studies are required to examine all of
the costs associated with these therapies.
PAM9
COST COMPARISON OF TREATING
RHEUMATOID ARTHRITIS PATIENTS WITH
COX-2 INHIBITORS OR NSAIDS IN A MANAGED
CARE POPULATION
Liao E, Kester G, Huse D
PharMetrics, Inc, Watertown, MA, USA
OBJECTIVE: To compare rheumatoid arthritis (RA)
treatment charges with a cyclooxygenase-2 specific inhibitor (COX-2) versus a non-steroidal anti-inflammatory
drug (NSAID) therapies in a managed care population.
METHODS: Patients with a diagnosis of RA between
January 1 and June 30, 1999 who had prescriptions for
COX-2s or NSAIDs were selected from the PharMetrics
Integrated Outcomes Database. Patients were excluded if
they had osteoarthritis or did not have 6 months of continuous enrollment following the first (index) COX-2 or
NSAID pharmacy claim. COX-2 and NSAID-treated
groups were compared on their demographics, comorbidities, and total RA-specific charges during the 6 month
follow-up period RESULTS: A total of 5,261 patients
met the patient selection criteria, including 668 who received COX-2 and 4,593 who received NSAID. The
COX-2 group was older (53.7 versus 49.6 years, p ,
0.0001) on average and more likely to have at least one
comorbidity (46.0% vs. 31.9%, p , 0.001) compared to
the NSAID group. They also had higher RA-related pharmacy ($914 versus $636) and medical charges ($611 versus $566). Total mean charges for the COX-2 cohort
were $323 higher (p 5 0.019) than the NSAID cohort.
CONCLUSION: In this initial cost comparison between
COX-2s and NSAIDs, the mean charge for a 6-month period with COX-2s was 27% higher than with NSAIDs,
mainly due to higher pharmacy charges. Longer-term
studies are required to examine whether the higher acquisition costs of COX-2 are offset by savings in the costs of
treating gastrotoxicity.
PAM10
THE IMPACT OF EARLY RHEUMATOID
ARTHRITIS ON PRODUCTIVITY
Kim SS, Drabinski AM, Williams GR, Formica CA
Knoll Pharmaceutical Company, Mount Olive, NJ, USA
BACKGROUND: Rheumatoid arthritis (RA) leads to physical and psychosocial functional disabilities affecting productivity of patients in their daily activities. OBJECTIVE:
to evaluate the impact of early RA on productivity.
METHODS: Baseline data was analyzed from the Study
of New Onset Rheumatoid Arthritis (S.O.N.O.R.A.SM),
a five-year prospective, longitudinal, inception-cohort
study to document long-term functional, clinical, and humanistic outcomes and patterns of treatment in patients
with new onset RA. Telephone interviews were performed by trained interviewers to collect data on employment status, annual household income (AHI) and productivity at work and normal activities, outside of paid
job (NAOPJ), including absenteeism over the past 4
months, reason for absenteeism, and effectiveness at
work and NAOPJ when working with arthritis symptoms
(AS). RESULTS: One hundred thirty one patients completed the baseline survey. Mean age was 56 6 15 years;
78% were female; 82% were Caucasian. Employment
status reported was full-time (52%), part-time (2%), retired (26%), and other (20%). AHI were ,$50,000
(63%), $50,000–74,999 (17%), .$75,000 (18%), and
2% refused to provide AHI. Ninety-one percent of patients were employed at a paid job. The mean absenteeism at work and NAOPJ were 4.3 days (SE 5 1.1) and
25.9 days (SE 5 3.3), respectively. Of the participants reporting absenteeism, 40% and 69% reported that the
majority of absenteeism was due to AS for work and
NAOPJ, respectively. Compared to their normal performance, patients were 78% and 64% as effective when
working with AS at work and NAOPJ, respectively.
CONCLUSION: Despite new onset of RA in this population, negative impact on productivity was observed. A
greater decline in productivity was reported for NAOPJ.
This may imply that NAOPJ is compromised before
work activities in early RA patients. Five-year follow-up
of this population will provide further insight on productivity changes and the economic burden associated with
progressive disease.
70
Abstracts
PAM11
APPLYING BACKGROUND RISK DISTRIBUTION
TO EVALUATE THE COST-EFFECTIVENESS OF
THREE PREVENTIVE DRUG THERAPIES FOR
OSTEOPOROTIC FRACTURES
Gao X1, Madhavan S2, Nau D2, Ambegaonkar A3, Islam S4,
Rosenbluth S2, Amonkar M2
1
PPD Development, Morrisville, NC, USA; 2West Virginia
University School of Pharmacy, Morgantown, WV, USA; 3Pfizer
Inc, New York, NY, USA; 4West Virginia University School of
Medicine, Morgantown, WV, USA
OBJECTIVE: To evaluate cost-effectiveness (CE) of three
drug therapies for preventing osteoporotic fractures in postmenopausal women from a state Medicaid Program perspective using the estimated risk distribution in the study
population. The three therapies are: hormone replacement
therapy (HRT), alendronate, and raloxifene. METHODS:
A hypothetical cohort of white women aged 45–85 years,
postmenopausal, and without past incidence of osteoporotic fractures was treated with one of the three alternatives, and tracked over 3 years in a decision model. The CE
ratio was defined as the treatment costs [e.g., medications,
monitoring, adverse events (AE)] divided by the number
of fractures averted. Treatment Willingness-To-Continue
(WTC) rate was also considered. Data were collected from
literature, expert panel survey, Medicaid claims data, and a
risk survey in the study population. Monte Carlo simulations were conducted (distributions used: background risk,
cost, and risk reduction rate). Risk or probability of osteoporotic fracture was also divided into three strata: low
(risk ,0.1), medium (0.10.3). RESULTS: Compared to no
therapy, the expected CE of HRT was $29,119 per fracture
averted, alendronate: $35,101, and raloxifene: $39,760.
The incremental CE was $42,181 for alendronate (relative
to HRT) and $85,509 for raloxifene (relative to alendronate). The incremental CE of alendronate and raloxifene
were $151,981 and $697,270 among women with low risk
(43% of the sample), compared to $11,099 and $34,017
respectively among high-risk women (26% of the sample).
CE was not sensitive to discount rate and AE probabilities.
CONCLUSIONS: HRT is the most cost-effective strategy
even though it may have relatively high monitoring and AE
costs, and low WTC rate. The significant decrease in marginal costs of Alendronate and Raloxifene in high-risk
women indicates an economic condition to use these two
drugs. The study provides a framework to make risk-appropriate coverage decisions for chemo-preventive agents.
PAM12
COST-MINIMIZATION ANALYSIS OF THE
TREATMENT OF RHEUMATOID ARTHRITIS
WITH LEFLUNOMIDE IN COMPARISON WITH
THE COMBINATION OF INFLIXIMAB AND
METHOTREXATE
Rubio-Terrés C1, Domínguez-Gil A2
1
Aventis Pharma SA, Madrid, Spain; 2Hospital Universitario de
Salamanca, Salamanca, Spain
OBJECTIVES: To carry out a pharmacoeconomic analysis to compare the efficiency of two rheumatoid arthritis
treatments in Spain. METHODS: The study consisted of
a systematic review of efficacy and toxicity as well as a
cost-minimization analysis, carried out using a pharmacoeconomic model, comparing the treatment with leflunomide and the combination of infliximab and methotrexate during one year. RESULTS: Clinical trials directly
comparing both treatments are not available. The response rate ACR20 combined, after one year, was 53.0%
(CI95%: 49.2%–56.4%) with Leflunomide and 42.0%
(CI95%: 31.2%–52.5%) with the combination of Infliximab and Methotrexate (P 5 0.051). There were no statistically significant differences in the ACR50 response
(27.0 vs 21.0, respectively; P 5 0.19). There were fewer
infections with Leflunomide than with the combination,
both respiratory (15.0% and 34.0%, respectively; P 5
0.0003) as well as urinary (0.0% and 3.0%, respectively;
P 5 0.10). In the basic case, the cost per patient of a
yearly treatment with Leflunomide or with Infliximab
and Methotrexate is estimated to be 315,023 Ptas (Spanish pesetas) (1,893 euros, €) and 2,596,286 Ptas (15,604 €),
respectively. Therefore, the incremental cost of the combined treatment would be 2,281,263 Ptas (13,711 €). The
sensitivity analysis was carried out using the minimum
and maximum costs given by the standard deviations of
the unit costs and by modifiying other variables, as no
significant differences compared to the basic case were
found. CONCLUSIONS: The cost per patient after one
year of treatment is higher with the combination of Infliximab and Methotrexate compared to Leflunomide,
this is basically due to the higher acquisition cost of Infliximab.
PAM13
A COST-EFFECTIVENESS MODEL COMPARING
CELECOXIB AND ROFECOXIB TO
TRADITIONAL NSAIDS FOR
OSTEOARTHRITIS TREATMENT
Schaefer MG1,2, Morreale AP2, Plowman BK2
1
University of the Pacific, San Diego, CA, USA; 2VA San Diego
Healthcare System, San Diego, CA, USA
OBJECTIVES: Recent studies have demonstrated slightly
improved gastrointestinal (GI) complication rates with
cyclooxygenase-2 (COX-2) inhibitors versus non-steroidal anti-inflammatory (NSAID) medications in patients
not taking aspirin, however the cost avoidance from such
events alone does not justify the high costs of these
agents. Evidence that other non-GI adverse events may be
lower with COX-2 inhibitors is emerging. Since efficacy
of these agents appears to be similar, analysis of value
can be compared by evaluating adverse event profiles.
The purpose of this pharmacoeconomic model is to characterize the relative cost-effectiveness of celecoxib and
rofecoxib compared to traditional NSAIDs in osteoarthritic patients not taking aspirin from the perspective of
the Veterans Affairs (VA) Health care System. METH-
71
Abstracts
ODS: Data from recently published outcome studies was
incorporated into TreeAge software to construct the oneyear decision analysis model. The primary cost drivers
thought to influence cost-effectiveness were complicated
GI bleeds, hospitalizations, and symptomatic ulcers, as
well as differences in renal toxicity, dyspepsia, anemia,
hypertension and edema. Sensitivity analysis was performed on all major indices based on variations in results
found in reviewed studies. RESULTS: Overall rates of
adverse events were similar for all agents (75% NSAIDs,
72% celecoxib, 78% rofecoxib), however celecoxib was
associated with less events relating to primary cost drivers. These differences are attributed mainly to variances
among adverse event probabilities for hypertension and
edema (NSAIDs 4.7%, 4.4%, celecoxib 1.6%, 2.9%, rofecoxib 6.4%, 6.3%, respectively). Cost of drug treatment
per year for NSAIDs, celecoxib, and rofecoxib are $36.00,
$466.00, and $482.00, respectively, based on Federal
Supply Schedule (FSS) pricing. CONCLUSIONS: Based
on preliminary data, therapy with COX-2 inhibitors does
not appear to be cost-effective to prescribe for all osteoarthritic patients within the VA Health care System.
Results may be extrapolated to other health care settings
assuming medical costs are similar.
PAM14
TREATMENT WITH LEFLUNOMIDE IMPROVES
THE UTILITY OF PATIENTS WITH ACTIVE
RHEUMATOID ARTHRITIS: AN APPLICATION
OF THE SF-6D
Crawford B1, Brazier JE2, Strand V3, Doyle J4
1
Mapi Values, Boston, MA, USA; 2University of Sheffield,
Sheffield, UK; 3Stanford University School of Medicine, Palo
Alto, CA, USA; 4Aventis Pharmaceuticals, Parsippany, NJ, USA
OBJECTIVES: To evaluate the changes in patient utility
with treatment of active rheumatoid arthritis (RA) with
leflunomide (LEF), placebo (PBO) or methotrexate
(MTX). METHODS: A 52 week multicenter doubleblind controlled trial comparing treatment with leflunomide, methotrexate or placebo in patients with active
rheumatoid arthritis was used to derive patient utilities.
Short Form 36 (SF-36) data were used to generate utility
scores using the algorithm developed by Brazier et al
(1999). These utilities would reflect general population
values and would not be specific to an RA population.
Inclusion in the utility analysis required consistent SF-36
responses, a baseline and at least one other completed assessment, and valid responses to derive the SF-6D utilities. The area under the curve was calculated for completers and the intent-to-treat population in order to
estimate incremental quality adjusted life years (QALYs)
for the treatments. RESULTS: The clinical study population consisted of 182 LEF, 180 MTX and 118 PBO patients. The population used for the utility analysis consisted of 165 LEF, 164 MTX and 114 (PBO). Baseline
utility values were comparable between groups, ranging
from 0.622 to 0.637. Incremental QALYs gained for
completers was statistically significantly superior for LEF
over PBO (p 5 0.0317) and MTX (p 5 0.0130). Treatment with LEF resulted in an incremental gain of 0.084
QALYs, starting from a baseline of 0.622. Similar results
were seen with the intent-to-treat population. CONCLUSIONS: Treatment of RA with LEF statistically improves
patient health state utility values and QALY gain over
MTX and PBO.
PAM15
EVALUATING DIRECT AND INDIRECT
MEASURES OF UTILITY: STABILITY OF THE
SF-6D IN A RHEUMATOID ARTHRITIS
POPULATION
Crawford B1, Brazier JE2
1
Mapi Values, Boston, MA, USA; 2University of Sheffield,
Sheffield, UK
OBJECTIVES: To evaluate the stability and discriminative ability of direct and indirect measures of utility in a
population of rheumatoid arthritis patients. METHODS:
Clinical trial data was used to compare the stability of direct measures of utility (SG and VAS) to that from an indirect approach to utility development (SF-6D). SF-36
data were transformed to the SF-6D utility using the algorithm developed by Brazier et al.(1999) based on values of the general UK population. These data were compared to SG and VAS data collected in the same trial.
Ability to discriminate across functional classes and variance around point estimates was examined. RESULTS:
The SF-6D generated utilities that were consistently
lower than the directly elicited SG and were closer to the
VAS valuations. The standard deviations, however, were
consistently smaller.
SG
VAS
SF-6D
Baseline
Week 24
Week 52
0.7759 (0.2399)
0.5902 (0.1942)
0.6287 (0.1290)
0.8684 (0.1850)
0.7425 (0.1623)
0.7323 (0.1109)
0.8794 (0.1858)
0.7701 (0.1629)
0.7443 (0.1089)
CONCLUSIONS: The indirect measure of utility (SF-6D)
was more stable in terms of variance of parameter estimates and was able to discriminate across functional
classes. The reduced variance around these estimates enhances statistical testing and accurately reflects changes
experienced by the patient.
PAM16
COST IMPACT OF COX-2 INHIBITORS IN A
MANAGED CARE PLAN: IMPLICATIONS FOR
FORMULARY DECISION-MAKING
Atherly DE1, Fullerton DS2, Sturm LL2, Bryant A1, Sullivan SD1
1
University of Washington, Seattle, WA, USA; 2Regence
BlueShield, Seattle, WA, USA
BACKGROUND: Regence BlueShield, a 1.2 millionmember Washington health plan currently requires prior
72
Abstracts
authorization for coverage of COX-2 inhibitors. Evidence-based coverage criteria limit these drugs to members who are at moderate to high-risk of NSAID-induced
GI events. Regence was interested in the economic impact
of the COX-2s. However, cost-effectiveness data were
not available from the manufacturers. OBJECTIVES: 1)
To evaluate the cost impact of COX-2 inhibitors on a
managed care population. 2) To determine the appropriateness (in economic terms) of the prior authorization
criteria. METHODS: The VIGOR trial assessed the development of clinically important ulcer events and complicated upper GI events, including perforation, obstruction, and bleeding (POBs), in patients using either
rofecoxib or naproxen. Using the same DRGs and ICD9
codes in the VIGOR study, Regence obtained their own
patient data for these events in the year 2000. The number needed to treat (NNT), cost to prevent one clinically
significant upper GI event, and the cost to prevent one
complicated upper GI event (needing hospitalization)
were calculated from the data presented in the VIGOR
trial. RESULTS: The average COX-2 drug cost per patient per year is $1,100. The cost to prevent one clinically
significant NSAID-induced upper GI event is $46,000,
and the cost to prevent one NSAID-induced complicated
upper GI event requiring hospitalization, is $137,500. In
the year 2000, 443 Regence members were hospitalized
for an upper GI POB with a total cost of nearly $4 million (average $9030 per hospitalization). CONCLUSIONS: In the absence of complete cost-effectiveness
data, a large health plan conducted a simple, yet very useful cost impact analysis to support and inform drug policy for COX-2 inhibitors. The cost per hospitalization
avoided is much higher than the actual hospitalization
costs. This supported the Regence decision to limit coverage of COX-2 inhibitors to a moderate to high-risk population.
PAM17
IMPORTANT ISSUES IN NUMBER NEEDED TO
TREAT ANALYSIS IN OSTEOPOROSIS
TREATMENT
Kemner JE
Eli Lilly and Company, Indianapolis, IN, USA
Number Needed to Treat (NNT) is calculated in clinical
trials by taking the inverse of the difference in absolute
risk in the placebo group from the treatment group. It
captures how many people would need to receive a treatment to prevent a disease or event. OBJECTIVES: To determine the roles of treatment efficacy and population
characteristics in Number Needed to Treat (NNT) calculations within randomized clinical trials of osteoporosis
pharmacological agents. METHODS: Data were collected from publications of three major clinical trials of
pharmacological osteoporosis agents. Trials valuated
were the Multiple Outcomes of Raloxifene Evaluation
(MORE), Fracture Intervention Trial 1&2 (FIT) which
evaluated Alendronate, and Vertebral Efficacy with
Risedronate Therapy (VERT). NNT, mean age, baseline
Bone Mineral Density (BMD) at spine, baseline vertebral
fracture rate, vertebral fracture rates in the placebo and
treatment groups, and relative risk reductions were abstracted. RESULTS: The Number Needed to Treat not
only varied among different agents but also in different
populations where the same treatment was used. The
MORE trial reported two NNTs. The “MORE 1” trial,
where few participants had a prevalent vertebral fracture
(11%), found an NNT of 46 while “MORE 2”, where
most participants had a prevalent vertebral fracture
(88%), found an NNT of 16. FIT1, where all participants
had prevalent vertebral fractures, reported an NNT of 15
while FIT2, no participants had a prevalent fracture, reported an NNT of 60. The VERT trial’s NNT was calculated to be 20 using the above method. VERT had an
80% prevalent vertebral fracture rate. CONCLUSION:
Variation in NNT is due to the different characteristics
like placebo fracture rates as well as treatment efficacy. If
one compares the trials with the most similar placebo
group fracture rates, “MORE2”, FIT1, and VERT, the
Number Needed to Treat is quite similar. Dissimilar population characteristics as opposed to differences in treatment efficacy can be responsible for differences in NNT.
PAM18
PERFORMANCE ASSESSMENT OF TWO
FATIGUE INSTRUMENTS IN AN EARLY
RHEUMATOID ARTHRITIS COHORT
Drabinski A, Kim SS, Williams G, Formica C
Knoll Pharmaceutical Company, Mount Olive, NJ, USA
OBJECTIVE: The importance of assessing fatigue in
rheumatoid arthritis (RA) has been confirmed in numerous studies. Several instruments are available to assess fatigue, however, the psychometric properties of most have
been determined in various populations other than RA
and the instruments tend to measure different aspects of
fatigue. The objective of this study was to assess the performance of two fatigue instruments, one was developed
in the RA population and the other in a nondisease-specific population. METHODS: This study is an ongoing
prospective, multi-center, observational study conducted
to document long-term functional, clinical, humanistic
and economic outcomes, and treatment patterns in patients with new onset rheumatoid arthritis. Two fatigue
instruments were used to assess RA patients: The Functional Assessment of Chronic Illness Therapy-Fatigue
Subscale (FACIT-F), an instrument used primarily in oncology populations, and the Multidimensional Assessment of Fatigue (MAF), developed in an RA population.
MAF measures four dimensions of fatigue (severity, distress, degree of interference in daily activities, and timing). At baseline, patients were requested to complete
both the 16-item, MAF and the 13-item, FACT-F via telephone interview. Using baseline data only, the correlation
between the MAF and the FACIT-F was tested in 133 patients with early RA (signs and symptoms .3 months and
73
Abstracts
,12 months). RESULTS: Patients mean 1 SD age was
55 1 15 years and 77% were female. Mean 1 SD MAF
score was 23.3 1 12.3 with a normal range of 1(no fatigue)–50(fatigue). Mean FACIT-F score was 33.2 1 9.3
with a normal range of 52 (no fatigue)–0 (fatigue). The
aggregate scores for each instrument were highly correlated with a Pearson’s coefficient of 20.81 (p , 0.001).
CONCLUSION: Based on this analysis, it appears that
the FACIT-F has validity for use in the early RA population. However, as follow-up assessments are completed, a
more detailed analysis may reveal additional psychometric properties of the instrument in the early RA population and with disease progression.
improve communication among investigators. Further research is needed to address neglected aspects of measurement—specifically, for mild-to-moderate upper extremity
disorders among workers—and to standardize valid and
reliable instruments.
PAM20
COST-EFFECTIVENESS OF ACETYLCISTEINE
AND DIMETHYLSULPHOXIDE (DMSO) 50% FOR
THE TREATMENT OF PATIENTS WITH REFLEX
SYMPATHIC DYSTROPHY
van Dieten HEM, Perez RSG, Tulder MW, Boers M,
Zuurmond WWA, de Lange JJ, Vondeling H, Boers M
Free University, Amsterdam, Netherlands
PAM19
A REVIEW OF FUNCTIONAL STATUS
MEASURES FOR WORKERS WITH UPPER
EXTREMITY DISORDERS
Salerno DF1, Copley-Merriman C1, Taylor TN1, Shinogle J2,
Schulz RM2
1
Pfizer, Inc. Ann Arbor Laboratories, Ann Arbor, MI, USA;
2
University of South Carolina, Columbia, SC, USA
OBJECTIVES: This review identifies instruments for
measuring functional status among workers with mildto-moderate disorders of the upper extremity. Functional
status measures correlate pain and discomfort to performance, with direct, practical relevance to employers and
workers. While many functional status measures exist for
patients with severe or degenerative illness, few measures
were designed for relatively healthy active workers. In
fact, the impact of mild-to-moderate disorders on the
workforce is largely unknown. The recently released
OSHA Ergonomics Program Standard has given this issue
a new sense of urgency. The intent is to give investigators
a tool for choosing appropriate functional status measures in a specific research or clinical context. METHODS: To identify self-reported functional status instruments for upper extremity disorders among workers, a
Medline literature search was conducted for English-language publications between the years 1966 and 2000.
Keywords included: carpal tunnel syndrome, functional
status, health surveys, musculoskeletal, occupational
health, outcome measures, questionnaire, neck, upper extremity, and worker. In selecting functional status instruments for review, three criteria were used: 1) Relevance
to neck and upper extremity conditions (indicated by
question content); 2) Assessment among workers; and 3)
Relevance to mild-to-moderate disorders (indicated by
level of severity). Parameters of interest were validity,
reliability, and responsiveness to change. RESULTS:
Among 13 functional status instruments reviewed, six
measures were tested among workers, including three
measures relevant for mild-to-moderate disorders: the
Nordic Musculoskeletal Questionnaire, Upper Extremity
Questionnaire, and Neck and Upper Limb Instrument.
CONCLUSIONS: The identification of three functional
status measures should encourage their use in studies, to
OBJECTIVE: The aim of this study was to determine the
cost-effectiveness of Acetylcysteïne and DMSO in the
treatment of patients with reflex sympathic dystrophy
(RSD). METHODS: The study was a prospective, double-dummy, double blind, controlled trial. Patients were
followed for one year. The primary outcome measure
was the Impairment-level Sum Score (ISS). Cost data
were prospectively collected using cost-diaries. Utilities
were determined using the EuroQol. Both cost-effectiveness and cost-utility analyses were performed. Differences in mean direct, indirect and total costs between
groups were estimated with corresponding 95% Confidence Intervals (CI). Also cost-effectiveness and cost-utility ratios with corresponding 95% CI were calculated using bootstrapping techniques. RESULTS: There was a
statistically significant difference in effect (ISS). DMSO
generated more reduction than Acetylcysteïne (diff: 1.82
CI:24.90;21.27). This significant difference appeared
also in the subgroup of patients with warm RSD. The total costs were statistically significant lower in the DMSO
compared to the Acetylcysteïne group (diff: 2866 CI:
666;5179). This significant difference was also found in
the subgroup of patients with warm RSD. The cost-effectiveness and cost-utility ratios showed that DMSO is
dominant over Acetylcysteïne. CONCLUSION: In general, DMSO is the preferred method of treatment for patients with RSD. There are some indications that Acetylcisteïne may be more cost-effective for cold RSD, but this
was found in a small subgroup only and should be confirmed in a larger trial.
PAM21
MANUAL THERAPY IS MORE COST-EFFECTIVE
THAN PHYSICAL THERAPY AND GP CARE FOR
PATIENTS WITH NECK PAIN
Korthals-de Bos IBC, Hoving J, Tulder M, Bouter L
Vrije Universiteit Amsterdam, Amsterdam, Netherlands
OBJECTIVES: This paper presents the results of an economic evaluation in conjunction with a randomized controlled trial to evaluate the cost-effectiveness of manual
therapy, physical therapy and GP care for patients with
74
Abstracts
neck pain. METHODS: Patients were recruited by 42
general practitioners if they had been suffering from neck
pain for at least two weeks. The 183 patients were randomly allocated to manual therapy (spinal mobilization,
n 5 60), physical therapy (exercise therapy and massage,
59), or GP care (counseling, education and medication,
n 5 64). Clinical outcomes included perceived recovery,
pain intensity, functional disability and quality of life
(EuroQol). Direct and indirect costs were measured by
means of cost diaries completed by patients during the intervention period and the 52-week follow up. Differences
in mean costs between groups were evaluated by applying non-parametric bootstrapping techniques. RESULTS:
The total costs of the manual therapy (Euro 447) were
approximately one-third of the costs of the physical therapy (Euro 1,297) and GP care (Euro 1,379). These differences were found to be statistically significant when
bootstrapping was applied. The cost-effectiveness ratios
and the cost-utility ratios showed that manual therapy
was dominant (less costly and more effective), compared
to physical therapy and GP care. The recovery rates
based on perceived recovery after 12 months were 72%
for manual therapy, 63% for physical therapy and 56%
for GP care. With regard to pain intensity and functional
disability, manual therapy was also found to be dominant over time, compared to physical therapy and GP
care, for these clinical outcomes, although the differences
were small. CONCLUSIONS: This study showed that
manual therapy (spinal mobilization) is more effective
and less costly than physical therapy and GP care.
PAM22
STUDYING PREDICTORS OF FRACTURES
AMONG OMNICARE NURSING HOME
RESIDENTS
Oderda GM1, Gause D2, Stuart B3, Erwin G4
1
University of Utah, Salt Lake City, UT, USA; 2Novartis
Pharmaceuticals, Inc, East Hanover, NJ, USA; 3University of
Maryland, Baltimore, MD, USA; 4Omnicare, King of Prussia,
PA, USA
Upon admission to a skilled nursing home facility, information is recorded on a Minimum Data Set (MDS), a
400 item instrument used as the basis of 1) reimbursement for Medicare eligible nursing home stays and 2)
care planning, survey and certification for all nursing
home stays. OBJECTIVE: To predict and evaluate variables related to hip fractures in the nursing home setting.
METHODS: Electronic MDS data was available from
200 homes for variable evaluation times. The first available Assessment Reference Date (A3A), was the baseline
for a regression of time to first fracture. Excluded were 1)
patients with a fracture having an A3A date within the
first 10 days of baseline visit, and 2) patients with ,60
days of follow-up, from first to last A3A visit. Analysis
included a Kaplan-Meier curve summarizing time to fracture, and a Cox Proportional Hazards regression model.
RESULTS: The initial data set included 23,045 patients.
11,465 met the inclusion criteria, and 336 of these had
fractures. Most important variables, based on the coefficient size, associated with increasing risk, were unsteady
gait, deterioration in ADL function, a hospital stay in the
last 90 days, use of full bed rails, and Alzheimer’s disease.
The risk was also higher among females and whites. The
need for full physical help while standing had a lower
risk when compared to need for less support, but this is
likely due to a lowered potential for falling, and increased
vigilance an the part of staff. “Deteriorated” ADL function had almost twice the risk when compared to “improved” ADL. CONCLUSION: Unsteady gait, deterioration in ADL, use of bed rails, presence of Alzheimer’s
disease, and hospital admissions were associated with an
increased risk of hip fracture. A larger sample of fractures
would be more likely to be successful in studying additional relationships.
PAM23
VERTEBRAL FRACTURES AMONG
GLUCOCORTICOID PATIENTS SIGNIFICANTLY
INCREASE MEDICAL CARE COSTS
Meyer JW1, Burge RT2, Steinbuch M2
1
Ingenix Pharmaceutical Services, Eden Prairie, MN, USA;
2
Procter & Gamble Pharmaceuticals, Mason, OH, USA
BACKGROUND: Previous studies have demonstrated
that high levels of glucocorticoid (GC) exposure are associated with increased fracture risk. However, none has
reported potential cost impacts. OBJECTIVE: To estimate the marginal costs from vertebral fractures among
GC patients. METHODS: Subjects 18–64 years old with
different GC exposure levels, with and without fractures,
were selected (n 5 50,191). GC exposure was categorized into three levels: high (31 claims of continuous use
or .9.5 prednisone-equivalent mg/day), low (other GC
use), and no GC use. Fractures, comorbid conditions,
and costs were determined 15 months before and up to
3.5 years after index date. Regression models were used
to estimate the marginal effects of vertebral fractures on
pharmacy costs, medical costs and total costs. The models controlled for age, gender, pre-index date costs, GC
exposure/fracture combinations, and pre-index and new
post-index date comorbid conditions. RESULTS: Vertebral fractures led to significant per-member per-month
(PMPM) cost increases in each GC exposure group. Furthermore, the additional increase in marginal cost from
vertebral fracture on total PMPM costs among high GC
patients versus low GC patients was 83% ($170; p ,
0.001). Differential increases in pharmacy and medical
PMPM costs between high and low GC patients were
151% ($56; p , 0.01) and 68% ($115; p 5 0.014), respectively. CONCLUSIONS: Vertebral fractures were associated with increased PMPM costs, holding constant
patients’ underlying conditions. High GC patients had
greater PMPM increases from vertebral fractures com-
75
Abstracts
pared to those with low or no GC exposure. These findings provide new evidence that vertebral fractures have
substantial increases on treatment costs among GC patients. Also, greater PMPM increases from vertebral fractures among high GC patients versus low GC patients
suggest vertebral fractures increase in severity with GC
exposure. These results also support the need for adjuvant therapy to reduce fracture risk and associated morbidities.
ASTHMA & RESPIRATORY DISORDERS
PAR1
COST OF ASTHMA IN CHILDREN IN
VLADIVOSTOK
Prosekova E1, Geltzer B2, Dercach V1, Bogdanovskiy P2
1
Child’s Municipal Asthma-centre, Vladivostok, Russia;
2
Vladivostok State Medical University, Vladivostok, Russia
OBJECTIVES: Estimation the cost of asthma in children
in Vladivostok. METHODS: In cost of disease we determined direct expenses: pharmacotherapy, hospital, outpatient and emergency expenditures; indirect expenses:
disability pension, temporary invalidity of parents and
quality of child’s life with asthma in Vladivostok during
1995–1998. 645 families with asthmatic children filled in
a questionnarie. RESULTS: Family expenses on pharmacotherapy of asthmatic child during the 1996 year averaged 1520,81 roubles (rb) ($303), in 1998—increased to
2149,45 rb at the expense of basic therapy. In 1996 direct family expenses on asthmatic child was 10,98 6
1,33% of annual income, in 1998—13,70 6 1,46% and
bulk of the expenditures was pharmacotherapy. 1159
children with asthma in 1995 had 618 cases of hospitalization, total duration was 16 058 days. One child with
asthma in 1995 year had 13,64 6 1,0 days of hospitalization, in 1998—8,81 6 0,92. Volume of hospitalization
depended on heaviness of disease. In 1996 among 22 651
emergency cases in city 230 (1,02%) was to asthmatic
children. In 1998 this index was decreased to 109. In
1996 out-patient expenses one asthmatic child was
223,05 6 32,50 rb, in 1998—272,46 6 36,96 rb. In
1997–1998 expenses for allergologist and pulmonologist
are increased. In 1996 among 1028 asthmatic children 37
got disability pension (270 rb in month). Total family expenses on asthmatic child in Vladivostok in 1996 was
4070,84 6 86,70 rb ($810,83 6 10,63), in 1997—
4767,58 6 69,94 rb ($821,99 6 8,46), in 1998—
4203,58 6 46,24 rb. In 1996 on asthmatic child in Vladivostok bulk of the expenditures was hospitalization, in
1998—pharmacotherapy. CONCLUSION: Introduction
in Vladivostok in 1997–1998 the National program of
treatment asthma in children resulted in wide use of basic
therapy, increasing family expenses asthmatic child on
pharmacotherapy and decreasing municipal expenses on
hospitalization, emergency care and indirect losses of
family.
PAR2
USE OF RESPIRATORY ASSIST DEVICES BY
MEDICARE BENEFICIARIES
Silverman BG
Health Care Financing Administration, Baltimore, MD, USA
OBJECTIVES: To identify factors associated with the increase in the use of bilevel positive pressure ventilators
with timed backup in the Medicare population from
1996 through 1999. METHODS: We extracted durable
medical equipment claims for bilevel positive pressure
ventilators with and without timed backup (RAD and
RAD-timed, respectively), continuous positive airway
pressure devices (CPAP) and oxygen supplies (gas, liquid,
concentrator) from the 1994–1999 claims files for 5% of
Medicare beneficiaries, and compared disease prevalence,
oxygen use, and other factors in the different user groups.
RESULTS: Between 1994 and 1998, new use increased
for both RAD and RAD-timed devices, but was significantly greater for the latter. Oxygen use remained relatively stable among CPAP and RAD users, but increased
in RAD-timed users. RAD-timed users were more likely
than RAD users to have claims for oxygen (80% vs.
44%), or diagnoses suggesting chronic lung disease (86%
vs. 35%) in the first year of device use; RAD users were
more likely to have a diagnosis of sleep apnea/other sleep
disorder in the first year of use (73% vs. 14%). CONCLUSIONS: Debate continues over appropriate indications, servicing and reimbursement for respiratory assist
devices, particularly those with timed backup. RAD and
RAD-timed device users differ significantly. The high
prevalence of COPD diagnoses reflects current interest in
the use of these devices in the long-term treatment of this
disorder; other indications suggested in the literature,
such as respiratory support in neuromuscular disorders
or congestive heart failure, appeared rarely. Growth in
the use of the more costly RAD-timed devices among
oxygen users varied by region as well as by year, possibly
reflecting regional differences in coverage, medical practice or marketing. Person-level, longitudinal analysis of
claims data supports the development and implementation of coverage and payment policies, by helping to delineate the demographic and clinical characteristics of
user groups.
PAR3
THE STANDARDIZED ASTHMA-RELATED
QUALITY OF LIFE QUESTIONNAIRE (AQLQ-S):
DOES SOCIOECONOMIC STATUS EFFECT
MEASUREMENTS?
Lynd LD1, Guh D2, Pare P2, Anis A1
1
University of British Columbia, Vancouver, BC, Canada;
2
Centre for Health Evaluation and Outcomes Sciences,
Vancouver, BC, Canada
OBJECTIVE: The objective of this analysis was to evaluate the impact of social class on correlation between the
standardized AQLQ, self-rated asthma severity and con-
76
Abstracts
trol, and patient utility. METHODS: 84 asthmatic subjects completed the AQLQ. Self-rated asthma severity
and control was measured on a 5-point Likert scale and
utilities were measured using a rating scale. SES was defined based on receipt of social assistance. Correlations
between AQLQ scores and each other variable were measured using Spearman’s Rank correlation coefficient (rS).
Differences in rs between social classes (rsdiff) were analyzed using Fisher’s r to z transformation (2-tailed). RESULTS: 38 (45%) patients were receiving social assistance. In the entire sample, there was significant
correlation (p , 0.05) between all AQLQ scores (symptoms, activity, emotion, environment, and global), selfrated asthma severity (rS 5 0.21–0.38), control (rS 5
0.21–0.38), and utilities. Symptom, activity, and global
AQLQ scores were correlated strongly with utility (rS 5
0.53–0.54; p , 0.0001) and moderately with environment and emotion scores (rS 5 0.38;p 5 0.002). However, AQLQ scores were consistently more strongly correlated with self-assessed severity and control in lower
SES patients. Although rS diff ranged from 0.07 to 0.55
(mean 5 0.27), only the most extreme difference was significant (activity score and control 2 rS diff 5 0.55; p 5
0.01). Conversely, rS between all AQLQ scores and utility
were consistently lower (mean rS diff 5 0.18; range 0.9–
0.23) in patients on social assistance, although not significantly. CONCLUSIONS: Correlations between AQLQ
scores and utility were consistently lower in lower SES
subjects, suggesting that AQLQ may be a better measure
of overall health in higher SES patients. Conversely,
AQLQ scores correlated more strongly with self-rated
asthma severity and control in lower SES subjects. Although most differences were not significant despite their
magnitude, this is likely due to a recognized lack of
power of the Fisher’s r to z transformation test.
PAR4
COMPARISON OF TWO QUALITY OF LIFE
INSTRUMENTS IN PATIENTS WITH CHRONIC
OBSTRUCTIVE PULMONARY DISEASE
Aubert RE, Alemayehu B, Feifer R
Merck-Medco Managed Care, Franklin Lakes, NJ, USA
OBJECTIVE: The St. George’s Respiratory Questionnaire (SGRQ) has been validated and widely used in assessing health-related quality (HRQL) of life among
Chronic Obstructive Pulmonary Disease (COPD) patients
but it is complicated to score and can be a burden on respondents when there is limited time. A shorter and more
concise instrument, Airways Questionnaire (AQ30), was
developed to measure Quality of Life (QoL) of patients
with obstructive airways. The AQ20 contains 20 items
on the AQ30. The purpose of this study was to evaluate
and compare the responsiveness of the AQ20 and the
SGRQ questionnaires to measure health-related quality
of life of patients with COPD. STUDY DESIGN: Responses from a survey of 1,000 COPD patients participating in a pilot health management program were included in the analysis. A total of 181 COPD patients
completed the AQ20 and the SGRQ. Spearman’s Rank
correlation was used to determine if the AQ20 and the
SGRQ scores for symptoms, activity and impact and the
overall score were correlated. A high correlation suggests
that both surveys are capturing the same information.
RESULTS: Scores for both AQ20 and the SGRQ were
available for 181 cases. The correlation between the
AQ20 and the symptoms component scores was 0.67
(p , 0.05). Correlation between the AQ20 and the activity component was 0.69 (p , 0.05) and the AQ20 and
the impact component was 0.79 (p , 0.05). The correlation between the AQ20 and the total SGRQ was 0.82
(p , 0.05). CONCLUSION: The AQ20 appears to have
similar properties and responsiveness that are similar to
complex questionnaires such as the SGRQ. Because it is
short and easy to administer the AQ20 may be useful in
settings with limited time for HRQL assessments.
PAR5
DIRECT AND INDIRECT COSTS OF
RESPIRATORY INFECTIONS
Birnbaum HG1, Morley MA1, Greenberg PE1, Cifaldi M2,
Colice GL3
1
Analysis Group/Economics, Cambridge, MA, USA;
2
Independent Consultant, Leawood, KS, USA;
3
Washington Hospital Center, Washington, DC, USA
OBJECTIVES: Morbidity due to respiratory infections
leads to significant adverse societal and economic consequences. This study investigates the extent to which treatment for respiratory infections imposes a financial burden on an employer, and documents variations in employer
payments between specific respiratory infections. METHODS: The data source is a rich administrative claims database for a national, Fortune 100 manufacturer. It includes 1997 medical, pharmaceutical, and disability claims
for employees, spouses, dependents, and retirees (n .
100,000) under age 65. The research sample consists of
individual patients with one or more medical or disability
claims for at least one of eleven respiratory infection condition. Resource utilization is contrasted with a 10 percent random sample of the employer’s overall beneficiary
population. RESULTS: Direct (medical and pharmaceutical) and indirect (disability and sporadic absenteeism)
costs are analyzed. The average per capita annual costs
are: for the entire employer population, $2,368; for all
respiratory infections patients, $4,397; and for respiratory infections employees eligible for disability, $6,838.
Total costs for respiratory infections patients are 1.8
times those for the typical beneficiary. Total costs are
highest for patients with pneumonia ($11,544) and lowest for patients with acute tonsillitis and acute pharyngitis ($2,180). Medical and pharmaceutical treatment account for 65% of total costs for all respiratory infections
employees, while the remaining 35% of costs are attributable to disability and sporadic absenteeism. CONCLUSIONS: Respiratory infections impose a significant financial burden on the employer. Resource utilization by
respiratory infections patients is substantial, not only for
77
Abstracts
the direct treatment of respiratory infections, but also for
the treatment of co-morbid medical conditions of respiratory infections patients. These costs also vary considerably by type of respiratory infection. The study also
shows that respiratory infections impose substantial indirect costs on employers from work loss associated with
these infections.
PAR6
PROPHYLACTIC MEDICATION UTILIZATION
AND HEALTH CARE COSTS IN OLDER ADULTS
WITH CHRONIC PULMONARY AILMENTS
Balkrishnan R1, Christensen D2, Bowton D1
1
Wake Forest University School of Medicine, Winston-Salem,
NC, USA; 2University of North Carolina at Chapel Hill,
Chapel Hill, NC, USA
OBJECTIVES: To examine the relationship between selfreported health status, prophylactic medication utilization, and health care service utilization in older adults
with asthma. METHODS: Design: A prospective longitudinal cohort study was conducted over a 2-year postenrollment period in a population of managed care enrolled
asthmatic older adults. Patients completed a comprehensive health risk screen at time of enrollment in the plan.
Setting: A Medicare HMO in the Southeastern United
States with prescription benefit. Participants: A total of
129 Medicare-HMO enrolled older adults with asthma
using inhaled corticosteroid therapy as prophylaxis were
available for complete follow up. Measurements: We
measured self-reported health perception, falls, lifestyle,
depressive symptomatology, and pre-enrollment health
care service use using a comprehensive risk screen. We
used the medication possession ratio and total annual
health care charges as measures of post-enrollment inhaled corticosteroid and health care service use. RESULTS: After adjusting for the effects of other variables
we found that depressive symptomatology (DS) at baseline and increased comorbidity severity (using the Charlson comorbidity index) were associated with significant
reductions in prophylactic medication possession (27%
with DS, and 6% with unit increase in Charlson’s index,
p , 0.05). Additionally we found, after adjusting for the
effects of baseline health status, a 10% increase in prophylactic medication possession was associated with a
5% decrease in total annual health care charges in this
population (p , 0.05). CONCLUSIONS: There seem to
be strong associations between poor health status at time
of enrollment, decreased post-enrollment prophylactic
medication use and increased post-enrollment health care
service utilization in older adults with asthma.
PAR7
VALIDATION OF A MODEL OF SEVERITY OF
ILLNESS IN CHRONIC RESPIRATORY DISEASE
Sullivan P, Nichol M
University of Southern California, Los Angeles, CA, USA
OBJECTIVES: The purpose of this study is to adapt a
previously validated questionnaire to a pharmacy claims
database and examine its construct validity in measuring
severity of illness in chronic respiratory disease (CRD).
METHODS: The authors modified an asthma severity of
illness questionnaire (13 items, total score range 0–28)
based upon symptoms, medication use, hospitalization
information and intubation history to a scale that is more
conducive to retrospective data analysis. The adapted
CRD scale (CRDS) was based on pharmacy claims data
and hospitalization history (11 items, total score range 0–
18). The CRDS was compared to utility as measured by a
general health visual analogue scale and quality of life
(QoL) as measured by the Physical Component Scale
(PCS), Physical Function (PF) and General Health (GH)
domains of the SF-36. Panel data analysis was performed
on pharmacy claims and survey data from the Kaiser Permanente/USC Consultation Study. QoL and utility were
regressed on the CRDS, along with covariates. A non-respiratory chronic disease score was used to control for
chronic disease while avoiding significant multicollinearity. The analysis was limited to 126 patients with CRD
followed over 3 years. The Hausman specification test
was used to determine the appropriateness of the random-effects model formulation. RESULTS: The Hausman specification test suggested the use of the fixedeffects formulation for utility (m 5 8.2, p . m 5 0.0420).
The CRDS was negative and significant (21.79, p ,
0.0286). The Hausman test suggested a fixed-effects formulation for PCS (p . m 5 0.0333) and random-effects
for GH (p . m 5 0.0628) and PF (p . m 5 0.1495). The
CRDS was significant and negative for all three QoL domains: (PCS: 20.68, p , 0.0085; PF: 20.97, p,0.0130;
GH: 20.065, p , 0.0077). CONCLUSION: The adaptation of the asthma severity of illness questionnaire appears to be a valid measure of chronic respiratory disease
in a pharmacy claims database.
PAR8
A COST-EFFECTIVENESS ANALYSIS
COMPARING LEVALBUTEROL AND ALBUTEROL
IN THE TREATMENT OF MODERATE TO
SEVERE ASTHMA
Carter CT, McGee MD
Northeastern University, Boston, MA, USA
OBJECTIVES: Adult patients with moderate to severe
asthma could potentially avoid utilizing excessive health
care resources by reducing the need for management of
severe adverse effects associated with albuterol. This
modeled analysis was performed from a managed care
payer perspective to determine if nebulized levalbuterol is
associated with a lower cost per decreased use of rescue
inhaler, as compared with nebulized racemic albuterol
over a four week period. METHODS: Cost data was obtained from a public hospital, an HMO, and the Red
Book. Costs were measured in 2000 US dollars. Probabilities were derived from a clinical controlled trial and the
National Center for Health Statistics. The primary out-
78
Abstracts
come of interest was cost per decreased puff of rescue
medication per twenty eight days. RESULTS: Levalbuterol (1.25 mg) decreased puffs by 7.5 over twenty
eight days. However, the average expected costs for treatment with racemic albuterol (2.5 mg) is $116.94/month,
$171.46/month for levalbuterol (0.63 mg) and $182.33/
month for levalbuterol (1.25 mg). Cost-effectiveness ratios were $8.35, $24.50, and $8.80 for albuterol (2.5
mg), levalbuterol (0.63 mg) and levalbuterol (1.25 mg),
respectively. Results were unchanged after sensitivity
analyses. CONCLUSIONS: Levalbuterol (1.25 mg) was
beneficial over racemic albuterol (2.5 mg) in decreasing
puffs of rescue medication over twenty eight days, but at
an additional cost. An incremental cost-effectiveness analysis demonstrated it costs $9.73 for each additional decreased puff per day. The decision-maker needs to evaluate whether the additional effect is worth the added cost.
PAR9
VALIDATION OF A RATING INSTRUMENT
ASSESSING THE INHALATION SKILLS OF
CHILDREN WITH ASTHMA
Pradel FG, Weiss S, Tsoukleris M, Bollinger MB, Fahlman C
University of Maryland, Baltimore, MD, USA
OBJECTIVES: Despite their complexity appropriate use of
asthma inhaled medicines is crucial to ensure optimal drug
delivery to the airways. We describe the validation of an
instrument to assess inhalation skills in children. METHODS: The instrument includes a breakdown of the steps
necessary for appropriate inhalation. We videotaped 25
children taking a placebo inhaler (metered dose inhaler
(MDI), MDI with AeroChamber® (MDI-AE®), and Diskus®). A gold standard (GS) was developed by agreement
of two asthma experts watching the videotaped demonstrations. Twenty-one raters scored the randomly ordered
demonstrations twice within a 2-week interval (sessions 1
and 2). Intra-class correlation coefficients (ICCs) were calculated to assess validity (comparing GS to raters’ scores),
interrater reliability, and test-retest reliability for each step
of the inhalation. RESULTS: ICCs varied considerably by
both, the device and the step. In session 1, a small proportion of raters agreed with the GS on whether patients actuated the MDI and inhaled simultaneously (9.5%, ICCs
0.62 to 0.74) and whether patients hold their breath
(19%, ICCs 0.62 to 1.00). A better agreement was observed for the MDI-AE® where actuation (43%, ICCs
0.43 to 0.56) and inhalation (57%, ICCs 0.43) are two
separate steps. The best interrater agreement was on the
shaking of the MDI (ICC 5 0.83) and the MDI-AE®
(ICC 5 0.74). Agreement for the Diskus® was poor for
all steps. Results for session 2 were similar. The best intra-rater agreement was for the Diskus® (ICCs 5 1 for 5
steps), though only a small proportion of raters agreed on
these steps (5% to 21%). CONCLUSIONS: There was
large variability within and between raters’ scores. Some
steps were better assessed than others. These results suggest that in addition to a detailed instrument, training of
raters is crucial to obtain a valid assessment of the childrens’ inhalation technique.
PAR10
IMPLEMENTING RASCH ANALYSIS IN
PSYCHOMETRIC EVALUATION OF
PATIENT-PHYSICIAN INTERACTION SCALE
Dalal M, Smith E, Lambert B, Olopade C, Crawford S
University of Illinois at Chicago, Chicago, IL, USA
OBJECTIVES: The study involved validating the scaling
properties of patient-physician interaction scale in a pulmonary specialty clinic using a clinic-specific scale
through the implementation of Rasch analysis. DATA:
Cross-sectional data from 65 adult asthma patients at the
University of Illinois Asthma clinic was used. Physician
interaction was measured using eight Likert-type items.
Patients responded from “strongly disagree” (1) to
“strongly agree” (4). METHODS: Scaling properties
were assessed by investigating its fit to a Partial Credit
Rasch Rating scale model that enabled item-by-item analysis. Winsteps® was used for analysis. Model determined
scale robustness in terms of unidimensionality, additivity
and functioning of the rating scale. RESULTS: Analyses
found person separation index of 1.86 with reliability of
0.77. The mean patient measure (0.69 logit) was greater
than mean difficulty of items (0.00 logit) implying patient
ability was greater than item difficulty. On average, ordering of items found item ‘physician instructed patients
on home steroid treatment’ (STETX) had the highest
logit measure of 0.69, however it misfitted the model.
Item ‘physician asked about smoking habits’ (ASKSMOK)
had lowest measure of 20.70 logits. Fit statistics revealed
high infit and outfit mean square (MNSQ) values (.1.4) for
16 patients. Seven items had MNSQ values within desired
range of 0.6–1.4. CONCLUSIONS: Items exhibited adequate reliability in separating persons, but they displayed
ceiling and floor effects in measurement. Some evidence of
construct validity was established since only one item misfitted the model. Item STETX was the most difficult to endorse (higher on construct), since it might not be applicable
to all, but severe asthmatics. Item ‘ASKSMOK’ was easiest
to endorse, probably because it is a standard asthma care
question. Nevertheless, misfitting persons implied inappropriate measurement of some patient attitudes. Thus, some
plausibility in the unidimensionality and validity of the scale
existed, and it exhibited moderate scaling properties.
PAR11
THE LONG-TERM SOCIETAL ECONOMIC AND
HUMANISTIC BENEFITS OF TREATING ACUTE
EXACERBATIONS OF CHRONIC BRONCHITIS
(AECB) WITH GEMIFLOXACIN VERSUS
CLARITHROMYCIN
Halpern M1, Kirsch JM2, Palmer C3, Zodet M3, Wilson R4
1
Charles River Associates, Washington, DC, USA;
2
GlaxoSmithKline, Harlow, UK; 3MEDTAP International,
Bethesda, MD, USA; 4Royal Brompton Hospital, London, UK
79
Abstracts
OBJECTIVES: To prospectively evaluate the long-term
societal economic and humanistic benefits of acute treatment of AECB with gemifloxacin compared with
clarithromycin. METHODS: Patients with AECB were
randomized to receive acute, double-blind, doubledummy treatment with either gemifloxacin 320 mg o.d.
for 5 days or clarithromycin 500 mg b.d. for 7 days. Patients in US (n 5 386) and Canadian centers (n 5 52)
were followed for 26 weeks from treatment initiation and
the following assessments were made: AECB recurrence
requiring antibiotic treatment; respiratory tract infectionrelated: health care resource utilization, time off and performance at work and usual activities; and health-related
quality of life using the St George’s Respiratory Questionnaire (SGRQ). RESULTS: In full sample analysis, significantly more patients who received gemifloxacin remained recurrence free after 26 weeks (73.8% [158/214]
vs. 63.8% [143/224]; p 5 0.024) and were hospitalized
less (2.34% [5/214] vs. 6.25% [14/224]; p 5 0.059).
Cost-effectiveness analysis indicated average direct and
indirect cost savings of $329 per patient for gemifloxacin
vs. clarithromycin. Ninety-five percent confidence intervals for bootstrapped incremental cost-effectiveness ratios ranged from a cost saving of $14,175 to a cost of
$8,888 per recurrence-free patient considering all costs.
There was an 82.5% probability of gemifloxacin being
both cost saving and more effective than clarithromycin
from the societal perspective. A greater improvement in
total weighted SGRQ score (lower scores being better),
adjusted for baseline, was observed for gemifloxacin vs.
clarithromycin at 4, 12 and 26 weeks after initiation of
acute treatment (43.3 vs. 44.6 [p 5 0.38], 39.4 vs. 41.8
[p 5 0.20] and 37.7 vs. 41.0 [p 5 0.09], respectively).
There was significantly less impact on performance at
work (p 5 0.01) and usual activities (p 5 0.03) at 26
weeks, due to bronchitis, among patients who received
gemifloxacin. CONCLUSIONS: Gemifloxacin was very
cost-effective from the societal perspective and improved
long-term patient outcomes compared with clarithromycin for the treatment of AECB.
PAR12
PROSPECTIVE USE OF WEB BASED
TECHNOLOGY TO EVALUATE HEALTH
OUTCOMES IN A LARGE COHORT OF SEVERE
OR DIFFICULT TO TREAT ASTHMATICS
Dolan CM1, Fisher KA1, Johnson C1, Fraher KE1, Rothermich
EA2, Fine JT1, Weiss ST3, Wenzel S4
1
Genentech, Inc, South San Francisco, CA, USA; 2The Lewin
Group, San Francisco, CA, USA; 3Harvard University, Boston,
MA, USA; 4National Jewish Medical and Research Center,
Denver, CO, USA
Severe and difficult to treat asthma patients represent a
small percentage of all asthmatics, yet they account for
much of the morbidity, mortality, and cost of the disease.
The factors that make this group of asthmatics difficult
to manage are poorly understood. OBJECTIVE: To es-
tablish a cohort of severe or difficult to treat asthmatics
to examine the relationships between features of asthma,
treatments and health outcomes using the Internet.
METHODS: This study, “An Observational Study of
The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regiments (TENOR),” is designed
to follow at least 5000 subjects for 3 years. Subjects 6
years or older with a diagnosis of asthma and considered
by their physician to have severe or difficult to treat
asthma are eligible for enrollment. Physicians and coordinators will conduct biannual visits to collect data including: health care utilization, days of work or school
missed, the asthma therapy assessment questionnaire
(ATAQ), asthma-related quality of life (AQLQ), medications, IgE level, and lung function. Data will be entered
onto a secure website. RESULTS: Subjects are being enrolled into the cohort from over 300 US pulmonologists
and allergists in managed care organizations, community
practices, and academic centers. All study sites have Internet access. The TENOR website was built using WebCollectSM services and PhaseForward’s InFormTM application. Built-in edit checks and an automatic electronic
audit trail ensure data accuracy and completeness. This
technology eliminates the need for paper case report
forms and improves data cleaning efficiency. CONCLUSIONS: TENOR provides a unique opportunity to examine factors related to poor health outcomes in this understudied patient population. The Internet allows real time
access to data and facilitates dissemination of data to investigators and the asthma community. TENOR may
serve as a model for future large epidemiologic or clinical
studies using web-based technology.
PAR13
HYPOTHETICAL VERSUS REAL WILLINGNESS
TO PAY IN THE HEALTH CARE SECTOR:
RESULTS FROM A FIELD EXPERIMENT
Blumenschein K1, Johannesson M2, Yokoyama K3, Freeman P4
1
University of Kentucky College of Pharmacy and Martin School
of Public Policy and Administration, Lexington, KY USA;
2
Stockholm School of Economics, Stockholm, Sweden; 3Scott &
White Memorial Hospital Department of Pharmacy, Temple,
TX, USA; 4American Pharmacy Services Corporation, Frankfort,
KY, USA
OBJECTIVE: Despite increased use in the health care
sector (HCS), the contingent valuation (CV) method remains controversial. The nucleus of the controversy is the
extent to which hypothetical choices in the CV method
mimic real economic choices. Correspondence between
hypothetical and real willingness to pay (WTP) has been
studied for private and environmental goods. These experiments demonstrate that dichotomous choice (DC)
CV questions lead to hypothetical bias (overestimation of
real WTP). Hypothetical bias has not been assessed in the
HCS. We conducted an experiment directly comparing
responses to a DC CV question with real purchase decisions using a pharmacist provided asthma management
80
Abstracts
service as the item being valued. We examined whether
DC CV questions lead to hypothetical bias for this good,
and we tested whether “definitely sure” hypothetical yes
responses, as identified in a follow-up question, correspond to real yes responses. METHODS: 172 subjects
with asthma were recruited from 10 Kentucky community pharmacies. Subjects received either a DC CV question or were given the opportunity to actually purchase
the service. Three different prices were used: $15, $40,
and $80. RESULTS: In the hypothetical group 38% of
subjects stated they would purchase the good at the given
price, but only 12% of subjects in the real group purchased the good (p 5 0.000). We cannot, however, reject
the null hypothesis that “definitely sure” hypothetical yes
responses correspond to real yes responses. CONCLUSIONS: The DC CV method overestimates WTP in the
HCS, but it may be possible to correct for this by sorting
out “definitely sure” yes responses.
PAR14
ASSESSMENT OF THE RELATIONSHIP
BETWEEN DISEASE SEVERITY, QUALITY OF
LIFE AND WILLINGNESS TO PAY IN ASTHMA
Zillich A1, Blumenschein K1, Johannesson M2, Freeman P3
1
University of Kentucky College of Pharmacy, Lexington, KY
USA; 2Stockholm School of Economics, Stockholm, Sweden;
3
American Pharmacy Services Corporation, Frankfort, KY, USA
OBJECTIVE: The primary objective was to evaluate the
relationship between willingness to pay (WTP), quality of
life (QOL), and disease severity measures in asthma patients. The hypothesis studied was that asthma patients
with more severe disease, as measured objectively via
forced expiratory volume percent predicted (FEV1%),
are willing to pay more for a hypothetical cure from
asthma than those with less severe disease. METHODS:
One-hundred asthmatic patients were recruited from
community pharmacies in Kentucky for 30 minute faceto-face interviews. Spirometry was used to assess objective disease severity while a multiple choice question
assessed subjective disease severity. The Short Form 36
(SF-36) and Asthma Technology of Patient Experience
(Asthma TyPE) measured QOL. WTP was obtained via a
dichotomous choice contingent valuation question. RESULTS: WTP was significantly related to both objective
disease severity (p 5 0.02) and subjectively assessed disease severity (p 5 0.01). For objective disease severity the
mean monthly WTP was $90 for mild asthma, $131 for
moderate asthma and $331 for severe asthma; and for
subjective disease severity the mean monthly WTP was
$48 for mild asthma, $166 for moderate asthma and
$241 for severe asthma. A majority of the QOL measures
were correlated with WTP. CONCLUSIONS: The results
suggest that the WTP for a cure from asthma is related to
both objective and subjective disease severity.
PAR15
COMPARISON OF HEALTH CARE RESOURCE
UTILIZATION OF COPD PATIENTS ON
CILOMILAST, 15 MG BID VERSUS PLACEBO
Bagchi I, Bakst A, Edelson J, Amit O
GlaxoSmithKline, Collegeville, PA, USA
OBJECTIVES: Cilomilast is a potent and selective phosphodiesterase type 4 (PDE4) inhibitor currently under
development for the treatment of chronic obstructive pulmonary disease (COPD) and asthma. METHODS: COPDrelated health care resource utilization including physician visits, emergency room visits, hospitalizations and
medication use were prospectively collected in a 6 month
randomized, double-blind, placebo controlled, parallel
group study of patients on cilomilast, 15 mg bid (n 5
431) versus patients on placebo (n 5 216). Methods of
analysis included descriptive statistics, Kaplan-Meier estimates and Poisson regression. RESULTS: In the year
prior to the study, COPD-related health care resource
utilization was comparable between patients eventually
randomized to cilomilast and those randomized to placebo; the majority of all patients had no or one emergency room visit or hospitalziation. During the entire 24week study period, the cumulative incidence of health
care utilization was significantly lower in the cilomilast
group than the placebo group in terms of all utilization
(11.0% vs. 21.1%, p 5 0.004); including physician visits
(11.9% vs. 23.1%, p 5 0.002), emergency room visits
(0.6% vs. 4.5%, p 5 0.004) and hospitalization (0.5%
vs. 3.4%, p 5 0.021). The relative utilization rates per
patient-month of follow-up for each of the utilization
types were lower in the cilomilast group than in the placebo group. Treatment with cilomilast resulted in reduction of all utilization by 51% (C.I.: 31%, 65%), physician visits by 41% (C.I.: 15%, 59%). ER visits and
hospitalizations were also significantly reduced. CONCLUSIONS: In this study, cilomilast was associated with
significantly less COPD-related health care resource utilization, including hospitalizations, emergency room visits
and physician visits than placebo.
PAR16
COST OF TREATING ASTHMA IN A MANAGED
CARE POPULATION
Armstrong EP, Malone DC, Rehfeld RA
University of Arizona, Tucson, AZ, USA
OBJECTIVES: Asthma is a common medical condition
that is increasing in prevalence. The purpose of this study
was to examine costs associated with treating asthma patients within a managed care organization (MCO).
METHODS: Data for this study were obtained from a
managed care organization located in the Western region
of the US. Patients were eligible for inclusion if they met
one of the following criteria: a diagnosis of asthma (ICD9 code of 493.xx); two or more prescriptions used to
control asthma (e.g., inhaled corticosteroid, leukotriene
81
Abstracts
modifier, mast cell stabilizer, xanthine derivative, or a
long acting beta agonist); or one prescription for an
asthma controller and one or more prescriptions for a
short acting beta-agonist. Patients also had to be full year
members of the MCO. Patients with a diagnosis of
chronic obstructive lung disease were excluded. RESULTS: A total of 351,140 persons were continuously
enrolled in the MCO during 1999. A total of 8,051 persons were identified as having asthma (2.3% of the MCO
enrollees), with 43% being male. Persons under 18 years
of age comprised 28.8% of persons with asthma. Median
pharmacy costs were $472, median medical costs were
$483, and median total health care costs were $1199 for
this population. CONCLUSIONS: Asthma appears to affect a significant number of enrollees within this MCO,
with persons less than 18 years of age representing almost 29% of the treated patients. Health care costs in
persons with asthma appears to be substantial.
PAR17
PATIENT SATISFACTION WITH
NON-SEDATING ANTIHISTAMINES
Sahu S, Millard R
Harris Interactive, Rochester, NY, USA
OBJECTIVES: The objective of this study is to determine
the factors that influence satisfaction with non-sedating
antihistamines (NSA) among people who suffer from allergies/hay fever. METHODS: An online survey was conducted in September, 2000 on respondents who had been
told by a health care professional that they suffer from allergies/hay fever and were recently (within 12 months)
prescribed one of three NSAs to relieve their symptoms.
The sample was weighted to ensure the generalizability of
the results. Satisfaction was measured according to the
medication’s ability to relieve side effects and control
symptoms from allergies/hay fever. A total of 4,081 respondents were included in the analysis. RESULTS: (1)
The mean satisfaction score for the first time users (defined as never having taken any medication for allergies/
hay fever) was higher than those who had used some
medication in the past (p , .01) (2) Of the respondents
who had a specific choice of medication in mind, those
who received their first choice medication had a higher
satisfaction score than those who did not (p , .01). (3)
The respondents who discussed their medication jointly
with their physician had a higher satisfaction score than
those whose doctor chose their medication for them (p ,
.01). (4) Respondents who were not taking any over-thecounter (OTC) medications reported higher satisfaction
scores than those who supplemented their NSA with
over-the-counter medications (p , .01). (5) Finally, respondents who had never requested a prescription after
seeing an advertisement for any medication had a higher
satisfaction score than those who did. (p , .01) CONCLUSIONS: The data provides evidence to suggest that
past knowledge or experience with NSAs, patient preference, and patient involvement in the treatment decision-
making process all play a role in determining satisfaction
with NSAs. Furthermore, both over-the-counter medication usage and direct-to-consumer advertising are likely
to influence how satisfied people are with their NSA.
PAR18
COSTS OF TREATING COPD IN ITALY:
A BURDEN OF ILLNESS STUDY
Bonzanini A, Avossa R, Scipioni E, Gianfrate F
GlaxoSmithKline, Verona, Italy
INTRODUCTION: Despite the high prevalence, morbidity and mortality of COPD, remarkably little is
known about its impact on health care costs and utilization of services. Information about health care utilization
and costs among patients with Chronic Obstructive Pulmonary Disease (COPD) is needed to improve care and
for appropriate allocation of resources. OBJECTIVE:
The purpose of this study was to quantify the burden of
illness in Italy, in terms of both medical consumption and
lost productivity associated with COPD. METHODS:
Design: In 1998 an epidemiological study was conducted
in Italy. Retrospectively, from a community perspective,
we quantified COPD’s costs related both with health care
consumption and lost of productivity and/or school days.
Main Outcomes Measures: The main goal of the present
study was to evaluate economic outcomes in a cohort of
355,000 patients with current diagnosis of COPD. RESULTS: As reported in previous studies, prevalence rate
for COPD in Italy is about 4,6% (2,637,000 subjects).
Among all COPD patients, 42,5% suffers from mild disease while 56,7% is affected by moderate-severe COPD,
on the basis of Flow Expiratory Value (FEV1) % of predicted criteria. The total cost of COPD we have quoted is
the sum of direct and indirect costs: it is worth US$18 billion, equal to US$6,843 average/patient/year. We have
not included intangible costs because they cannot be
quantified correctly as yet. CONCLUSIONS: COPD is
associated with significant both direct and indirect costs.
Previous studies reported that prevalence figures for
COPD based on recorded diagnoses are underestimated.
Notwithstanding, data from our study suggest that when
patients seek medical advice they were correctly diagnosed and treated. Education of patients will allow them
to take control of their disease and of costs related to
COPD.
PAR19
IMPACT OF THE ADDITION OF SALMETEROL
TO THE TREATMENT OF ASTHMA PATIENTS IN
A MEDICAID FEE-FOR-SERVICE POPULATION
Klaurens LM, Dodd MA, Gupchup GV, Kelly HW, Hollarbush J
The University of New Mexico, Albuquerque, NM, USA
OBJECTIVE: Salmeterol, a long acting beta-2 agonist,
improves lung function and symptom control with twice
daily dosing in moderate-to-severe asthmatics. This in-
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Abstracts
vestigation was performed to determine whether the introduction of salmeterol to moderate-to-severe asthmatics in a Medicaid fee-for-service population reduces the
overall asthma related health care expenditures. METHODS: The New Mexico Medicaid fee-for-service claims
database was searched between 1/1/94 and 12/31/98 to
identify both a salmeterol and control group. The inclusion criteria for the salmeterol group were: patients receiving salmeterol, who were 66% compliant with salmeterol therapy, had a diagnosis of asthma (ICD-9: 493.0,
493.1, 493.9), were 13 years of age or older, did not have
a diagnosis of COPD (ICD-9: 496.x) and must have been
Medicaid eligible for 2 consecutive years. In addition to
the above criteria for the salmeterol group, to be included
in the control group, patients must not have received salmeterol between 4/12/95 and 4/12/97 (around the median start date of salmeterol, 4/12/96), and in order to
match for severity must have received other asthma
maintenance medications. Patients meeting these criteria
for the salmeterol and control groups were 57 and 58, respectively. ANCOVA were performed to compare costs
between the two groups controlling for baseline costs.
Average per patient benefit-cost ratios were calculated by
dividing total cost savings by increase in medication costs
for both groups. RESULTS: No significant difference existed among average per patient total health care expenditures between the salmeterol and control groups ($2266
and $1955, respectively). Interestingly, in the salmeterol
group, total medication costs increased significantly (t 5
27.895, p 5 0.000) while total health care costs decreased, although not significantly. The average per patient benefit-cost ratio for the salmeterol group was
0.061 ($41/$668). CONCLUSION: Introduction of salmeterol in the New Mexico Medicaid fee-for-service population did not significantly reduce total asthma related
health care costs.
PAR20
EFFECTIVENESS OF COMPLIANCE ON HEALTH
CARE RESOURCE USE IN ASTHMA PATIENTS
TREATED WITH MONTELUKAST VS. INHALED
CORTICOSTEROIDS
Kutikova L1, Bowman L2, Morris L3
1
University of Tennessee Health Science Center, Memphis, TN,
USA; 2Eli Lilly and Company, Indianapolis, IN, USA; 3IMS Health,
Plymouth Meeting, PA, USA
OBJECTIVES: To compare effectiveness of compliance
on health care utilization between montelukast and standard therapy (inhaled corticosteroid—ICS) patients. Indicators for health care resource use include drug use, ER
visits, and total charges. METHODS: Retrospective cohort analysis using LifeLink employer claims database of
1.6 million Americans. ANOVA models examined health
care resource use of montelukast and ICS patients in six
months prior (pre-period) and six month following (postperiod) new treatment of interest adjusting for age, gender, region, plan type, and prescriber specialty. RE-
SULTS: The study cohort consisted of 3,775 montelukast
patients and 7,331 ICS patients. Average compliance, defined as medication possession ratio, of montelukast patients (63%) was significantly greater (p 5 0.001) than
that of ICS patients (31%). Montelukast patients were
more likely to receive short-acting beta-agonist therapy in
pre-period than ICS patients (p 5 0.001), which suggests
more severe patients in montelukast group, but there was
no significant difference between two groups in postperiod (p 5 0.854). Among patients with concomitant
methylxanthine therapy, montelukast patients had more
days of methylxanthine therapy than ICS in pre-period
(p , 0.001), but there was no significant difference in
post-period (p 5 0.130). For patients with at least one
asthma-related ER visit, montelukast patients had more
ER visits per patient than ICS patients in pre-period (p 5
0.010), but no significant difference was noted in postperiod (p 5 0.325). Average total charges for montelukast
were higher than for ICS patients in both pre-period (p ,
0.001) and post-period (p , 0.001). CONCLUSIONS:
Compliance with montelukast treatment was markedly
better than with ICS therapy. Initially, montelukast patients were higher resource users than ICS patients. During six months treatment with montelukast, some health
care resources used decreased to the level of ICS patients.
Results suggest that markedly improved compliance of
montelukast decreased asthma-related health care utilization, however total charges for montelukast patients remained higher than for ICS patients.
PAR21
LEVALBUTEROL USE IS ASSOCIATED WITH
DECREASED HEALTH CARE COSTS IN
PATIENTS WITH MORE SEVERE ASTHMA
Huse D1, McLoney A2, Yeager B3, Cerasoli F3
1
PharMetrics, Inc, Watertown, MA, USA; 2NDC Health
Information Services, Phoenix, AZ, USA; 3Sepracor, Inc,
Marlborough, MA, USA
Preliminary pharmacoeconomic analyses suggest that
levalbuterol (LEV) therapy is associated with decreased
outpatient asthma health care costs. OBJECTIVE: Examine treatment costs in asthma patients stratified by the
number of prescribed controller medications (CM), an index of asthma severity. METHODS: Claims data on patients prescribed LEV and RAC were obtained from the
PharMetrics Integrated Outcomes Database. Age- and
sex-matched samples of patients initiating therapy with
LEV or RAC (no prescriptions for either agent in prior 6
months) were selected and their asthma-related charges
were assessed over 6 months following the initial prescription. RESULTS: 544 LEV-treated patients were
identified and matched to 544 RAC-treated patients.
62% of RAC patients previously received no CM, 20%
had 1 CM, and 18% had .1 CM. Following RAC treatment 30% had 1 CM and 29% had .1 CM. Use of leukotriene modifiers increased from 8% to 14% and corticosteroid use increased from 33% to 46%. Although
83
Abstracts
LEV patients previously received more CM (41% no
CM; 24% 1 CM; 34% .1 CM), after treatment the percent with .1 CM declined to 28%. Their leukotriene
modifier use increased from 22% to 25% while long-acting bronchodilator use decreased from 13% to 10%. In
patients without prior CM, mean charges declined by
similar amounts in both groups (LEV: $360, RAC: $306)
following treatment. In patients with 1 CM, LEV was associated with a $116 reduction despite a $121 increase in
pharmacy charges while RAC was associated with a $22
decrease. In patients with .1 CM, LEV was associated
with a $435 reduction in mean charges while RAC was
associated with a $311 increase. CONCLUSIONS: Asthmatic patients treated with LEV required no additional
CM and some patients reduced the number of CM. Cost
reductions associated with LEV increased with severity.
PAR22
IMPACT OF LEVALBUTEROL VERSUS RACEMIC
ALBUTEROL ON OUTPATIENT ASTHMA
CARE CHARGES
Huse D1, McLoney A2, Yeager B3, Cerasoli F3
1
PharMetrics, Inc, Watertown, MA, USA; 2NDC Health
Information Services, Phoenix, AZ, USA; 3Sepracor, Inc,
Marlborough, MA, USA
Preliminary evidence suggests that levalbuterol (LEV),
the therapeutically active isomer of albuterol, can improve clinical outcomes while reducing health care costs
compared to racemic albuterol (RAC). OBJECTIVE: Explore the impact of LEV versus RAC on resource utilization, co-medication use, and cost of therapy in asthmatics. METHODS: Claims data on patients prescribed LEV
and RAC were obtained from the PharMetrics Integrated
Outcomes Database. Age- and sex-matched samples of
patients initiating therapy with LEV or RAC (no prescriptions for either agent in prior 6 months) were selected and their asthma-related charges were assessed
over 6 months following the initial prescription. RESULTS: 544 LEV-treated patients were identified and
matched to 544 RAC-treated patients. 70% of all patients were ,12 years of age. 32% of RAC patients and
59% of LEV patients received asthma controller medication during the prior 6 months. Mean asthma-related
(pharmacy and medical) charges during the prior 6
months were $872 versus $587 in the LEV and RAC
groups respectively. During the 6 months follow-up period, controller medication use increased among RAC patients to 59%, while use among LEV patients remained
unchanged. Overall mean charges decreased by $298 for
LEV and $61 for RAC. In patients receiving concomitant
controller medications, LEV was associated with a $247
decline in charges versus a $116 increase for RAC.
Among patients treated in primary care (pediatricians,
family practitioners, and internists), the reduction in
mean charges was $262 for LEV, while RAC was associated with a $180 increase. CONCLUSIONS: 1) LEV was
prescribed to patients who were “sicker” than those pre-
scribed RAC; 2) Patients treated with RAC, but not LEV,
tended to require additional controller medications; 3)
LEV was associated with greater reduction in total cost
compared to RAC, which in “sicker” and primary care
patients was associated with increased cost.
PAR23
DETERMINANTS OF INAPPROPRIATE
ANTIBIOTIC PRESCRIBING
Willis MK
NJ Carpenters Funds, Edison, NJ, USA
BACKGROUND: Previous studies have shown that antibiotics are prescribed for nasopharyngitis, upper respiratory infection, and acute bronchitis approximately 40–
80% of the time. Because these conditions tend to be viral in nature, the efficacy of treating with antibiotics is
questionable at best and potentially dangerous at worst.
OBJECTIVE: The purpose of this study is to determine
those physician characteristics that are associated with
inappropriate antibiotic prescribing. METHOD: This
study reviewed the antibiotic prescribing patterns of 138
physicians treating members of the NJ Carpenters Funds
from 1997–1998 for upper respiratory infection and
acute bronchitis. Using logistic regression analysis, the
rate of antibiotic prescribing was used to evaluate the potential relationship with the following physician characteristics: specialty, year of graduation from medical
school, gender, ABMS (American Board of Medical Specialties Status), type of practice (group versus solo), and
foreign versus domestic medical graduate status. RESULTS: The results indicate that there were significantly
disparate rates of prescribing by physician specialty, as
compared to pediatricians: family practitioners (OR
3.296 95% CI 2.459–4.419), internal medicine (OR 1.67
95% CI 1.145–2.436) and other (primarily general practice) (OR 1.421 95% CI 1.008–2.003). In the pediatric
subgroup, there was a definite trend in inappropriate antibiotic prescribing according to the year of graduation
from medical school (1950s: OR 3.779 95% CI 1.774–
8.051; 1960s: OR 3.088 95% CI 1.994–4.783, and
1970s: OR 1.713 95% CI 1.123–2.614). CONCLUSION: Although some of these findings are significant,
the majority of physician characteristics reviewed were
not significantly related to inappropriate antibiotic prescribing. The findings may be indicative of the fact that
this problem is widespread and multi-faceted. This study
suggests that there is a definite need for education of both
patients and physicians to change long held beliefs that
antibiotics are a cure-all for all types of infections, and
that there are no negative consequences to inappropriate
antibiotic use.
84
Abstracts
CANCER
PCN1
CATEGORIZATION OF RISK OF PROSTATE
CANCER: PILOT TEST OF CLINICAL OUTCOMES
AND RISK PERCEPTIONS
Bruner DW, Parlanti AA, Ross E, Raysor S, Mazzoni SE,
Hanks GE
Fox Chase Cancer Center, Philadelphia, PA, USA
OBJECTIVES: To define clinically useful categories for
prostate cancer (PC) risk and associated outcomes.
Translating relative risk (RR) and cumulative risk (CR)
into risk categories is important if studies of PC epidemiology and genetic predisposition are to have clinical utility for education, counseling and decision-making. Individual risk perceptions compared to clinical risk are
important for the study of behavioral outcomes. METHODS: Risk categories were determined by an extensive
review of the literature. Using RR and CR for specific
risk factors, 4 categories were defined from low to very
high. The categories were then used to assess PC outcomes in men at increased risk for PC (defined by race
and family history). Risk perceptions were assessed by
asking men to rate their chance of getting PC on a scale
from 0 to 100%. RESULTS: 264 men participated in this
study. Mean age was 47.7 years, and 52% were African
American, 48% were Caucasian. By nature of study eligibility, only 3(1%) men were in the low risk category. According to study criteria, 54(20%) were in the moderate
risk, 129(49%) in the high risk, and 62(24%) in the very
high risk categories, 16(6%) were unknown. PC was diagnosed in 0 of the low and unknown, 7% of the moderate, 5% of the high and 10% of the very high-risk
groups. Of the 62 men who answered the risk perception
item, there was no correlation between risk category and
risk perceptions. CONCLUSIONS: Lacking a Gail-like
model for PC risk, the search continues for quantifiable
risk categories with clinical utility. The extreme categories proposed in this pilot study show a trend toward
clinically meaningful categorization of PC risk. A metaanalysis of RR and CR is underway to refine the categories. Risk categories and risk perceptions were not associated, as has been shown in breast cancer.
PCN2
WHICH VARIABLES DO METASTATIC BREAST
CANCER PATIENTS AND ONCOLOGY NURSES
ANCHOR ON WHEN USING THE EUROQOL
DESCRIPTIVE SYSTEM IN MEASURING
UTILITIES WITH THE STANDARD
GAMBLE TECHNIQUE?
Hauser R1,2, Koeller J1
1
University of Texas at Austin, Austin, TX, USA; 2Abt
Associates Clinical Trials, Cambridge, MA, USA
OBJECTIVE: To determine which of seven EuroQoL descriptives used in collecting utility scores were the an-
chors for metastatic breast cancer patients (pts) and oncology nurses (nur). METHODS: Eight states of health
describing metastatic breast cancer were presented to 45
pts and 56 nur. Each health state had seven bullet points
describing varying degrees of severity in the following
categories: Mobility, Activities of Daily Living (ADL),
Hand/finger use (NOT EuroQoL), Usual Activity, Anxiety/Depression, Ability to think (NOT EuroQoL), and
Pain/Discomfort. After the utility scores were obtained,
subjects were asked which of the seven variables were
most important and second most important to them.
RESULTS:
PATIENTS, N545
Most
Important
Variable,
N (%)
Next Most
Important
Variable,
N (%)
Row
Total,
N (%)
Mobility
ADL or Self Care
Hand or finger use
Usual Activity
Anxiety/Depression
Ability to Think
Pain/Discomfort
11 (24.4)
14 (31.1)
0 (0)
3 (6.7)
9 (20.0)
5 (11.1)
3 (6.7)
3 (6.7)
10 (22.2)
0 (0)
7 (15.6)
11 (24.4)
10 (22.2)
4 (8.9)
14 (31.1)
24 (53.3)
0 (0)
10 (22.2)
20 (44.4)
15 (33.3)
7 (15.6)
Column Total
45 (100%)
45 (100%)
Mobility
ADL or Self Care
Hand or finger use
Usual Activity
Anxiety/Depression
Ability to Think
Pain/Discomfort
9 (16.1)
18 (32.1)
0 (0)
1 (1.8)
14 (25.0)
4 (7.1)
10 (17.9)
7 (12.5)
14 (25.0)
0 (0)
3 (5.4)
15 (26.8)
9 (16.1)
8 (14.3)
Column Total
56 (100%)
56 (100.1% rounded)
NURSES, N556
16 (28.6)
32 (57.1)
0 (0)
4 (7.2)
29 (51.8)
13 (23.2)
18 (32.2)
CONCLUSIONS: It appears that both pts and nur anchored mainly on the Self-Care variable. Combining the
most important with the next most important variable
demonstrates that the Anxiety/Depression variable was
also an important anchoring variable for both groups. Pts
appear to anchor more on Usual Activity than nur. Nur
appear to anchor more on Pain/Discomfort than pts. The
results also suggest that the Hand and Finger use variable
(NOT a EuroQoL variable) may not be necessary and
may actually overburden subjects. Overall, these finding
may help explain why metastatic breast cancer patients
differ from oncology nurses on utility scores.
PCN3
PREDICTORS OF CHEMOTHERAPY-RELATED
NEUTROPENIA: A REVIEW OF THE
CLINICAL LITERATURE
Palmer C1, Brown R1, Wilson-Royalty M2, Lawless G2
1
MEDTAP International Inc, Bethesda, MD, USA; 2Amgen, Inc,
Thousand Oaks, CA, USA
OBJECTIVES: A literature review was conducted to
identify risk factors and predictors of chemotherapyrelated grade 3–4 and/or febrile neutropenia to assist
85
Abstracts
with assessing who might benefit from treatments such as
prophylactic G-CSF. METHODS: The literature review
included publications from 1990–2000 of adults with
any tumor type; 121 articles were identified that referenced risk factors or predictors for severe/febrile neutropenia. Study design, patient characteristics, chemotherapy treatment, and incidences of neutropenia were
recorded. RESULTS: Twenty-one relevant publications,
including prospective, retrospective, and modeling studies, were further analyzed. These articles yielded 27 potential risk factors/predictors in 3 categories: patient (n 5
14), treatment-related (n 5 8), and disease-related (n 5
5) characteristics. Although most of the 27 potential risk
factors/predictors were not validated to identify patients
at higher risk for severe/febrile neutropenia, the review
suggests that several simple-to-use and commonly available risk factors may be reliable predictors of neutropenia. These included low hemoglobin and neutrophil
counts in cycle one; depth of the neutrophil nadir; low
lymphocyte, monocyte and platelet levels; and a precipitous, early drop in blood cell counts. Several other risk
factors, such as serum albumin <3.5g/dL on day 1, serum LDH .13 normal alone or combined with bone
marrow involvement, and high dose chemotherapy, also
warrant further investigation. CONCLUSIONS: Few
studies have explicitly explored risk factors associated
with the occurrence of Grade 3–4 neutropenia. However,
this literature review identified several common characteristics that may be measured with early and frequent
CBC monitoring and may reasonably predict predisposition of patients to severe/febrile neutropenia.
PCN4
COMPARING MEAN VERSUS MEDIAN SURVIVAL
AS A PRELUDE TO COST-EFFECTIVENESS
(C/E) ANALYSES
Gagnon DD1, Martin SC1, van Hout B2
1
The R.W. Johnson Pharmaceutical Research Institute, Raritan,
NJ, USA; 2Utrecht University, Utrecht, Netherlands
BACKGROUND: In a multinational trial designed to
determine the efficacy of epoetin alfa in chemotherapyinduced anemia, patients receiving non-platinum chemotherapy having a hemoglobin 10.5 g/dL or less, or a decline
in hemoglobin of 1.5 g/dL or greater were randomized
(2:1) to epoetin alfa or placebo. A total of 375 patients
(251 epoetin alfa, 124 placebo) were assessed for survival
status twelve months after completing the protocol, but
prior to unblinding. A log-rank test showed a trend in
survival favoring epoetin alfa (median of 17 vs. 11
months, p 5 0.128). OBJECTIVES: The primary efficacy
endpoint for many cancer clinical trials is median survival. In preparing for an economic analysis, however, we
analyzed mean survival, the appropriate survival endpoint for a C/E analysis. METHODS: Sampling with replacement, we conducted a post hoc analysis that examined the difference in mean survival by drawing 10,000
samples in a bootstrapping simulation. Within each sam-
ple the survival curves were truncated to maintain identical follow-up periods between treatment groups. The difference in mean survival was computed for each sample.
The probability of superior efficacy was obtained by sorting the results from the samples. RESULTS: The average
mean survival difference, across the 10,000 samples,
showed a 0.212-year survival benefit for epoetin alfa.
The probability that the difference in mean survival favors epoetin alfa was 0.965. CONCLUSIONS: Comparing differences in median and mean survival may lead to
different conclusions about the value of a therapy. Given
that mean survival is the appropriate effectiveness endpoint for survival-based C/E analyses, a non-significant
difference in median survival does not preclude full C/E
analyses. Specifically, the mean survival results from this
trial warrant a full C/E analysis of epoetin alfa in treating
anemia for patients receiving non-platinum chemotherapy.
PCN5
DOCETAXEL/DOXORRUBICIN (DD) AS FIRST
LINE CHEMOTHERAPY: QUALITY OF LIFE (QOL)
IN PATIENTS (PTS) WITH METASTATIC BREAST
CANCER (MBC)
Bonicatto SC
FUNDONAR Foundation, La Plata, Argentina
OBJECTIVE: In spite of initial treatment of MBC with DD
showed high level of efficacy expressed as improved disease-free interval, time to relapse and overall response, it remains as a palliative one. Because of there is some evidence
that QOL is improved with this treatment, we designed the
study to investigate the impact and changes on QOL in patients (pts) with MBC treated with DD, and its relationship
with clinical parameter of response. Material and METHODS: Between July 1999 and July 2000, we treated 42
MBC pts with doxorrubicin 50mg/m2 and docetaxel 75
mg/m2, i.v., day 1. Inclusion criteria: female between 18–
75 years old, ECOG PS 0-2, and stage IV of MBC histologically confirmed. QOL was assessed at baseline and prior to
the first, third and fifth cycle of chemotherapy with the
EORTC QLQ-C30 version 2.0, an integrated measurement
system to evaluate QOL of cancer pts. RESULTS: To date,
33 pts (median age 5 51.7; range 40–67) with available
data, have completed 5 cycles of chemotherapy. Repeated
measures analysis of variance (MANOVA) showed time effects statistically significant (p , 0.5) for Emotional Functioning (EF; p 5 .001), and Cognitive Functioning (EF; p 5
.001) scales, and pain (p 5 .000), insomnia (p 5 .05) and
constipation (p 5 .02) symptom scales. When baseline
QOL was compared with that after 5 cycles (paired t-test),
it was observed significant improved in EF (p 5 .003), pain
(p 5 .005) and Insomnia (p 5 .04). We grouped pts with
CR and PR (n 5 14) for comparing with SD pts (n 5 19)
and we observed significantly improve in the first group after the fifth cycle, in physical functioning (p 5 .05) and social functioning (p 5 .005). CONCLUSION: These preliminary data suggest that pts with MBC undergoing DD
chemotherapy experience improvement in several QOL pa-
86
Abstracts
rameters, showing correlation with the clinical response
achieved. There were significant changes in major components of QLQ-C30 in pts who achieved clinical response.
PCN6
CAN ICD-9 CODES BE USED AS A PROXY FOR
DISEASE STAGING IN ECONOMIC
EVALUATIONS?
Thomas SK, Brooks SE, Mullins CD
University of Maryland, Baltimore, MD, USA
Administrative health care databases are increasingly
used as a source of data for economic studies in cancer.
In order to adjust for disease severity, several investigators have utilized ICD-9 codes indicating metastases as a
proxy for cancer staging. OBJECTIVE: To determine the
validity of using ICD-9-CM codes indicating metastases
as a proxy to classify lung cancer patients by stage of disease. METHODS: This retrospective database analysis
used diagnosis codes to classify subjects to either localized or advanced stage disease and then compared this
classification to the tumor registry staging, which was
considered as the “gold standard”. Study subjects included all lung cancer patients treated at an academic institution during 1996–97 who were also members of a
large insurance company. Data was derived from inpatient cancer-related claims linked with the institution’s
tumor registry data. Advanced stage disease (stages II to
IV) was defined by claims indicating lymph node involvement or metastases (ICD-9 codes 196-199.1). The tumor
registry staging of the disease for these patients were clustered into two groupings, stages 0–I (localized) and stages
II–IV (advanced). RESULTS: Tumor registry entries were
identified for 85.7% of patients. The crude concordance
between the claims and tumor registry classifications was
74.2% (Kappa coefficient 5 0.4848). The positive predictive value of identifying localized disease utilizing
ICD-9 coding was 57.6%,while the predictive value of a
negative test was 91%. The sensitivity and specificity for
dichotomized disease stage was 86.4% and 68.2% respectively. CONCLUSIONS: For a population of lung
cancer patients in an academic institution, the use of
ICD-9 coding was associated with modest predictability
for disease staging. The use of ICD-9 coding as a proxy
for disease staging in economic evaluations should be executed with caution.
OBJECTIVES: Lung cancer is a leading cause of morbidity and mortality. Chemotherapy is one of the main treatment options but its availability in the UK is limited in
comparison to other countries, is inconsistent across geographical regions, with many patients receiving only palliative care. The present study reports results of an economic evaluation of Gemzar (one of the newer agents
available) and best supportive care (BSC) relative to BSC
in the treatment of advanced NSCLC. BSC relates to all
forms of care which are non-curative in intent excluding
chemotherapy. METHODS: The study is undertaken
from the perspective of the UK NHS. Data were extracted from a comparative trial undertaken in the UK
(Anderson et al in 1997). Cost estimates are based on:
chemotherapy and associated infusion, hospitalisations,
health care professional visits, concomitant medications,
radiotherapy and terminal palliative care. Resource utilisation data from the clinical trial were combined with
unit-cost data from various UK sources. Costs are presented in 2000 price levels and the time horizon for their
estimation is one year; hence discounting was unnecessary. Treatment effectiveness is measured by progressionfree survival and tumour response. Extensive sensitivity
analysis was also performed. RESULTS: Total treatment
cost per patient in the Gemzar/BSC arm was estimated at
£5,502 and at £3,861 for the BSC arm, the difference attributed mainly to the drug (Gemzar) and its administration costs. The intervention arm had lower radiotherapy/
concomitant medication costs, but this did not offset the
drug acquisition cost. Progression free life years and
overall tumour response rates were 0.789 and 18.5% in
the Gemzar/BSC arm and 0.474 and 0% in the BSC arm.
The incremental cost-per-progression-free-life-year gained
in Gemzar/BSC relative to BSC is £5,228 and the incremental cost-per-tumour-response £8,873. Changes in the
key variables varied the above ratios between £3,000 and
£23,000. CONCLUSIONS: The economic evaluation
presented above shows that Gemzar/BSC is a cost-effective therapy for advanced NSCLC relative to BSC alone.
PCN8
ECONOMIC EVALUATION OF GEMZAR IN THE
TREATMENT OF PANCREATIC CANCER IN
THE UK
Stephenson D1, Botwood N1, McKendrick J1, Aristides M2,
Lees M2, Maniadakis N3, Wein W3
1
Eli Lilly, Basingstoke, UK; 2M-TAG, London, UK; 3Eli Lilly,
Windlesham Surrey, UK
PCN7
ECONOMIC EVALUATION OF GEMZAR AND
BEST SUPPORTIVE CARE (BSC) RELATIVE TO
BEST SUPPORTIVE CARE ALONE IN THE
TREATMENT OF NON SMALL CELL LUNG
(NSCLC) CANCER IN THE UK
McKendrick J1, Botwood N1, Aristides M2, Lees M2,
Maniadakis N3, Wein W3, Stephenson D1
1
Eli Lilly, Basingtsoke, Hampshire, UK; 2M-TAG, London, UK;
3
Eli Lilly, Windlesham Surrey, UK
OBJECTIVES: Pancreatic cancer is a significant and increasing cause of morbidity and mortality in the UK.
Treatment with chemotherapy has shown to improve
symptoms and survival of patients. Gemzar is licenced
for treatment of pancreatic cancer in the UK. This study
reports on an economic evaluation of Gemzar relative to
5-FU, a commonly used regimen for advanced pancreatic
cancer patients in the UK. METHODS: The perspective
is that of the UK-NHS. Data were derived from a clinical
87
Abstracts
trial (Burris et al in 1998). Total treatment costs estimates are based on chemotherapy, infusions, hospitalisations, visits to health care professionals and concomitant
medications. Resource utilisation data, derived from the
trial, were combined with unit cost data from various UK
sources. The time horizon is 18 months and costs relate
to 2000. A 6% discounting rate was applied. Effectiveness was measured by: survival, progression-free survival,
and % of clinical benefit responders Extensive sensitivity
analysis was performed to test the robustness of the results. RESULTS: Total treatment cost per patient on
Gemzar was estimated at £3,569 and on 5-FU at £1,262—
the difference attributed mainly to higher drug acquisition costs. Gemzar was associated with an incremental
gain of 0.188 life years, 0.116 progression-free-life-years
and 19% of patients could be classifed as clinical benefit
responders. As such, relative to 5-FU, the incremental
cost-per-clinical-benefit-responder with Gemzar is £12,172,
the incremental cost-per-life-year-gained is £12,206 and
the incremental cost-per-progression-free-life-year gained
is £19,888. Sensitivity analyses showed that the results
did not vary significantly with changes of the parameters.
When 5-FU is administered by continuous infusion, the
cost per patient increases to £1,900 and the incremental
cost-effectiveness of Gemzar is improved. CONCLUSIONS: This economic evaluation demonstrates that
Gemzar consists a cost-effective alternative to an existing
therapy that is commonly used in the UK for treatment of
pancreatic cancer. The incremental cost-effectiveness of
Gemzar compares favourably with that of other treatments funded by the NHS.
PCN9
ECONOMIC EVALUATION OF GEMZAR/
CISPLATIN RELATIVE TO OTHER NEW AGENTS
FOR NON SMALL CELL LUNG CANCER (NSCLC)
IN THE UK
Lees M1, Aristides M1, Botwood N2, McKendrick J2,
Maniadakis N3, Wein W3, Stephenson D2
1
M-TAG, London, UK; 2Eli Lilly, Basingstoke, UK; 3Eli Lilly,
Windlesham Surrey, UK
OBJECTIVES: Lung cancer is a leading cause of morbidity and mortality. Chemotherapy is a main treatment option but its availability in the UK is limited in comparison
to other countries and is not consistent across geographical regions. The present study reports on two economic
evaluations of Gemzar/cisplatin relative to: paclitaxel/
cisplatin, paclitaxel/carboplatin, docetaxel/cisplatin (evaluation 1); and vinorelbine/cisplatin (evaluation 2). METHODS: The perspective is that of the UK-NHS. Information was derived from randomised clinical trials (Schiller
et al 2000 (evaluation 1), Comella et al 2000 (evaluation
2)). Total treatment costs include: chemotherapy and infusion, hospitalisations, visits to health care professionals, and concomitant medications. Resource utilisation
information was combined with unit cost data from various UK sources. Costs relate to 2000 and were adjusted
with the NHS inflation index if necessary. The time horizon for the estimation of costs is one year; hence discounting was unnecessary. Treatment effectiveness is
mainly measured by time to disease progression and
overall survival. RESULTS: In the first evaluation the
cost per patient in the Gemzar/cisplatin, paclitaxel/cisplatin, paclitaxel/carboplatin, docetaxel/cisplatin arms was
£5,537, £9,043, £8,444, and £5,779 respectively. Thus,
the Gemzar/cisplatin achieves cost savings up to 2£3506,
which is driven by lower chemotherapy costs. Progression-free-life-years for each treatment arm, in the order
presented above, were 0.375, 0.292, 0.300 and 0.275 respectively. Thus, the Gemzar/cisplatin combination dominates the other three combinations. In evaluation 2, a
conservative approach was used whereby the survival
outcome was assumed to be equivalent between Gemzar/
cisplatin and vinorelbine/cisplatin arms. However, the
cost in the Gemzar/cisplatin arm was £4,476 and in the
vinorelbine/cisplatin arm £5,047. Despite significant
changes to important parameters Gemzar with cisplatin
maintains dominance or achieves very low positive incremental cost-effectiveness ratios, the maximum of which is
£1,200. CONCLUSIONS: Gemzar/cisplatin is less expensive and equally or more effective than the other alternative regiments. Thus, on cost-effectiveness grounds, it
should be encouraged in the treatment of NSCLC patients in the UK.
PCN10
COST-EFFECTIVENESS MODEL OF PROSTATESPECIFIC ANTIGEN (PSA) SCREENING FOR
PROSTATE CANCER
Sokolskiy L, Hay JW
University of Southern California, Los Angeles, CA, USA
BACKGROUND: Prostate cancer is the most common
type of malignancy found in US male population and the
second leading cause of cancer fatality in men. PSA
screening is a common test in prostate cancer diagnosis.
This research investigates its cost-effectiveness. METHODS: A cost-effectiveness model is constructed following
a cohort of patients aged 60 to 75 taken from a general
US population. Clinical outcomes, costs, and transition
state probabilities were derived from medical literature
and used to construct a Markov state probability model.
The analysis takes a societal perspective and all costs
were converted to 2000 dollars. Discount rate in base
case was 3%. The parameters in the base-case were assessed for robustness using one-way sensitivity analysis.
RESULTS: We found that a screening program with
annual PSA testing starting at age 60 would result in
cost-effectiveness ratios of $8000 per QALY. One-way
sensitivity testing found the results to be very stable.
Threshold analysis revealed that screening ceased to be
cost-effective (CE ratio .$50,000/QALY) only when
costs for procedures such as prostate surgery approached
$500,000 or prostate cancer was detected at high levels
(80% true positives in first year of testing, up from cur-
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Abstracts
rent 20%) in the population. CONCLUSIONS: The
model suggests that annual PSA screening of male population for prostate cancer is extremely cost-effective,
given current data. Further research into outcomes of
prostate cancer is needed to estimate cost-effectiveness of
screening in various subpopulations. In particular, given
the long clinical progression of prostate cancer, more research is required into outcomes and cost-effectiveness in
relatively healthy patients versus those burdened by serious co-morbidities.
PCN11
ECONOMIC EVALUATION OF LIPOSOMAL
DOXORUBICIN VS TOPOTECAN FOR
RECURRENT OVARIAN CANCER IN THE UK
Smith DH1, Drummond MF2, Johnston S3, Gordon A4
1
Kaiser Permanente Center for Health Research, Portland, OR,
USA; 2University of York, York, UK; 3Royal Marsden Hospital
and Institute of Cancer Research, London, UK; 4Sammons
Cancer Center, US Oncology, Dallas, TX, USA
OBJECTIVES: To conduct an economic evaluation of an
open label, phase III randomized trial involving centers in
North America and Europe. METHODS: There were 239
and 235 patients in the liposomal doxorubicin (50mg/m2
every 4 weeks) and topotecan (1.5mg/m2 for 5 days every
3 weeks) arms, respectively. Overall median survival was
420 days and 397 days for liposomal doxorubicin and topotecan, respectively (hazard ratio 5 1.12 (90% CI
0.92,1.37; p 5 .34)). Because the outcomes were not clinically different for the 2 groups, a cost minimization analysis was performed. Costs included were: study drug;
drug administration; and management of adverse events.
Actual mg of drug administered and frequency and severity of adverse events were obtained from the clinical trial.
Expert opinion was used to estimate the resources used in
the treating adverse events, and unit costs were based on
UK practice data. Further validation of the expert opinion
is currently underway. RESULTS: Severe (Grade III/IV)
toxicities were more frequent for liposomal doxorubicin
versus topotecan in terms of palmar-plantar erythrodysesthesia (PPE) (n 5 64 vs. 0), and stomatitis/pharyngitis (n 5
32 vs. 2) but less frequent for thrombocytopenia (n 5 3
vs. 238), anemia (n 5 19 vs. 146), neutropenia (n 5 55
vs. 764) and fever (n 5 2 vs. 13). The average cost per patient was estimated to be EUR16,230 (95% CI 14,780 to
17,680) and EUR20,554 (95% CI 18,764 to 22,344) for
liposomal doxorubicin and topotecan, respectively. Per
patient cost for drug 1 administration were similar between the two groups, (EUR14,974 and EUR15,073); the
main differential in cost was management of anemia
(EUR407 and EUR2,219) and neutropenia (EUR57 and
EUR1,454) for the liposomal doxorubicin and topotecan
groups, respectively. CONCLUSIONS: In settings where
the current standard of care for platinum refractory or resistant ovarian cancer is topotecan, liposomal doxorubicin offers the potential for savings through reduction in
cost of adverse event management.
PCN12
COST-UTILITY ANALYSIS COMPARING
PACLITAXEL TO DOCETAXEL IN THE
TREATMENT OF METASTATIC BREAST CANCER
Hauser R1,3, Theriault R2, Shepherd M3, Lawson K3, Wilson J3,
Koeller J3
1
Abt Associates Clinical Trials, Cambridge, MA, USA;
2
University of Texas M.D. Anderson Cancer Center, Houston,
TX, USA; 3University of Texas, Austin, TX, USA
Cost-utility analysis is rapidly becoming the standard
pharmacoeconomic measure in oncology. OBJECTIVE:
To compare paclitaxel (pac) and docetaxel (doc) in the
treatment of second line or greater metastatic breast cancer using a cost-utility analysis. METHODS: Utilities we
collected from 45 patients using eight modified Markov
modeled health states (Pharmacoeconomics, 1996;
60:504) describing metastatic breast cancer; the standard
gamble procedure was utilized to obtain utility. Costs
were collected prospectively from 31 patients in a single
outpatient center. Direct medical costs were collected
(e.g., all medications, physician/clinic/laboratory visits,
ER, hospitalizations, home health care, consultations,
special procedures, transfusions, phone calls, and miscellaneous) and costs were defined using Medicare reimbursement rates and AWP for drugs. Sensitivity analyses
are currently underway. RESULTS: The average cost per
cycle of chemotherapy was $4,298 and $2,869 for doc
and pac respectively. The mean utility score obtained
from patients was .78 and .76 for doc and pac respectively. The utility scores suggest that doc offers 7.3 days
of perfect health when compared to pac. However, the
incremental cost-utility analysis (cost of doc 2 cost of
pac/QALY of doc 2 QALY of pac) indicates that the use
of doc costs $71,450 per Quality Adjusted Life Year
(QALY) when compared to pac. Another way to view
these results is that it costs $195.75 more per Quality Adjusted Day (QAD) to treat a patient with docetaxel.
CONCLUSIONS: Our results indicate that docetaxel is
more expensive ($4,298/cycle vs. $2,869/cycle) than paclitaxel, and that metastatic breast cancer patients do not
perceive the drugs as being different (utility scores .76 for
pac and .78 for doc). This cost-utility analysis suggests
that the use of docetaxel over paclitaxel may not be justified in the treatment of metastatic breast cancer.
PCN13
COST OF THROMBOCYTOPENIA-RELATED
BLEEDING AMONG PATIENTS WITH CANCER
Elting LS, Martin CG, Hamblin L, Chau Q
The University of Texas M. D. Anderson Cancer Center,
Houston, TX, USA
OBJECTIVE: Chemotherapy-induced bone marrow toxicity is expensive because of the cost of managing complications of pancytopenia. Growth factors minimize these
complications. Economic analyses of growth factors typically focus on common, less serious outcomes, rather
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Abstracts
than on rare, serious outcomes. As a result, the samples
are too small to estimate the financial burden of less common outcomes; underestimation of the economic value of
these agents may occur. To illustrate, we examined the
cost of a less common, but serious outcome of chemotherapy, thrombocytopenia-related bleeding, in large and
small samples of cancer patients. METHOD: The cost of
1562 chemotherapy cycles in 612, randomly-chosen cancer patients was estimated from retrospective review of
medical and administrative databases. Cost was estimated using a resource-based strategy (pharmaceuticals,
hospital and clinic costs, transfusions) from the provider’s perspective, in 1999 dollars. Twelve random,
10% samples of the cycles were selected, approximating
the size of most growth factor trials. Mean costs were
compared with two-tailed t-tests. RESULTS: Using the
entire sample, cycles with thrombocytopenia were more
expensive than those without ($7933 vs 4875, p ,
0.0001). Cycles with bleeding were more expensive than
those without ($13,728 vs $7374, p , 0.0001). They
were comparable in the costs of all inpatient and outpatient services except monitoring ($538 vs $472, p 5
0.01), transfusions to prevent bleeding ($1367 vs $758,
p 5 0.007), and bleeding treatment ($4702 vs $0, p ,
0.0001). However, the cost of cycles with bleeding
(range: $8289–$16,277) was significantly higher than cycles without bleeding (range: $5796–$8872) in only 5 of
the 12 small samples. CONCLUSIONS: The economic
impact of uncommon, but expensive outcomes should be
examined in samples large enough to permit calculation
of stable estimates of cost. The high cost of rare outcomes such as bleeding will be better appreciated, as will
the importance of avoiding such episodes by preventing
thrombocytopenia.
PCN14
CHOICE OF LOCALIZED BREAST CANCER
TREATMENTS IN A MEDICARE POPULATION:
A COMPARISON OF OUTCOMES AND COSTS
Polsky D1, Venditti L1, Mandelblatt JS2, Weeks JC3, Hadley J4,
Hwang YT2, Schulman K5
1
University of Pennsylvania, Philadelphia, PA, USA;
2
Georgetown University, Washington, DC, USA; 3Harvard
Medical School, Boston, MA, USA; 4The Urban Institute,
Washington, DC, USA; 5Duke University Medical Center,
Durham, NC, USA
OBJECTIVES: In this study we compared outcomes and
costs between three treatments options (mastectomy
(MRM), breast conservation surgery with radiation (BCSRT), and breast conservation surgery only (BCSO)) for
elderly women with localized breast cancer. METHODS:
The sample was a national random sample from Medicare claims of 2,821 elderly women treated between
1992 to 1994 for localized breast cancer. Data on patient
preferences were collected in patient interviews conducted in 1997. The outcomes studied were 5-year survival, Quality Adjusted Life Years (QALY), total costs
and cost/QALY. For each outcome we used univariate,
multivariate and instrumental variable analysis to compare the differences between treatments. The instrumental variables used were geographic region, and distance to
nearest radiation facility. RESULTS: There were 1813
patients who received MRM, 704 who received BCSRT,
and 304 who received BCSO. The multivariate analysis
showed significantly higher survival for BCSRT relative
to MRM (4.21 vs. 4.13) and significantly higher QALYs
(3.50 vs. 3.45), but the IV analysis found an insignificant
difference opposite in sign. Costs were significantly
higher for BCSRT relative to MRM ($54,073 vs.
$37,327 in multivariate analysis). The cost-effectiveness
ratio of BCSRT relative to MRM is $334,920/QALY
(CI:$80,000 to NW) per QALY using multivariate estimates and dominated using IV estimates. CONCLUSION: Survival and QALYs are statistically higher in traditional analyses of the BCSRT group relative to MRM,
but the IV analysis suggests an upward bias due to the selection of healthier patients into BCSRT. This finding is
consistent with previous studies. Costs are unequivocally
higher in the BCSRT group suggesting BCSRT is not a
cost-effective option relative to MRM. Supplemental
analyses suggests that the presence of choice between
MRM and BCSRT raises the quality of life for all elderly
women independent of the choice that is made. Thus,
choice is costly but valuable.
PCN15
DIFFERENCES BETWEEN PREFERENCES FOR
HEALTH STATES: THE CHEMOTHERAPY
ADVERSE EVENT SELF-ASSESSED RESPONSE
(CAESAR) QUESTIONNAIRE
Purdum AG1, Globe D2, Mathes A3, Nichol MB2
1
Protocare Sciences, Santa Monica, CA, USA; 2University of
Southern California, Los Angeles, CA, USA; 3Independent
Health Outcomes Consultant, Odessa, FL, USA
OBJECTIVE: This study assesses the health state preferences for adverse effects of chemotherapy on healthy
individuals. Time trade off (TTO), Standard Gamble
(SG), and Visual Analogue Scale (VAS) scores were compared between side-effects and across two time points.
METHOD: A convenience sample of healthy pharmacy
students self-administered a questionnaire of TTO, SG
and VAS preferences for 12 different chemotherapy-related
side-effects ranging from anorexia to severe nausea. Respondents completed the questionnaire on two separate
occasions separated by 2 weeks. RESULTS: Ninety-three
students completed at least one survey; 53 subjects completed both surveys (57%). The mean age of the sample
was 25 years; 21% were male. While no missing values
were seen in VAS questions, 23 missing responses were
noted in the TTO and 72 in the SG. TTO had the highest
test-retest correlation (ranging from 0.35 to 0.75) and
VAS had the lowest correlation (ranging from 0.29 to
0.65). The order of the preference measures was consistent across nine of the twelve side-effects. The widest
90
Abstracts
range of preferences occurred in the VAS, with the mean
score for severe nausea rated at 0.27, and anorexia at
0.82. The TTO and SG ranges were narrower than the
VAS (0.55 to 0.90, and 0.80 to 0.95, respectively). Consistent with other studies, the lowest median score for all
three preference measures was severe nausea. CONCLUSION: Similar scores were obtained from the three methods to estimate preferences for cancer related health
states, although the narrowness of the TTO/SG distributions may limit the ability to distinguish between the 12
side-effects. The methods were not equivalent in ease of
administration as shown by the number of missing items
in the TTO/SG. Additional comparisons across these
three methods and different populations would assist in
determining the association between side effects and preferences.
PCN16
CHEMOTHERAPY TREATMENT IN NEWLY
DIAGNOSED BREAST CANCER PATIENTS IN A
MANAGED CARE POPULATION
Yazdani C1, McLaughlin T1, Koos F2, Hansen J1
1
NDC Health, Phoenix, AZ, USA; 2PharMetrics, Inc,
Watertown, MA, USA
OBJECTIVE: To characterize the antineoplastic treatment of newly diagnosed breast cancer patients in a managed care population. METHODS: Adult subjects contained within PharMetric’s Integrated Outcomes database
possessing a diagnosis of breast cancer (ICD-9-CM 5
174) followed by a procedure code for chemotherapy
during 1997–1999 were eligible for study inclusion. Patients with diagnoses for other neoplasms and pre-diagnosis treatment were excluded. Utilization of antineoplastic agents, radiation therapy (RT) and mastectomy
during the 6-month post-diagnosis period was measured.
RESULTS: 6,652 patients met the inclusion criteria. The
mean age was 53.7 years. 3,396 (51.1%) patients received RT, while 3,469 (52.2%) patients underwent mastectomy. Patients 61 year of age and older were significantly less likely to undergo RT or mastectomy as
compared to younger patients (p , 0.0001). Doxorubicin
and cyclophosphamide were extensively used in younger
patients (ADR: 32.7% in 711 vs. 64.4% in ,40; cyclophosphamide: 53.3% in 711 vs. 73.2% in 711). In contrast, fluorouracil and methotrexate appeared to be the
drug of choice in elderly (5-FU: 49.1% in 711 vs. 33.3%
in ,41; MTX: 30.9% in 711 vs. 19.8% in ,41). Use of
paclitaxol was consistent across all age categories
(24.4%). Elderly were less likely to undergo partial mastectomy (8.7% in 711 vs. 23.1% in ,41). The difference
in the rate of modified radical mastectomy between age
groups was less pronounced (22.3% in 711 vs. 29.5% in
,41). After adjusting for age, RT and health plan identifier, the administration of cyclophosphamide or doxorubicin was more likely to follow any mastectomy, while
the association between mastectomy and fluorouracil use
was limited to modified radical. RT was likely to be used
as adjunct therapy to all antineoplastics, with the exception of cyclophosphamide. CONCLUSIONS: The elderly
appeared to be treated less aggressively with anti-neoplastic agents. The choice of agent is governed by age and
the mode of other treatments.
PCN17
AN ANALYSIS OF RESOURCE USE IN THE
TREATMENT OF ADVANCED COLORECTAL
CANCER IN THE UK
Sorensen S1, Brown R1, De Cock E1, Bearne A2
1
MEDTAP International Inc, Bethesda, MD, USA; 2Aventis
Pharma, Kent, UK
OBJECTIVE: This study aims to estimate the non chemotherapy costs of treatment of advanced metastatic colorectal cancer from the perspective of the UK National
Health Service. METHODS: Resource use collected during comparative clinical trials often is insufficient in determining the actual costs of patient management. Large
data bases can be used to estimate patient health care resource consumption, but these are not always available.
Soliciting expert opinion from clinicians may provide the
only reasonable data source. A questionnaire was developed to obtain resource utilization for routine treatment
and monitoring, adverse event management and other
clinical parameters in the first line setting. Responses
were obtained from five oncologists from various centres
in the UK with experience of treating advanced metastatic colorectal cancer with chemotherapy. Data on second line treatment came from resource use collected during a trial. RESULTS: The clinicians estimated that 40%
of first line patients would receive only palliative care at
disease progression and 60% would receive second line
therapy. Resources included physicians, acute care admissions, labs, hospice, palliative drugs, community
nurses and radiology.
Non-Chemotherapy Costs
One time cost for insertion of tunneled
catheter at start of chemotherapy
Non chemotherapy costs during 1st line
chemotherapy
Non chemotherapy costs during disease
remission (1st time)
Non chemotherapy costs during 2nd line
chemotherapy (derived from trial)
During Terminal Palliative Care
Average cost/
patient/week £
250
485
116
108
256
CONCLUSIONS: Chemotherapy drug costs are only a
part of the costs incurred in treating advanced colorectal
cancer. These results clearly show the substantial nonchemotherapy costs throughout the remaining life of patients that also need to be considered when treating these
patients.
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Abstracts
PCN18
COLORECTAL CANCER SCREENING:
AWARENESS, UTILIZATION, AND BARRIERS
Straus W1, Schaffner P1, Gold K2, Pashos C3, Mansley E1
1
Merck & Co., Inc, West Point, PA, USA; 2Abt Associates Inc,
Cambridge, MA, USA; 3Abt Associates Clinical Trials,
Cambridge, MA, USA
BACKGROUND: Screening can reduce colorectal cancer
mortality, yet screening rates remain low. Data from the
Centers for Disease Control and Prevention (CDC) for
1999 suggest that only 33.7% of US adults over 40 have
ever received a sigmoidoscopy (SIG) or colonoscopy
(COL), and 31.1% have ever received a fecal occult
blood test (FOBT). OBJECTIVE: To inform policy that
may improve screening rates, we sought to characterize
the barriers associated with low screening compliance.
METHODS: A national random sample of US adults 50
years and older was conducted via random digit dial
methods. A computer assisted telephone survey was administered to 502 subjects. Data including utilization of
FOBT, SIG, COL and x-ray with barium enema (XBE),
as well as demographics, awareness, concerns, attitudes
and beliefs about those tests were collected. RESULTS:
Screening rates were low, with awareness and screening
rates lower for Blacks/Hispanics than for Whites. For example, Blacks and Hispanics were less aware of screening
tests (aware of FOBT 5 73.3%; SIG 5 51.7%; COL 5
70%; XBE 5 68.3%) than Whites (88.1%, 81.8%,
87.6% and 80.1%, respectively) (p , .05). Significantly
lower screening compliance is apparent with FOBT
screening rates of 21.7% (Blacks/Hispanics) compared
with 34.8% (Whites). Other significant barriers to
screening found were: discomfort with exam; low health
care seeking behavior; low belief in value of prevention;
and low perceived personal health threat (all p , .05).
FOBT
SIG
COL
XBE
Knowledge
of Test
Ever Had Test
Compliant with
Standards
86.7%
78.1%
85.1%
78.1%
70.3%
52.0%
40.7%
38.5%
33.5%
29.7%
31.1%
17.5%
CONCLUSIONS: Lack of awareness about screening
still exists, especially among Blacks and Hispanics. Barriers to screening have been observed and can potentially
be addressed by outreach and education programs.
PCN19
COLORECTAL CANCER SCREENING TESTS:
VARIATION IN PREFERENCES BASED ON
GENDER AND RACE
Straus W1, Schaffner P1, Gold K2, Pashos C3, Mansley E1
1
Merck & Co., Inc, West Point, PA, USA; 2Abt Associates Inc,
Cambridge, MA, USA; 3Abt Associates Clinical Trials,
Cambridge, MA, USA
BACKGROUND: There exists a larger number of screening procedures for colorectal cancer than for any other
type of cancer. Unfortunately, screening rates remain
low. Data from the Centers for Disease Control and Prevention (CDC) for 1999 suggest that only 33.7% of US
adults over 40 have ever received a sigmoidoscopy (SIG)
or colonoscopy (COL), and only 31.1% have ever received a fecal occult blood test (FOBT). OBJECTIVE: To
better understand the types of barriers associated with
each screening method (stool-based, scope-based, x-ray/
enema-based) in order to develop patient-based preference profiles that could be used to increase compliance
with one of the recommended screening regimens. METHODS: A national random sample of US adults 50 years
and older was conducted via random digit dial methods.
A computer assisted telephone survey was administered
to 502 subjects. Data including utilization of FOBT, SIG,
COL and x-ray with barium enema (XBE), demographics,
concerns, attitudes and beliefs were collected. RESULTS:
There were significant gender differences in screening
rates based on procedure. Overall, 26.2% of women were
in compliance with SIG recommendations compared to
38.6% of men (p , .01). White respondents appeared to
be the source of this difference. Black/Hispanic men and
women had similar SIG screening rates. Conversely, there
was a significant difference in stool-based screening compliance between Black/Hispanic men (40.0%) and women
(15.6%) with no gender difference among Whites. The
importance of some potential barriers differed significantly with exam type (p , .05), with respondents being
less bothered by, and associating less discomfort with,
the FOBT. CONCLUSIONS: Preferences and perceptions
with respect to screening procedures varied by patient
characteristics. The impact of screening barriers varied by
procedure. Understanding these variations may help in
education and information dissemination and may also
assist in directing patients to more compatible screening
regimens. This might increase screening rates for this
largely preventable disease.
PCN20
COST MINIMIZATION ANALYSIS OF CEFEPIME
VERSUS IMIPENEM-CILASTATINE IN CANCER
PATIENTS WITH SHORT-DURATION
FEBRILE NEUTROPENIA
Vorobjov P, Fisenko V, Gerasimov V, Avxentieva M, Moscow
Medical Academy, Moscow, Russia
OBJECTIVE: To perform pharmacoeconomical comparison of cefepime versus imipenem-cilastatine used for empiric therapy in cancer patients with short-duration febrile neutropenia in Russia. METHODS: The decision
tree was designed to analyse the costs and outcomes of
studied treatment. Probabilities of clinical success, adverse events, switching to a new drug and adding extra
antibiotics were extracted from a published multicentral
randomised clinical trial. Firstly the study was planned to
be a cost-effectiveness analysis, but data obtained from
the trial, demonstrated equal efficacy of both drugs. So fi-
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Abstracts
nally the study was performed as cost-minimization analysis. The following costs were taken into account: the
drug acquisition price, drug preparation and administration, medications to treat failures and adverse events, including antibiotics added to main medication. Schemes of
treatment for adverse events and choice of antibiotics for
treating clinical failures typical for clinical practice in this
country were obtained from expert panel. Costs of drugs
were derived from official price-lists of pharmacies. Hospital costs were excluded, as there was no difference in
the length of treatment between the groups according to
the results of the trial. RESULTS: According to clinical
trial the probability of clinical success for short-duration
febrile neutropenia treatment in cancer patients is equal
in both drugs (79 % for cefepime and 72% for imipenem, equivalence, p , 0.0001). Cost of treatment of 1
patient with imipenem-cilastatine including added antibiotics, drugs for treating failures and adverse events was
21 207,2 roubles (757,4 USD), for cefepime—10 512, 32
roubles (375,44 USD). CONCLUSION: Cefepime monotherapy being clinically as effective as imipenem-cilastatine is twice less costly for the empirical treatment of fever in short-duration neutropenia. Changing of widely
recommended for empiric therapy of febrile neutropenia
imipenem-cilastatine for cefepime will save 10 694,88
roubles (382 USD) in each treated patient.
PCN21
HEALTH-RELATED QUALITY OF LIFE AFTER
ANDROGEN DEPRIVATION THERAPY IN MEN
WITH PROSTATE CANCER
Lubeck DP, Grossfeld GD, Carroll PR
University of California, San Francisco, San Francisco, CA, USA
INTRODUCTION and OBJECTIVES: Treatment for
prostate cancer has significant impact on health-related
quality of life (HRQOL). We examine HRQOL in a cohort of men who opted for surveillance as initial treatment followed by androgen deprivation therapy (ADT)
and compare them with other treatments. METHODS:
CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) is a national observational database of
men with prostate cancer. We identified a cohort of
newly diagnosed men with prostate cancer who completed two or more instruments that measure generic and
disease-specific HRQOL. Individuals were grouped by
initial treatment: ADT, surveillance, radical prostatectomy, and radiation therapy. RESULTS: Initial treatment
was as follows: ADT (n 5 167), surveillance (n 5 106),
radical prostatectomy (n 5 351), radiation therapy (n 5
75). Sixty-seven men selected surveillance followed by
ADT. Mean age at diagnosis was 73 years with surveillance patients being older. Men had significantly poorer
urinary (decline of 7 points on a 100 point scale) and sexual function (decrease of 10 points) compared with surveillance. HRQOL for ADT, surveillance and radiation
therapy patients changed little over the year following
treatment, while men undergoing radical prostatectomy
showed improvement in all aspects of HRQOL. Scales
are scored from 0–100 with 100 5 better function and a
difference of 7–10 points is considered clinically significant. CONCLUSIONS: Patients receiving ADT had reduced energy, poorer sexual and urinary function and
were more bothered by their urine function than patients
undergoing other treatments. Longer follow-up after
start of ADT and surveillance is needed to discern the impact of other factors, including comorbidities.
PCN22
COST-EFFECTIVENESS ANALYSIS COMPARING
PACLITAXEL TO DOCETAXEL IN THE
TREATMENT OF METASTATIC BREAST CANCER
Hauser R1,2, Koeller J1
1
University of Texas at Austin, Austin, TX, USA; 2Abt
Associates Clinical Trials, Cambridge, MA, USA
OBJECTIVE: To compare paclitaxel (pac) and docetaxel
(doc) in the treatment of second line or greater metastatic
breast cancer using a cost-effectiveness analysis. METHODS: Costs were collected prospectively from 31 patients
in a single outpatient center. Direct medical costs were
collected (e.g., all medications, physician/clinic/laboratory visits, ER, hospitalizations, home health care, consultations, special procedures, transfusions, phone calls,
and miscellaneous) and costs were defined using Medicare reimbursement rates and AWP for drugs. Effectiveness measures were obtained from two phase III trials
conducted by Nabholtz. Sensitivity analyses are currently
underway. RESULTS: The average cost per cycle of chemotherapy was $4,298 and $2,869 for doc and pac respectively. The objective response rates (OR) obtained
for doc and pac in the phase III trials were 30% and 26%
respectively. The cost-effectiveness (CE) ratio for doc is
$14,327 per one-percent increase in OR. The CE ratio
for pac is $11,035 per one-percent increase in OR. An incremental CE analysis suggests that using doc costs
$35,725 per one-percent increase in OR compared to
pac. CONCLUSIONS: The cost-effectiveness ratios suggest that pac is the more cost-effective choice. The incremental cost-effectiveness analysis still supports the use of
pac; however, doc is not out of the standard range of
payment for gains in effectiveness. Physicians and third
party payers should use this information along with costutility studies to help guide decisions on treatment for
metastatic breast cancer patients.
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Abstracts
PCN23
PCN24
DISEASE MODELING: DEVELOPING THE
INFRASTRUCTURE FOR A COMPREHENSIVE,
MULTI-NATIONAL, CLINICAL AND ECONOMIC
BREAST CANCER TREATMENT MODEL
Becker RV1, Noe L1, Gore M2, Martino S3, Eiermann W4,
Namer M5, Howell A6, Bianco A7, Watanabe T8
1
Ovation Resarch Group, Highland Park, IL, USA; 2Avalon
Health Solutions, Wilmington, DE, USA; 3John Wayne Cancer
Institute, Santa Monica, CA, USA; 4Rot-Kreuz-Hospital, Munich,
Germany; 5Centre Antoine Lacassagne, Nice, France; 6Christie
Hospital, Manchester, England; 7Univ. Frederico II Department
of Medical Oncology, Naples, Italy; 8National Cancer Center
Hospital, Tokyo, Japan
INCIDENCE AND COST OF HOSPITALIZATION
FOR 5-FU TOXICITY AMONG MEDICARE
BENEFICIARIES WITH METASTATIC
COLORECTAL CANCER
Delea TE1, Vera-Llonch M1, Edelsberg JS1, McGarry L2,
Anton S3, Ulcickas-Yood M4, Oster G1
1
Policy Analysis Inc, Brookline, MA, USA; 2Innovus Research Inc,
Medford, MA, USA; 3Boehringer Ingelheim Pharmaceuticals,
Ridgefield, CT, USA; 4Bristol Myers Squibb, Wallingford, CT,
USA
OBJECTIVES: To develop the cost data infrastructure to
support a comprehensive, multi-national breast cancer
treatment decision-analysis model. The specifications required a user-friendly interactive interface for over 70
comparators composed of nearly 350 cost components
used in 24 unique decision trees. The model required an
ability to vary components readily and add new treatments and cost components to multiple trees. METHODS: Since standard decision-analysis software doesn’t
permit categorization of variables or application of the
same variable to multiple decision trees: (1) trees were
programmed in Visual Basic for the interactive interface,
and (2) cost data were loaded into a Microsoft ACCESS
database linked to the trees. Because of this structure, it
was possible to categorize cost data as: 1) Drug Acquisition and Administration, 2) Adverse Events/Complications, 3) Concomitant Medications, 4) Hospitalizations,
and 5) Monitoring Costs. For each country in the model,
a separate database was developed with country-specific
costs obtained from standardized databases, government
sources, published literature, and a provider survey. RESULTS: This model was developed for six countries—US,
U.K., Germany, Japan, France, and Italy—and included
clinical and economic variables related to the diagnosis,
treatment, and outcomes of breast cancer. The structure
permits dynamic analyses via varying cost and probability scenarios that reflect country-specific treatment practices and international variations. Each country’s cost database applies to four distinct decision trees representing
different stages of breast cancer. The costs can be easily
summarized by category and modified so that multiple
cost components in multiple trees can be varied with one
edit. New cost components can be added to each country’s database and linked to the trees. CONCLUSION:
When constructing large models (such as disease models)
with several treatments having common cost components
in multiple decision trees, using a categorized cost database linked to the treatment pathways will generate a
user-friendly model with easily-varied cost inputs.
BACKGROUND: While treatment with 5-fluorouracil
(5-FU) plus leucovorin has been shown to prolong survival in patients with metastatic colorectal cancer, it also
can cause significant toxicity, sometimes necessitating
hospitalization. The incidence and costs of these admissions have not been fully documented. OBJECTIVE: To
estimate the incidence and cost of hospitalizations for
toxicities associated with 5-FU therapy in patients with
metastatic colorectal cancer. METHODS: Using the
1994 Medicare 5% sample, we identified all patients
with metastatic colorectal cancer who underwent colorectal surgery. We stratified these selected subjects into
those who received 5-FU therapy within 90 days of their
surgery (“5-FU group”) and those who did not receive
any chemotherapy (“no-chemotherapy group”); patients
receiving chemotherapeutic agents other than 5-FU were
dropped from the sample. Using techniques of survival
analysis, we then compared the incidence and cost of all
hospital admissions with listed ICD-9-CM diagnosis
codes (principal or secondary) for conditions that may be
related to 5-FU toxicity (e.g., volume depletion, stomatitis, nausea and vomiting). RESULTS: A total of 441 patients met all study entry criteria, including 192 who received 5-FU and 249 who did not receive chemotherapy
following surgery. 5-FU patients were significantly
younger than those in the no-chemotherapy group (p ,
.001). Mean (6SD) follow-up time was slightly longer in
the 5-FU group (137 6 96 days vs 117 6 88 days for no
chemotherapy). The incidence at 10.5 months of toxicityrelated hospitalizations (principally volume depletion,
agranulocytosis, gastroenteritis, and nausea and vomiting) was 31% among patients who received 5-FU and
8% among those who did not receive chemotherapy. The
cost of inpatient care was $2,716 higher among 5-FU patients. CONCLUSIONS: Hospitalization for 5-FU toxicity is frequent and costly among Medicare patients with
metastatic colorectal cancer.
PCN25
A QUALITY OF LIFE AUDIT OF PATIENTS WITH
NON-SMALL CELL LUNG CANCER HAVING
CHEMOTHERAPY AT ONE INSTITUTION
Musgrave KR, Wyld D, Abraham R
The Prince Charles & Royal Brisbane Hospitals,
Brisbane, Australia
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Abstracts
OBJECTIVES: Establish the impact that present chemotherapy management is having on the quality of life (qol)
of patients being treated at the Prince Charles Hospital;
Allow comparison of the effect on the patients qol between established treatment modalities; Allow comparison of the effects on patients qol between established and
future trial treatment protocols. We report the interim
findings of this ongoing quality of life study. METHODS: All patients referred for chemotherapy management of their non-small cell lung cancer (NSCLC) were
asked to participate. The EORTC QLQ 30 and LC 13
were used to assess patients qol when disease restaging
tests were conducted. Data was entered into an access database that allowed comparison. Protocols used were
CIV, CV- adjuvant-neoadjuvant setting. CG and single
agent Gemcitabine 1000mg/m2 on days 1, 8, 15, in the
palliative setting. RESULTS: Patients ages ranged 39 to
73 yrs, average age 53 yr, median, 51, mode 47years. The
sample consisted of 3 females & 12 males, 6 patients are
not reported, 3 neoadjuvant had progressive disease after
two cycles and were not followed, 3 palliative patients
died after one cycle of treatment. Of the 21 patients
treated 15 (71%) had improved Quality of Life scores
paralleled other measures of assessment. Scans show response to single agent Gemzar in the palliative setting
and response to CIV in the neoadjuvant setting. CONCLUSION: we demonstrated 71% of our patients had
qol improvements. Management of patients with NSCLC
should consider chemotherapy. FUTURE DIRECTION:
An outcomes study is being conducted at two campuses
in Brisbane. This study seeks to include all newly diagnosed lung cancer patients and follow their progress
through their disease using clinical Quality of Life and
economic criteria to determine outcome. Comparison between treatment and within treatment arms will be compared.
PCN26
SYSTEMATIC ASSESSMENT OF HEALTHRELATED QUALITY OF LIFE INSTRUMENTS FOR
USE IN CLINICAL TRIALS OF NON-SMALL CELL
LUNG CANCER
Huang JC, Veenstra DL
University of Washington, Seattle, WA, USA
OBJECTIVE: To critically evaluate the quality of healthrelated quality of life (HRQoL) instruments for use in
clinical trials of non-small cell lung cancer (NSCLC).
METHODS: A structured review of literature was
conducted by searching MEDLINE (1975–2000) and
PsycINFO (1977–2000) using the keywords “lung cancer”, “quality of life” and “questionnaire”, and manually. HRQoL instruments that had been used in or designed for lung cancer were selected for review. Each
instrument was assessed for its general features, feasibility, scoring and interpretation, and psychometric properties. RESULTS: Ten instruments were selected for review:
EORTC-QLQ30, EORTC-LC13, FACT-L, LCSS, FLIC,
CARES, CARES-SF, RSCL, FLIC and MQOL. Most
questionnaire items were appropriately generated through
multiple cycles of input from patients and clinicians. The
most studied psychometric properties were internal consistency and convergent/divergent validity, with most instruments having Cronbach’s a .0.7 and acceptable correlation coefficients for convergent/divergent validity.
Responsiveness, interpretability of the scale score, and
validity testing in cross-cultural settings were either inadequately evaluated or missing. All instruments have a
good readability level, an administration time less than
20 minutes, a time horizon of one week or less, and are
multilingual. All questionnaires have been used in clinical
trials for non-small cell lung cancer except CARES,
CARES-SF and MQOL. CONCLUSIONS: There are several reliable and validated HRQoL instruments that are
appropriate for use in clinical trials of NCSLC. In particular, the EORTC-QLQ30 and its lung cancer supplement, the LC13, LCSS, RSCL, FACT-L, and CARES
have greater evidence of good psychometric properties.
Further research is required to evaluate the cross-cultural
performance, score interpretability and correlation with
clinical outcomes of these instruments.
PCN27
COST OF TREATMENT FOR SQUAMOUS CELL
CARCINOMA OF THE HEAD AND NECK IN THE
UNITED STATES
Cronin K, Lee B, Wang D
The Lewin Group, Falls Church, VA, USA
BACKGROUND: Cancer of the head and neck is the
11th most common cancer in the US, however, there are
no published, comprehensive studies examining the costs
associated with the treatment of head and neck cancer in
the United States. The objective of this research was to
design a model to estimate the cost of treatment for squamous cell carcinoma of the head and neck (SCCHN).
METHODS: A decision analytic model was designed to
project the outcomes and costs associated with SCCHN.
The model was stratified by site of disease, stage of presentation, treatment, and outcome. The most common
therapeutic options for SCCHN were modeled: 1) surgery, 2) radiation therapy, 3) surgery and radiation therapy, 4) radiation therapy and chemotherapy, and 5) palliation. Base case data were obtained from the National
Cancer Data Base, the published literature, a modified
Delphi survey of experts, and an analysis of the Medicare
Standard Analytic Files. RESULTS: Average per patient
cost of care for SCCHN in the US was estimated to be
$20,876. Higher costs resulted for patients that present
with advanced cancers. The estimated cost of treating a
patient with Stage IV lip SCC ($19,274) was four times
that of Stage 0 lip SCC ($5,062). The site with the lowest
cost of treatment was lip ($7,261) while the highest cost
was associated with hypopharyngeal SCC ($28,584). The
cost per patient for palliative care ranged from $2,052
for lip SCC (28% of total cost of care) to $7,172 for si-
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Abstracts
nonasal SCC (30% of total cost of care). The lifetime
cost of managing annual incident SCCHN cases was estimated to approximate $976 million. CONCLUSION:
This study found that tumor stage and location are useful
predictors of increased treatment costs. The results suggest that prevention and early detection are critical in reducing the treatment costs of SCCHN.
PCN28
DETECTING RECURRENT PAPILLARY OR
FOLLICULAR THYROID CANCER IN
CLINICALPRACTICE: NEED FOR A CHANGE?
Hooft L, Hoekstra OS
University Hospital Vrije Universiteit, Amsterdam, Netherlands
OBJECTIVES: Patients with thyroid carcinoma (TC) can
present a diagnostic dilemma when elevated tumormarkers (thyroglobulin, Tg) suggest relapse but whole body
131-iodine scanning (131I WBS) is negative. Then, battery of imaging modalities is available. In recent years,
positron emission tomography has been proposed as an
effective and comprehensive staging procedure. To estimate the effort and yield of present clinical practice, we
performed a retrospective study. METHODS: From our
Tg database we identified all TC patients, and included
those with elevated Tg levels ( 1.5 pmol/l on
thyroid hormone medication) after ablation with 131I,
between 1-5-96 and 1-1-98, and recorded the applied diagnostic work-up. RESULTS: Tg data were identified
from 116 patients with TC. Twenty met the inclusion criteria, 18 of which (90%) had a complicated work-up. Recurrent disease was confirmed in 16. The mean number
of imaging tests required to arrive at a clinical conclusion
was 5 (range 3–9), within a mean period of 18 months.
Since 1997, PET has been performed in 15 patients with
negative or equivocal high dose 131I WBS (8 positive and
7 negative scans). Tumor sites first disclosed by PET were
found in 5 patients. CONCLUSIONS: The current diagnostic trajectory in the majority of the patients with elevated Tg and negative 131I WBS proved to be protracted
and complicated. Even though prognosis may not necessarily be adversely affected by this delay, patient anxiety
is a considerable problem. FDG-PET may solve clinical
problems in some of these patients, but the currently
available evidence does not allow for implementation of
a routine diagnostic algorithm.
CARDIOVASCULAR DISEASE
PCV1
A COST-EFFECTIVENESS ANALYSIS OF
CLOPIDOGREL VERSUS ASPIRIN AS
PREVENTION OF ISCHEMIC EVENTS IN
PATIENTS WITH ESTABLISHED PERIPHERAL
ARTERY DISEASE
Decerbo MC, Baroletti SA, Isopo S, Silva M, Talati DK
Northeastern University, Boston, MA, USA
OBJECTIVES: Since becoming widely recognized for its
antithrombotic effects in the 1970s, aspirin has become
first-line antiplatelet therapy across most patient populations. However, newer data suggests that clopidogrel is
more effective than aspirin for prevention of ischemic
events in peripheral artery disease (PAD) patients. In this
analysis, a decision analytic model was constructed in order to evaluate the cost-effectiveness of clopidogrel versus
aspirin as prevention of ischemic events in patients with
established PAD. METHODS: Data on the probability of
ischemic events was extracted from the PAD subgroup of
the CAPRIE trial, in which event rates for clopidogrel
and aspirin were 3.71% and 4.86%, respectively. Costs
included in this analysis were obtained from the medical
literature. RESULTS: In the base case analysis, the expected cost of treatment over a one-year time frame with
clopidogrel and aspirin was $2075 and $1088, respectively. Furthermore, to effectively treat one patient, it
would cost $2155 with clopidogrel and $1144 with aspirin. An incremental cost-effectiveness analysis concluded
that one additional event of vascular death, MI, or
ischemic stroke will be prevented with clopidogrel at an
additional one-year cost of $85,826. A univariate sensitivity analysis demonstrated that aspirin must have ischemic
event rates greater than 13% for clopidogrel to be the
preferred option based solely on cost. Furthermore, in order for clopidogrel to be considered cost-effective with an
event rate of 3.71%, aspirin must have an event rate of
11.48%, a rate 2.4 times greater than was observed in
the CAPRIE trial. CONCLUSIONS: The result of this
analysis concluded that it would cost a third-party payer
an extra $85,826 to effectively treat one additional patient over a one-year period when using clopidogrel instead of aspirin. This cost can play a major role in the decision of appropriate antiplatelet therapy used to treat
PAD patients in the prevention of ischemic events.
PCV2
VENOUS THROMBOEMBOLIC (VTE)
COMPLICATIONS FOLLOWING MAJOR
ORTHOPEDIC SURGERY: FREQUENCY AND
ECONOMIC CONSEQUENCES IN HOSPITAL
Gabriel S1, Dinet J1, Dispot T2, Radal C2
1
Sanofi-Synthelabo, Bagneux, France; 2Medcost, Paris, France
OBJECTIVES: The risk of VTE disease in patients undergoing major orthopedic surgery (MOS) has extensively
been studied in randomised clinical trials and more recently in cohort studies. Our objective was to estimate
the risk of VTE disease in a much larger population and
to calculate its economic consequences in hospital.
METHODS: We conducted a retrospective study of the
risk of occurrence and associated costs of VTE complications (including deep vein thrombosis (DVT) and pulmonary embolism (PE)) in patients undergoing MOS
(including hip replacement, hip fracture and knee replacement). Data were obtained from the National inpatient Diagnosis Related Group (DRG) data base with ex-
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Abstracts
haustive information concerning all the patients having
undergone MOS in the year 1998 in France. These patients were stratified based on the presence or absence of
a listed secondary diagnosis of DVT or PE. Length of stay
in hospital and cost of inpatient care were then compared
between patients with and without secondary diagnosis
of VTE. RESULTS: 105,952 hospital stays, 37,034 and
58,135 were respectively recorded for hip replacement,
knee replacement and hip fracture. Rates of VTE were recorded to be 1.4% and 2.6% for hip replacement and
knee replacement respectively. For each primary Diagnosis Related Group, the length of stay was shown to be significantly higher in case of occurrence of VTE complications (19.1 days versus 15.1 for hip replacement, 18 days
versus 15.2 for knee replacement, 21.4 days versus 13.8
for hip fracture). Consequently, total costs of inpatient
care were substantially higher for patients with VTE
complications. CONCLUSION: The rates of VTE observed from the National inpatient database provide information on the frequency of VTE complications after
MOS in real setting. In patients undergoing major orthopedic surgery, the occurrence of VTE is associated with a
longer hospital stay and higher cost of inpatient care.
PCV3
AN ANALYSIS OF THE COST OF ADVERSE
EVENTS ASSOCIATED WITH THE USE OF
HMG-COA REDUCTASE INHIBITORS
McBurney CR1,2, Smith D2
1
Pfizer Inc., Ann Arbor, MI, USA; 2University of Michigan, Ann
Arbor, MI, USA
OBJECTIVE: To perform an analysis of the cost of adverse events (AEs) associated with treatment by atorvastatin, fluvastatin, lovastatin, pravastatin, and simvastatin following NCEP low density lipoprotein-cholesterol
(LDL-C) guidelines. METHODS: Data come from a 54week randomized, open-label, double-blind controlled
trial conducted in 158 US centers between May 1997 and
January 1999. Patients (n 5 3916) with or without coronary heart disease and/or peripheral vascular disease
were randomized to receive atorvastatin (n 5 1958), fluvastatin (n 5 497), lovastatin (n 5 498), pravastatin (n 5
481), and simvastatin (n 5 482). Inclusion criteria included elevated LDL-C for patients 18–80 years of age.
Exclusion criteria included known hypersensitivity to
HMG-CoA reductase inhibitors, use of selected medications, and other patient characteristics. Data were collected on AEs. RESULTS: A total of 9707 AEs were reported during the trial. Of these AEs, 1327 (14%) were
related to the use of study medications. Related AEs involved the digestive system (387, 29%), musculoskeletal
system (356, 27%), central nervous system (269, 20%),
skin (124, 9%), abnormal laboratory values (68, 5%),
respiratory system (40, 3%), urogenital system (25, 2%),
cardiovascular system (24, 2%), and miscellaneous (35,
3%). The 1327 medication related AEs were associated
with the use of 1384 medical services. Many AEs were
treated at scheduled study visits (239, 18%) and did not
involve additional costs. Additional medical services typically consisted of physician office visits. There was one
hospitalization (gastroenteritis). Costs of AEs were measured at Medicare payment rates—a third party perspective. The average cost of treating AEs were similar among
study arms: atorvastatin $27.78, fluvastatin $31.78, lovastatin $26.58, pravastatin $25.17, and simvastatin
$32.58 (no differences were significant at p , 0.1).
CONCLUSIONS: Results suggest that the cost associated
with adverse events related to study medications did not
vary significantly among HMG-CoA reductase inhibitors
used to treat patients with elevated cholesterol levels.
PCV4
ASSESSING QUALITY OF LIFE IN PATIENTS SIX
MONTHS AFTER A MYOCARDIAL INFARCTION
USING THE SF-12
McBurney CR1,2, Erickson SR2, Kline-Rogers EM2, Cooper JV2,
Mani OCM2, Eagle KA2
1
Pfizer Inc., Ann Arbor, MI, USA; 2University of Michigan, Ann
Arbor, MI, USA
OBJECTIVES: To assess patients’ quality of life (HQL)
post-myocardial infarction and to identify related variables. METHODS: Patients admitted to the University of
Michigan Medical Center with diagnosis of MI were
identified consecutively and prospectively from October
1999 to May 2000. Clinical data were obtained retrospectively from medical records. Six months after discharge, patients were administered the Short Form-12
(SF-12), via telephone, to determine physical (PCS-12)
and mental (MCS-12) functional status. RESULTS:
Complete information was obtained from 148 patients.
The mean age of patients was 64.7 years (613.2) and
79.1% were male. The mean PCS-12 scores were 35.4
(69.12), and the mean MCS-12 scores were 51.6
(610.01). The median PCS-12 scores were significantly
lower in patients with an ejection fraction (EF) ,40%
(31.9 versus 38.4 for EF340%, p 5 0.02), and prior MI
(31.2 versus 38.5 without a history of MI, p 5 0.01),
congestive heart failure (CHF) (32.6 versus 37.4 without
a history of CHF, p 5 0.03), renal insufficiency (27.9
versus 37.7, p 5 0.003), or peripheral vascular disease
(29.4 versus 38.2 without a history of PVD, p 5 0.004).
The median MCS-12 scores were significantly lower for
patients under 65 years of age (49.6 versus 57.4 for patients 365 years of age, p 5 0.001) and with a history of
coronary artery bypass graft (CABG) (60.1 versus 54.7
without history of CABG, p 5 0.01). There were no differences detected between gender, type of MI, diabetes,
hypertension, angina, or smoking. CONCLUSIONS: HQL
scores were lower for patients post-MI with various comorbidities. Physical scores were significantly lower for
patients with low EFs, prior MI, or CHF. Mental scores
were significantly lower for patients ,65 and those not
having already undergone CABG surgery. Post-MI, particular attention should be paid to these patients. Further
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Abstracts
work is needed to determine whether interventions aimed
at these patients will result in improved quality of life.
PCV5
COST OF TREATMENT AND PREVALENCE OF
CARDIOVASCULAR DISEASE COMORBIDITIES
AND RISK FACTORS IN THE SEVERE AND
PERSISTENTLY MENTALLY ILL
Bellnier TJ1, Labrum A2, Karki SD1, Sundberg J2
1
SUNY University at Buffalo, School of Pharmacy, Buffalo, NY,
USA; 2University of Rochester, Rochester, NY, USA
OBJECTIVE: It has been estimated that 92% of geriatric
psychiatric patients have at least 1 comorbid physical disorder. The baby boomers will be turning 65 by 2011 and
over 130 million people will be over 45 by 2050. The severe and persistently mentally population have not been
extensively studied concerning comorbidities and physical and behavioral risk factors of cardiovascular disease.
We propose to determine the cost of treatment and prevalence of these comorbidities and risk factors in this population. METHODS: We conducted a chart review of all
adult inpatients (N 5 179) of a state psychiatric hospital
during July and August 2000. All subjects had a medical
history, physical exam, screening blood tests, ECG and
medical service utilization data collected. The cost of
treatment and prevalence of cardiovascular disease in our
population was compared to a control group of Medicaid
recipients matched for age and sex. RESULTS: Subject
Characteristics: 47 1 16 years; 113 male; 29% African
American, 10% Hispanic. Cardiovascular Disease Comorbidities: 40% ECG abnormalities, 15% Hypertension, 10% Diabetes, 7% Thyroid Dysfunction, 6% CAD.
Physical and Behavioral Risk Factors: 69% overweight
(BMI . 25), 38% obese (BMI . 30); 18% hyperlipidemia, 67% nicotine & 49% alcohol abuse, 35% chemically addicted. Cost of Treatment: Total cost: $2539
($2257–$2821), Cost of cardiovascular disease comorbidities: $3889 ($2105–$5673). CONCLUSION: 49%
had cardiovascular disease comorbidities. 62% had multiple behavioral and physical risk factors for developing
cardiovascular disease in their life time. The sample size
limits our ability to make population inferences yet an association between severe and persistently mentally ill patients and a increased risk for cardiovascular disease exists in our group (T 5 28.101, df 5 356, P , .00001).
This association is also evident in the greater cost of
treatment $1985 ($1518–$2452) of the severe and persistently mentally ill compared to the control group (T 5
4.78, df 5 108, P , .00001).
PCV6
ESTIMATING INCREMENTAL COSTS FOR
ADDITIONAL HOSPITAL DAYS
Friedman JY1, Reed SD1, Gnanasakthy A2, Schulman KA1
1
Duke Clinical Research Institute, Durham, NC, USA; 2Novartis
Pharmaceutical Corporation, East Hanover, NJ, USA
OBJECTIVE: Methods to develop resource costs from
administrative data remain underdeveloped. Our objective was to improve current methods of estimating daily
hospitalization cost by determining the pattern of resource utilization for patients hospitalized with cardiovascular-related diagnoses. METHODS: Using a proprietary cost-accounting system, we assessed the proportion
of total hospital costs for each hospital day for patients
within 10 DRGs. From these proportions, a series of
equations were developed to calculate cost for each day
of hospitalization. The dataset for this analysis included
records for 2,698 patients for FY 2000. RESULTS:
27.39% of costs occurred on Day 1 for medical DRG
127 (Heart Failure, ALOS 5 5). For each of the remaining four days the proportion of cost was 18.15%. For
surgical DRG 112 (PTCA, ALOS 5 3), 65.56% of costs
occurred on Day 1 and 17% occurred on each of the remaining two days. The average proportion of costs for
the first day of hospitalization and for each day thereafter
for the remaining medical and surgical DRGs were 30%
and 17%, and 62% and 19%, respectively. To illustrate,
the average cost per day of a DRG 112 hospitalization
was $4,333, totaling $13,000. By using the developed
equations, the cost for the first day of hospitalization was
calculated to be $8,500. The cost for each remaining day
was $2,238.60. In this example, use of an average cost
per day overestimates the marginal cost of the last day by
approximately $2,000. CONCLUSION: Average cost
per day grossly overestimates the cost savings of reduced
length of stay, especially for surgical diagnoses. The developed methodology will more accurately reflect any
cost savings from a reduced length of stay by accounting
for the greater intensity of care during the first day of a
hospital admission.
PCV7
COST-UTILITY ANALYSIS OF DRUG THERAPY
OPTIONS FOR INTERMITTENT CLAUDICATION
McGhan WF
University of the Sciences, Philadelphia, PA, USA
Peripheral artery disease manifests as intermittent claudication in over 4 million people in the US. In people older
than 60 years, intermittent claudication occurs in 5% of
men and 3% of women. OBJECTIVES: The purpose of
this study was to develop a cost-utility model to compare
cilostazol, pentoxifylline, and placebo based on published randomized control trial data. METHODS: In the
trial, 698 patients received either cilostazol 100 mg twice
a day, pentoxifylline 400 mg 3 times a day, or placebo.
Quality of life was measured with the SF-36. Survival
was projected to be similar between the three groups
from this study of 24 weeks duration and SF-36 was converted to a single utility score using the regression formula published by Bosch. RESULTS: On SF-36, cilostazol was significantly better on the physical components
over baseline. Pentoxifylline and placebo were not significantly different on either the physical or mental compo-
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Abstracts
nents over baseline. On the Bosch calculated single index,
cilostazol was better than pentoxifylline and placebo.
Pentoxifylline had a lower calculated QALY score than
cilostazol or placebo. Based on this model, cilostazol had
an incremental cost per QALY of $72,153 over placebo
and $21,294 over pentoxifylline. As expected the model
is sensitive to changes in price and utilities, and patients
who have substantial improvements in QOL scores over
baseline have better cost per QALY results. From a managed care perspective with a patient co-pay of 20%, the
patient’s incremental cost of cilostazol over placebo was
$14,431 per QALY and the managed care plan cost is
$57,722 per QALY. CONCLUSION: Based on this analysis of treatments for intermittent claudication, cilostazol
had a reasonable incremental cost per QALY over pentoxifylline or placebo. Lower cost per QALY results can
be obtained by continuing on therapy patients who attain
higher than average gains in quality of life scores from
baseline.
PCV8
PATIENT COMPLIANCE WITH DIFFERENT
PRESCRIBED REGIMENS OF DILTIAZEM IN
ANGINA PECTORIS: DATABASE ANALYSIS
IN FRANCE
Baptiste C1, Guilhaume C2
1
G.Y.D. institute, Lyon, France; 2Sanofi-Synthelabo, Bagneux,
France
OBJECTIVE: Patient compliance is an important component in the successful management of any disease. In
general, it is assumed that in disease states involving periodic, intense pain, such as angina pectoris (AP), compliance rates would be high, and unaffected by dosing
regimen. We verified this hypothesis by examining the
compliance rates of patients taking different formulations
(o.d. (200–300mg), b.d. (90–120mg) and t.d.s. (60mg))
of diltiazem (princeps) for AP. METHOD: We performed
a retrospective analysis of 3455 electronic patient records
with a diagnosis of AP and a prescription of diltiazem
(princeps) from June 1st 1997 to June 1st 1998 (Mediplus-IMS Health) with a one-year follow-up. The above
patient cohort was then divided into 3 subgroups according to the different formulation taken. The two subgroups b.d. and t.d.s. were paired to the third one, according to 4 criteria: age, sex, disease history and comorbidities. Compliance was assessed using initial prescription and refill rates ((pills dispensed/daily dose)/duration of therapy). RESULTS: The proportion of patients
showing “good compliance” (. 0.8) was significantly
higher for the o.d. versus b.d. (36.1% versus 25.9%, p 5
0.001) and for the o.d. versus t.d.s. (36.1% versus
27.1%, p 5 0.008). We observed the same trend when
we compared the mean rate of compliance for the o.d.
versus b.d. (0.62 versus 0.55, p 5 0.0027) and for the
o.d. versus t.d.s. (0.62 versus 0.60, p 5 0.0121). CONCLUSION: Even for life threatening cardiac disease like
AP, dosing regimens have a significant effect on compli-
ance. Giving diltiazem as an o.d. formulation could significantly improve compliance and potentially decrease
health care resources used.
PCV9
AN ECONOMIC ANALYSIS OF CONGESTIVE
HEART FAILURE (CHF) IN THE LOUISIANA
MEDICAID PROGRAM
Ogale SS, Blake SG, Biglane GC, Medon PJ
The University of Louisiana at Monroe, Monroe, LA, USA
OBJECTIVE: To examine the cost of illness of Congestive Heart Failure (CHF) in the Louisiana Medicaid program. METHODS: Study design: A retrospective review
of the medical and pharmacy claims data (1999–2000) in
the Louisiana Medicaid program. We reviewed pharmacy
and medical claims data for the years 1999–2000 from
the Louisiana Medicaid program. The data were obtained from Unisys, the fiscal intermediary for the Louisiana Medicaid program, in a PC compatible format. We
extracted the claims for CHF patients on the basis of the
ICD-9-CM codes. A total of 13,947 patients met the
study criteria, which included at least one primary or secondary diagnosis of CHF and availability of claims data
for at least one year after the first CHF diagnosis related
claim. We reviewed all the charges incurred for a oneyear period after the initial CHF claim. RESULTS: The
total cost for CHF patients for one year was over $182
million. The majority of the patients (73.63%) were female and accounted for 70% of the total cost. The mean
age was 70 years and the largest portion of the total cost
(55%) came from those 65 years and older. Of the
13,947 patients 11,065 (79%) were hospitalized at an
average cost of $4,679 per hospitalized patient. Approximately 87% of the study population received prescription
drugs at an average cost of $2,897 per prescription drug
user. Hospitalizations and prescription drugs contributed
28% and 19.38% respectively to the total cost. Almost
one third of the total cost was due to long-term care at
$13,817 per utilizer. Costs for CHF diagnosis related
claims were 14% of all costs. CONCLUSION: CHF represents a significant financial burden from the perspective
of the Louisiana Medicaid program. Improved management of the condition is needed to reduce the cost of
treatment associated with CHF.
PCV10
INCIDENCE OF RHABDOMYOLYSIS IN
PATIENTS INITIATED ON HMG CO-A
REDUCTASE INHIBITOR THERAPY IN A
MANAGED CARE ORGANIZATION
White TJ, Chang EY
Prescription Solutions, Costa Mesa, CA, USA
Recent evidence suggests there is an increased risk of
rhabdomyolysis in patients initiated on cerivastatin compared to patients initiated on other HMG CoA reductase
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Abstracts
inhibitors (HMGs). OBJECTIVE: The primary objective
is to determine if there are differences among specific
HMGs regarding the incidence of rhabdomyolysis. The
secondary objective is to identify significant risk factors
associated with rhabdomyolysis such as age, gender, and
concurrent gemfibrozil use. METHODS: Retrospective
pharmacy and medical claims from a large managed care
organization were analyzed. Patients were included if
they received any HMG (cerivastatin, fluvastatin, atorvastatin, lovastatin, pravastatin, or simvastatin) during
the period between 7/1/99 to 12/31/99. All patients were
followed for 6 months. ICD-9 diagnosis codes for rhabdomyolysis (idiopathic), myalgia and myositis not otherwise specified, or adverse effect to antilipemics were used
to define rhabdomyolysis events. RESULTS: There were
133,454 patients identified who received an HMG during
the identification period. The average age was 67.8 years
(S.D. 5 11.1) and 51.5% were female. The rates of rhabdomyolysis with and without concurrent gemfibrozil use
were 0.861% and 0.632%, respectively (P 5 0.13).
Overall, the incidence across individual drugs was similar
for cerivastatin [0.486%(95%CI 5 0.363%–0.609%)],
fluvastatin [0.679%(95%CI 5 0.589%–0.769%)], atorvastatin [0.889%(95%CI 5 0.783%–0.995%)], lovastatin [0.741%(95%CI 5 0.158%–1.332%)], pravastatin
[0.530%(95%CI 5 0.468%–0.592%)], and simvastatin
[0.378%(95%CI 5 0.212%–0.544%)]. With concurrent
gemfibrozil use, the incidence was significantly higher for
cerivastatin [6.341%(95%CI 5 3.005%–9.677%)] compared to fluvastatin [0.713%(95%CI 5 0.000%–1.439%)],
atorvastatin [0.494%(95%CI 5 0.062%–0.926%)], lovastatin (0.0%), pravastatin [0.452%(95%CI 5 0.091%–
0.813%)], and simvastatin (0.0%). In a logistic regression model, there was no significant relationship between
the incidence of rhabdomyolysis and age or gender.
CONCLUSION: In this population, it appears that the
risk of rhabdomyolysis is substantially higher when cerivastatin is used concurrently with gemfibrozil. The findings of this analysis indicate there is a substantial need
for managed care organizations and pharmacy benefits
management companies to proactively prevent the concurrent use of cerivastatin and gemfibrozil.
PCV11
COST OF WARFARIN TREATMENT OF ATRIAL
FIBRILLATION IN CLINICAL PRACTICE
Abdelhafiz AH, Wheeldon N
Sheffield University, Sheffield, UK
OBJECTIVES: Trials of anticoagulation in non-rheumatic atrial fibrillation have demonstrated a reduction in
the risk of stroke by two-thirds. In these trials, the safety
of anticoagulation appeared good, but this may be related to highly selected patient groups. Exclusion rates of
93% were reported. Participants may have had fewer
complications than might be expected among less selected patients in clinical practice. No trials had actually
looked at the costs of anticoagulation in a real day-to-day
clinical practice. The aim of this study is to investigate
the actual cost of warfarin treatment of atrial fibrillation
in a real clinical practice. METHODS: A one-year retrospective study involving patients of all ages admitted to
hospital with non-rheumatic atrial fibrillation on longterm oral anticoagulation. Patients were interviewed and
their medical records reviewed. The costs of anticoagulation were viewed as follows: 1. The cost of the active
drug. 2. The cost of monitoring the patient’s INR i.e.
traveling costs, staffing cost, and analysis costs. 3. The
costs associated with bleeding complications. RESULTS:
We studied 139 patients. The mean (SD) age was 73.6
(8.9) years, ranging from 41 to 93 years. The mean duration of oral anticoagulant therapy was 36 months (range
2 to 105 months), forming a total of 417 patient-years of
treatment. Mean (SD) INR was 2.5 (0.36). The target
range of 2.0–3.0 was achieved 54% of the time. Bleeding
occurred in 21 patients, with incidence of 7.2% per patient-year for minor bleeding, 2.4% per patient-year for
major bleeding and 0.2% for fatal bleeding. The cost of
warfarin tablets was £14.6 ($23.36), per patient-year,
but was £262.6 ($420.16), per patient-year after considering monitoring and bleeding complication costs. The
cost per stroke prevented was estimated at £8,141
($13,026). CONCLUSION: Anticoagulation appeared
safe and cost-effective in clinical practice but control was
not as good as in clinical trials.
PCV12
QUALITY OF CARE IN OLDER PATIENTS
ADMITTED TO HOSPITAL WITH
HEART FAILURE
Abdelhafiz AH, Wheeldon N
Sheffield University, Sheffield, UK
OBJECTIVES: To evaluate the quality of care given to
older patients hospitalised with heart failure and to identify areas in which treatment could be improved. METHODS: A two-year retrospective study involving the analysis of the case notes of a random sample of 145 elderly
patients (aged >75 yrs) admitted to hospital with heart
failure. From The International Classification of Diseases, we identified patients with a principle discharge diagnosis of heart failure (ICD codes 428.0-428.1-428.9).
Cases were excluded if the diagnosis could not be validated by medical record review. A total of one hundred
and forty five patients formed all the admissions with
heart failure during the study period. The standard of
care received was evaluated using the relevant quality of
care indicators derived from the Agency for Health Care
Policy and Research (AHCPR) Clinical Practice Guidelines. RESULTS: The study sample included 145 patients.
The mean age (SD) was 82 (5) years. Symptoms and signs
of heart failure were documented in 145 (100%) patients. All patients with symptoms and signs of hypervolaemia received diuretic therapy. Only fifty-five patients
(38%) had an objective assessment of left ventricular
100
Abstracts
function by echocardiography. After exclusion of patients in whom Angiotensin Converting Enzyme (ACE)
inhibitors were contraindicated, only seventy-five (58%)
patients received ACE inhibitors of whom, only 7 (9%)
patients received the target dose recommended by the
clinical practice guidelines. There was no documentation
in the records regarding patient counselling about medication, diet, weight, exercise or smoking. CONCLUSION: ACE inhibitors were underused in elderly patients
with heart failure; also achieving the target dose was
poor. This data demonstrated a very low rate of use of
echocardiography in elderly patients with heart failure.
Counseling appeared to be a neglectedaspect of patient
care.
PCV13
IMPACT ON QUALITY ADJUSTED LIFE YEARS
OF ENOXAPARIN FOR PREVENTING
THROMBOSIS AMONG HOSPITALIZED
MEDICAL PATIENTS
Raisch DW1, Fye CL1, Sather MR1, Henderson WG2,
Reda DJ2, Sacks JM2, Lederle FL3
1
Veterans Affairs Cooperative Studies Program, Albuquerque,
NM, USA; 2Veterans Affairs Cooperative Studies Program,
Chicago, IL, USA; 3VA Medical Center, Minneapolis, MN, USA
OBJECTIVES: Prophylactic anticoagulants, such as low
molecular weight heparin, to prevent thrombosis in hospitalized medical patients has been recommended in clinical guidelines, however the impact on quality adjusted
life years (QALYs) is unclear. This pilot study evaluated
enoxaparin for this indication among elderly (.age 59)
hospitalized medical patients. METHODS: Patients were
randomized to receive subcutaneous injections of enoxaparin 30 mg or placebo daily. Patients who had medical
indications for anticoagulation (e.g., myocardial infarction, history of thrombosis) were excluded. QALYs were
measured for the period of 30 to 90 days post randomization, using the Health Utilities Index(HUI). At 30 and
90 days, 51 and 40 patients in the active group completed the HUI versus 49 and 36 patients in the placebo
group, respectively. Surveys were received at both time
points among 40 enoxaparin and 21 placebo patients.
QALYs and changes in domain scores were analyzed
over the time between the two surveys. Data were analyzed using t-tests. RESULTS: Significantly more QALYs
were gained (p 5 .007)among enoxaparin treated patients. The mean QALY values were 0.005 6 0.015 vs
20.008 6 0.015. The change in the HUI, Mark III domain score for ambulation approached significance (p 5
0.053. The mean values were 0.012 6 0.098 for enoxaparin versus 20.027 6 0.056 for placebo. A significant
change in the HUI, Mark II domain score for mobility
was found (p 5 0.017, mean values 0.015 6 0.064 versus 20.022 6 0.050). CONCLUSION: Among medical
patients prophylactic treatment with enoxaparin was associated with increased QALYs.
PCV14
IMPACT OF OBESITY ON HEALTH-RELATED
QUALITY OF LIFE (HRQOL): AN ANALYSIS OF
BEHAVIORAL RISK FACTOR SURVEILLANCE
SYSTEM (BRFSS) DATA
Hassan M, Joshi AV, Madhavan S, Amonkar M
West Virginia University School of Pharmacy, Morgantown,
WV, USA
OBJECTIVES: With over one-third of the population
considered to be obese, obesity has reached epidemic proportions in the US The direct costs associated with obesity are currently estimated at about $238 billion. As the
underlying cause of various chronic diseases, obesity negatively impacts quality of life due to impaired physical
and mental well being and reduced daily functions. The
objective of this study is to evaluate the relationship between obesity and health-related quality of life using the
Centers for Disease Control and Prevention’s (CDC) Behavioral Risk Factor Surveillance System (BRFSS) data.
METHODS: The BRFSS is an ongoing, state-based, random digit dialed telephone survey of the civilian, noninstitutionalized population aged 3 18 years conducted by
CDC. Data from sixteen states that collected information
on health status (4 items), HRQoL (10 items), and demographic characteristics including weight and height from
50,454 participants in 1998 were utilized for the analysis. Participants who had a Body Mass Index (BMI) 3 30
were defined as obese. Prevalence of obesity by demographics and disease presence was determined, as were
corresponding HRQoL scores. RESULTS: On the basis
of BMI, 31.9% of the respondents were identified as
obese. Obesity was higher in males as compared to females and higher among African-Americans and Hispanics as compared to whites. Obesity increased with age but
decreased as income and education increased. Obese respondents reported poorer health status. Impact of obesity on HRQoL due to reduced physical and mental functioning in the presence of no health problems, as well
as in presence of self-reported major health problems
such as arthritis, cardiovascular disease, diabetes, cancer,
depression, and pulmonary disease is discussed. CONCLUSIONS: Health related quality of life is significantly
affected due to obesity and should be an important consideration in the treatment of obesity. It also has important implications in case of illnesses that have obesity as
an underlying cause.
PCV15
ECONOMIC EVALUATION OF OUTPATIENT
ANTICOAGULANT/ANTIPLATELET THERAPY
FOLLOWING CORONARY STENTING IN A
MANAGED CARE POPULATION
Liao E, Fronk M, Newell J, Huse D
PharMetrics, Inc, Watertown, MA, USA
OBJECTIVE: To determine the impact of outpatient anticoagulant/antiplatelet therapy on treatment charges in
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Abstracts
patients receiving coronary artery stents in a managed
care population. METHODS: Patients were selected
from the PharMetrics Integrated Outcomes Database
who underwent coronary angioplasty and stent insertion
between January 1 and June 30, 1999 and who had at
least 6 months of continuous enrollment in their health
plan following the beginning of the treatment episode.
Patients were grouped according to whether they received
outpatient anticoagulant/antiplatelet prescription drug
therapy following their stent procedure. Patients were
also stratified by history of acute myocardial infarction
(AMI) and presence of comorbid conditions (diabetes
and hypertension). Total charges associated with the
stenting treatment episode (up to 6 months following the
procedure) were assessed. RESULTS: 2,713 patients receiving anticoagulant/antiplatelet therapy and 438 untreated patients met all selection criteria. The two treatment groups were similar in age (58.6 vs. 58.0 years
respectively, p 5 0.322) and in the frequency of AMI
(37.7% vs. 37.9% respectively, p 5 0.939) and of one or
more comorbidities (73.3% vs. 71.5% respectively, p 5
0.427). Mean charges over the study period for the anticoagulant/antiplatelet cohort exceeded those in the untreated cohort by $4,748 (p 5 0.014). Pharmacy charges
accounted for only $297 of this excess ($660 vs. $363,
respectively). Most of the difference between treatment
groups was in the medical costs of interventional cardiology. CONCLUSION: Among coronary stent recipients,
the mean charge for a 6-month period in patients who
also received anticoagulant/antiplatelet prescription drug
therapy was 14% higher than in the untreated cohort,
due mainly to higher medical charges. It is possible that
untreated patients were less severely ill or had a favorable
risk profile. Further investigation of these data will examine this issue.
PCV16
COST-EFFECTIVENESS ANALYSIS OF
ENOXAPARIN VERSUS UNFRACTIONATED
HEPARIN IN ACUTE CORONARY SYNDROME
PATIENTS IN POLAND
Orlewska E1, Budaj A2, Tereszkowski-Kaminski D3
1
Medical University of Warsaw, Warsaw, Poland; 2Postgraduate
Medical School, Grochowski Hospital, Warsaw, Poland;
3
Uniformed Services Health Fund, Warsaw, Poland
OBJECTIVE: To estimate the cost-effectiveness of enoxaparin (1 mg/kg s.c. bid) vs unfractionated heparin
(UFH) (i.v. bolus and constant infusion adjusted to maintain a therapeutic APTT) in acute coronary syndrome
(ACS) patients from a Polish hospital perspective. The intention was to facilitate the decision-making process in
selecting the most cost-effective treatment for ACS.
METHODS: Decision model was used to quantify costs
and effectiveness of alternative treatments. Published results from ESSENCE study were used to estimate the
probability for clinical end-points (death, MI, recurrent
angina) at 30 days. Probabilities of patients receiving
revascularisation procedures were obtained from the
GRACE registry (961 patients at 6 centres in Poland).
The analysis assessed only direct medical costs resulting
from the treatment of events comprising the composite
end-point, revascularisation procedures, enoxaparin and
UFH therapy, related medications. The costs were determined from actual resource consumption on a patientspecific basis (6 months observational study) and estimated using Polish data on unit costs. One- and two-way
sensitivity analysis and treshold analysis were performed.
RESULTS: At 30 days 19,8% of patients receiving enoxaparin compared with 23,3% of patients receiving UFH
reached one event of the composite end-point (p 5 0,02).
The average costs (in PLN, 1 USD 5 4 PLN) were 1085
per patient receiving enoxaparin compared with 1097 per
patient receiving UFH. Therefore for every 29 patients
treated, enoxaparin therapy would not only avoid one
event of the composite end-point, it would also save 348
PLN. The threshold analysis revealed, that enoxaparin
would lose the dominance, when cost of enoxaparin therapy would increase by 30%, cost of UFH—decrease by
47%, probability end-point in enoxaparin arm increase
to 0.22 or in UFH arm decrease to 0.2. CONCLUSION:
Since enoxaparin resulted in a better effect at a lower
cost, this antithrombotic strategy was considered to be
dominant for Polish patients with ACS.
PCV17
QUALITY OF LIFE AND PATIENT PREFERENCE
AS PREDICTORS FOR RESOURCE UTILIZATION
AMONG PATIENTS WITH HEART FAILURE;
INTERIM ANALYSIS
Shin GP1, Tooley JF2, Southworth MR1, Dunlap S1, Boyer JG2,
Johnson NE1
1
University of Illinois at Chicago, Chicago, IL, USA; 2Pharmacia,
Skokie, IL, USA
OBJECTIVE: The objective of this study was to examine
the role of quality of life (QOL) and patient preference as
predictors for resource utilization among patients with
heart failure (HF). METHODS: QOL, patient preference,
resource utilization, and survival are being assessed in 94
patients with HF managed in an urban HF specialty
clinic. QOL is measured using a disease-specific questionnaire, the Kansas City Cardiomyopathy Questionnaire
(KCCQ) and a generic questionnaire, the Short Form 12
(SF-12), at baseline, 3 months, and 6 months. Patient
preference is measured using standard gamble technique
at baseline. Resource use including hospitalization, ER
visits, procedures, and outpatient visits are captured by
patient interview and verified by clinic and hospital
records. Health care costs are derived from clinic cost
data, University Health System Consortium database,
and literature. RESULTS: To date, 81 patients have completed 3 months follow-up (mean age 49.9 6 14.0 years;
69% African American; 53% male; NYHA class I 5 15,
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Abstracts
II 5 24, III 5 38; mean left ventricular ejection fraction 5
34.3% 6 15.5). Mean disease-specific QOL (KCCQ
Overall Summary Score 5 66.9) and generic QOL (Physical Component Summary 5 38.7; Mental Component
Summary 5 48.2) were similar to literature values for HF
patients. Mean utility was 0.832. Using linear regression,
lower KCCQ scores, SF-12 scores, and utility at baseline
were all significantly associated with higher resource utilization at 3 months. When patients were grouped into
three categories based on their baseline KCCQ Overall
Summary Score (I 5 0–50, II 5 .50 to £75, III 5 .75),
resource utilization over 3 months was significantly different across the groups (I 5 $4033; II 5 $2500; III 5
$2010; p 5 0.0003). CONCLUSION: Among patients
with HF, QOL and patient preference appear to predict
future resource utilization.
PCV18
FRAMINGHAM RISK EQUATIONS PREDICT
HOSPITAL USAGE AND MORTALITY
Milne RJ, Gamble GD, Whitlock G, Jackson RT
University of Auckland, Auckland, New Zealand
Risk equations based on the Framingham Heart Study
(FHS) are used in NZ to predict the 5y risk of incident
cardiovascular (CV) events. OBJECTIVE: To establish
how well the FHS equations predict first hospitalisation
or mortality from CV events in a New Zealand (NZ)
population without overt CV disease. METHODS: Observations were taken from a cohort study with 6354
(4638 M 11716 F) participants age 32–74 without
known CV disease, taken from the workforce of a nation-wide multi-industry corporation plus a random sample of the Auckland electoral rolls. Prognostic factors
were assessed in 1992/93 by a questionnaire plus physiological measurements (BP, cholesterol etc.). Age-specific
risk predictions from the FHS were compared with agespecific mortality plus relevant hospital discharges from
January 1988 to December 1998 (NZ Health Information Service). RESULTS: The 5y incidence of first hospitalisation for any CV event was 6.4% (male) and 4.4%
(female). Table 1 compares observed hospitalised events
or mortality with predicted incident events, averaged
across 5y age bands.
Ratio of observed to predicted events, averaged across 8 3
5y age bands
Mean ratio (6SD)
CHD
MI
STROKE
Male
Female
Both
1.03 6 0.15
1.24 6 0.19
0.98 6 0.40
0.92 6 0.35
1.49 6 1.19
0.74 6 0.57
1.03 6 0.06
1.26 6 0.15
0.94 6 0.42
CONCLUSIONS: FHS risk equations accurately predict
age-specific incident hospitalized CHD or stroke events
or mortality for NZ males age 30–74 but under-estimate
MI events. Prediction is less accurate and precise for females.
PCV19
DISCRIMINABILITY FOR RISK OF
CARDIOVASCULAR EVENTS
Milne RJ, Gamble GD, Whitlock G, Irwin RJ, Jackson RT
University of Auckland, Auckland, New Zealand
Risk equations based on the Framingham Heart Study
(FHS) are used in NZ to predict the 5y risk of an incident
CV event for individuals without cardiovascular (CV)
disease. OBJECTIVES: To establish in a NZ population
without overt CV disease: (i) the discriminability of the
relevant FHS risk equation for prediction of first hospitalisation or mortality for any cardiovascular event; (ii)
whether FHS risk equations have better discriminability
than single risk factors. METHODS: Observations were
taken from a cohort study with 6354 (4638 M 1 1716 F)
participants age 32–74 without known CV disease, taken
from the workforce of a nation-wide multi-industry corporation plus a random sample of the Auckland electoral
rolls. Prognostic factors were assessed in 1992–93 by a
questionnaire plus physiological measurements (BP, cholesterol etc.). Outcomes data were CV mortality and hospital discharges from Jan. 1988 to Dec. 1998 (NZ Health
Information Service). Risk predictions were compared
with outcomes, and receiver-operator characteristics
(ROC) curves were constructed. The area under the ROC
curve was obtained by fitting a dual-Gaussian unequal
variance model. RESULTS: Table 1 shows the area under
the ROC curves.
Area under ROC curves (695% CI).
FHS
Age
SBP
Chol/HDLc
BMI
Male
Female
Total
.72 6 .030
.70 6 .029
.62 6 .034
.61 6 .034
.56 6 .034
.78 6 .055
.77 6 .058
.69 6 .062
.64 6 .066
.61 6 .063
.74 6 .025
.71 6 .026
.64 6 .030
.63 6 .030
.58 6 .029
CONCLUSIONS: FHS risk equations or age alone provide moderate discriminability for individuals with 5y
risk of a CV event that requires hospitalisation. SBP and
serum lipids have weaker discriminability.
PCV20
ASSESSING THE TOTAL COST OF
MANAGEMENT OF A PATIENT WITH DEEP VEIN
THROMBOSIS (DVT) IN FRANCE AND IN ITALY
Levy E1, Gabriel S2, Dinet J2, Rudelli G3
1
University Paris-Dauphine, Paris, France; 2Sanofi-Synthelabo,
Bagneux, France; 3Sanofi-Synthelabo SPA, Milano, Italy
OBJECTIVES: Economic studies on the cost of DVT usually take into account the acute care costs only although
the patients are treated and followed-up after hospital
discharge for at least six months. We calculated the true
economic burden of the disease. METHODS: We assessed from the Health Care System perspective the total
cost of managing a patient with DVT over a one-year
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Abstracts
period in France and in Italy. For assessing the inpatients
costs, we used the National inpatient Diagnosis Group
data base in France and in Italy. We studied the patient
profile, the mean length of stay and the subsequent complications. Data on outpatient care for DVT were based
on literature, questionnaire filled in by practitionners,
ambulatory care data base (in France) and compared to
practice guidelines. Inpatient and outpatient costs were
combined to provide total costs of care for DVT over an
one-year period. In addition, we modelled, from published data, the risk of pulmonary embolism (PE) and
DVT recurrences, and we costed these complications.
RESULTS: The average French inpatient cost for DVT is
3,220 Euros (average length of hospital stay: 9.6 days)
while this cost is 2,865 Euros in Italy (average length of
hospital stay: 7 days). In both countries, the total cost of
management of a DVT patient over an one-year period
was calculated to be at least 30% higher than the only
costs of acute care. CONCLUSION: The assessment of
the global economic burden of DVT has to take into account the costs occurring after hospital discharge. Our
approach was conservative as we did not take into account the risk of occurrence of Post Phlebitic Syndrome
and its economic consequences.
PCV21
COST-EFFECTIVENESS ANALYSIS OF
ABCIXIMAB, EPTIFIBATIDE, AND TIROFIBAN IN
PATIENTS WITH CORONARY SYNDROMES
Shahriar J, Shaw JW, Malone D
The University of Arizona, Tucson, AZ, USA
BACKGROUND: In recent years, significant advances
have been made in the pharmaceutical treatment of coronary syndromes. The GPIIb/IIIa receptor antagonists
have been shown to increase the success rate of invasive
procedures, such as PTCA. However, acquisition costs
for these agents are high when compared with traditional
therapy (i.e., heparin). Three GPIIb/IIIa receptor antagonists have been approved for use by the US Food and
Drug Administration. OBJECTIVE: To assess the relative
cost-effectiveness of abciximab, eptifibatide, and tirofiban when treating US patients with coronary syndromes.
METHODS: A decision analytic model compared the
three drugs on the basis of major bleeding events and myocardial infarction. Costs included those for medications
and adverse events. Transition probabilities were based
on published trials and clinical judgement. The time horizon for the model was 30 days. Cost-effectiveness ratios
were computed for the three agents and rank order stability analysis used to test the robustness of results. A hospital perspective was adopted for the analysis. RESULTS:
Average per-patient treatment cost was $1,393, $2,480,
and $2,409 for eptifibatide, abciximab, and tirofiban, respectively. The probability of successful treatment (i.e.,
no bleeding or myocardial infarction) was 0.86, 0.89,
and 0.78 for eptifibatide, abciximab, and tirofiban, re-
spectively. The cost per successfully treated patient was
$1,616, $2,799, and $3,080 for eptifibatide, abciximab,
and tirofiban, respectively. The incremental cost of eptifibatide was $45,292 less than abciximab and $12,700 less
than tirofiban per successfully treated patient. Estimates
of cost-effectiveness were robust to alterations in model
parameters. In order for eptifibatide and abciximab to be
equally cost-effective, the bleeding rate for eptifibatide
would have to increase by 26.9% or the probability of
myocardial infarction for eptifibatide would have to increase by 12.8%. CONCLUSIONS: Results indicate that
the higher costs of abciximab and tirofiban may not be
justified when treating US patients with coronary syndromes. Our model was limited by the availability of
event probability estimates for eptifibatide and tirofiban.
PCV22
IN-PATIENT AND OUT-PATIENT RESOURCE
UTILIZATION AMONG PATIENTS WITH ACUTE
ISCHEMIC STROKE—THE VA EXPERIENCE
L’Italien GJ1, Williams LS2, Weinberger M2
1
Bristol-Myers Squibb, Wallingford, CT, USA; 2Roudebush
Veterans Affairs Medical Center, Indiana University School of
Medicine, Regenstrief Institute for Health Care, Indianapolis, IN,
USA
OBJECTIVE: To study patterns of medical resource utilization among VA patients following admission to VA
hospitals for acute ischemic stroke. METHODS: All VA
patients were identified with a first-listed live discharge
diagnosis of acute ischemic stroke between 1991 and
1997. The frequency and type of re-admissions, total bed
section days, and of outpatient clinic visits was measured.
RESULTS: A total of 49,101 patients were identified.
Mean age of the predominantly male (98.2%) cohort was
67.8 years and 72.5% were Caucasian. Over 48% of patients were re-hospitalized, and 13% of these re-admissions were for recurrent stroke. There were an average of
3.3 re-admissions and the mean time to readmission was
0.9 years. Readmitted patients spent most days in rehabilitation wards (26.8 days), followed bygeneral/acute
medicine wards (22.5 days), surgery (15.1 days). neurology (14.9 days), and cardiology (8.5 days). Thirty-five
percent of outpatient medical clinic visits were to specialty clinics and 41% of these visits were to neurology
followed by cardiology (22%) and Coumadin clinics
(21%). CONCLUSIONS: Hospitalization for recurrent
stroke is high among VA stroke patients and much of the
inpatient and outpatient resource utilization is associated
with stroke rehabilitation and neurologic care. Efforts
should focus on innovations in acute stroke treatment to
improve the functional status of these patients at the time
of the index admission and reduce the incidence of subsequent adverse events.
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Abstracts
PCV23
PHARMACOECONOMIC EVALUATION OF
USAGE OF UNFRACTIONATED HEPARIN AND
LOW MOLECULAR WEIGHT HEPARIN IN THE
TREATMENT OF DEEP VEIN THROMBOSIS IN
LONG-TERM CARE RESIDENTS
Karki SD1, Bellnier TJ1, Karki J1, Patterson W2, Masood R2
1
SUNY University at Buffalo School of Pharmacy, Buffalo, NY,
USA; 2Clifton Springs Hospital & Clinics, Clifton Springs, NY, USA
OBJECTIVE: Nursing home residents with acute proximal deep-vein thrombosis (DVT) are usually transferred
to the hospital and treated initially with unfractionated
heparin administered by continuous infusion for five to
seven days. The anticoagulant response to this treatment
varies markedly among patients and therefore the dosage
must be adjusted by measuring the activated partialthromboplastin time closely. With the availability of low
molecular weight heparins and their proven efficacy and
safety in treatment and prophylaxis of deep vein thrombosis and no need to closely monitor any parameter and
adjust the dosage, it has become possible to treat DVT in
nursing home setting. We describe our findings of the economic implications of two different therapies. METHOD:
All residents treated for DVT in the last 2 years were
identified and their charts reviewed as to the use of heparin or enoxapirin (formulary LMWH in our institution).
Charts of 25 residents from each group matched for sex
and age were randomly reviewed as to efficacy, transfer
to hospital, days of hospitalization and costs of treatment. RESULTS: The residents, in the heparin arm, were
transferred to the hospital, treated with continuous heparin infusion, initiated on warfarin therapy and then
transferred back to the nursing home. The hospitalization
ranged from 5–15 days and the mean hospitalization cost
was $4196 1 225. Of the residents on enoxapirin arm,
only 9 residents were transferred to the hospital and the
hospitalization ranged from 3–5 days. The mean hospitalization and nursing home costs were $2258 1 150.
There was additional drug cost $490 in the heparin arm
and $800 in the of enoxapirin arm resulting in cost saving of $1628 per resident in the enoxapirin arm CONCLUSION: Our results indicate that enoxapirin is costeffective in the treatment of DVT in the nursing home
residents.
PCV24
BEYOND THE FIRST YEAR: PATTERNS AND
PREDICTORS OF LONG-TERM STATIN
UTILIZATION
Benner JS1, Federman AD1, Smitten AL2, Duty S2, Glynn RJ1,
Avorn J1
1
Brigham and Women’s Hospital, Harvard Medical School,
Boston, MA, USA; 2Harvard School of Public Health, Boston,
MA, USA
INTRODUCTION: Noncompliance with lipid-lowering
medications has important implications for clinical and
economic outcomes of therapy. Little is known about
long-term utilization of HMG Co-A reductase inhibitors
(statins) because previous data have been based on
closely monitored trials or have observed patients for
short periods of time. OBJECTIVE: To describe patterns
and predictors of long-term compliance with statin therapy in a US elderly population. METHODS: Cohort
study (n 5 607) of enrollees in the New Jersey Medicaid
and Pharmacy Assistance for the Aged and Disabled
(PAAD) programs aged 65 and older who began statin
therapy in the first half of 1990. Filled prescription data
were used to assess the proportion of days with any statin
available in each of 12 consecutive 6-month intervals after initiation of therapy. Demographic and clinical predictors of noncompliance, measured at baseline, were
identified using linear models for repeated measures. RESULTS: Mean days with statin available was 64% in the
first 6 months of therapy and 45% in the next 6 months;
it then decreased linearly to 32% at the end of year 6.
The proportion of patients with 80% of days covered
was 41% in the first 6 months, 30% in the next 6
months, and 25% at the end of year 6. After controlling
for baseline demographic and clinical variables, lower
compliance in years 2 through 6 was significantly associated with duration of treatment, black race, lower income, older age, and taking fewer other medications. By
contrast, first-year compliance was significantly better
among blacks than other races and age was not associated with utilization. CONCLUSIONS: Compliance with
statin therapy declines over time, with the greatest reductions occurring in the first year of treatment. Predictors
of short- and long-term compliance differ, with long-term
noncompliance most strongly predicted by age, race, and
socioeconomic status.
PCV25
CHD RISK FACTORS AND THERAPY DURATION
OF HMG-COA REDUCTASE INHIBITORS
(STATINS) IN A MEDICAID POPULATION
Nichol MB1, Bron MS1, Yu W2
1
University of Southern California, Los Angeles, CA, USA;
2
Wellpoint Pharmacy Management, Thousand Oaks, CA, USA
INTRODUCTION: The purpose of this research is to
explore the relationship between the number of CHD
risk factors (RF) and duration of therapy of statins. CHD
risk factors play an important role in choice and goals of
lipid-lowering therapy. OBJECTIVE: To determine if the
median duration of therapy differs among Medicaid hypercholesteremic patients with 0,1,2 and 3 or greater
CHD risk factors who were treated with statins currently
on formulary. METHODS: Retrospective database analysis of pharmacy claims data for an intent-to-treat analysis of Medicaid monotherapy statin patients. Patients
were required to be eligible 35 days before and 365 days
after the first statin prescription. New patients (n 5 767)
must have a 90 day washout period. Continuing patients
(n 5 1191) do not. The Medians test was used for non-
105
Abstracts
parametric data. OLS regression tested the relationship
between duration of therapy and presence of CHD risk
factors. RESULTS: For each statin, days on therapy differed significantly (p , 0.001) by the number of risk factors. The number of CHD risk factors was positively significant in predicting duration of therapy (p , 0.0001) in
both new and continuing therapy. Duration of therapy
was associated with an increase of 48 days for each risk
factor for new patients and 58 days for continuing patients.CONCLUSIONS: Number of CHD risk factors is
positively correlated with length of therapy when using
statins as lipid lowering therapy for new and continuing
patients.
Statin
Overall Median
atorvastatin
fluvastatin
pravastatin
Risk Factors (RF): 0
RF: 1
RF: 2
RF: 3 OR 4
305
345
289
303
431
419
428
444
481
424
505
469
550
562
568
533
PCV26
CARING FOR HYPERTENSION ON INITIATION:
COSTS AND EFFECTIVENESS (CHOICE). DESIGN
AND RATIONALE OF A NATURALISTIC STUDY
Payne K1, Caro J1, Hollenberg N2, Jackson J3, L’Italien G3, for
the CHOICE Study Group
1
Caro Research Institute, Dorval, QC, Canada; 2Harvard
Medical School and Brigham and Women’s Hospital, Boston,
MA, USA; 3Bristol-Myers Squibb, Princeton, NJ, USA
INTRODUCTION: Naturalistic studies are essential to
prospectively study real-world antihypertensive treatment OBJECTIVE: to evaluate the feasibility of performing a naturalistic study in newly diagnosed hypertensives
in terms of enrollment, adequacy, timeliness of data collection, and study procedures. METHODS: CHOICE
prospectively collected actual practice data on the treatment of newly-diagnosed hypertensive patients. Initial
therapy was randomly assigned to either Group 1 (beta
blockers or diuretics) or Group 2 (ACE inhibitors or calcium channel blockers). The protocol made no demands
in scheduling visits or changing treatment during followup. Physicians were blind to study purpose and hypotheses. Only a final visit at 5 6 1 months, if none occurred
naturally, was mandated. Direct involvement of the
CHOICE study team was minimized using a Remote
Study Monitoring System to collect data and communicate with study sites. RESULTS: Within 30 weeks, a total
of 55 physicians enrolled 512 patients with a mean age of
51 years and blood pressure of 158/99 mmHG. In all, 46
different antihypertensive medications were prescribed
and 2,554 office visits (range 5 1–16 visits per patient)
were attended. Other medical resource use was low during the study period. A final, clean database was ready
for analysis 30 days after last patient last visit. CONCLUSIONS: It has been demonstrated that CHOICE is a
feasible framework to study the real-world effectiveness
of initial therapy for newly diagnosed hypertension. Protocol flexibility and a novel electronic data entry system
are core elements of this naturalistic design.
PCV27
A PHARMACOECONOMIC MODEL TO
EVALUATE TREATMENT OPTIONS FOR DVT
PHARMACOPROPHYLAXIS
Spruill WJ, Wade WE, Leslie RB
University of Georgia College of Pharmacy, Athens, GA, USA
Economic analysis of various treatment modalities used
to prevent deep vein thrombosis (DVT) in various medical and surgical at-risk patients has been limited by lack
of consistent and representative methods to evaluate various resource costs attributed to both the prevention of
DVT and the diagnosis and treatment of prophylaxis failures. OBJECTIVE: To develop a systematic and comprehensive method to identify and prioritize all direct costs
associated with DVT prophylaxis. METHODS: A decision tree was developed to identify and prioritize all medical, surgical and diagnostic procedures that contribute to
overall direct cost. Included were costs of prophylaxis,
cost of diagnosing a prophylaxis failure (a DVT) and
costs of major complications of this therapy (pulmonary
embolism, major bleeding and thrombocytopenia.) Diagnostic procedures were also prioritized clinically as either
a “standard”, “alternative or confirmatory”, or “supplemental” procedure. This prioritization allows for probability multipliers to be assigned to each category of diagnostic procedures in order to get a weighted average of
the cost of this procedure. Likewise, the various costs associated with prophylaxis failure were prioritized. Next a
spreadsheet was developed to match this decision tree.
This spreadsheet contained all identified resource costs
shown on the decision tree and indicated the quantity or
units of each resource that are typically used. Lastly, the
corresponding CPT and ICD9 codes for all resources
were identified. RESULTS: Major categories of resources
identified include diagnostic, treatment, and monitoring.
These 3 areas are divided into 13 sub-categories which in
turn include over 60 specifically identified cost related resources. CONCLUSION: This model allows any institution to accurately identify, prioritize and analyze institution specific resource costs instead of using literature
values to determine the cost-benefit of various pharmacoprophylactic regimens including unfractionated heparin and various low molecular weight heparins used at
their site.
PCV28
CHOLESTEROL REDUCTION SUCCESS RATES
AND RESOURCE UTILIZATION BY GENDER
Graff JS1,2, Plante M1, Smith D2
1
Pfizer Inc, Ann Arbor, MI, USA; 2University of Michigan,
Ann Arbor, MI, USA
106
Abstracts
OBJECTIVE: To assess relative success rates and resource utilization differences between males and females
treated to NCEP and EAS cholesterol goals with HMGCoA reductase inhibitors. METHODS: In three openlabel clinical trials in the US and Europe, 998 patients (375
females and 623 males) with a CHD risk factor, documented CHD and/or PVD, were randomized to receive
one of five HMG-CoA reductase inhibitors (atorvastatin,
fluvastatin, lovastatin, pravastatin, or simvastatin). Physician visits occurred every 6 weeks and dose titrations
(either increased statin dose, or the addition of colestipol
or cholestyramine) were made every 12 weeks if target
LDL-C concentration levels were not achieved. The analysis takes a third party perspective by using insurance
payment rates for study medications, physician visits,
add-on therapies and treatments for adverse events, all
denominated in 1997 US dollars. RESULTS: NCEP or
EAS LDL-C targets were achieved with similar frequency
by males (75.7%) and females (74.7%). Accordingly, resource utilization was similar for males and females.
Mean total costs were similar for all males ($1529.94)
and females ($1470.99, p 5 0.776); males ($1280.62)
and females ($1252.95, p 5 0.665) reaching goal and
males ($2306.32) and females ($2115.59, p 5 0.103) not
reaching goal. Finally, mean total costs for males and females (and respective percentages achieving LDL-C targets) were similar among study medications: atorvastatin
$1044.49 (88.2%) and $1020.29 (90.7%); fluvastatin
$1815.03 (58.4%) and $1709.72 (55.5%); lovastatin
$2031.78 (77.9%) and $2045.43 (80.3%); pravastatin
$1878.90 (53.6%) and $1776.19 (35.7%) and simvastatin $1475.48 (80.3%) and $1293.43 (77.0%). CONCLUSIONS: Successes in achieving LDL-C targets and
resource utilization were independent of gender. However the ability to reach target LDL-C, by use of specific
study medications, significantly impacts the total cost of
cholesterol reduction.
PCV29
ECONOMIC OUTCOMES OF PATIENTS
RECEIVING CARVEDILOL COMPARED TO
THOSE RECEIVING NO BETA-BLOCKER
THERAPY FOR THE TREATMENT OF
CONGESTIVE HEART FAILURE IN A MANAGED
CARE ORGANIZATION
White TJ, Chang EY, Leslie RS, Jackson AJ
Prescription Solutions, Costa Mesa, CA, USA
Considerable clinical trial data is available to support the
use of beta-blockers for the treatment of congestive heart
failure (CHF). OBJECTIVES: The primary objective is to
compare differences in health care costs (pharmacy, medical, and total) between patients receiving carvedilol and
those not receiving a beta-blocker for the treatment of
CHF. The secondary objective is to determine differences
among cohorts with respect to CHF-related costs and
total health care costs (CHF and non-CHF related).
METHODS: Retrospective claims data from a large managed care organization were analyzed. Patients were included if they had an ICD-9 diagnosis code for CHF between 1/1/97 and 12/31/99, received an ACE inhibitor
and a diuretic, were continuously eligible, and at least 18
years old. The carvedilol group was newly started on
carvedilol and did not receive another beta-blocker. The
non beta-blocker group did not receive any beta-blockers
and had no contraindications to beta-blocker therapy. All
patients were followed for 1 year. Total health care costs
include costs for all services covered. CHF-related costs
include those directly related to the treatment of CHF.
RESULTS: There were a total of 9,439 patients, 52.3%
were female, and the average age was 77 (S.D. 5 9.5)
years. Total cost (CHF and non-CHF related) were measured after adjusting for age, gender, pre-total cost, and
Charlson Comorbidity Index. Patients in the carvedilol
group had higher pharmacy cost ($2,586 versus $1,343,
P , .0001), lower medical cost ($18,196 versus $22,168,
P 5 0.362), and lower total cost ($20,782 versus
$23,511, P 5 0.619). When measuring only CHF-related
costs, patients in the carvedilol group had higher pharmacy cost ($1,489 versus $416, P , .0001), lower medical cost ($2,232 versus $3,105, P 5 0.450), and slightly
higher total cost ($3,721 versus $3,521, P 5 0.959).
CONCLUSION: The higher pharmacy cost of carvedilol
use appears to be offset by a reduction in total (CHF and
non-CHF related) medical cost.
PCV30
COST-EFFECTIVENESS MODEL OF
THROMBOLYTIC THERAPY FOR ACUTE
MYOCARDIAL INFARCTION
Mulani P, Hay J
University of Southern California, Los Angeles, CA, USA
OBJECTIVE: To conduct a cost-effectiveness analysis of
tissue-Plasminogen Activator (t-PA) versus Streptokinase
(SK) for treating acute myocardial infarction (AMI). PERSPECTIVE: Societal. DATA SOURCES: The cost, clinical outcomes and utilities were obtained from literature.
METHODS: Decision analytical model was used to evaluate the short and long-term outcomes and costs associated with the use of SK or t-PA for AMI. Clinical benefit
is expressed as Quality Adjusted Life Years (QALY) resulting from the treatment. Patients presenting within six
hours after onset of symptoms, with a certain probability
of death may be treated with SK or t-PA. Survivors may
either get a disabling stroke or no stroke, patients with
no disabling stroke may or may not have a reinfarction.
Inpatient and long-term costs of coronary disease and
disabling stroke were included. Costs and QALYs were
discounted at 3%. Expected costs and QALYs yielded the
Incremental Cost-effectiveness Ratio (ICER). Sensitivity
analyses were performed on important factors. OUTCOMES: QALY which incorporated 30 days mortality,
impacts of disabling stroke, reinfarction. Short-term and
107
Abstracts
long-term medical costs. RESULTS: Using 30-day mortality data from the Global Utilization of Streptokinase
and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial, the baseline analysis yielded
an ICER for t-PA of $24,882/QALY compared to SK.
The ICER was sensitive to the difference in reinfarction
rate (baseline 3.83%: 3% ICER $19,326: 6% ICER
$120,767) and mortality rate (baseline 6.3%: 6.7%
ICER $46,688: 7.2% ICER $197,850) of t-PA. CONCLUSION: t-PA is a cost-effective therapy for MI compared to SK. In addition, despite using costs and utilities
from varied sources, and employing a simpler model the
findings support previously published results.
PCV31
CLOSURE OF ATRIAL SEPTAL DEFECT:
MEDICO-ECONOMIC ARGUMENTS TO CHOOSE
BETWEEN INVASIVE SURGERY AND
PERCUTANEOUS TECHNIQUE USING
SEPTAL OCCLUDER
Laroche S, Allenet B, Foroni L, Calop J
CAMSP—CHU Grenoble, Grenoble, France
OBJECTIVES: The medical device implantation techniques via percutaneous aboard tend to substitute to surgical techniques, in various cardio-vascular therapeutics.
However, prosthesis implantation is often accompanied
high implementation costs (linked to the device acquisition) which are difficult to justify to the decision-maker,
in a context of high financial constraint. METHOD:
Available clinical data show similarity of effectiveness
and complication rates between these two techniques.
Therefore, the economic appraisal consists in a cost minimization approach. First, we modeled the two technique
protocols before costing each action (personnel, facilities, . . . ) according to the internal costs of Grenoble
hospital. Moreover, we estimated the budgetary productivity of these two strategies using the French DRG classification system used to adjust the annual financial allocation of French public hospitals. RESULTS: Results show
the percutaneous technique (septal occluder Amplatzer®)
is dominant (1.5 times less expensive than surgery),
mainly by decreasing the hospital stay (two hospitalization days instead of 12 days in the surgery strategy).
DRG system classification generates 1473 ISA (hospital
productivity index) for the percutaneous technique and
7556 ISA for invasive surgery. CONCLUSIONS: Comparing between cost-minimization technic using internal
costs and incremental budgetary impact using French
DRG classification, we conclude that the prosthesis implantation via percutaneous aboard is economically dominant (cheaper than invasive surgery) but 5 times less
contributive to annual budget allocation. Therefore incitation for the hospital decision-maker to use septal
occluders must come with the adaptation to new technologies of financial public allocation using the DRG classification.
PCV32
STRATEGIES FOR IMPROVING COMPLIANCE
WITH HMG-COA REDUCTASE INHIBITORS
Coombs JH1,3, Cornish L2, Hiller P2, Smith DG3
1
Pfizer, Ann Arbor, MI, USA; 2M-CARE, Ann Arbor, MI, USA;
3
University of Michigan, Ann Arbor, MI, USA
OBJECTIVE: To assess medication compliance and predictors of compliance with HMG-CoA reductase inhibitors for patients following a myocardial infarction (MI)
or other atherosclerotic event. METHODS: Patients were
identified from a managed care organization (MCO) database who had an MI or other atherosclerotic event in
1997 or 1998 and were continuously enrolled in the
MCO for the year following the event. All patient records
were collected following guidelines for HEDIS reporting.
Pharmacy claims data review identified 216 patients who
had at least one prescription filled for a statin. A number
of compliance measures were calculated, including the
CMA, a continuous multiple-interval measure of medication availability. A multivariate linear regression of CMA
included the following independent variables: age, sex,
ICD-9 of admission, DRG of admission, statin prescribed,
medication days supply dispensed, number of unique
medications prescribed, number of unique chronic medications prescribed, and prescription drug copay amount.
RESULTS: The mean CMA was 0.820. Regression results (adjusted r-square 0.11) indicate that several factors
had potentially large impacts on CMA, but the estimates
were associated with large standard errors (age, gender,
ICD-9 of admission, DRG of admission, statin prescribed). Four factors with estimates statistically significantly different from zero are as follows (t-statistics in
parentheses): days supply (each 30-day increment) 0.116
(3.61), number of concomitant unique medications 20.009
(2.29), number of concomitant unique chronic medications 0.012 (1.83), copay (each $1) 20.007 (2.84). CONCLUSIONS: Compliance with statins was high in this
sample, but not ideal (1.0). Strategies for improving compliance that may have merit include: providing patients
with 60 or 90-day supplies (rather than 30-day supplies),
controlling the number of other medications prescribed
and having lower patient copayments for these important
medications.
PCV33
COST-ANALYSIS OF CABG SURGERY IN
PATIENTS WITH AND WITHOUT
RETHORACOTOMY FROM THE HOSPITAL
PERSPECTIVE IN GERMANY
Spannheimer A1, Mast O2, Schlereth T1, Thate-Waschke IM2,
Dietrich W3
1
Kendle International Inc, Munich, Germany; 2Bayer Vital GmbH
& Co KG, Leverkusen, Germany; 3Deutsches Herzzentrum,
Munich, Germany
OBJECTIVES: German hospitals receive the same reimbursement by the statutory health insurance for CABG
108
Abstracts
surgery irrespective of whether or not a rethoracotomy,
which involves higher in-hospital costs, has to be performed following hemorrhage. In order to evaluate the
in-hospital costs for CABG with and without rethoracotomy from the hospital perspective, a cost-analysis of
CABG surgery was performed. Furthermore, the costeffectiveness of prophylactic administration of the antihemorrhagic agent aprotinin was investigated. METHODS: The detailed resource utilization of 138 CABG
patients, 68 with rethoracotomy and 70 without, was
analysed based on sample of patient medical records
from 7 German hospitals. Resource costs were provided
by hospital administrations and supplemented by literature. The overall costs for both groups were then combined with rethoracotomy rates in patients with and
without prophylactic administration of aprotinin derived
from a published meta-analysis of all relevant clinical trials in open heart surgery. RESULTS: The total in-hospital costs per patient with CABG were on average DM
21,241 and increased to DM 31,326 for a CABG patient
requiring rethoracotomy. Besides the costs of the rethoracotomy, the costs of intensive care were the main cost
driver in patients with rethoracotomy. The meta-analysis
showed with statistical significance that aprotinin can reduce the rethoracotomy rate from 5.0% to 1.8% in patients undergoing heart surgery. When combining the
cost data with the results of the meta-analysis, the expected average costs per patient treated with aprotinin
(including drug costs) were DM 21,432 compared to DM
21,655 per patient without aprotinin treatment. A costeffectiveness analysis (costs per patient without rethoracotomy) resulted in a difference of DM 970 in favour of
the prophylactic antihemorrhagic treatment. CONCLUSION: The analysis showed that CABG patients requiring an additional rethoracotomy generated about 47%
higher costs than patients with CABG surgery only. The
administration of the antihemorrhagic agent aprotinin
can be recommended in the light of the reduced complication rate and improved cost-effectiveness of CABG-surgery.
PCV34
DECISION ANALYSIS MODEL OF ABCIXIMAB,
EPTIFIBATIDE OR STANDARD THERAPY IN
ELECTIVE STENT PLACEMENT:
A CANADIAN PERSPECTIVE
Sridhar K, Gwadry F, Kidwai B, Almond D, Teefy P
London Health Sciences Centre, London, ON, Canada
The use of glycoprotein 2b/3a receptor antagonists has
been shown to be beneficial in elective coronary stent implantation. In Canada, the cost of abciximab has limited
widespread use in this population. Recently presented
data comparing eptifibatide with heparin alone in a similar population has suggested a significant improvement in
clinical outcomes with this less expensive agent. There
are no trials directly comparing these two agents in the
elective stent patient population. OBJECTIVE: the pur-
pose of this study was to assess the cost-effectiveness of
abciximab or eptifibatide compared to standard therapy
in patients undergoing elective stent placement in a Canadian setting using a decision analysis model. METHODS:
Clinical outcome data was abstracted from the Epistent
and Esprit trials. Economic data assessing direct costs for
coronary intervention procedures and complications was
acquired from the London Health Sciences Centre hospital cost database for the period 1998–99. The composite
clinical endpoint was freedom from death, myocardial infarction and urgent revascularization at 30 days. The primary study outcome was the incremental cost per event
prevented. RESULTS: In the baseline analysis, both
agents compared favorably with standard therapy. Abciximab had an incremental cost-effectiveness of $US
10,320 per event prevented. Eptifibatide was less costly
and more effective, hence dominant over standard therapy. The baseline analysis yielded a benefit of 6 events
per 1,000 patients treated in favour of abciximab over
eptifibatide. However the incremental cost per event prevented was $US 125,218, a less favorable value. CONCLUSION: The incremental cost-effectiveness of abciximab compared to eptifibatide was sensitive to the cost of
abciximab and to the incidence of myocardial infarctions.
A randomized trial comparing abciximab and eptifibatide in elective coronary stent placement is necessary to
better assess this issue.
PCV35
COMPARABILITY OF PUBLISHED STUDIES ON
COST-EFFECTIVENESS OF ANTIHYPERTENSIVE
THERAPY: DO THE RESULTS HELP THE
DECISION-MAKING PROCESS?
Mullins CD1, Akhras KS2, Blak B1
1
University of Maryland, Baltimore, MD, USA; 2Pharmacia
Corporation, Skokie, IL, USA
OBJECTIVES: Cost-effectiveness studies can provide
valuable information for decision-making processes,
where limited resources need to be allocated across a variety of different treatments. However, it is argued that
the current methods for conducting and reporting costeffectiveness results for this purpose are sub-optimal.
This literature review and analysis compares the most recent hypertension cost-effectiveness studies. The goal is
to contribute information so that future cost-effectiveness
studies of hypertension treatments will provide more
optimal information for clinicians and other decisionmakers for the choice of antihypertensive treatment.
METHOD: A literature search of several databases for
the years 1995–2000 was conducted using the following
keywords: hypertension and cost-effectiveness and/or
economics. RESULTS: The search resulted in 89 articles,
of which only 11% (10 studies) were true pharmacoeconomic studies that contained actual data analysis. Of the
10 studies, the majority reported outcome measures in
terms of cost per life year gained, but usually considered
more than one outcome measure. Coronary heart dis-
109
Abstracts
eases and stroke were the most consistent endpoints
across the studies but the number and types of endpoints
that were included differed significantly among the studies. Only two studies included within-clinical trial treatment effectiveness data, whereas the remaining studies
modeled treatment effects from previously published trials. The projected cardiac event rates and life expectancy
were most often derived and estimated from the Framingham study. Treatment costs were obtained from several
different sources outside clinical trials, and only one
study considered costs solely from the trial. CONCLUSION: Despite the increasing emphasis on hypertension
as one of the most costly long-term diseases, and the need
to reduce costs associated with it, there are relatively few
recently published studies on the cost-effectiveness of antihypertensive therapies. Methodologically, these published studies are very different and they do not seem to
agree on a common way to provide a cost-effectiveness
measure for hypertension treatment, making interpretations and comparability of results across different studies
more difficult.
PCV36
EVALUATION OF COMPLIANCE AND
PERSISTENCE WITH HMG-COA REDUCTASE
INHIBITORS AFTER A MYOCARDIAL
INFARCTION USING PHARMACY CLAIMS DATA
Coombs JH1,3, Cornish L2, Hiller P2, Smith DG3
1
Pfizer, Ann Arbor, MI, USA; 2M-CARE, Ann Arbor, MI, USA;
3
University of Michigan, Ann Arbor, MI, USA
OBJECTIVE: To determine compliance and persistence
with cholesterol-lowering therapy with HMG-CoA reductase inhibitors (statins) in patients following a myocardial infarction (MI) or other atherosclerotic event.
METHODS: Patients were identified from a Midwestern
managed care organization (MCO) database who had an
MI or other atherosclerotic event in 1997 or 1998 and
were continuously enrolled in the MCO for the year following the event. Patient records were collected following
HEDIS reporting guidelines. Pharmacy claims data review identified 216 patients who had at least one prescription filled for a statin. Compliance and persistence
were assessed using length of therapy, single-interval
medication availability, multiple-refill-interval medication availability, single-interval medication gaps, and
multiple-refill-interval medication gaps. RESULTS: The
population was predominantly male (76%) and the mean
age was 61 years (SD 10.2 years, range 34 to 77). The
cardiovascular events were as follows: 52% MI, 45%
coronary atherosclerosis, and 4% other atherosclerotic
event. The proportion of patients persistent with statin
therapy at 3, 6, 9, and 12 months were 88, 86, 80, and
69 percent respectively. Patients achieved 90% compliance with each refill (SD 25%, median 94) and cumulative compliance for all refills was 83% (SD 24%, median
92). The average single-interval treatment gap was 11
days (SD 28.5 days, median 2 days) while the average cu-
mulative total treatment gap over the study period was
44 days (SD 70 days, median 13 days). CONCLUSIONS:
Compliance with HMG-CoA reductase inhibitors as
measured by single-interval and multiple-refill-interval
was generally high, but not ideal (100%) following an
MI or other atherosclerotic event. These pharmacy claims
data may be further analyzed using multivariate regression to determine the impacts of age, sex, diagnosis, number of concomitant medications, medication days supply,
type of statin prescribed, and patient copay on compliance and persistence with therapy.
PCV37
THE COST-EFFECTIVENESS OF STATINS:
EVIDENCE FROM THE ACCESS TRIAL
Smith DG
University of Michigan, Ann Arbor, MI, USA
OBJECTIVE: There are now a host of HMG-CoA reductase inhibitors (statins) for treating persons with elevated
cholesterol levels. The objective of this is to determine the
relative cost of treatment among statins. METHODS:
The ACCESS study was a 54-week open label trial of
atorvastatin as compared to fluvastatin, lovastatin, simvastatin and pravastatin. After a screening phase and a
lead-in phase, patients were treated to NCEP target LDL-C
levels with statins, starting at the lowest dose level. At
six-week intervals (weeks 6, 12, 18) patients who had not
yet reached their LDL-C target were titrated up to the
next dose level, to a maximum of 40–80 mg, depending
on the statin. Costs of services used were recorded, including: study medications, physician visits, laboratory
and diagnostic tests associated with cholesterol treatment
and other medical services associated with adverse
events. RESULTS: A total of 3916 patients were enrolled
in ACCESS, with 3262 patients completing the study. Patients treated with atorvastatin had the highest rate of
NCEP goal achievement (76.3% v. 34.2%–57.9%; P ,
0.01 for each comparison). As a result of NCEP goal
achievement, atorvastatin-treated patients required the
fewest physician visits through weeks 6–18 (2.81 v. 2.95–
3.45; p , 0.01 for each comparison) and the lowest direct study cost per patient achieving NCEP goal ($915 v.
$1393–$2421; p , 0.01 for each comparison)—the ultimate measure of cost-effectiveness. CONCLUSIONS:
The ACCESS trial demonstrates that treatment with atorvastatin yielded the highest proportion of patients reaching NCEP LDL-C goals at the lowest cost per patient.
110
Abstracts
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IT
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D
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PCV38
and drug costs. RESULTS: Of the 691 patients in the
atorvastatin arm, 682 used health care resources. Of the
337 patients in the simvastatin arm, 332 used health care
resources. The monthly drug costs with atorvastatin was
$48.30 for 10mg, $66.93 for 20mg, with simvastatin at
$42.06 for 10 mg, $58.12 for 20mg. The average cost of
health care for atorvastatin and simvastatin was $460.48
and $490.11 respectively (p 5 0.47). Adverse events accounted for 60% of all health care costs in the atorvastatin group, 77% in the simvastatin group. The weighted
average monthly drug costs (WAMDC) after 6 weeks of
treatment were $48.30 for atorvastatin and $42.06 for
simvastatin. 38% of patients reached NHF target cholesterol levels on atorvastatin, 25.5% on simvastatin. The
cost per responder was $1.27 with atorvastatin, $1.63
with simvastatin. After 12 weeks of treatment the
WAMDC was $59.53 for atorvastatin, $53.77 for simvastatin with 47.5% and 33.8% response rates, respectively. The incremental cost-effectiveness of an extra patient achieving target on atorvastatin was $0.50 at 6
weeks, $0.42 at 12 weeks, $0.26 at 18 weeks and $0.51
at 24 weeks. CONCLUSION: Atorvastatin achieved a
greater percentage reduction in total cholesterol per mg
than simvastatin, and was equally well tolerated. While
drug costs for atorvastatin were slightly higher, overall
health care costs were lower than for simvastatin. Atorvastatin was more cost-effective than simvastatin in
achieving NHF targets. The incremental cost-effectiveness of atorvastatin suggests additional patients can
achieve NHF targets relatively inexpensively.
PCV40
PCV39
COST OF TREATMENT OF
HYPERCHOLESTEROLAEMIA TO NHF GOALS
IN AUSTRALIA
Wlodarczyk J1, Barter PJ2, O’Brien R3, Talmont D4, Ortiz M4
1
John Wlodarczyk Consulting Services, Newcastle, NSW,
Australia; 2Royal Adelaide Hospital, Adelaide, Australia;
3
Monash Medical Centre, Melbourne, Australia; 4Pfizer Pty Ltd,
Sydney, Australia
OBJECTIVE: To estimate the comparative cost-effectiveness of atorvastatin and simvastatin. METHODS: A randomized clinical trial set in general practice. Effectiveness
was measured by percentage reduction in total cholesterol and percentage of patients achieving NHF targets.
The costs calculated in the study were hospital admissions, emergency room/clinic visits, visits to GPs and specialists, tests/investigations, treatment of adverse events
COST-EFFECTIVENESS OF LIPID LOWERING
INTERVENTIONS IN A NATIVE AMERICAN
CARDIOVASCULAR RISK
REDUCTION PROGRAM
Kumar RN1, Borrego ME2, Gupchup GV2, Anderson JR2,
Burden RW3, Phillips DL3
1
University of Michigan, Ann Arbor, MI, USA; 2University of
New Mexico, Albuquerque, NM, USA; 3Santa Fe Indian
Hospital, Santa Fe, NM, USA
OBJECTIVES: To determine the cost-effectiveness (CE)
of managing patient low density lipoprotein-cholesterol
(LDL-C) levels with exercise plus nutritional therapy and
exercise plus nutritional plus pharmacotherapy from the
Indian Health Service perspective. METHODS: A retrospective database analysis was performed on data collected from a pharmacist managed Cardiovascular Risk
Reduction Program (CVCRRP) from March 1997
through October 1999. Patients received exercise plus
nutritional therapy (Group 1) or exercise plus nutritional
plus pharmacotherapy (Group 2). Effectiveness measures
included unit and percent LDL-C reduction from initial
to last recorded visit. Costs (fixed plus variable) and reimbursements were determined in terms of 1999 dollar
values through clinic staff interviews and billing records
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Abstracts
analysis. Average and incremental cost-effectiveness ratios (ICE) were calculated. One-way sensitivity analyses
were performed varying pharmacist salary, medication
costs, and levels of reimbursement. RESULTS: Net costper-patient in Group 1 (n 5 40) was $1,204; in Group 2
(n 5 32) was $1,432. Mean LDL-C reduction was
12.67mg/dl (Group 1) and 42.03mg/dl (Group 2). Mean
percent LDL-C reduction was 8.95% (Group 1) and
50.70% (Group 2). Average CE ratios were $95.01 (unit
LDL-C reduction) and $134.50 (percent LDL-C reduction) for Group 1; $34.07 (unit LDL-C reduction) and
$50.70 (percent LDL-C reduction) for Group 2. ICE ratios for Group 2 versus Group 1 was $7.77 (unit LDL-C
reduction) and $11.82 (percent LDL-C reduction). The
obtained CE ratios were robust to sensitivity analysis parameters. CONCLUSIONS: The CVCRRP showed positive lipid management results for enrolled patients.
Group 2 (those including pharmacotherapy) interventions were associated with higher costs and better LDL-C
outcomes. Group 2 interventions also resulted in more
favorable average CE ratios compared to Group 1. Study
results could be used to develop similar cardiovascular
risk reduction programs, expanding the clinical role of
the pharmacist and improving patient outcomes.
PCV41
SOCIOECONOMIC RELEVANCE OF TREATMENT
OF CHRONIC HEART FAILURE STAGE NYHA II
WITH CRATAEGUS EXTRACT WS 1442—
ONE-YEAR-RESULTS OF A PROSPECTIVE
PHARMACOECONOMIC STUDY
Pfeil T1, Rychlik R1, Daniel D1, Habs M2, Klapper HG2, Böhm M3
1
Institute of Empirical Health Economics, Burscheid, Germany;
2
Dr. Willmar Schwabe Arzneimittel, Karlsruhe, Germany;
3
Medizinische Klinik u. Poliklinik, Bad Homburg, Germany
OBJECTIVES: To evaluate the pharmacoeconomic properties of crataegus treatment compared to any other
treatment option of CHF at stage NYHA II, a prospective
3-year observational study has been conducted since
summer 1999. A cost-utility-analysis will be performed
to investigate, if crataegus treatment avoids rapid deterioration with higher costs and lower HRQL. The results of
the first year are presented. METHODS: Open, non-randomized observational cohort study. The first cohort
(Crataegus-Cohort, CC) comprises patients receiving crataegus extract therapy of CHF. In the second cohort
(Standard-Cohort, SC) patients without crataegus but
any other treatment were observed. In 217 study centres
952 patients were included (CC: 588; SC: 364). For measuring HRQL the EuroQoL-5D was used. The perspective of the German statutory health insurance funds and
the matched-pairs technique were applied. RESULTS:
No significant differences in physical condition and demographic variables were detected between the matched
groups. HRQL (143 pairs) shows significant improvement in both cohorts. The mean EuroQoL-VAS value for
the CC is 55.50 before and 67.13 after half-a-year (SC:
58.06 before and 66.78 after). Improvement of HRQL in
the CC is significantly higher (p 5 0.023). After one year,
an improvement of clinical symptoms were diagnosed in
both cohorts (79 pairs) but slightly higher in the CC with
no significance. Mean direct costs for CC patients
amounted to DM 1,373 in the first year whereas SC patients amounted to DM 1,551 with no significant difference (p 5 0.998, 98 pairs). Cost driving factors were
drug acquisition and physicians fees. CONCLUSIONS:
Even if the first analysis of the three-year-study indicates
comparable direct costs in both cohorts and suggests improved HRQL in the CC further investigation in the second and third period is mandatory.
PCV42
PATIENTS’ WILLINGNESS TO PAY FOR
PHARMACIST MANAGED WARFARIN THERAPY
AT COMMUNITY PHARMACIES
Wong PK, Jang R
University of Cincinnati, Cincinnati, OH, USA
OBJECTIVES: This study determined the benefits of
pharmacist managed warfarin therapy (PMWT) at community pharmacies by the contingent valuation (CV)
method. Benefits of PMWT in clinic have been documented. These are reduction in hospitalizations, emergency room visits and thromboembolic events due to side
effects of inappropriate dosing and monitoring. However, these benefits were never measured from patient’s
perspective using CV method. This study elicited willingness-to-pay (WTP) values for PMWT from community
pharmacy patients. METHOD: A self-administered 24
question CV survey was mailed to 2800 patients’ homes.
These patients were selected from files in community
pharmacies or a rural health plan. They were divided into
warfarin clinic (ex post) and non-warfarin clinic (ex ante)
groups. A payment card method with visual aid charts
elicited WTP values in form of out-of-pocket (OOP) expense and additional insurance premium (INS) for
PMWT with six probabilities for success (3 probabilities
for reduction in hospitalizations & 3 probabilities for reduction in blood clot events). RESULTS: Five hundred
and thirty patients (393 usable) responded. Overall mean
WTP values for PMWT in the form of OOP or INS were
significantly greater than zero. The monthly mean OOP
WTP amounts for 28% blood clot event reduction and
26% hospitalization reduction were $17.19 6 15.57 and
$19.26 6 17.56 respectively. The monthly mean INS
WTP for the same probabilities were $11.97 6 13.66 and
$12.66 6 14.63 respectively. Regression analysis identified that annual household income, selection of health
plan with PMWT and attitude towards the health plan’s
inclusion of PMWT were significant predictors for OOP
scheme and only annual household income and selection
of health plan with PMWT for INS scheme. CONCLUSION: Patients were able to assign WTP values to different sizes of health gains. Range bias and inconsistency of
choice were detected from this sampled population.
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Abstracts
SE
E
PC
V
8
PCV43
from a national managed care database representing 6
million lives in 23 US health plans and 8 geographic regions over a 4 year period. Cohorts by agents were created based on diabetes type and initial treatment agent.
Cost and utilization analysis included evaluation of patients by age, gender, geographic region, type of medical
service and provider speciality. Diagnosis codes were
used to differentiate between all health care services and
disease related services. Treatment analysis evaluated
treatment progression, compliance with therapy and dose
progression. Treatment efficacy and practice patterns in
five possible outcomes were defined for each cohort. RESULTS: The highest proportion of patients in each cohort remained on the initial therapy. Combination therapy was the most frequent therapeutic choice for patients
failing monotherapy. Evaluation of the maximum daily
dose (MDD) showed patients who were switched to an
alternate agent of the same class reached 41–48% of
MDD, a different class 49–57% MDD and combination
therapy 57–72% MDD. Compliance was consistent. The
combination therapy cohorts tended to have significantly
higher (p , .05) pharmacy costs than the monotherapy
cohorts. The study did not conclusively support differences in medical costs between the cohorts. CONCLUSION: Therapy in all cohorts changed before MDD of
the original agent was attempted. Patients in each cohort
progressed to insulin monotherapy without a recommended trial of combination agents. Although pharmacy
and medical costs influence the total cost of diabetic care,
there was no significant difference in medical costs identified. Cost differences were driven by pharmacy costs.
PDB2
USING RETROSPECTIVE CLAIMS DATA TO
DESIGN CLINICAL SAFETY SURVEILLANCE OF
THIAZOLIDINEDIONE DRUGS
Henriques C1, Schultz D2, Milanette T1, Todoroff K1, Kim M1
1
Solucient, Waltham, MA, USA; 2Solucient, Ann Arbor, MI, USA
DIABETES
PDB1
DIABETIC MANAGEMENT THROUGH ORAL
GLUCOSE LOWERING AGENTS: TREATMENT
PATTERN, COST AND UTILIZATION ANALYSIS
Thompson FD1, Rosenblum MS2, O’Neill JM2, Celebi D1,
Olmsted E1
1
IHCIS, Lexington, MA, USA; 2Integrail, Latham, NY, USA
OBJECTIVES: Assess the treatment progression of Type
2 diabetic patients taking glimepiride, glipizide xl, and/or
metformin as initial monotherapy and the impact these
agents have on the cost and utilization of health care services. METHOD: Medical and pharmacy claims data for
7,585 patients meeting inclusion criteria were collected
HYPOTHESIS: Prescription patterns for the newer thiazolidinedione (TZD) drugs, pioglitazone and rosiglitazone, will reflect historic prescription patterns for troglitazone. Predicting what drugs are commonly prescribed
in combination with pioglitazone and rosiglitazone might
help anticipate the most common drug interactions for
these drugs, and possible adverse effects due to additive
drug toxicity. This information can be used to design surveillance monitoring to detect toxicity due to additive
effects early. If this type of toxicity is detected, recommendations for multidrug regimens can be revised appropriately. METHODS: This retrospective data analysis
used data from Solucient’s proprietary Medical Claims
Data Warehouse of over 6 million lives. Patients in the
troglitazone cohort took troglitazone for at least 4 consecutive months between 9/1/1998 and 6/30/2000, and
had at least one other prescription for a diabetic drug
written after the last troglitazone prescription. Patients in
the pioglitazone and rosiglitazone cohorts took pioglita-
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Abstracts
zone or rosiglitazone for at least 4 consecutive months
between 1/1/1999 and 6/30/2000. RESULTS: All three
TZDs show similar prescription patterns, even though
both newer TZDs are approved as monotherapy and troglitazone was not. The combination of TZD and sulfonylurea occurred most commonly (troglitazone 28%, pioglitazone 26% and rosiglitazone 30%), followed by
monotherapy (troglitazone 20%, pioglitazone 23% and
rosiglitazone 23%). Combination with insulin (troglitazone 20%, pioglitazone 19% and rosiglitazone 16%)
ranked third for all. CONCLUSIONS: Our results suggest that pioglitazone and rosiglitazone are prescribed in
a manner similar to troglitazone. This suggests that physicians should be particularly vigilant for drug interactions between sulfonylureas and TZDs, as well as for additive drug toxicities between from these drugs. This
analytic approach could be expanded to other drugs frequently used in patients with type II diabetes, particularly
antihypertensives, drugs for congestive cardiac failure
and antihyperlipidemics.
PDB3
THE BURDEN OF ILLNESS OF DIABETES
MELLITUS TYPE 2 IN GERMANY—
A PILOT STUDY
Tepe M1, Kilburg A2, Daniel D2, Kirchhoff D2, Rychlik R2
1
Novartis Pharma GmbH, Nuremberg, Germany; 2Institute of
Empirical Health Economics, Burscheid, Germany
OBJECTIVES: A study was performed to assess the costs
of diabetes mellitus type 2 considering costs for co-morbidities and diabetes related complications in Germany.
The main objective of this cross-sectional study was to
describe the cost structure of the treatment of diabetes
mellitus type 2. The study focuses particularly on costs
for oral antidiabetic treatment. METHODS: The resource utilization of a population of 201 diabetes mellitus patients with type 2 diabetes was retrospectively documented over a period of 2 years in a cross-sectional
study. The documentation was performed by general
practitioners (GPs) and diabetologists across Germany.
Only direct costs were considered (perspective from statutory health insurances). Subgroups were analysed considering diabetes related macro- and microvascular complications. Costs were analysed taking the perspective of
the statutory health insurance into consideration. RESULTS: Total costs of 201 patients suffering from diabetes mellitus type 2 amounted to DM 1,477,061 over a period of two years, which translates into DM 7,349 per
patient. Costs per year were DM 3,674 with a maximum
of DM 63,915. The largest cost-driving factor is the hospitalisation representing 34.1 % of the total costs followed by drug acquisition costs (20.4 %). Patients
treated with insulin cause the 3,5 times higher costs than
patients treated with oral drugs. The amount of costs also
correlates with the complication status and the duration
of diabetes. The lowest costs are caused by patients
treated with oral antidiabetic drugs and/or diet and with-
out complications. CONCLUSION: The highest costs
were caused by patients with a high complication status,
a long duration of diabetes and those treated with insulin. This result emphasises the necessity of an early treatment of diabetes mellitus type 2 preventing expensive diabetes related long-term complications e.g., myocardial
infarction, stroke, diabetic foot lesion or dialysis.
PDB4
COST-EFFECTIVENESS AND CARDIOVASCULAR
RISK—AN ANALYSIS OF ROSIGLITAZONE
COMPARED WITH OTHER ORAL
HYPOGLYCEMIC AGENTS IN THE TREATMENT
OF TYPE 2 DIABETES MELLITUS
Oh PI1, Shane LG2
1
Sunnybrook and Women’s College Health Science Centre,
Toronto, ON, Canada; 2Glaxo SmithKline Beecham,
Mississuaga, ON, Canada
BACKGROUND: Avandia (rosiglitazone) is a novel insulin sensitizing agent. Compared with traditional therapies for type 2 diabetes mellitus (T2DM), it is as efficacious in lowering glycemic parameters with the additional
benefit of improving insulin resistance (IR); both of these
are linked to increased risk of cardiovascular (CV)
events. An evaluation was conducted from a government
payer perspective to explore the potential cost-effectiveness of Avandia compared with less costly generic agents,
glyburide and metformin. METHODS: A Markov model
was used to calculate direct medical costs and expected
survival. The discount rate was 5%. Long-term outcomes
were modeled based on clinical and epidemiologic studies
and the 10 year UKPDS data. Costs were obtained from
the manufacturer, literature, case costing and provincial
sources. The base case analysis considered a 70 y.o. male
with T2DM with a risk factor profile representative of
the UKPDS cohort. Further analyses of patients with
other combinations of CV co-morbidity were conducted
to examine the range of cost-effectiveness. RESULTS:
Avandia, compared to glyburide and metformin, is a potentially attractive option. In the base case Avandia was
associated with the highest expected cost but also the
greatest survival ($7,781 and 6.254 years); metformin the
lowest cost ($3,655) and intermediate survival (6.181
years); glyburide was dominated by metformin ($3,667
and 6.1608 years); the incremental CE ratios for Avandia
were $56,888 and $44,237 per LY gained vs. metformin
and glyburide respectively. For patients with other clusters of risk factors, the CE ratios ranged from $6,886/
LYG (4 additional CV risk factors) up to $59,947/LYG
(0 additional risks). The sensitivity analyses showed that
the base case results were robust. CONCLUSIONS:
While acknowledging the limitations of modeling techniques, the results of this analysis suggest that Avandia,
which addresses both dysglycemia and IR, may be a costeffective alternative for T2DM compared to the conventional therapies.
114
Abstracts
PDB5
A COST-MINIMIZATION STUDY TO DETERMINE
THE IMPACT OF ADDING GLUCOVANCE TO A
COUNTY HOSPITAL FORMULARY
Lal LS1, Ogbonnaya KI2
1
Texas Southern University, College of Pharmacy, Houston,
TX, USA; 1Baylor College of Medicine, Houston, TX, USA
OBJECTIVE: This study is conducted to determine the
economic impact of the addition of a new diabetic agent,
Glucovance (metformin/glyburide) to a county hospital
system with over 21,000 diabetic patients. METHODS:
A cost minimization analysis between Glucovance and
metformin plus any of the sulfonylureas is conducted.
Initially, a database of all diabetic patients in the county
hospital system is created to determine total number of
patients who are being treated with metformin alone and
in combination with other sulfonylureas, glipizide XL,
generic glipizide, glyburide, and glimepiride. Next, the
cost difference between treating with Glucovance alone
or as a dual therapy with both metformin 500mg plus the
most common dose of each sulfonylurea is calculated to
determine the incremental cost savings over a year’s time
of therapy. Only the direct costs of the drugs involved are
utilized in this study. RESULTS: The results indicate that
if all of the 6,622 patients who are on dual therapy with
both metformin 500mg and a usual maintenance dose of
a sulfonylurea drug are switched to the new combination
product, the county system can save over half a million
dollars ($555,566.00) in a year, in direct drug costs alone.
CONCLUSION: These results illustrate that there is an
economic incentive to add the new combination product
to the formulary. However, future cost-effectiveness studies are needed to determine the impact of this decision
both in terms of clinical and economic outcomes.
PDB6
AN EARLY LOOK AT TZD USE AMONG TYPE 2
DIABETES PATIENTS
Schabert VF1, Guo M2, Conklin JE1, Neslusan CA2
1
The MEDSTAT Group, Santa Barbara, CA, USA; 2R.W.
Johnson Pharmaceutical Research Institute, Raritan, NJ, USA
OBJECTIVE: One of the newest drug classes used in the
treatment of type-2 diabetes is the thiazolidinediones
(TZDs). TZDs enhance insulin action in insulin-dependent tissues without stimulating insulin secretion. These
drugs are used both as monotherapy and in combination
with other anti-diabetic pharmacotherapies. Two TZDs
are currently on the market, rosiglitazone and pioglitazone. Both of these compounds were approved in the US
mid-year 1999. This study examines the patient characteristics, drug use, and resource utilization of individuals
treated with a TZD in the first year following approval.
METHODS: Patients who received at least one prescription for rosiglitazone or pioglitazone were selected from
over 2.3 million employees, retirees, and dependents in
the MarketScan® databases. Health plan enrollment
data, medical claims, and pharmacy claims were used to
construct the final sample. Descriptive information is presented on patient demographics, inpatient, outpatient
and prescription drug use. Comparisons between these
variables across the different therapy groups (e.g., monotherapy versus combination therapy) were made using
appropriate statistical tests. RESULTS: 18,801 patients
received at least one prescription for rosiglitazone or pioglitazone during the study period. Mean age is 60.0
years (SD 5 11.6 years), including 6,510 who were 65 or
older. The sample is almost evenly split between males
and females (52.3% and 47.7%, respectively). 54.9%
(10,324) of the patients had at least three months followup available. Of these, 6.3% (655) were hospitalized
within three months of TZD initiation. Patients filled
other types of diabetes medications after initiating therapy with a TZD—28.8% (n 5 5,417) insulin, 52.0%
(n 5 9,776) sulfonylureas, 39.8% (n 5 7,475) metformin, and 7.1% (n 5 1,340) other types of diabetes
drugs. CONCLUSIONS: Additional TZD-type compounds are being developed. This study provides an early
look at the characteristics and subsequent outcomes of
patients who are being prescribed this important new
type of therapy for diabetes.
PDB7
COSTS AND EFFECTIVENESS OF INTENSIVE
INSULIN THERAPY FOR TYPE 2 DIABETES
Hisashige A, Katayama T, Mikasa H
University of Tokushima, School of Medicine, Tokushima, Japan
OBJECTIVE: To estimate the lifetime benefits and costs of
intensive insulin therapy for type 2 diabetes mellitus (2DM),
cost-effectiveness analysis was carried out. METHODS:
Cost-effectiveness analysis (CEA) and cost-utility analysis
(CUA) were carried out to estimate the lifetime benefits
and costs of intensive insulin therapy (IIT) for 2DM. A
Markov model base on a randomized controlled trial
(Kumamoto Study) was developed. As a comparator,
conventional therapy (CV) was used. A societal viewpoint
was adopted for the estimation of costs, and both direct
and indirect costs were evaluated. A Monte Carlo simulation was done to evaluate a confidence interval of costeffective or cost-utility ratio. Quality of life (utility) was
measured by a time-trade off method among 2DM patients. RESULTS: At lifetime follow-up among 40 years
of men, expected life years (28.7 years) for IIT were
longer than those (26.5 years) for CT. On the other hand,
expected costs ($106,500) for ITT were higher than those
($95,600). The incremental cost per life-year gained for
IIT was $3,020 (discount rate of cost and effectiveness:
5%). The incremental cost per QALY gained was $3,270.
Sensitivity analysis for age, costs, and health outcomes
confirmed robustness of these results. CONCLUSION:
Over lifetime, IIT for 2DM not only reduces complications, but also improves QOL and increases length of life.
From a societal perspective, efficiency of IIT is considerably high.
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Abstracts
PDB8
FACTORS ASSOCIATED WITH PRESCRIPTION
CLAIMS FOR BLOOD GLUCOSE TEST STRIPS
AMONG FEE-FOR-SERVICE NEW MEXICO
MEDICAID PATIENTS
Cordova CJ, Shah BM, Dodd MA, Gupchup GV
The University of New Mexico, Albuquerque, NM, USA
OBJECTIVE: Continuous blood glucose monitoring
which requires the use of blood glucose test strips (BGTS)
is essential for diabetes management. The objective of
this study was to identify predictors of claims for BGTS
submitted to the New Mexico Medicaid fee-for-service
(NMMFFS) program. METHODS: Patients with prescription claims for insulin or oral diabetic medications
between December 1, 1999 and November 30, 2000
were identified from the NMMFFS claims database. It
was determined if these patients had claims for BGTS. Information on demographic predictors including age, gender, race/ethnicity, insulin use, and area of residence (rural, urban, intermediate) were extracted. A forward
stepwise logistic regression analysis using the likelihoodratio (LR) test, was performed to identify significant predictors of claims for BGTS. RESULTS: A total of 5636
diabetic patients, mean age 65.93 (SD 5 17.25), were
identified. Of these, 38.6% (n 5 2178) had claims for
BGTS. About 70% (n 5 3974) were female, 45.1% (n 5
2543) had claims for insulin, and 38.8% (n 5 2185) resided in an urban area. Additionally, there were 42.7%
(n 5 2408) non-Hispanic whites, 30.8% (n 5 1738) Hispanics, and 9.2% (n 5 519) American Indians. The logistic regression results indicated that younger patients (OR
5 0.97, 95% CI 5 0.97–0.98) and patients with claims
for insulin (OR 5 1.88, 95%CI 5 1.68–2.11) were more
likely to have claims for BGTS. However, males (OR 5
0.64, 95% CI 5 0.56–0.73), patients who lived in intermediate areas (OR 5 0.74, 95% CI 5 0.65–0.83), nonHispanic whites (OR 5 0.78, 95% CI 5 0.67–0.91), Hispanics (OR 5 0.63, 95% CI 5 0.53–0.75) and American
Indians (OR 5 0.40, 95% CI 5 0.32–0.51) were all less
likely to have claims for BGTS. CONCLUSIONS: Elderly
patients who are female, non-insulin users, non-Hispanic
white, Hispanic or American Indian and live in intermediate areas are less likely to have claims for strips. Therefore, educational interventions are needed to increase
claims for BGTS in these patients, thus improving blood
glucose monitoring.
PDB9
COST-EFFECTIVENESS ANALYSIS OF A
MULTIDISCIPLINARY DIABETES CARE CLINIC
Yokoyama KK, Griffin KC, Godley PJ, Cryar AK,
Woodward BW
Scott & White Memorial Hospital, Temple, TX, USA
OBJECTIVES: Diabetes affects more than 15.7 million
people in the United States, resulting in an estimated annual cost of $98 billion (1997). With numerous compli-
cations, including heart disease, retinopathy, nephropathy, and neuropathy, contributing to the direct and
indirect costs of diabetes, control is vital. A cost-effectiveness analysis was performed to compare health care resource utilization related to diabetes care incurred by
health plan patients. METHODS: Subjects were enrolled
in the Diabetes Care Clinic (DCC) for at least one year
and were members of the health plan for one year prior
to enrollment. Pharmacy and medical claims data from
1997–2000 were analyzed to identify diabetes-related
charges incurred one year pre- and post-enrollment in the
DCC. Charges were used to estimate costs and were adjusted to year 2000 dollars at a rate of inflation of 3%.
Using the electronic medical record and clinic charts, hemoglobin A1c (HgbA1c), cholesterol profile, microalbuminuria, and blood pressure were evaluated. RESULTS:
23 diabetic patients met the inclusion criteria. These patients were mostly Type 2 diabetics (91%), female
(65%), and Caucasian (70%). The mean age was 58
years. A preliminary analysis of the data indicated that
the average HgbA1c decreased from 10.3 to 8.5, with 9
patients attaining glycemic control (defined as HgbA1c ,
8.0) after one year of enrollment. Additionally, average
blood pressure decreased from 152/80 to 136/73. The average annual cost per patient for diabetes-related care
was $3,090 pre-enrollment and $4,760 post-enrollment.
A marginal cost-effectiveness ratio, in terms of cost to
number of patients attaining glycemic control, was calculated. The added cost for glycemic control of one patient
was $186. CONCLUSIONS: An analysis of short-term
outcomes demonstrated the cost-effectiveness of a diabetes care clinic. By maintaining tight glycemic and blood
pressure control, diabetic complications can be reduced
with significant savings to the health plan.
PDB10
THE COST OF NEW ONSET DIABETES
MELLITUS AMONG US RENAL
TRANSPLANT RECIPIENTS
Woodward RS1, Schnitzler MA1, Lowell JA1, Haider S2,
Brennan DC1
1
Washington University, St. Louis, MO, USA; 2Pfizer, Inc,
Groton, CT, USA
OBJECTIVES: Immunosuppressive medications are associated with increased diabetes among kidney transplant
recipients. We used data from the USRDS database to estimate the incidence and the average cost to Medicare of
new onset diabetes Mellitus (NODM). METHODS: The
USRDS database merges the UNOS renal transplant registry with Medicare billing and payment records. The
USRDS registry recorded 9,541 single-organ, first, kidney
transplants in 1996; 5,987 (63%) of these were not diabetic at transplantation. For the 4,515 (75% of 5,987)
patients with Medicare claims, we merged all Medicare
institutional and physician supplier claims records from
1996 through 1997 with the clinical information from
UNOS. We classified patients as newly diabetic if any
116
Abstracts
ICD-9 diabetes diagnosis (250.00 to 250.79) occurred
within one year of the patient’s transplant. We then used
a Kaplan-Meier-style non-parametric calculation to estimate the average accumulated costs for patients with and
without NODM. RESULTS: Among the 4,515 transplant recipients studied, 621 (13.7%) reported diabetes
diagnoses within the first year post-transplant. By the end
of the first post-transplant year, Medicare had paid
$35,288 for each non-diabetic recipient and an extra
$17,614 (P 5 0.001) for each of the NODM recipients.
By two years post-transplant, Medicare had paid an average $46,869 for each of the non-diabetic recipients and
an extra $26,032 for each of the NODM recipients (P 5
0.001). CONCLUSIONS: Our 13.7% NODM exceeds
the 2% to 5% previously reported, and the extra
$26,032 is 55.5% above what Medicare paid for recipients without NODM. New immunosuppressives unassociated with NODM may generate substantial savings
worldwide.
PDB11
ECONOMIC OUTCOMES OF DIABETES AMONG
AN EMPLOYED POPULATION
Leong SA1, Summers KH2, Birnbaum HG1, Kemner JE2,
Lentz EC1, Greenberg PE1
1
Analysis Group/Economics, Cambridge, MA, USA; 2Eli Lilly and
Company, Indianapolis, IN, USA
OBJECTIVES: The two major types of diabetes, Type I
and Type II diabetes, can have life-threatening complications, which often lead to significant adverse economic
consequences. This study investigates the extent to which
Type I and Type II diabetes impose significant financial
burdens on an employer METHODS: The data source is
a rich administrative claims database from a national,
Fortune 100 manufacturer. It includes all medical, pharmaceutical, and disability claims for employees, spouses,
dependents, and retirees (n . 100,000). The diabetes research sample consists of individuals with at least two
medical and/or disability claims for diabetes or at least
one prescription drug claim for a hypoglycemic agent.
Resource utilization by diabetes patients, who are identified as either Type I or Type II diabetics, is contrasted
with that of matched samples from the employer’s overall
beneficiary population. RESULTS: Direct (medical and
pharmaceutical) and indirect (disability and sporadic absenteeism) costs of Type I and Type II diabetes are analyzed. The total average per capita annual costs are
$2,612 for the Matched Type I Control sample compared
to $9,397 for Type I diabetics, and $3,432 for the
Matched Type II Control sample compared to $7,639 for
Type II diabetics. While Type I diabetics cost the employer more than Type II diabetics on average, the cost of
Type II diabetes patients, who were prescribed insulin,
exceeds the cost of Type I diabetes patients. Also, while
the costs of both types of diabetes are relatively high, less
than 50% of total medical costs for these patients are for
the treatment of diabetes or related co-morbid condi-
tions. CONCLUSIONS: Diabetes adds a significant financial burden on the employer. The resources used by
both types of diabetics are substantial, not only for the
treatment of diabetes, but also for the treatment of related co-morbid conditions, as well as other conditions.
PDB12
A PHARMACOECONOMIC ANALYSIS OF
WEIGHT-REDUCTION THERAPY IN A
HYPOTHETICAL COHORT OF OBESE CHINESE
PATIENTS WITH IMPAIRED
GLUCOSE TOLERANCE
Lee KK, You JH, Ho SS, Leung WY, Thomas G, Chan TY,
Critchley J
The Chinese University of Hong Kong, Hong Kong, China
OBJECTIVES: To conduct a pharmacoeconomic analysis
to estimate the potential cost avoidance due to reduced
rate of incidence of diabetes after weight-reduction therapy in obese Chinese patients with impaired glucose tolerance (IGT). METHODS: The incidence of IGT-to-diabetes mellitus (DM) conversion of two hypothetical
cohorts of obese Chinese patients with IGT, either managed with diet control (n 5 100) or diet control plus orlistat (n 5 100), were projected over a two-year period.
The probabilities of IGT-to-DM progression in the orlistat plus diet group and the diet only group were estimated from a published study in a non-Chinese and a
westernized Chinese population, respectively. Direct medical
costs of management of type 2 diabetes were estimated
from a public budget perspective. RESULTS: The estimated rates of IGT-to-DM conversion were 1.9% for the
orlistat plus diet group and 8% for the diet only group.
The total costs of DM management at the end of the first
and second years were estimated to be HK$8,187 and
HK$23,390 ($HK 7.8 5 $US 1) for the orlistat group. In
the diet only group, the costs of DM management were
HK$34,469 in year one and HK$100,123 in year two.
The cost avoidance associated with orlistat therapy were
calculated to be HK$26,282 and HK$75,092 per 100 patients at the end of the first and second years, respectively. CONCLUSIONS: Results of the present study suggest positive economic impacts of weight-reduction therapy
in a hypothetical Chinese population with IGT in the prevention of type 2 diabetes.
PDB13
OPTIMIZATION OF DIABETES MANAGEMENT
IN GERMANY USING A COMPUTER BASED
OUTCOME PROGNOSES MODEL
Brandt A, Gozzoli V, Palmer A, Weiss C, Neeser K,
Schramm W
Institute for Medical Informatics and Biostatistics (IMIB), Riehen,
Switzerland
OBJECTIVES: Optimization of type 2 diabetes intervention strategies in Germany based on stepwise prognoses
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Abstracts
of expected medical and economic outcomes in population subgroups. METHODS: A published, editable diabetes model was used to assess the outcomes of different
degrees of secondary prevention measures for different
diabetes type 2 patient sub-groups in Germany. Clinical
data were derived from German diabetes quality of care
circles. Incremental cost-effectiveness ratios (ICERs) were
calculated as the differences of average lifetime cost divided by the difference of average life expectancy. Optimization was approximated by calculating ICERs for
stepwise modified prevention strategies, including screening and complication treatments for variable population
risk characteristics. RESULTS: Compared to the prognosis of overall life expectancy and cost consequences the
more refined stepwise approach generates a series of results for all combinations of intervention strategy and
population subgroup. At certain risk levels the ICER
based treatment recommendation may change if subgroup prognosis is applied. But for all age groups of diabetes patients secondary prevention of complication is
the dominant variant. Medical outcomes and incremental
cost-effectiveness are improved by additional secondary
prevention measures except for patients with non-reversible risks. The potential savings from improved prevention amount to 10% of total expenditures for diabetes
care in Germany, i.e., DEM 3000 million. CONCLUSIONS: With the stepwise assessment of subgroup outcomes a treatment optimization and optimal allocation of
diabetes management to patient subgroups is feasible. Using average data to calculate overall ICER for the total
diabetes population may ignore the best treatment strategy in different population subgroups. Subgroup analysis
represents a helpful tool in the health economic evaluation of diabetes treatment strategies when variable population risk characteristics and baseline complications affect the clinical and economic outcome.
PDB14
IMPACT OF A DIABETES DISEASE
MANAGEMENT PROGRAM: A RETROSPECTIVE
CLAIMS-BASED EVALUATION
Berger J, Slezak J, O’Leary W, McStay P, Johnson K, Addiego J
Caremark Inc, Northbrook, IL, USA
OBJECTIVE: Evaluate the impact of a comprehensive diabetes disease management (DM) program on health care
costs, quality of life and patient satisfaction. METHODS:
Diabetes patients targeted by pharmacy claims were invited to enroll in a voluntary payor-sponsored DM program (n 5 2,178). Eligible non-enrollees were used for
the control group (n 5 6,396). Medical and pharmacy
claims were combined to determine health care costs.
Quality of life and patient satisfaction were also assessed,
via patient interview. The analysis timeframe encompassed two years prior and one year following program
initiation. RESULTS: Enrollees had higher direct health
care costs than non-enrollees. We were able to predict accurately the medical spend in our control group in ab-
sence of intervention with standard time series analysis
within 4%. Following DM intervention, enrollees’ health
care spend was lower than their baseline spend and lower
than their projected spend (2$116, 2$1,056). Conversely, health care spend increased in the non-enrollee
group from baseline (1$714) (Table 1). Additionally, enrollee quality of life measures improved from baseline
and patient satisfaction with the DM program was high.
CONCLUSIONS: A comprehensive diabetes DM program can lower health care cost and improve patient reported quality of life while demonstrating consistently
high patient satisfaction.
PDB15
DOES PATIENT EXPERIENCE MATTER? TYPE II
DIABETES PATIENTS’ STATED PREFERENCES
FOR INSULIN THERAPIES
Smith G1, Bingham M1, Johnson FR1, Bolinder B2
1
Triangle Economic Research, Durham, NC, USA; 2Aventis
Pharmaceuticals, Bridgewater, NJ, USA
OBJECTIVES: Patient preferences for alternative treatments may be affected by health status and experience
with the treatment. Randomized Clinical Trials (RCTs)
offer a unique opportunity to collect preference data
while controlling for patient experience. METHODS: Patients with Type II diabetes in a large US RCT answered a
series of stated preference (conjoint format) questions regarding attributes of alternative insulin therapies. All patients are insulin-naïve and take insulin as part of the
trial. Preference data is collected before the patient begins
insulin, after 3 months, and after 6 months of insulin
therapy. Insulin attributes include the frequency of insulin injections, method of injection (syringe or pen), glucose control and frequency of hypoglycemia. Personal
health data such as glucose control are collected at each
administration of the stated preference survey. RESULTS: Preferences are analyzed in an ordered probit
panel model that controls for individual health status. Insulin administration attributes have the largest importance scores. The importance score of the insulin injection frequency attribute decreases during the later
observation points. While few patients experience nighttime hypoglycemia, this attribute is significant and has a
larger importance score than glucose control. CONCLUSIONS: Patient experience significantly affects patient
preferences and the derived pharmacoeconomic measures
and should be controlled in preference experiments. Results suggest that some insulin-naïve patients are more
averse to insulin injections before they begin insulin therapy. Results also suggest that increased experience with
diabetes control measures during the trial affects treatment preferences.
118
Abstracts
PDB16
AN OVERVIEW OF PHARMACOECONOMICS IN
TURKEY: COST ANALYSIS AND
REIMBURSEMENT OF ANTIDIABETIC DRUGS
Sapci AH1, Sapci HA2, Demirdamar R3
1
Numune Research Hospital, Ankara, Turkey; 2Faculty of
Medicine, Gazi University, Ankara, Turkey; 3Faculty of
Pharmacy, Hacettepe University, Ankara, Turkey
OBJECTIVE: The Turkish health care system is increasingly pressured by costs. In 1980 total health expenditures were 2.1 billions of dollars and in 2000, 8.2 billion
dollars. In the present study, we aimed to analyze health
insurance system and inpatient expenditures for diabetic
prescription drugs. People in Turkey are covered by four
different health insurance systems. 1) Emekli Sandigi: retirement foundation for the government employees. 2)
Sosyal Sigortalar Kurumu: social security system for laborers. 3) Bag-Kur: governmental free security system. 4)
Private insurance companies that cover health care. All
these social security systems, namely the government, pay
90–100% of both inpatient and outpatient prescriptions,
whereas in other countries this is not the case. Although
Turkey is living with a high rate inflation, our country
has been spending increasing amounts on health care
most of which is reimbursement. However, since there
are scarce number of pharmacoeconomic studies, an estimation cannot be made. METHODS: Numune Hospital
is the biggest governmental hospital with a 1453 active
bed capacity. We analyzed prospectively prescription
costs per diabetic patient from January between December 2000 at Endocrinology and Diabetes Inpatient Unit.
RESULTS: Our results revealed that 122.69 dollars are
paid per patient. This cost does not include the other
treatment costs or the hospital expenditures, it is the
amount paid per patient for drugs. CONCLUSIONS: For
the inpatients, we know that the treatment and prescription is rational. On the other hand our previous research
revealed polypharmacy and irrational drug use is a serious problem for outpatients. We therefore conclude that
pharmacoeconomic studies should be encouraged and
used to evaluate health costs.
EYE/EAR/SKIN/DENTAL
PEE1
ANTIBIOTIC PRESCRIBING PATTERNS FOR THE
TREATMENT OF INITIAL ACUTE OTITIS MEDIA
IN CHILDREN ENROLLED IN IOWA MEDICAID
FROM 1990 THROUGH 1997
Park TR, Brooks JM
University of Iowa, Iowa City, IA, USA
INTRODUCTION: Otitis media and acute otitis media
(AOM) are the most common diseases among children in
the US with an annual cost of more than $3 billion in
1996. Historically, a ten-day course of antibiotics has
been the standard treatment for AOM. Providers can
choose first-line antibiotics (Amoxicillin, TrimethoprimSulfamethoxazole, and Erythromicin-Sulfisoxazole) or a
group of second-line antibiotics. Second-line antibiotics
generally have a broader spectrum of activity but are
more costly relative to first-line antibiotics. Presently,
policy-makers have little evidence to evaluate the increased effectiveness of second-line antibiotics for AOM
in practice. OBJECTIVES: As a first step to address this
question, this study describes the factors related to the
choice between first-line and second-line antibiotics for
initial AOM in Iowa Medicaid population. METHODS:
We identified 19,987 Iowa Medicaid eligible children less
than 13 year of age who had initial AOM from 1990
through 1997. We estimated the probability of the second-line agent use across the patient demographics (age,
sex), previous antibiotic use, year of diagnosis, patient’s
county, and the specialty of the treating physician. RESULTS: Factors of age (p , 0.01), county (p , 0.01),
previous antibiotic use (p , 0.01), provider specialty
(p , 0.01), and year of diagnosis (p , 0.01) had statistically significant effects on second-line prescribing. We
found that second-line prescribing increased over time.
With respect to specialty, general practitioners (OR 5
1.33, 95% CI 5 1.18–1.49), family practitioners (OR 5
1.10, 95% CI 5 1.01–1.19), and otolaryngologists
(OR 5 1.83, 95% CI 5 1.53–2.18) were more likely to
prescribe second-line antibiotics than pediatricians. In
addition, the effect of the timing of previous antibiotic
use on second-line prescribing varied with type of antibiotic previously used. Any second-line antibiotic used
within the last 180 days was positively related to secondline antibiotic use for initial AOM. However, only firstline antibiotic use within the last 60 days contributed to
increased second-line use.
PEE2
THE COST-EFFECTIVENESS OF GENETIC
TESTING FOR PERIODONTAL DISEASE.
A PAYER’S PERSPECTIVE
Higashi MK1, Veenstra D1, del Aguila M2, Hujoel P1
1
University of Washington, Seattle, WA, USA; 2Washington
Dental Service, Seattle, WA, USA
BACKGROUND: Genetic testing for disease predisposition is rapidly becoming available for a variety of chronic
diseases, but it is not clear how the health insurance industry will make reimbursement decisions for these new
diagnostics because the long-term clinical and economic
benefits are unclear. A provider of dental health benefits
requested assistance in assessing a genetic test for a composite interleukin-1 (IL-1) genotype. This test is being
marketed to predict risk for progression of periodontal
disease. OBJECTIVE: To estimate the incremental clinical and economic outcomes associated with the use of
IL-1 testing to identify high-risk patients. METHODS: A
disease simulation model was developed using decisionanalytic and Markov modeling techniques over a 30-year
time frame. RESULTS: In the base-case analysis, using
119
Abstracts
the genetic test resulted in an incremental cost-effectiveness ratio was $32,633 per QALY gained. Sensitivity
analysis produced results ranging from increased costs of
$300,430 and 3.6 additional cases of severe periodontitis
(per one thousand patients) to cost savings of $830,140
and 52.8 fewer cases of severe periodontitis. Sources of
uncertainty were 1) patient compliance based on test result, 2) effectiveness of non-surgical therapy, and 3) the
relative risk for progression based on genotype. CONCLUSION: The use of genetic testing to guide treatment
for periodontitis may result in a wide range of outcomes
under different modeling scenarios. These results range
from improved patient health and cost-savings to additional costs and poorer health. Economic modeling has
identified the additional data required to determine if IL-1
testing can be implemented in a primary care setting in a
cost-effective manner. These methods may be used by the
health insurance industry to assess the cost-effectiveness
of genetic testing for predisposition towards other diseases.
PEE3
DRY-EYE RELATED INCREASES IN HEALTH
CARE UTILIZATION AND EXPENDITURES
Smeeding JE1,4, McLaughlin T2, Yazdani C2, Walt JG3
1
PharMetrics, Athens, GA, USA; 2NDC Health Information
Services, Phoenix, AZ, USA; 3Allergan, Irvine, CA, USA;
4
University of Texas, Athens, GA, USA
OBJECTIVE: This study investigates the incremental cost
of dry eye disease (keratitis sicca) in a managed care population. METHODS: Patients with dry eye diagnoses
(ICD-9-CM 5 370.33, 375.15, 710.2) or punctal occlusion procedures (CPT-4 5 68760, 68761) during 1997–
1998 were identified from PharMetrics’ Integrated Outcomes database of 7 million patients. Controls were randomly selected and matched 1:1 to dry eye cases on age
category, gender and managed care plan. Costs were calculated for 6 months before and after the first dry eyerelated claim for cases, or the midpoint of claims history
for controls. RESULTS: The prevalence of dry eye disease was 0.48% in 1997 and 0.39% in 1998. Dry eye patients (n 5 31,683) were more likely than controls to use
ophthalmic medications, many of which are not indicated
for dry eye (P , .001). Use of non-ophthalmic medications
was similar between cohorts. Total charges rose $454.79
(22.2%) for dry eye patients, significantly more than for
controls ($289.48 [15.9%]) (P , .001). This was mostly
due to a rise in outpatient charges ($257.40 [28.7%] for
cases versus $76.14 [11.2%] for controls). Dry eye diagnoses/procedures were associated with greater increases
in outpatient charges, pharmacy charges, and total medical charges (P , .0001). Dry eye patients experienced a
greater average increase in total medical costs than did controls, mostly arising from outpatient charges. CONCLUSION: We conclude that a major factor in dry eye-related
cost increases is additional physician visits, which may be
a consequence of the ineffectiveness of available therapies.
PEE4
THE FRENCH VERSION OF THE PSORIASIS
DISABILITY INDEX
Finlay A1, Corvest M2, Lefrançois P3, Taieb C4
1
University of Wales College of Medicine, Cardiff, UK;
2
Association Pour La Lutte Contre Le Psoriasis, Eragny, France;
3
Pierre Fabre Dermatologie, Lavaur, France;
4
PharmacoEconomics Programs, Pierre Fabre SA, Boulogne
Billancourt, France
OBJECTIVE: The objective of our work was to translate
the PDI into French, with careful attention to the linguistic aspects and the cultural context of the French patients.
CONTEXT: The PDI is a scale devised by Prof. A. Finlay
of Cardiff to evaluate the impact of psoriasis on the life
of the patient. This questionnaire has been used in numerous studies to evaluate the consequences of the disease in daily life or the effects of different treatments. RESULTS: With the author’s approval, the questionnaire
was translated from English to French by two independent translators. The two versions were compared and a
few non significant differences were noted. A third translation from English to French was realized with the assistance of the APLCP, psoriasis patient support group.
When compared to the first two, this third translation
brought out the specificity of the French cultural context
and the reality of the disease. To make sure that the
translation was consistent with our objective, the questionnaire was sent to five patients and translated from
French to English by two independent translators. For a
large-scale validation, this questionnaire was sent by post
to 5000 psoriasis patients belonging to the APLCP. With
the addition of a questionnaire on the patient’s behavior
in respect to the treatment, “Living With Psoriasis” will
make it possible to evaluate every two years the impact
and the daily consequences of psoriasis on French patients and thus become a decision support tool. CONCLUSION: The novelty of this initiative resides in the involvement of a patient support group at every step on a
level rarely attained, not only in the translation but also
in the validation of the questionnaire. This close involvement reflects the key role of a patient support group in
the management of the disease.
PEE5
INAPPROPRIATE ANTIBIOTIC PRESCRIBING
AND ECONOMIC OUTCOMES FOR PEDIATRIC
OTITIS MEDIA
Rahman AM1, Feldhaus J2, Lawrence L2, Rappaport H2, Moser E2
1
St. John’s University, Jamaica, NY, USA; 2University of Louisiana
at Monroe, Monroe, LA, USA
OBJECTIVES: To examine physician prescribing pattern
of antibiotics for otitis media in children and compare
them with therapeutic guidelines issued by the American
Academy of Pediatrics, Family Physicians, and Otolaryngology, for appropriateness. Also, to calculate the cost
savings that could be achieved by adhering to the guide-
120
Abstracts
lines. METHODS: Data from the National Ambulatory
Medical Care Survey (NAMCS) 1997 was utilized. Patients with principal diagnosis of otitis media with age
less than or equal to 12 years were analyzed using multiple linear and binomial logit regression models. Appropriate antibiotics are defined as those that are recommended by the guidelines. The average wholesale price of
recommended antibiotics was compared with the inappropriate antibiotics prescribed. The dosage of antibiotics was confirmed by the IMS health and the advice of a
practicing Otolaryngologist. Antibiotics cost was calculated by using the Red Book 1997 and 1998. The
weighted average method was used to calculate the average wholesale price of the various quantity packages and
dosage forms. This study utilized the methodology of relating a secondary database to an outside source (Red
Book) to calculate the cost. RESULTS: The average cost
of a course of appropriate antibiotic (penicillin and its derivatives) was found to be $8.07, compared to $69.56 for
expensive antibiotics (difference 5 $61.49). Children less
than four years of age were prescribed more expensive
antibiotics (R2 5 0.287). Pediatricians, and Otolaryngologists prescribed appropriate and less expensive antibiotics than other family physicians (R2 5 0.144). There was
no relationship between the physician’s specialty and patient’s age for inappropriate antibiotics prescribing (R2 5
0.345). CONCLUSIONS: Adhering to the guidelines and
prescribing of appropriate antibiotics appears to save
cost. Inappropriate prescribing of antibiotics for otitis
media should be addressed more explicitly in general
practice.
PEE6
COST-EFFECTIVENESS OF ARTIFICIAL SKIN
SUBSTITUTE VS ALLOGRAFT FOR
BURN PATIENTS
Bron MS, Hay J
University of Southern California, Los Angeles, CA, USA
INTRODUCTION: Healing after a burn injury requires
a temporary wound cover until the skin epithelium heals.
Traditional wound covering, human cadaver allograft
(HCA), is expensive, and limited by availability. OBJECTIVE: To determine if artificial skin substitute (Transcyte) wound cover is cost-effective for temporary wound
coverage in patients with major total body surface
(TBSA) burns. METHODS: Incremental cost per quality
adjusted life year (QALY) in 2000 US dollars is estimated
assuming a base case adult patient who has 40% TBSA
burn with no inhalation injury, complications, or facial
burn followed for one year after HCA or Transcyte procedure. A societal perspective is used. Utilities were surveyed from burn-unit hospital employees. Other variables are taken from literature. RESULTS: Under the
base case, Transcyte saves $3600 over HCA, and adds
0.04 QALYs. Quality of life was significantly greater in
the Transcyte group (0.54, 95% CI 5 0.48–0.59) vs.
HCA group (0.65, 95% CI 5 0.57–0.74, p 5 0.04) while
in the hospital, but not significantly different while recovering at home, after recovery, and at work. The incremental QALY of Transcyte minus HCA must be ,20.07
in order for the ICER to reach a threshold of $50,000.
Sensitivity analysis shows that a 33% increase in Transcyte price will reach the threshold ICER of $50,000. In
addition, this model is highly sensitive to utility at work;
a 22% decrease of at-work utility with Transcyte will result in an ICER greater than $50,000. CONCLUSIONS:
The results show that use of Transcyte as a temporary
wound covering for 40% TBSA burns is a dominant
strategy relative to standard HCA. Use of this artificial
skin results in cost savings, due to faster healing and less
operation room time. A gain in QALYs is seen with
Transcyte, due to less scarring and pain during the healing process.
PEE7
A COST COMPARISON STUDY OF COMMON
PRACTICE AND BEST PRACTICE TREATMENT
FOR PRIMARY OPEN-ANGLE GLAUCOMA IN
THE UNITED STATES
Evans SJ1, Casciano J1, Doyle JJ1, Walt JG2
1
The Analytica Group, New York, NY, USA; 2Allergan, Irvine,
CA, USA
OBJECTIVE: To compare the total, drug, and medical
care costs of common practice and best practice management of primary open-angle glaucoma (POAG). METHODS: A Delphi panel of ophthalmologists specialized in
glaucoma management was convened in order to delineate practice patterns representative of community physicians (common practice), and to characterize the ideal or
optimal standards of care (best practice). A decision analytic approach was used to depict and economically
quantify the clinical sequelae under each scenario for
POAG patients initiated on medical therapy. Common
and best practice decision trees were developed for prototypic agents of the most commonly used first-line classes
of medications. Percentage likelihood of drug usage was
determined based upon physician consensus whereas
drug and surgical efficacy rates were determined based
upon a composite of published data. Typical drug dosing
regimens and number of medical visits, as determined by
physician consensus, were used to estimate the cost of
treatment. RESULTS: The total average annual cost of
treatment per eye was estimated at $733.85 for common
practice and $732.09 for best practice. Drug costs were
estimated at $358.66 for common practice and $341.38
for best practice. Costs of medical care were estimated at
$375.19 for common practice and $390.71 for best practice. Surgical costs comprised a larger proportion of medical care costs in best practice as compared to common
practice (17.84% vs. 14.29%). In comparing best practice and common practice decision analyses, non-selective
beta-blockers were used less often whereas alpha-2 ago-
121
Abstracts
nists were used more often as first-line medical therapy.
The probability of first-line success has been estimated at
71.2% for common practice and 72.3% for best practice.
CONCLUSION: Despite higher surgical costs and improved outcomes associated with best practice management of POAG as compared with common practice, total, drug, and medical care costs of best practice were
comparable to those of common practice.
PEE8
FOUR YEAR COST-EFFECTIVENESS OF INITIAL
TRABECULECTOMY VERSUS CONVENTIONAL
THERAPY IN PRIMARY OPEN-ANGLE
GLAUCOMA (POAG)
Yu E, Hay J, Varma R, Globe D
University of Southern California, Los Angeles, CA, USA
OBJECTIVES: To determine the cost-effectiveness of the
primary treatment of primary open-angle glaucoma
(POAG) with trabeculectomy versus conventional therapy. METHODS: A four-year incremental cost/qualityadjusted life year (QALY) model (year 2000 US dollars)
of POAG using a societal perspective; including direct
and indirect costs with a 3% annual discount rate for the
base case. In the Glasgow trial, patients newly diagnosed
with POAG with an intraocular pressure of 26mmHg
and/or with glaucomatous field defects were randomized
to trabeculectomy or conventional therapy (up to three
medications). In the trabeculectomy branch, patients
would either be 1) controlled without extra medication,
2) controlled with extra medication or 3) die from natural causes. Annual chance nodes for the conventional
were 1) controlled by medication, 2) surgery or 3) death
from natural causes. QALYs were calculated assuming a
decline in utility would accompany loss in visual field. A
65-year old patient with a 5% rate of decline in utility
was used as the base case. Sensitivity analyses were performed on the rate of utility decline, cost of medications,
trabeculectomy cost, and discount rate. RESULTS: For
the base case, the cost of initial trabeculectomy was
$8316 versus $6339 for conventional therapy. The incremental cost was $1977 and the incremental QALY was
0.08, with ICE ratio of $24,830/QALY. CONCLUSIONS: Initial trabeculectomy is cost-effective for POAG.
The model was most sensitive to the rate of decline in
utility (,2%) and robust to changes in the costs of medications and trabeculectomy. Limitations include the lack
of long-term clinical and QALY data on glaucoma patients with different treatments. Currently the standard of
practice in the US is to start with conventional therapy
for patients with moderate or severe glaucoma. Our results indicate that trabeculectomy may be a cost-effective
option for these patients.
GASTROINTESTINAL DISORDERS
PGI1
EFFECTS ON HEALTH CARE CONTACTS AND
DAYS ABSENT FROM WORK WITH
BUDESONIDE CIR CAPSULES IN THE
MAINTENANCE TREATMENT OF CROHN’S
DISEASE IN A US SETTING
Ericsson K, Borg S
AstraZeneca R&D Lund, Lund, Sweden
INTRODUCTION: Crohn’s disease (CD) is a debilitating chronic disease. It also has economic implications
(both for patient and society). Reduced work (or school)
attendance and continuous need for health care contacts
are two important aspects. Data comparing the impact of
different treatment approaches are scarce. OBJECTIVE:
To assess health care utilisation and absence for work (or
school) in a US setting of patients treated with budesonide CIR maintenance therapy compared to patients
with no maintenance treatment (placebo). A societal perspective was adopted. METHODS: Data was collected in
a double-blind randomised clinical trial comparing
budesonide CIR 6 mg daily with placebo for a one year
period. Patients, 55 in each group, had CD localised to
the distal ileum and/or the ascending colon and were between the ages of 18 and 73 (mean 40.3 and 40.5 years).
The collected data included physician visits, different minor procedures (e.g., radiographic, endoscopic), medications, hospitalisations and surgical procedures. Number
of days of absence due to symptoms or treatment of the
disease was also collected. All resource utilisation related
to the design of the clinical trial was excluded in order
not to overestimate real health care use and productivity
losses. RESULTS: The budesonide CIR treatment group
had 26.3% fewer physician visits (87.14 vs. 118.27 ns)
and 27% fewer days absent from work or school (311.73
vs. 427.23 days ns). Numerical differences in other variables were smaller but in favour of budesonide CIR.
CONCLUSION: Treatment with budesonide CIR capsules suggests benefits in terms of reduced health care resource utilisation and absence from work (school), that
also could represent favourable cost implications in the
delivery of health care.
PGI2
ALTERNATIVE MANAGEMENT STRATEGIES
FOR DYSPEPSIA
Wu EQ, Hay J
University of Southern California, Los Angeles, CA, USA
OBJECTIVE:To compare the cost-effectiveness of alternative dyspepsia management strategies: (1) H. pylori
testing; if seropositive, providing H. pylori eradication
treatment using oral omeprazole, clarithromycin, and
amoxicillin; (2) empiric antisecretory therapy using omeprazole. METHODS: Decision analytical models compared cost/QALY for alternative strategies in patients
122
Abstracts
grouped by gender and age. The study was conducted
from the societal perspective using Year 1996–1999
prices, adjusted to year 2000 by CPI. Life expectancies
were adjusted for QOL using the Index of Well-Being.
Probabilities and prices were collected from the literature, the SEER program, National Vital Statistics, and
BLS. The model considered H. pylori reinfection and gastric carcinogenesis risk over time. One-way sensitivity
analyses were conducted on critical or uncertain parameters and threshold analyses on pivotal parameters. RESULTS: The incremental cost-effectiveness ratio (ICE) for
pooled patients (both genders) decreases with age from
$3,612 per quality adjusted life year (QALY) saved at age
40–44 to the minimum of 2$200 (dominant) per QALY
saved at age 65–70. After age 70, the ICE increases with
age. Females have higher ICEs than males in every age
subgroup. The ICE was sensitive to discount rate, relative
risk of gastric cancer (GC) in H. pylori infected patients,
cost of treating GC, and cost of empiric antisecretory
therapy, but not to the reinfection rate or infection rate
of H. pylori, the change of the utility rate of GC and the
one-year utility of dyspepsia patient under empiric antisecretory therapy. CONCLUSIONS: Taking $50,000/
QALY as the societal ICE threshold, H. pylori screening
and eradication is cost-effective for both genders at any
age group, especially for male patients at older ages. Better estimates are needed for certain key parameters such
as the relative risk reduction of GC with H. pylori eradication.
PGI3
A PROSPECTIVE, RANDOMIZED COST
ANALYSIS OF MEPERIDINE AND MIDAZOLAM
VERSUS PROPOFOL FOR COMPLEX UPPER
ENDOSCOPY PROCEDURES
Shermock KM, Vargo JJ, Zuccaro G, Maurer WG
Cleveland Clinic Foundation, Cleveland, OH, USA
OBJECTIVES: Meperidine/midazolam (M/M) and propofol (P) are clinically effective alternatives for sedation
during endoscopic procedures. Propofol has a higher acquisition cost, but may be associated with cost savings
due to shorter duration of post-procedure care. The objective of this project was to compare the costs associated
with complex upper endoscopic procedures (ERCP/EUS)
in subjects who received either M/M or propofol.
METHODS: Subjects scheduled for ERCP/EUS were randomized to receive M/M or P during the procedure. A
blinded observer assessed time to recovery using a standard 10-point postanesthesia recovery score (PARS) every 15 minutes. Once a PARS score of 10 was reached,
the study terminated and the subject was discharged from
the recovery ward. The cost of drug (source: Redbook),
an anesthetist for the propofol group (source: Bureau of
Labor Statistics), recovery room personnel costs (source:
Bureau of Labor Statistics), and overhead costs were
compared from the institutional perspective. A sensitivity
analysis was performed by assuming generic drug, a
nurse anesthetist, and licensed practical nurse (LPN) care
in the recovery ward. RESULTS: 33 and 31 subjects were
randomized to receive M/M and P, respectively. There
were no significant differences detected between the
groups in age, gender, case severity, or procedure duration. P group subjects had a significantly shorter postprocedure recovery time (19 minutes) compared with
M/M group subjects (71 minutes, p , 0.001). Subjects in
the M/M group cost an average of $65 per case, while P
group subjects cost an average of $144 per case (p ,
0.001). The sensitivity analysis resulted in an average
cost of $77 per case in the P group and $34 in the M/M
group (p , 0.001). CONCLUSIONS: Subjects in the P
group had a significantly shorter post-procedure recovery
time but this did not result in cost savings compared with
subjects treated with M/M.
PGI4
HEALTH-RELATED QUALITY OF LIFE (HRQOL)
DATA REVEAL DIFFERENCES AMONG
CLINICAL “RESPONDERS”
Watson ME, Heath AT, Northcutt AR
GlaxoSmithKline, Research Triangle Park, NC, USA
OBJECTIVES: Treatment effects are often evaluated by
comparing groups in terms of the proportion of “responders”, i.e., patients who achieve some prospectively
defined outcome. In the absence of additional data, it is
assumed that responders in different treatment groups
achieve comparable benefits and therefore that the treatment benefit is fully described by the responder rates.
This study compared the HRQOL changes of responders
in two treatment groups. METHODS: In two identical
randomized, double-blind, placebo-controlled studies
(S3BA3001; S3BA3002) in women evaluating 12 weeks
of treatment with alosetron 1mg BID, patients completed
the Irritable Bowel Syndrome Quality of Life Questionnaire (IBSQOL) at baseline and at the final treatment
visit. A patient was classified as a responder if she
achieved adequate relief of IBS pain and discomfort on at
least 2 of 4 weeks for all 3 months. This post-hoc analysis
compared responders from the two treatment groups in
terms of IBSQOL change from baseline scores at the final
visit using analysis of covariance. The analysis focused on
patients with diarrhea-predominant IBS. RESULTS: Our
analyses included 154 patients (96 alosetron and 58 placebo) in S3BA3001 and 172 (110 alosetron and 62 placebo) in S3BA3002. Compared with placebo responders,
those in the alosetron group had significantly higher (p ,
.05) scores on 5 of 9 IBSQOL scales (sleep; energy; physical functioning, food and role-physical) in S3BA3001 and
on 4 scales (sleep, energy, food and social functioning) in
S3BA3002. CONCLUSIONS: Adequate relief responders
in the alosetron group experienced significantly greater
HRQOL improvements relative to placebo group responders. This suggests that treatment benefits may be
underestimated when described only in terms of the additional proportion of responders. Reporting HRQOL dif-
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Abstracts
ferences between responders in the treatment groups provides a more comprehensive characterization of the
treatment effect.
PGI5
HEALTH CARE COST SAVINGS WITH
BUDESONIDE CONTROLLED ILEAL RELEASE
CAPSULES (CIR) IN CROHN’S DISEASE
Ericsson K1, Löfberg R2, Danielsson Å3, Floren CH4, Borg S1
1
AstraZeneca R&D Lund, Lund, Sweden; 2Karolinska Institute,
Stockholm, Sweden; 3Umeå University Hospital, Umeå,
Sweden; 4Lund University Hospital, Lund, Sweden
BACKGROUND: Economic aspects are important when
assessing the overall benefit of a treatment strategy. The
number of investigations of these aspects are few within
the field of Crohn’s disease (CD). OBJECTIVE: To assess
the economic consequences, from a health care budget
perspective, of treating CD patients with budesonide CIR
(Entocort capsules) 6 mg per day as maintenance therapy
compared to no maintenance treatment (NMT). METHOD:
A validated decision-analytic model (Noble et al., 1998)
on the treatment of CD in Sweden was used. The model
used pooled patient data from randomised, double blind
trials of budesonide CIR capsules (n 5 90) versus placebo
(n 5 90) and covers a study period of one year. For
events not investigated in the clinical trials, literature and
panel data were used. Cost inputs for health care resources were based on costs observed for 11 regional hospitals in Sweden in year 1996. The analysis took into account costs for health care resources associated with
managing inactive and active phases of CD, e.g., diagnostic and surgical procedures, physician visits, hospitalisations and drug consumption. Panel data and cost inputs
were tested in a sensitivity analysis. RESULT: Average
annual cost per patient was SEK 36,745 for budesonide
CIR capsules patients compared to SEK 38,130 for NMT
patients. With a Swedish prevalence between 13,000 to
18,000 patients this could mean annual savings of 18 to
25 million SEK (2–2.8 million USD). Stability of the results was confirmed when altering values on panel data
and cost inputs. CONCLUSION: Budesonide CIR capsules,
prolonging time in remission, is a cost-saving treatment
strategy for the treatment of Crohn’s disease in Sweden.
PGI6
COST-EFFECTIVENESS ANALYSIS OF
HELICOBACTER PYLORI ERADICATION TRIPLE
THERAPY VERSUS CONVENTIONAL THERAPY
FOR GASTRIC AND DUODENAL ULCERS
IN JAPAN
Ikeda S1, Tamamuro T1, Asaka M2
1
Keio University School of Medicine, Tokyo, Japan; 2Hokkaido
University School of Medicine, Sapporo, Hokkaido, Japan
OBJECTIVES: Helicobacter pylori (H.pylori) eradication
triple therapy with a combination of lansoprazole, amox-
icillin, and clarithromycin was approved in September
2000 in Japan. The objective of this analysis was to compare the cost-effectiveness of this eradication therapy
with conventional H2RA therapy in Japan. METHODS:
We used decision analysis software to establish two
Markov models, one for gastric ulcers and the other for
duodenal ulcers. The model design was based on the Japanese H. pylori eradication guideline and specialists opinions. The model input data were derived mainly from a
literature review. The models predict the direct medical
costs, number of disease free days (DFDs) and cost per
DFD for five years. Sensitivity analyses were conducted
by varying the success rate and the probability of endoscopic relapse in symptomatic patients. The payer’s perspective was selected. RESULTS: According to the gastric
ulcer model, the expected total costs of eradication and
conventional therapies for an individual patient at the
end of five years would be 169,719 Yen and 390,921
Yen, respectively; the expected DFDs 1,454 days and
1,313 days, respectively; and the expected cost per DFD
117 Yen and 298 Yen, respectively. According to the
duodenal ulcer model, the expected total costs of the
eradication and conventional therapies would be 134,786
Yen and 324,689 Yen, respectively; the expected DFDs
1,503 days and 1,387 days, respectively; and the expected cost per DFD 90 Yen and 234 Yen, respectively.
The sensitivity analyses showed the results of baseline
analysis to be robust. CONCLUSIONS: We found that
this eradication therapy is less costly and more effective
than conventional therapy for the treatment of gastric
and duodenal ulcers in a Japanese medical setting. Thus,
eradication therapy is recommended for gastric and
duodenal ulcers from an economic as well as a clinical
viewpoint, in Japan.
PGI7
BUDESONIDE CIR IS COST-EFFECTIVE IN
MAINTENANCE THERAPY OF CROHN’S
DISEASE IN FINLAND
Ericsson K1, Karvonen AL2, Sintonen H3, Borg S1
1
AstraZeneca R&D Lund, Lund, Sweden; 2Tampere University
Hospital, Tampere, Finland; 3University of Helsinki, Helsinki,
Finland
OBJECTIVE: To assess the economic outcome, from a
health care budget perspective, of treating Crohn’s disease (CD) patients with budesonide controlled ileal release (CIR) 6 mg per day as maintenance therapy compared to no maintenance therapy (NMT). METHODS: A
validated decision-analytic model (Noble et al., 1998) on
the treatment of (CD) was used. The model was adjusted
to specifically depict CD patient management in Finland.
The analysis was based on pooled patient data from randomised, double blind clinical trials comparing budesonide CIR (n 5 90) in maintenance therapy with placebo
(n 5 90). In accordance with the clinical trials the analysis covered a study period of up to one year. The analysis
took into account clinical outcomes and consequences of
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Abstracts
these in terms of health care resource use and associated
costs, e.g., costs of hospitalisations, diagnostic and surgical procedures, outpatient care and drug consumption.
Panel and literature data was used for events not investigated in the clinical trials. Cost inputs were derived from
Tampere University Hospital for year 1998. Days in remission and relapse were translated into Quality Adjusted Life Years (QALYs) using CD specific health-state
utility data from the literature. RESULTS: The outcomes
of the clinical trials were reflected in the model as a
26.4% reduction in annual number of relapses for the average patient in the budesonide CIR treatment group.
Mean annual health care cost per patient was 17,740
FIM (2,000 USD) for the budesonide CIR patient and
16,608 FIM (1,877 USD) for the NMT patient. The difference between the groups amounted to a cost per
gained QALY of 68,610 FIM (7,753 USD), which is well
in line with what is considered a cost-effective treatment
strategy. CONCLUSION: Budesonide CIR means fewer
relapses per average patient and is a cost-effective treatment strategy for the treatment of Crohn’s disease in Finland.
PGI8
RAPID IMPACT OF RABEPRAZOLE ON
SYMPTOM DISTRESS AMONG PATIENTS WITH
GASTROESOPHAGEAL REFLUX DISEASE
Damiano A1, Adler E1, Siddique R2, Sloan S2, Bhattacharjya A2
1
Covance Health Economics and Outcomes Services Inc,
Gaithersburg, MD, USA; 2Janssen Pharmaceutica Inc, Titusville,
NJ, USA
OBJECTIVES: Gastroesophageal reflux disease (GERD)
is a common condition associated with a variety of symptoms, particularly heartburn. The purpose of this study
was to assess patient-reported symptom distress in a randomized trial of rabeprazole (RAB), a proton pump inhibitor. METHODS: Symptom distress was measured using the Distress subscale of the GERD Symptom Assessment
Scale (GSAS) that asks patients about the degree of
bother they experience for 15 symptoms. Patients completed the GSAS at baseline and week 4. We evaluated
the impact of treatment (RAB 10mg, RAB 20mg, or placebo) on mean change in GSAS Distress scores using an
ANCOVA model. We also conducted a relative variability analysis using ANOVA models to determine which of
5 clinical indicators are most useful to explain changes in
GSAS Distress scores. Mean change was assessed as a
function of baseline daytime heartburn severity, baseline
nighttime heartburn severity, time to first 24 hours without heartburn symptoms, complete daytime heartburn relief, and complete nighttime heartburn relief. RESULTS:
The sample consisted of 169 patients (RAB10mg 5 55,
RAB 20mg 5 56, placebo 5 58). Overall, a significant
difference in mean change in GSAS Distress scores was
observed across treatment groups (p 5 0.0007). Both the
RAB 10mg and RAB 20mg groups reported significantly
greater improvements in GSAS Distress scores than the
placebo group (p 5 0.0036 and p 5 0.0004, respectively).
Of the 5 clinical indicators examined, time to first 24
hours without heartburn explained the greatest amount
of variability in GSAS Distress scores. Achieving complete daytime and complete nighttime heartburn relief
also were significant factors. CONCLUSIONS: In clinical
studies, RAB provided fast and consistent (both daytime
and nighttime) heartburn relief. Given that speed of
heartburn relief as well as achieving complete heartburn
relief were significant factors explaining variability in patient-reported symptom distress, the positive impact of
RAB on the GSAS distress scale was consistent with its
clinical efficacy.
PGI9
COST-EFFECTIVENESS OF ‘TEST&TREAT’
HELICOBACTER PYLORI INFECTED DYSPEPTIC
PATIENTS IN A PRIMARY CARE SETTING
Chen KS, Hay J
University of Southern California, Los Angeles, CA, USA
OBJECTIVES: With recent recognition of the primary
role of Helicobacter pylori (HP) in peptic ulcer disease, it
has been proposed that patients with dyspepsia undergo
noninvasive testing for HP, instead of endoscopy, followed by antibiotics if positive. We evaluated cost-effectiveness of ‘Test&Treat’ strategy versus empirical treatment for HP infection in dyspeptic patients presenting in
the primary care setting. METHODS: The study was a
one-year incremental cost (yr2000 US dollars) per quality-adjusted life year (QALY) model for dyspeptic patients age less than 45 years old in a primary care setting
from a societal perspective. With ‘Test&Treat’ algorithm, patients were tested for HP infection using urea
breath test. If positive, eradication was prescribed. Alternatively, patients were given conventional treatment of
H2RA for four weeks. If not cured, HP would be eradicated empirically. Both direct and indirect costs were included. The model took into consideration preventing
gastric cancer from eradication. Sensitivity analyses were
performed on prevalence of HP infection, drug treatment
efficacy, laboratory test costs, drug treatment costs, and
drug treatment utility loss. RESULTS: At baseline, with
HP prevalence of 40% and HP antibiotic eradication efficacy of 89%, results showed that ‘Test&Treat’ had an incremental cost-effective ratio (ICER) of $31,723/QALY.
One-way sensitivity analysis showed that antibiotic treatment efficacies lower than 45–46% would exceed the societal threshold ICER of $50,000. CONCLUSIONS: The
model showed that ‘Test&Treat’ was cost-effective for
uncomplicated dyspeptic patients in primary care. Although NIH guidelines state that all ulcer patients with
HP infection require eradication regimen, universal endoscopic diagnosis of ulcer causation (HP1/HP2) would not
be cost-effective. However, treating all patients empirically
could increase antibiotic resistance. The ‘Test&Treat’
strategy has the benefits of slowing antibiotic resistance
while avoiding high endoscopy costs. The model was ro-
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Abstracts
bust to changes of most parameters—most sensitive to
prevalence and eradication efficacy changes.
PGI10
IRRITABLE BOWEL SYNDROME COSTS
SICKNESS FUNDS DM 2.8 BILLION PER YEAR
Schultes HJ1, Guminski W2, Rosche U2, Ries B1, Pirk O3
1
Novartis Pharma, Nuremberg, Germany; 2I1G
Gesundheitsforschung, Munich, Germany; 3Fricke & Pirk,
Nuremberg, Germany
BACKGROUND: With a prevalence of up to 20%, Irritable Bowel Syndrome (IBS) could cost the German Sickness Funds (GKV) more than DM 28 billion (10,5% of
its total expenditures) per year. Despite these potentially
tremendous costs it is still a fairly obscure disease in
terms of proper diagnosis and lacking effective treatment.
OBJECTIVE: To assess diagnosis and treatment options
of IBS using strict Rome-II criteria. METHODS: Face-toface interviews of patients (121) and physicians (147
GPs, 53 internists). RESULTS: The patient survey (age
14–74 yrs.; strict Rome-II criteria) puts the prevalence of
IBS (constipated and alternating type) in Germany at
around 2.3% (1.4 million). This figure correlates well
with previous findings. The patients responded that they
experienced an average of 7 episodes per year, each lasting about 4–5 days. Some 11% of them suffer permanently. Of the physicians questioned, only 73% recognize
IBS when given the symptoms; 57% of these actually
classify it accordingly while an alternative diagnosis is
“irritable colon” (24%). When choosing a drug, daily
treatment costs outweigh every other factor of the physicians relevant set (efficacy, onset, side-effects, mode of
action etc.) by about 3:1. In consequence a drug treatment is initiated in (only) 40% of the cases. This is also
due to a lack of effective and specific treatment which
could help to reduce the frequency of episodes. Results of
another study put the direct costs of the average IBS patient at around DM 1,729 per year. Combining this with
the above findings results in a more realistic figure of
around DM 988 million in direct costs per year (0.37%
of total GKV expenditures). CONCLUSION: These comparably high costs (insulin treated diabetes: DM 1,217
p.a.) could be significantly reduced by DM 247 for each
episode prevented through proper diagnosis and consequent treatment with a specific and effective medication.
PGI11
CHARACTERIZATION AND MARKOV
MODELING OF GASTROESOPHAGEAL REFLUX
DISEASE STATES IN A LARGE HEALTH
CARE PLAN
Brelje T1, Heaton A1, Martin S1, Bhattacharjya A2, Dodd S2,
Thornhill J2
1
Prime Therapeutics, Inc, Eagan, MN, USA; 2Janssen
Pharmaceutica Products, L.P, Titusville, NJ, USA
OBJECTIVES: The objective was to describe the disease
state (DS) transition patterns of gastroesophageal reflux
disease (GERD) by applying a multi-state model assuming a Markov process. METHODS: This retrospective
study utilized administrative claims for subjects with
GERD from a large Midwest USA health care plan. Subjects were tracked for six, six-month time periods (baseline and five followups). Within each time period, ICD-9
diagnosis codes were used to categorize subjects’ GERD
into four DS plus a non-symptomatic state: DS0 {no
GERD diagnosis}, DS1 {mild esophagitis}, DS2 {reflux
esophagitis}, DS3 {esophageal ulceration}, and DS4 {strictures and complications}. GERD transition probabilities
and patterns were analyzed in a five-state Markov framework. Disease regressions and progressions were allowed. The effects of patient and provider covariables on
transition probabilities were modeled using logistic regression techniques. RESULTS: A total of 7575 subjects
with GERD were analyzed. In the five followup periods
combined, 79% of the subjects were in GERD DS0, 6%
in DS1, 8% in DS2, 2% in DS3, and 5% in DS4. For all
initial DS, the most frequent transition path was to regress to DS0 (becoming non-symptomatic) and the second most common was to stay in the initial disease state.
For subjects ending a time period in DS1, 89% regressed
to DS0 in the next time period, while 6% stayed in DS1,
3% progressed to DS2, 1% progressed to DS3, and 1%
progressed to DS4. Multivariate modeling of risk factors
influencing transitions showed that progressing from
DS1 is associated with age .70, a proton pump inhibitor
prescription, and absence of a diagnostic procedure.
CONCLUSIONS: The Markov analysis showed that subjects with GERD commonly have their symptoms regress,
with only a small percent progressing. The Markov
model is a useful methodology to research disease states
in a retrospective database setting within a health care
plan.
PGI12
ESTIMATING POTENTIAL UTILIZATION OF
ESOMEPRAZOLE BY ASSESSING GERD
SYMPTOM CONTROL ON TRADITIONAL PPI’S
DeLattre ML, Schaefer M, Morreale AP, Plowman BK
VA San Diego Healthcare System, San Diego, CA, USA
OBJECTIVES: Approximately one-half of the American
population experiences weekly symptoms of gastroesophageal reflux disease (GERD). With the hypothesis that
not all patients are completely symptom free on proton
pump inhibitor’s (PPI’s), the pharmaceutical industry is
formulating more potent anti-secretory drug therapies. In
November of 2000 the FDA approved esomeprazole for
the treatment of Erosive Esophagitis (EE). Esomeprazole
is a more potent inhibitor of gastrin and gastric acid,
with clinical studies demonstrating quicker symptom relief with more complete 24-hour acid control. If complete
acid control translates into better long-term symptom relief for chronic symptomatic GERD it may play a vital
126
Abstracts
role in refractory GERD patients. The purpose of this
cross-sectional survey study is to estimate the percentage
of patients actively treated with PPI’s (omeprazole and
lansoprazole), who perceive control of their symptoms.
The Gastrointestinal Symptom Rating Scale (GSRS), a
validated rating scale to assess GERD patients’ quality of
life, was utilized. The study hypothesis is that 80% of the
patients will perceive their symptom control is very good
or excellent. METHODS: An unblinded self-administered questionnaire, including the GSRS, was mailed to
300 patients who were currently receiving GERD maintenance therapy with a PPI. Patients were asked questions
regarding the duration and severity of symptoms, dosing
of medication, contributing lifestyle factors and debilitation of disease. RESULTS: 153 questionnaires were returned fully completed, a 51% response rate. The surveyed patients were 60 6 14 years with 89% of
respondents being male. Of the PPI’s prescribed 86% and
14% were lansoprazole and omeprazole respectively. The
median total score of the GSRS was 19, representing mild
to moderate patient symptomatology. CONCLUSIONS:
66% of respondents treated with currently prescribed
PPI’s had very good or excellent symptom control, however the need exists for a more effective PPI for adequate
symptom control in 34% of patients.
PGI13
FACTORS ASSOCIATED WITH PHYSICIAN
KNOWLEDGE OF WHETHER PRESCRIPTION
DRUGS ARE ON FORMULARY
Shih YCT1, Sleath B2
1
MEDTAP International, Bethesda, MD, USA; 2School of
Pharmacy, University of North Carolina at Chapel Hill,
Chapel Hill, NC, USA
OBJECTIVE: Prescription drug formularies have been
used by many pharmacy benefit managers (PBMs) as a
tool to control the rising costs of prescription drugs and
became increasingly popular since the 1990s. Despite its
popularity, little is known about how familiar physicians
are with what prescriptions are on formulary. This study
examines factors associated with physician knowledge of
formulary. METHODS: The National Ambulatory Medical Care Survey (NAMCS) is a data series of annual survey of a national representative sample of physician office visits. It provides up to six medications associated
with each office visit. The 1998 NAMCS collected information regarding the formulary status (yes, no, do not
know, or not applicable) of each medication and provided a unique opportunities to assess physicians’ knowledge of formulary. Univariate analyses as well as multivariate logit model were used to examine the association
between physician knowledge of formulary and types of
visits, physician specialty and practice locations. RESULTS: On average, 47% of physicians did not know
whether the drug they prescribed was on formulary. Physicians whose patients belonged to an HMO and were
paid by capitation were seven times more likely to know
whether a drug was on formulary, compared to those
whose patients were neither in an HMO nor capitated.
Physicians in the South were 1.7 times more likely to
know than those in the West, whereas the odd-ratios was
0.7 for those in the Midwest. Neither physician specialty
(primary care physician versus specialist) nor patient history (new versus established patient) was found to be significantly associated with physician knowledge of formulary. CONCLUSIONS: It is important for PBMs to find
mechanisms to increase physician awareness of whether a
patient’s medications are on formulary. Improving physicians’ understanding of what medications were on formulary could potentially decrease prescription drug costs
for health care plans and patients.
PGI14
HOW IMPORTANT IS APPROPRIATE EMPIRICAL
ANTIBIOTIC TREATMENT FOR
INTRA-ABDOMINAL INFECTIONS?
Davey P1, Libby G1, Hunter K1, Broomhall J1, Kofteridis D1,
Steinke D1, Taylor E2, Yin D3
1
University of Dundee, Dundee, Scotland; 2Vale of Leven
Hospital, Alexandria, UK; 3Merck & Co., Bridgewater, NJ, USA
OBJECTIVES: To assess the association between hospital costs and the appropriateness of empirical antibiotic
treatment for community-acquired intra-abdominal infection. METHODS: Patients were identified from hospital discharges from three hospitals for 1993 to 1997.
Medical records were obtained to validate the diagnosis
and obtain details of antibiotic therapy and its outcome.
Valid cases had macroscopic evidence of intra-abdominal
infection at operation, therefore all cases had surgical
control of infection in addition to antimicrobial therapy.
Appropriateness of empirical therapy was assessed from
the results of in-vitro sensitivity tests (culture positive
cases) and compliance with local antibiotic policies (culture negative cases). RESULTS: We identified 294 valid
cases of intra-abdominal infection of whom 162 (55%)
were culture positive. Appropriate antibiotic treatment
was associated with significantly shorter length of stay
and lower investigation costs for patients with positive
cultures but not for patients with negative cultures or no
test/result (data not shown). Culture 1ve cases, appropriate (n 5 129) vs inappropriate (n 5 33): mean length of
stay 12 vs 22 days, p 5 0.0007 boot strap t test, mean investigation cost £250 vs £409 p 5 0.04, mean antibiotic
cost £138 vs £128 p 5 0.9. A log transformed linear regression analysis was carried out on the cost data for the
culture positive cases adjusting for five independent variables. Inappropriate antibiotics, increasing age and a
higher number of comorbidities and previous admissions
were significantly associated with increased cost of hospital stay but not gender. This model accounted for 34% of
the variance in cost of hospital stay. For the cost of investigations inappropriate treatment, increasing age and
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Abstracts
number of comorbidities were all significant predictors
accounting for 26% of variance in costs. Number of comorbidities was the only variable significantly associated
with the cost of antibiotics. CONCLUSIONS: Appropriate empirical antibiotic treatment of patients with culture
positive intra-abdominal infection is strongly associated
with length of stay and hospital costs.
PGI15
COMPUTERIZED ASSESSMENT OF
COMPLICATIONS FOLLOWING
COLORECTAL SURGERY
Kroch E1, Azimuddin K2, Rosen L2, Reed JF2
1
Villanova University, Villanova, PA, USA; 2Lehigh Valley
Hospital, Allentown, PA, USA
OBJECTIVES: Historically, complication rates following
colorectal surgery were stratified by disease process, type
of operation, or anesthesia risk derived after an intensive
review of the medical record. Newer computer applications purport to shorten this process and predict the
probability of postoperative complications by distinguishing them from comorbidities that are co-mingled on
uniform discharge codes. We analyzed CaduCIS software
(CareScience, Inc., Philadelphia, PA) which uses discharge codes to see if its predictions of comorbidity and
complications accurately track the medical record.
METHODS: Two-hundred and seventy patients were analyzed using principal and secondary diagnoses coded on
discharge. Coding inaccuracies of clinical occurrences
were identified by physician review of each medical
record. The actual incidences of 17 common preoperative
comorbidities and 11 postoperative complications were
compared to computerized predictions by applying standard statistical tests. RESULTS: The overall incidence of
complications obtained by physician (actual) review was
47%, compared to 46% by computer. The computerized
predicted distribution of comorbidities was similar to the
actual occurrences in 15 of 17 categories. Analysis
showed a statistical difference between the computer-predicted and “actual” complication rates in 5 of the 11 categories; however these differences (underestimates) were
due to charting and coding inaccuracies, not to computerized errors. The most common preoperative comorbidities and complications were cardiopulmonary (47% and
28%, respectively). CONCLUSIONS: The computer-system’s accurate measurement of the overall complication
rate supports the claim that aggregate complication estimates derived from readily available administrative data
are sufficient for across-the-board comparisons among
hospitals. The computerized system can generate such
measurements in a fraction of the time is takes to manually review the medical records. As uniform discharge
coding of co-mingled comorbidity and complications are
increasingly used to rapidly compute surgical outcomes,
colon and rectal surgeons need to ensure compatibility of
the actual and coded medical record.
PGI16
ANALYSIS OF THE LONG-TERM COSTS,
SAVINGS AND EFFECTS GENERATED BY
INFLIXIMAB TO NORMALIZE QUALITY OF LIFE
IN PATIENTS WITH CROHN’S DISEASE
Annemans L1, Moeremans K1, Rutgeerts P2, Lemmens L1
1
HEDM, Meise, Belgium; 2University of Louvain, Leuven,
Belgium
OBJECTIVES: Infliximab (Remicade) (I) 5mg/kg is effective to control refractory Crohn’s disease in 81% and to
improve fistulas in 68% of patients, thus greatly improving quality of life (QoL). The objective of this study was
to calculate the direct costs and savings generated by I to
achieve this improvement of QoL. METHODS: This mirror-image study was carried out in 48 patients, of which
22 had fistulas, all responding to therapy. Patients were
followed for 6 to 24 months prior and 6 to 24 months after I. All direct costs to the Belgian public payer were recorded separately for every 6 month time period before
and after I, in order to control for a bias due to changed
management regardless of I. The cost of I was calculated
separately. IBDQ scores were recorded before and after I
for each period. RESULTS: There was an important
build up of costs in each period before I: 22–1.5y: 1,002
(6459) Euro; 21.5–1.0y: 1,486 (6459) Euro; 21.0–0.5:
2,114 (6391) Euro; 20.5–0: 2,427 (6302) Euro. After I
there was a sharp decrease of the cost of care (excluding
the cost of I) to 1,760 (6239) Euro (010.5y) and 1,380
(6264) Euro (10.511.0y). The decrease was statistically
significant (p50.016). The average cost of I in the first
six months was 4,850 (6327) Euro and in the second six
months 1,300 (6280) Euro. The IBDQ increased from
147.8 (SE 8.4) to 187.8 (SE 7.0). The total direct cost of
care after I, adjusted for the non-responders, was calculated to be 17.0 Euro per day of normalised QoL. CONCLUSIONS: Although the cost of infliximab is substantial, the total direct cost to produce a normal QoL in the
entire year after therapy is quite acceptable, providing
that patients not responding are not further treated.
PGI17
COMPARISON OF GENERIC VERSUS DISEASE
SPECIFIC TOOLS FOR THE MEASUREMENT OF
HEALTH-RELATED QUALITY OF LIFE IN
CROHN’S DISEASE
Wurtzbacher JD1, Gourley GK1, Reed PJ1, Gourley DR1,
Solomon DK1, Haas JW2
1
University of Tennessee Health Science Center, Memphis, TN,
USA; 2University of Tennessee, Knoxville, TN, USA
Health-related quality of life (HRQoL) research suggests
that, due to unique characteristics of a disease state, disease specific tools are better discriminators of health status than generic tools. OBJECTIVE: To compare generic
(SF-12) versus disease specific (SIBDQ) quality of life
tools in a cohort of patients receiving treatment for
Crohn’s Disease (CD). METHODS: Structural Equation
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Abstracts
Modeling techniques were used to evaluate the effectiveness of the SF-12 and the SIBDQ for evaluating health
status patients with CD. A cohort of 151 patients with
CD receiving drug therapy was administered both instruments via telephone survey. RESULTS: The variance explained by the SIBDQ in this population was 11.6%
while the SF-12 explained 55.7%. Adapted models of
both the SIBDQ and SF-12 resulted in explained variance
of 54.8% and 84.1%, respectively. CONCLUSIONS:
Given these results, the generic HRQoL tool was significantly better than the disease specific tool at measuring
and accounting for health status in this population. Patients with moderate or severe CD have previously been
shown to have differing clinical response to therapy
based upon disease severity, whereby patients with more
severe disease have better response. Due to these possible
unique clinical outcomes of newer medications such as
infliximab, the effectiveness of disease specific tools may
be compromised since improving therapies may affect
HRQoL in a different manner than therapies previously
available. Other innovative therapies, such as biologic response modifiers for rheumatoid arthritis, may have similar findings related to HRQoL measurement. This potential problem with HRQoL measurement is likely to
increase as biopharmaceutical and pharmacogenomic research increases the number and rate of new product approvals. These findings have important implications related to measurement of HRQoL in clinical trials and
pharmacoeconomic evaluation of medications. This suggests a need for careful reevaluation of disease specific
tools given the clinical effects of newer therapies.
INFECTIOUS DISEASES
PID1
EFFICACY OF ZINC LOZENGES ON THE
DURATION OF COMMON COLD SYMPTOMS:
A META-ANALYSIS REVISITED
Chaiyakunapruk N1, Veenstra DL1, Sullivan SD1, Saint S2,
Bent S3
1
University of Washington, Seattle, WA, USA; 2University of
Michigan, Ann Arbor, MI, USA; 3University of California,
San Francisco, CA, USA
OBJECTIVE: Cold symptoms are both common and
costly. The effectiveness of zinc lozenges in reducing the
duration of common cold symptoms has been investigated in several studies with discrepant results. We therefore performed a meta-analysis in an attempt to clarify
these discrepancies and determine the overall effectiveness of zinc lozenges in the treatment of the common
cold. METHODS: A computerized search of the MEDLINE database from January 1966 to December 2000
was performed to identify randomized controlled trials
comparing zinc lozenges to placebo for the common cold.
Data were systematically abstracted. The outcome assessed was the duration of cold symptoms. Quantitative
pooling was undertaken using the Dersimonian and Laird
random-effects model. RESULTS: Five studies met the inclusion criteria and provided sufficient information to
calculate the mean duration of cold symptoms. A total of
562 subjects were included in these trials: 283 in the zinc
group and 279 in the placebo group. The summary mean
duration of cold symptoms in the zinc group was 2.25
days less than that in the placebo group (95% confidence
interval [CI], 1.07–3.43). However, there was evidence of
statistical heterogeneity among studies (P 5 0.003). In a
subgroup analysis, we found that there were two sets of
homogeneous studies with different magnitudes of reduction: 3.6 days (95% CI: 2.77,4.43) and 1.32 days (95%
CI: 0.52,2.13). CONCLUSIONS: Zinc lozenges appear
to be an effective treatment for reducing the duration of
cold symptoms. However, further analyses are required
to explore the sources of heterogeneity. A formal costeffectiveness analysis may be necessary to determine
whether this intervention is economical.
PID2
IMPACT OF CYTOMEGALOVIRUS (CMV)RELATED READMISSION ON POST HEART
TRANSPLANT RESOURCE USE
Leader S, Henderson R, Carlin D
MedImmune Inc, Gaithersburg, MD, USA
OBJECTIVES: The incidence and costs associated with
the rehospitalization of heart transplant patients for the
treatment of CMV infection have not been well documented. Two adult heart transplant centers participated
in a Transplant Infection Cost Analysis program that was
implemented in several centers covering different solid
organ programs. METHODS: A retrospective chart review of all patients rehospitalized within two years posttransplant identified the number of such readmissions,
hospital costs and charges for the CMV associated readmission, and the length of stay. Data were pooled for
analysis. All dollar amounts were standardized to 1997
dollars using the Medical Care component of the Consumer Price Index. RESULTS: Between 1994 and 1996,
the two hospitals performed a total of 163 heart transplants. There were a total of 34 readmissions (21%) to
these hospitals associated with a CMV infection. Total
direct hospital costs were $740,220 (average $21,771
and range $1,324–$349,224). Total related charges were
$1,431,793 (average $42,111 and range $2,323–
$698,447). Total days of inpatient care for CMV infection were 371 days (average 10.9 and range 2–95) at an
average cost per day of $1,997. CONCLUSIONS: Data
from two heart transplant centers demonstrate that CMV
infection caused significant readmissions. Use of hospital
resources to treat CMV infection one to two years posttransplant was substantial. Total cost of CMV was not
captured: readmission to other hospitals, outpatient costs,
physician costs, mortality and lost productivity should be
included for a complete assessment of the economic burden of CMV infection.
129
Abstracts
PID3
TRENDS IN INPATIENT COSTS FOR ACUTE
PANCREATITIS IN THE UNITED STATES
Bell CF, Stephens JM, Botteman MF, Pashos CL, Ewing M
Abt Associates Clinical Trials, Bethesda, MD, USA
Although the care of patients with pancreatitis-related
complications is estimated to be much more resourceintensive than that provided to other critically-ill patients,
information on the cost of acute pancreatitis is limited.
OBJECTIVES: To examine trends in the incidence and
cost of acute pancreatitis-related hospitalizations in the
United States, and to ascertain patient disposition at discharge to evaluate the extent to which costs may extend
beyond the initial hospitalization. METHODS: Data
were obtained from the 1995–1997 Health care Cost and
Utilization Project database. ICD-9-CM code 577.0 was
used to identify hospitalizations with a primary or secondary diagnosis of acute pancreatitis. Patient demographics, length of stay (LOS), total charges (in constant
1995 dollars), and discharge status were assessed. RESULTS: Between 1995 and 1997, the number of acute
pancreatitis-related hospitalizations increased by 9.1%
from 241,178 to 263,136. During that period, the average LOS decreased by 9.5% from 8.4 days to 7.6 days
and the mean hospital charges decreased by 4.9% from
$19,222 to $18,280. Using LOS 15 days as a proxy for
severity, severe acute pancreatitis-related hospital discharges decreased from 30,444 in 1995 to 27,839 in
1997. During that period, the average LOS remained
constant (28.9–28.4 days) and the mean charges increased from $77,572 to $82,043. Nationwide, the projected pancreatitis-related inpatient charges have increased from $4.6 to $4.8 billion. Despite representing
12% of admissions, severe acute pancreatitis-related
charges represented 49% of all acute pancreatitis-related
inpatient charges. 38–41% of patients were discharged to
another facility, suggesting that these cost estimates are
conservative. CONCLUSIONS: Acute pancreatitis is a
major financial burden on health care systems due to
high inpatient costs and frequent need for medical care
that extends beyond the hospital stay. Despite a reduction in charge per case, total inpatient charges of pancreatitis have increased to rising incidence.
PID4
ECONOMIC COST OF HIV INFECTION IN
UNTREATED WORKERS: AN EMPLOYER’S
PERSPECTIVE
Chaikledkaew U1, Liu GG2, Lyu R3, Louie S1
1
University of Southern California, Los Angeles, CA, USA;
2
University of North Carolina at Chapel Hill, Chapel Hill, NC,
USA; 3Rutgers University, New Brunswick, NJ, USA
It is necessary to understand the direct and indirect costs
of HIV infection in untreated workers in order to estimate the value of aggressive antiretroviral therapies from
an employer’s perspective. Currently the cost of HIV/
AIDS from an employer’s perspective is not well understood. OBJECTIVES: To estimate lifetime costs of HIV
infection in untreated employees from an employer’s perspective. METHODS: A simulation model was developed
to predict costs of HIV infection in untreated employees
from an employer’s perspective over a ten-year time
frame. This model utilized age, CD41 cell counts, and
plasma HIV-1 RNA level as major predictors of disease
progression and expected patient survival to estimate lifetime costs. Major direct cost components were health insurance premium, life insurance premium, short-term disability benefits, long-term disability benefits, and hiring/
training expenses. The indirect cost included productivity
loss at work. RESULTS: For a hypothetical 35-year old
HIV-positive employee with CD41 cell counts at 380
cells/mm3 and HIV-1 RNA at 22,000 copies/ml, the
model estimated that the total direct and indirect costs of
HIV infection was $165,873 from the employer’s perspective over a 10-year period. This included $66,659 for
health insurance, $12,788 for life insurance costs, $8,580
for short-term and long-term disability benefits, $25,894
for hiring and training expenses and $51,952 due to productivity loss. Sensitivity analyses suggested that changes
in employee age, CD41 cell count, HIV-1 RNA viral
load, and CD41 cell decline rate were important parameters that significantly impact the costs of untreated HIV
workers to employers. CONCLUSION: Without effective antiretroviral therapy, HIV infection could result in
significant direct and indirect costs to employers. Therefore, the cost-effectiveness of treatment with advanced
antiretroviral regimen should be considered for HIV infected workers.
PID5
MOXIFLOXACIN VS AMOXICILLIN/
CLAVULANATE IN THE TREATMENT OF ACUTE
MAXILLARY SINUSITIS (AMS):
EFFICACY, SAFETY AND PATIENT-REPORTED
OUTCOMES IN PRIMARY CARE
Rakkar S
Plano Medical Center, Plano, TX, USA
OBJECTIVE: This study was designed to reflect realworld experience in the treatment of patients with AMS.
Efficacy, safety, and patient-reported outcomes variables
were compared between moxifloxacin (MXF) and amoxicillin/clavulanate (AC) for the management of AMS in a
primary care setting. METHODS: In this prospective,
multicenter, non-blinded phase IIIb trial, 475 adult patients with symptoms of AMS were randomized to receive a 10-day oral regimen of either MXF (400mg oncedaily) or AC (875mg twice-daily). Clinical success at the
test-of-cure (TOC) visit (post-therapy days 14–21) was
the primary efficacy measure. Secondary outcomes included rate of clinical relapse at follow-up (post-therapy
days 26–46) and exploratory evaluation of patientreported outcomes variables. Safety data was also tabulated from intent-to-treat (ITT) patients. RESULTS: Of
130
Abstracts
471 adults comprising the ITT population (234 MXF,
237 AC), MXF treatment was statistically equivalent to
AC at the TOC visit (85.2% vs 81.8%; 95%CI 5
26%,13%). Per-protocol analysis also confirmed statistical equivalence between MXF and AC (86.5% vs 83.6%;
95%CI 5 27%,13%). Rates of relapse were similar for
the ITT (4% MXF, 5% AC) and the per-protocol (4%
both) populations. The frequency of drug-related adverse
events were similar between MXF (30%) and AC (25%)
and were primarily gastrointestinal-related: nausea (11%
MXF, 5% AC) and diarrhea (3% MXF, 10% AC). At
the TOC visit, significantly more MXF-treated patients
(n 5 47; 24%) in the ITT population than AC-treated
patients (n 5 28; 14%) reported symptomatic improvement by day 3 (p , 0.02). No differences existed in terms
of lost work hours or time to return to normal activities
between treatment groups. CONCLUSIONS: In this primary care clinical trial, once-daily MXF was as effective
and safe as twice-daily AC in the treatment of AMS. In
some patients, MXF was associated with more rapid
symptomatic relief, which has potential clinical and socioeconomic implications.
PID6
HIV/AIDS HEALTH STATE UTILITIES USING
COMMUNITY AND PATIENT PREFERENCE
WEIGHTS: WHEN DOES IT MATTER?
Schackman BR1, Goldie SJ1, Freedberg KA2, Losina E3,
Brazier J4, Weinstein MC1
1
Harvard School of Public Health, Boston, MA, USA;
2
Massachusetts General Hospital, Boston, MA, USA; 3Boston
University School of Public Health, MA, USA; 4University of
Sheffield, Sheffield, UK
OBJECTIVES: To compare utilities for HIV/AIDS health
states derived from community-based preferences with
those derived from patients, and to examine the implications of differences for a cost-effectiveness analysis of
early versus deferred treatment of HIV patients presenting with CD4 cell counts of 500/mL. METHODS: We
used data from the HIV Cost and Services Utilization
Study (HCSUS), a probability sample of 2,864 HIVinfected adults receiving care in the United States in 1996,
to derive utilities for HIV/AIDS health states. Community-based utilities were calculated from the SF-6D responses in the HCSUS survey using algorithms derived by
Brazier et al. Patient utilities were calculated from patient
self-assessments using a rating scale transformation derived by Torrance et al. We used a computer-based statetransition simulation model of HIV disease to conduct
cost-effectiveness analyses using both community and patient utilities. RESULTS: Patient utilities were significantly higher (by 4% to 9%, p , 0.001) than community
utilities for all disease stages: for asymptomatic HIV patients 0.970 (0.963–0.977) vs. 0.937 (0.926–0.949); for
symptomatic HIV patients 0.910 (0.902–0.919) vs. 0.841
(0.826–0.855); and for patients with a history of an
AIDS-defining condition 0.845 (0.832–0.858) vs. 0.778
(0.761–0.795). The cost-effectiveness ratio of early therapy (initiated at 500 CD4 cells/mL) versus deferred therapy (initiated at ,200 CD4 cells/mL) was $20,100/QALY
using community utilities and $18,400/QALY using patient utilities. In a sensitivity analysis, when we assumed a
20% reduction in quality of life due to side effects during
early therapy but not during deferred therapy, the costeffectiveness ratio of early versus deferred therapy was
$50,900/QALY using community utilities and $46,300/
QALY using patient utilities. CONCLUSIONS: There
are differences between community and patient utilities
for HIV/AIDS health states. The impact of these differences on HIV/AIDS cost-effectiveness results should be
considered when treatment side effects are important.
PID7
OBSERVATIONAL EVALUATION OF HEALTH
STATE UTILITIES AMONG A COHORT OF
SEPSIS PATIENTS
Drabinski A, Williams G, Formica C
Knoll Pharmaceutical Company, Mount Olive, NJ, USA
OBJECTIVE: Among sepsis survivors, during recovery
and thereafter, it is not established if patients resume or
improve their quality of life. The study objective was to
assess change in health status among sepsis survivors
over a 6-month period. METHODS: This was a prospective, multicenter, cohort study involving 701 patients
with severe sepsis of presumed infectious origin from 53
hospitals. Patients’ health status was assessed at day 30,
60, 90 and180 using EuroQoL-5D and a visual analog
scale. Instruments were completed by the patient while in
hospital and follow-up assessments were performed by
telephone interview. RESULTS: For this interim analysis,
93 patients had completed health state information for
day 30, 60, 90, and 180. Mean (SD) age was 60 1 17
years and 48% were female. The number of patients remaining in the hospital decreased from 56% at day 30 to
7%, thereafter. The average utility score/VAS score at
each time point was: 0.53/0.61 (day 30), 0.62/0.68 (day
60), 0.68/0.71 (day 90), 0.69 (p , 0.0001)/0.72 (day
180). Based on patients’ subjective assessment of their
health status during the last 12 months, 60% had improved or maintained their health. The improvement in
utility scores was influenced primarily by changes in mobility, self-care, and usual activities. Pain and anxiety appeared to have a minimal influence on overall improvement in health status. At day 30, 28% of the patients
reported no problems in walking, compared to 58% at
day 180. Likewise, 48% and 26% of patients reported no
problems with self-care and performing usual activities at
day 30, respectively, and 67% (self-care) and 47% (usual
activities) at day 180. CONCLUSION: Sepsis survivors
experienced a continual improvement towards population-based normal levels in their health utility scores over
a 6-month period. Improvements in physical activity,
self-care and usual activities were predominantly associated with improved health utility.
131
Abstracts
PID8
COSTS OF HEALTH CARE FOR HEPATITIS
C-INFECTED MEMBERS IN A MANAGED
CARE ORGANIZATION (MCO)
Schaffer M1, Phillips AL2, Mansukani S1
1
Health Partners, Inc, Philadelphia, PA, USA; 2Thomas Jefferson
University, Philadelphia, PA, USA
The current literature provides limited information about
the cost-burden of Hepatitis C. OBJECTIVES: To identify all medical and pharmacy costs accrued by members
with Hepatitis C in a Medicaid MCO during 1999.
METHODS: Hepatitis C-infected patients were identified
from a database of continuously enrolled members from
an inner-city Medicaid MCO in Philadelphia during
1999 using ICD-9 codes indicative of Hepatitis C. Medical and pharmacy claims for these identified members
during this study period were obtained and analyzed. A
subanalysis comparing patients prescribed combination
ribavirin/interferon alfa-2b therapy with patients not prescribed combination therapy was performed. Costs were
reported as reimbursements paid for medical claims and
pharmacy claims (AWP—14.5%). RESULTS: From a cohort of 73,869 members, 395 members (0.535%) met inclusion criteria for Hepatitis C. The mean age was 46.5
years (SD 5 9.5; range 5 4–81) and 213 (53.9%) were
male. These members had 17,507 medical claims resulting in payments of $4,075,082. Inpatient hospital services accounted for 48% of these costs. There were
27,681 pharmacy claims that totaled $1,495,096. Sixty
patients received combination therapy, which totaled
$375,468 in pharmacy claims (n 5 444). Comparing patients prescribed combination therapy and patients not
prescribed combination therapy, medical costs were
$2,580/member and $11,702/member, respectively. In
addition, pharmacy costs were $8,610/member and
$2,920/member, respectively. Total costs in 1999 for patients prescribed combination therapy was $11,190/
member and for patients not prescribed combination
therapy was $14,622/member. These results were not adjusted for disease severity. CONCLUSIONS: Hepatitis C
is a very costly disease. Total health care costs to this
Medicaid MCO during 1999 for the 395 members identified with Hepatitis C exceeded $5.5 million. In addition,
total costs were less for members prescribed combination
ribavirin/interferon alfa-2b therapy compared with members not prescribed combination therapy. Further investigation is needed to explain the observed differences in
health care expenditures between these two populations.
PID9
COST-EFFECTIVENESS OF INTERFERON ALFA
THERAPY FOR CHRONIC HEPATITIS C
WITH CIRRHOSIS
Hisashige A, Katayama T, Mikasa H
University of Tokushima, School of Medicine, Tokushima, Japan
OBJECTIVE: To estimate the lifetime benefits and costs
of interferon alfa therapy for active hepatitis C with cirrhosis (HC), cost-effective analysis was carried out.
METHODS: Cost-effectiveness analysis (CEA) and costutility analysis (CUA) were carried out to estimate the
lifetime benefits and costs of interferon alfa therapy (IFA)
for HC. A Markov model base on a randomized controlled trial was developed. As a comparator, conventional therapy (CV) was used. A societal viewpoint was
adopted for the estimation of costs, and both direct and
indirect costs were evaluated. A Monte Carlo simulation
was done to evaluate a confidence interval of cost-effectiveness or cost-utility ratio. Quality of life (utility) was
measured by a time-trade off method among HC patients. RESULTS: At lifetime follow-up among 40 years
of men, expected life years (15.2 years) for IFA were
longer than those (9.0 years) for CT. Moreover, expected
QALYs (9.86) for IFA were longer than those (5.30) for
CT. On the other hand, expected costs ($548,500) for
IFA were higher than those ($459,000) for CT. The incremental cost per life-year gained for IFA was $4,900
(discount rate of cost and effectiveness: 5%). The incremental cost per QALY gained was $6,240. Sensitivity
analysis for age, costs, and health outcomes confirmed
robustness of these results. CONCLUSION: On the basis
of this analysis, IFA for HC should prolong length and
quality of life at a reasonable incremental costs, from a
societal perspective.
PID10
EFFECTS OF LINEZOLID ON HOSPITAL LENGTH
OF STAY IN METHICILLIN-RESISTANT
STAPHYLOCOCCUS INFECTIONS ESTIMATED
FROM MULTIVARIATE SURVIVAL ANALYSIS
Willke RJ1, Li ZJ2, Glick H3, Rittenhouse BE1, Hafkin B4
1
Pharmacia, Peapack, NJ, USA; 2Pharmacia Corporation,
Kalamazoo, MI, USA; 3University of Pennsylvania, Philadelphia,
PA, USA; 4Pharmacia Corporation, Portage, MI, USA
OBJECTIVES: To estimate differences in adjusted hospital length of stay (LOS) between linezolid and vancomycin
using multivariate survival analysis. Linezolid’s bioequivalent
IV and oral formulations may enable earlier hospital discharge compared to vancomycin treatment. METHODS:
460 hospitalized patients with suspected/confirmed methicillin-resistant Staphylococcus infections were treated
with either linezolid (LZD) or vancomycin (VAN) in a
randomized controlled trial. Covariate imbalances between treatment groups were tested using t-tests and chisquare tests. Multivariate Cox proportional hazards and
several parametric models for LOS were tested for best fit
using the Akaike Information Criteria and log-likelihood
ratio statistics. The Cox proportional hazards assumption was rejected (p , .05); log-logistic survival models
fit best. The log-logistic estimates are used to create two
alternative adjusted survivorship functions, one based on
individual corrections to LOS (Individual correction),
and the other based on means of the predicted survivor-
132
Abstracts
ship function for each individual (Mean survivorship).
Adjusted LOS at quartiles of % discharged for each function was compared with unadjusted LOS using KaplanMeier method. RESULTS: Hospital unit type at randomization and number of comorbidities both differed significantly between groups and significantly affected LOS.
With covariate controls in the log-logistic model, linezolid treatment significantly reduced LOS (p 5 .04). Adjusted/unadjusted LOS at quartiles of % discharged were:
%
discharged
25
50 (median)
75
Adjusted LOS (days)
Individual
correction
LZD
6
14
26
VAN
10
16
28
Mean
survivorship
LZD
6
13
28
VAN
9
16
29
Unadjusted
LOS
Kaplan-Meier
LZD
6
14
29
VAN
8
15
29
CONCLUSIONS: When adjusted for covariate differences, median LOS for linezolid patients was at least 2
days shorter than for vancomycin patients. Other differences in the LOS distribution are evident and may be important to decision-makers but off-median estimates may
be sensitive to the adjustment method used. Methodologic considerations are explored further.
PID11
PEGYLATED (40KDA) INTERFERON ALFA-2A
(PEGASYS®) SIGNIFICANTLY IMPROVES
TOLERABILITY, QUALITY OF LIFE, AND WORK
PRODUCTIVITY IN PATIENTS WITH CHRONIC
HEPATITIS C
Imperial J1, Thuluvath P2, Perrillo RP3, Rothstein KD4,
Poulios NS5, Pappas SC5, Ackermann SP5, Doerschuk BS5
1
Stanford Medical School, Palo Alto, CA, USA; 2John Hopkins
Hospital, Baltimore, MD, USA; 3Ochsner Clinic, New Orleans,
LA, USA; 4Albert Einstein Medical Center, Philadelphia, PA,
USA; 5Roche Laboratories Inc, Nutley, NJ, USA
BACKGROUND: Several studies have demonstrated the
negative impact of chronic hepatitis C (CHC) and respective treatments on patient health-related quality of life.
Studies suggest PEGASYS provides an improved sustained virological response compared with interferon (IFN)
monotherapy (30–39% vs 10–19%) and may provide
safety, quality of life (QoL), and work productivity benefits compared with standard interferon/ribavirin (IFN/RBV,
REBETRONTM) combination therapy. OBJECTIVE: To
compare the safety and tolerability of treatment with PEGASYS vs REBETRON in previously untreated patients
with chronic hepatitis C (CHC). METHODS: A 72-week,
multicenter study randomized 412 patients to PEGASYS
180 mg qw or REBETRON (IFN-26 3 MIU tiw 1 RBU
1000-1200 mg qd). Tolerability was assessed by the Hepatitis Quality of Life Questionnaire (HQLQ, assessed at
weeks 4, 12, 24, 48, 60, and 72; SF-36 plus 4 Hepatitisspecific domains) and the Work Productivity and Activity
Impairment (WPAI) instrument. RESULTS: After 12
weeks of treatment, HCV-RNA was negative in 46.8%
of PEGASYS and 50.3% of REBETRON patients. Patients on PEGASYS showed a clinically significant difference compared to REBETRON in several AEs: anemia
(2.0% vs 32.4%), dyspnea (9.5% vs 18.1%), pruritus
(6.7% vs 17.5%). At weeks 4 and 12, patients on PEGASYS compared to REBETRON had significantly better
work productivity (Estimated Wkly Work Productivity
Lost: $32.10, PEGASYS; $86.60, REBETRON) in 7 of 7
domains. Week 4 and 12 HQLQ assessments indicated
patients on PEGASYS vs those on REBETRON had clinically and statistically better QoL scores in 8 of 8 SF-36
domains, both physical and mental summary scores, and
4 CHC-specific domains (P , 0.05). CONCLUSIONS: The
12-week data demonstrate that patients treated with PEGASYS had a superior tolerance to therapy, were more
productive as measured by the WPAI, and had better
health related quality of life profiles compared with patients treated with REBETRON, while maintaining similar virological response.
PID12
AVERTING FUTURE AIDS CASES:
MODELING COSTS OF INTERVENTIONS WITH
OUT-OF-TREATMENT SUBSTANCE ABUSERS
Richter A, Loomis BR, Wechsberg WM
Research Triangle Institute, Research Triangle Park, NC, USA
OBJECTIVE: The North Carolina Cooperative Agreement (NCCoOp) for AIDS Intervention Research implemented an AIDS intervention in an urban, high-risk, primarily African-American, crack and injection drug-using
population. Estimated costs for the standard intervention
are $242 per person. How many future AIDS cases will
be averted by making this expenditure? METHODS: We
constructed an epidemic model to assess the long-term
impacts of intervention related changes on HIV incidence
and prevalence. Our model is a dynamic compartment
model focusing on 8 distinct sexual and drug use risk
groups within the community. Cost data are available
from existing intervention analyses. RESULTS: 778 persons were enrolled in the NCCoOp intervention in Wake
and Durham counties, NC. Of these, 80 (11.5%) were
HIV positive. Using data collected prior to intervention,
our model predicts that HIV prevalence will rise to 18%
of the NCCoOp population in five years. The epidemic is
driven predominantly by high-frequency needle users
(HFNU), primary needle users (PNU), and primary crack
users (PCU) who account for 79% of new infections over
this time period. Using data collected after intervention,
our model predicts HIV prevalence will decline to 7% of
the NCCoOp population in five years. However, HFNU,
PNU, and PCU account for 89% of new infections in this
case. Risky drug use and sexual behaviors were dramatically reduced by intervention and this accounts for most
of the reduction in HIV prevalence. Other factors influencing the reduction in HIV prevalence are AIDS mortality and growth in the drug using population. CONCLU-
133
Abstracts
SIONS: Our model provides evidence than an effective
AIDS intervention in a high-risk population of out-oftreatment substance abusers can avert significant numbers of new HIV infections, which may offset initial
costs.
PID13
ECONOMIC EVALUATION OF ROTAVIRUS
VACCINATION FOR THE NETHERLANDS
Welte R, Jager J, van Duynhoven Y, de Wit M
National Institute of Public Health and the Environment,
Bilthoven, Netherlands
OBJECTIVES: To estimate the cost-effectiveness of a national rotavirus (RV) vaccination program for the Netherlands, from a societal perspective. METHODS: Three
RV-vaccine doses are administered to infants as part of
the routine schedule of childhood immunizations. Based
on clinical trials we assume a vaccine protection duration
of 4 years and a vaccine effectiveness of 55% against
mild RV-diarrhea, 65% against moderate RV-diarrhea
(outpatient treatment), and 80% against severe RV-diarrhea (inpatient treatment). Resource consumption caused
by RV-diarrhea is derived from recent national studies
and the findings of expert panels and valued according to
the Dutch costing guidelines. Direct medical (e.g., for
vaccine administration or RV-tests) and non-medical
costs (e.g., for transportation or extra diapers) are considered. Indirect costs include the productivity loss of
paid (friction cost method) and unpaid work (substitution approach) caused by parents caring for their sick
child. Costs are presented in 1998 EUR and both future
costs and effects are discounted at 4%. A decision analysis model is employed to calculate the health outcomes
and costs of the vaccination program. RESULTS: RVvaccination would avoid 34,300 cases of gastroenteritis
and 2,300 hospitalizations per year. The break-even dose
price of the vaccine is EUR 4 or EUR 9, depending on the
exclusion or inclusion of the productivity loss of unpaid
work. However, at a dose price of the 1999 withdrawn
RV-vaccine (EUR 30) the program would yield costs of
EUR 15,000 (paid work only) or EUR 12,100 (paid and
unpaid work) per avoided hospitalization. These results
are sensitive to the incidence of RV-gastroenteritis, the
vaccine effectiveness, the length of hospitalization, and
the productivity loss caused by RV-gastroenteritis while
variations in outpatient care and direct non-medical costs
have limited influence. CONCLUSIONS: Depending on
its price the RV-vaccine might be a promising candidate
for the Dutch national immunization program.
PID14
PREDICTORS OF THE MENTAL (MHS) AND
PHYSICAL HEALTH SUMMARY (PHS) SCORES
OF THE MOS-HIV IN A SAMPLE OF
HIV-INFECTED PATIENTS
Griffis DL, Delate T, Coons SJ
The University of Arizona, Tucson, AZ, USA
OBJECTIVE: Studies evaluating predictors of heathrelated quality-of-life (HRQOL) in patients infected with
HIV have primarily been limited to clinical, sociodemographic, and psychological factors. Little is known about
the relationship between HRQOL and behaviors such as
medication adherence or complementary and alternative
medicine (CAM) use. The purpose of this study was to
determine the clinical, sociodemographic, and behavioral
predictors of HRQOL. METHODS: A sample of 242
HIV-infected patients was recruited. Data were collected
using a self-administered instrument containing the Medical Outcomes Study (MOS)-HIV Health Survey and
items relating to CAM use, medication adherence, and
sociodemographic characteristics. Clinical information
was abstracted from medical records. Independent associations of the Mental (MHS) and Physical Health Summary (PHS) scores with CD4 cell counts, HIV-1 viral
loads, CAM use, self-reported medication adherence, antiretroviral use, and sociodemographic characteristics
were assessed. Linear regression models were created for
each score. Variables independently associated (p , 0.05)
with a score were entered into that model. RESULTS: The
mean MHS and PHS scores were 46.6 and 42.8, respectively.
Education, income, CAM use, and self-reported adherence to HIV medication regimens were independently associated (p , 0.03) with MHS scores. PHS scores were
independently associated (p , 0.003) with age, income,
HIV-1 viral load, CD4 count, and CAM use. In the multivariate analyses, income and self-reported adherence
were found to be significant (p , 0.005) predictors of the
MHS scores (Adj. R2 5 0.197); age, income, CD4
counts, and CAM use were found to be significant (p ,
0.03) predictors of PHS scores (Adj. R2 5 0.182). CONCLUSIONS: Our research suggests that, along with clinical and sociodemographic characteristics, self-reported
behaviors are important predictors of HRQOL among
HIV-infected patients.
PID15
MANAGING AIDS IN THE ERA OF
ANTIRETROVIRAL THERAPY: CHANGES IN THE
RATE AND COST OF HOSPITALIZATIONS
O’Brien JA, Pierce D, Patrick AR, Caro JJ
Caro Research Institute, Concord, MA, USA
BACKGROUND: Clinical trials have shown that highly
active antiretroviral therapy (HAART) alters the natural
progression of HIV. This study was undertaken to determine if, apart from the beneficial clinical impact, there
has been a change in the cost of AIDS-related care.
METHODS: Data from the Massachusetts (MA) Department of Public Health and hospital discharge databases
for 1995–1998 were used to examine changes in hospital
admission and discharge patterns, and hospital costs for
adults with AIDS across the four years. Analyses involved
log transformation to address highly skewed distributions, ANOVA to compare continuous variables and ChiSquare to compare the proportions. Hospital costs in-
134
Abstracts
clude all accommodations and ancillaries. Cost estimates,
adjusted for medical inflation and cost-to-charge ratios,
are reported in 1998 US$. RESULTS: From 1995 to
1998, the rate of hospital admissions for MA residents
with AIDS declined substantially. In 1995, 86% of the
3,162 AIDS patients were admitted at least once during
the year compared to 31% of the 5,636 patients in 1998.
The mean number of annual admissions per patient
dropped from 2 to 1.76 and the inpatient case fatality
rate fell from 6.7% to 4.6%. The mean LOS per AIDS
admission fell by 1.3 days; a greater decline than the 0.4
day average observed in MA over the same period. The
mean hospital stay cost decreased from $8,070 to
$7,538. These changes accounted for a $2,900 drop in
the mean annual hospitalization cost per AIDS patient
during that time. Discharge to sub-acute inpatient and
home health services fell by 8.6% in this period. All
changes reported are statistically significant (p , 0.05).
CONCLUSIONS: The change in LOS is not the result of
post-discharge resource use shifting. The decrease in resource use and costs observed after the introduction of
HAART are consistent with an economically beneficial
impact of these agents.
PID16
COST BURDEN OF VARICELLA-ZOSTER VIRUS
INFECTION IN A MANAGED CARE SETTING
Schaffer M1, Liu M1, Scott W2, Mansukani S1
1
Health Partners, Inc, Philadelphia, PA, USA; 2Hospital of the
University of Pennsylvania, Philadelphia, PA, USA
Although information exists in the form of projected
costs, limited data are available on the overall cost of illness resulting from varicella-zoster virus (VZV) infection.
VZV is usually a benign childhood illness, but reactivation of latent VZV can lead to serious complications.
OBJECTIVE: To assess via medical claims the costs associated with VZV infection and its resultant complications
from the payers’ perspective. METHODS: We conducted
a retrospective database analysis of 73,869 managed care
members continuously enrolled throughout calendar year
1999. Records of members with a diagnosis code of either primary varicella (ICD9-052) or herpes zoster (ICD053) were selected. Data was extracted and cost information
was tallied for all medical claims including inpatient hospitalizations, primary care visits, specialist visits, emergency department visits, and specialty procedures. Cost
data are reported in 1999 US dollars. RESULTS: In 1999,
a total of 119 patients were diagnosed with varicella
(52%) and herpes zoster (48%). The mean cost to the
payer was $496.77/patient. The average amount paid out
for members with varicella was $181.87. The average
cost per member with herpes zoster was $786.27. Sixtytwo (52%) VZV afflicted members were diagnosed with
varicella while 57 were diagnosed with herpes zoster. The
amount paid for members over age 19 (n 5 56) was
$640.30/patient. Of these patients, 14% were classified
with varicella infection, whereas 86% were classified as
having zoster. For members aged ,19 (n 5 63), the mean
amount paid was $369.18/patient. In this group, 78%
were diagnosed with varicella infection, whereas 22%
were diagnosed with zoster. CONCLUSION: The above
costs document for the first time the true cost of VZV infection from the payers’ perspective. Further efforts to
expand vaccination programs should take these costs into
consideration.
PID17
ECONOMIC EVALUATION OF OSELTAMIVIR
FOR INFLUENZA PATIENTS IN JAPAN
Kobayashi M
Crecon Research and Consulting Inc, Tokyo, Japan
OBJECTIVES: The aim of this analysis is to estimate the
economic impacts of oseltamivir treatment for influenza
in Japan. METHODS: A decision tree with endpoints of
occurrences of pneumonia was constructed to compare
two treatment strategies, oseltamivir treatment and conventional treatment, for otherwise healthy adult (over 16)
patients with influenza like illness in Japan. Drug consumption data (e.g., acetaminophen, antibiotics, and palliative drugs for influenza like illness related symptoms)
were collected prospectively as well as work absenteeism
data as part of the Japanese placebo-controlled doubleblind multicenter study by oseltamivir that included 316
patients. Parameters used in the decision tree were mainly
derived from this study and combined with published
data. Sensitivity analyses were also performed to examine
the robustness of the results. RESULTS: Expected total
medical cost per patient was 14,100 yen and 14,412 yen
for oseltamivir treatment and conventional treatment, respectively. Expected cost including production loss was
56,654 yen and 63,485 yen, for oseltamivir treatment
and conventional treatment, respectively. Based on the
results of basic analyses, the savings that could be expected in Japanese nationwide health care costs with
widespread use of oseltamivir ranged from 1.1 billion yen to
3.4 billion yen. CONCLUSION: This study suggested that
oseltamivir treatment for patients with flu-like symptoms
can be attractive from the societal perspective in Japan.
PID18
METHICILLIN-RESISTANT STAPHYLOCOCCUS
SPECIES TREATMENT PATTERNS IN CANADA
Becker D, Rosner AJ
Innovus Research Inc, Burlington, ON, Canada
Antibiotic resistance is of growing importance to the Canadian health care system due to the morbidity, mortality, and financial costs of certain pathogens for which
there are limited therapeutic options. Among the resistant
organisms, the incidence of methicillin-resistant Staphylococcus species (MRSS) is rising and is posing an increasing burden to health care systems. OBJECTIVE: To
characterize MRSS treatment patterns in patients with
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Abstracts
complicated and uncomplicated skin and soft tissue infections (SSTIs). METHODS: Five infectious disease experts
from across Canada were interviewed to understand their
current treatment practices. The interview responses were
used to design a chart review of 100 patients from three
acute-care facilities who were hospitalized for a SSTI
caused by MRSS. RESULTS: Approximately 60–100%
of SSTIs caused by MRSS are currently being treated with
vancomycin and, in the majority of these patients, the entire treatment course (approximately 5–28 days) is received via IV infusion. Other therapies included fusidic
acid and clindamycin. In all cases, IV therapy is initiated
in hospital, although approximately 20–60% of patients
are eventually able to be discharged to complete their IV
therapy with the assistance of home care. Additional data
collected in the survey include duration of intravenous
(IV) therapy, frequency of switch to oral therapy, and
length of oral therapy, hospital stay, and home IV care.
CONCLUSIONS: Despite the proven economic benefits
and wide acceptance of switch therapy, a large portion of
patients with SSTIs caused by MRSS are currently completing their entire treatment course via IV infusion. The
major reason cited is the lack of an effective oral therapeutic alternative. An oral antibiotic that is effective at
treating these types of infections, therefore, represents
cost-savings to hospitals by potentially reducing drug administration costs, hospital length of stay due to early
discharge, and costs associated with home IV care.
PID19
AN ECONOMIC ANALYSIS OF CEFDINIR VERSUS
LORACARBEF FOR TREATMENT OF ACUTE
EXACERBATIONS OF CHRONIC BRONCHITIS
Shah SN1,2, Smith D1, Copley-Merriman C2
1
University of Michigan, Ann Arbor, MI, USA; 2Pfizer
Pharmaceuticals Group, Ann Arbor, MI, USA
OBJECTIVE: To perform an economic analysis for the
treatment of Acute Exacerbations of Chronic Bronchitis
(AECB) comparing cefdinir 300mg twice a day for five
days to loracarbef 400mg twice a day for seven days.
METHODS: A randomized double-blind controlled trial
conducted in twenty-four US centers between October
1995 and June 1997 collected data whether patients became cured or not after treatment with cefdinir or loracarbef as well as hospitalizations, clinic visits, and medications not related to the study medication. The final
analysis is reported from a third party payer perspective.
A total of 585 patients were randomized into two groups,
290 patients receiving cefdinir and 295 patients receiving
loracarbef. Symptoms for inclusion criteria were cough
and mucopurulent or purulent sputum production for
three consecutive months. History or clinical evidence of
other diseases and concomitant infections requiring systemic antimicrobial therapy were among the exclusion
factors. RESULTS: The unadjusted cure rates for cefdinir
and loracarbef were very similar at 82.4% (239/290) and
80% (236/295) using ANOVA. Comparable efficacy was
further supported through a probit regression showing an
insignificantly higher cure rate for cefdinir of 10.3% (p 5
0.4903). The unadjusted mean medical costs per case for
loracarbef were $345.03, 27.5 percent higher than cefdinir ($270.60). An ordinary least squares regression, including patient characteristics as covariates, showed a
cost savings of $74.43 (p , 0.001) associated with cefdinir. CONCLUSIONS: The key findings of the economic analysis showed a significant cost savings by treating AECB with cefdinir 300mg twice a day for five days
as compared with loracarbef 400mg twice a day for seven
days. Furthermore, patients taking cefdinir had four less
doses, resulting in a higher state of compliance and convenience.
PID20
TARGETING POPULATIONS AT-RISK FOR
URINARY TRACT INFECTION COMPLICATION
Doyle B, Hess G
CareScience, Philadelphia, PA, USA
OBJECTIVES: Urinary Tract Infection (UTI) was identified as the second most frequent complication at a large
hospital, occurring in 3% of patients admitted, and contributing to $1.4 million in costs, during the study period
October 1998 to September 1999. This project was designed to increase hospital awareness concerning UTI
complication, identify patient populations at-risk, and
evaluate treatments. METHODS: Risk adjustment developed at the University of Pennsylvania School of Medicine was used to predict patients’ hospitalization complications. Complication rates were compared between
patients with and without UTI as a secondary diagnosis.
Laboratory data were analyzed to identify whether patients with a secondary diagnosis of UTI met CDC laboratory diagnosis criteria. Differentiating patients by day
of onset identified potentially nosocomial UTI’s. Such patients were differentiated by DRG. Finally, the distribution of antibiotic treatments was determined. RESULTS:
While the predicted complication rate for patients with
UTI as a secondary diagnosis was 55.0%, their actual
rate was 79.2% (p , .001). 55% of such patients met
CDC laboratory diagnosis criteria; of these patients, 36%
were diagnosed .3 days from admission, i.e., had potentially nosocomial UTI’s. Four DRG’s—Tracheostomy,
PTCA, CHF, and Hip & Knee Replacement—accounted
for 40% of all patients with UTI as a secondary diagnosis, but 80% of potentially nosocomial UTI patients.
Treatment for all UTI patients showed widespread Levofloxacin use, regardless of DRG. Of note, most UTI’s were
related to E. Coli, which can be treated more cost-effectively with trimethoprim sulfamethoxazole. CONCLUSIONS: Based on this investigation, the hospital re-initiated the National Nosocomial Infections Surveillance
System program for UTI’s, evaluated Levofloxacin use,
developed physician guidelines for UTI diagnosis and
treatment, and increased nursing education concerning
catheter care and maintenance protocols.
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Abstracts
PID21
THE COST-EFFECTIVENESS ANALYSIS OF
LAMIVUDINE IN THE TREATMENT OF CHRONIC
HEPATITIS B IN POLAND
Orlewska E
Unimed Research Centre for Pharmacoeconomics, Warsaw,
Poland
OBJECTIVES: To estimate the C/E of lamivudine in the
treatment of chronic hepatitis B (CHB) in Poland.
METHODS: Model for the Polish health-care context
was developed, based on the use of clinical data from literature and local data on health-care resource utilisation
and unit cost. Costs and effects of a population of CHB
patients were modelled using 4 scenarios, which attempt
to reflect real-life practice, in which patients may receive
any of the treatment options available and a proportion
of patients may still receive no treatment because therapy
is not suitable. Scenario A and B assumed the availability
of both treatment options: the first choice of treatment is
in A-lamivudine and in B-INFa. In scenario C the only
approved treatment is INFa, in scenario D patient received no antiviral treatment. The measure of outcomes
were: HBeAg seroconversion and nonprogression to cirrhosis. Only direct medical costs were analysed. The perspective of health-care payers and time horizon of 1 year
were taken. The one-way sensitivity analysis and extreme
scenario analysis were performed. RESULTS: The best
results in terms of seroconversion and nonprogression to
cirrhosis were achieved in scenario A, costs were lowest
in scenario D. Mean cost/HBeAg seroconvertion and
mean cost/cirrhosis avoided were (in PLN, 1 USD 5 4
PLN): for A—35238 and 6480, for B—72654 and
16289, for C—49370 and 8689, for D—20985 and
1474. The incremental analysis vs scenario D indicated,
that A is a more cost-effective alternative than B and C.
Changing in value of key drivers for sensitivity analysis
did not have any significant effect on the ICER. CONCLUSIONS: Lamivudine as the first choice treatment of
CHB (scenario A) allows to receive the best results in
terms of seroconversion and nonprogression to cirrhosis.
This is the most cost-effective alternative to “no treatment” (scenario D).
PID22
AN APPRAISAL OF HEALTH-RELATED QUALITY
OF LIFE INSTRUMENTS FOR USE IN PATIENTS
DIAGNOSED WITH HUMAN
IMMUNODEFICIENCY VIRUS (HIV) DISEASE
Joshi AV, Nau DP, Kalsekar ID
West Virginia University, Morgantown, WV, USA
OBJECTIVES: The increasing effectiveness of medical
treatments for HIV (Human Immunodeficiency Virus)
has increased survival time of patients infected with the
virus. Because of the high incidence of side effects and the
burden of complex medication regimens, an increased
emphasis has been placed on the assessment of health-
related quality of life (HRQL) in HIV patients. The purpose of this study is to review and compare instruments
used for measuring HRQL in HIV patients. METHODS:
Clinical trials involving HIV patients were identified
through the use of MEDLINE and AIDSLINE. The
HRQL instruments used in these trials included: 1) generic instruments such as the Medical Outcomes Study
(MOS) Short-Form (SF-36), Sickness Impact Profile, Nottingham Health Profile; 2) utility-based measures such as
the Quality of Well-Being Scale and the Q-TWIST (Quality adjusted Time Without Symptoms of disease and Toxicity); and 3) disease-specific instruments such as the
Multidimensional Quality of Life questionnaire for HIV
(MQoL-HIV), Functional Assessment of HIV Infection
(FAHI) scale, HIV/AIDS-Targeted Quality of Life Instrument (HAT-QoL), HIV Overview of Problem/Evaluation
System (HOPES) instrument, HIV Patient Reported Status and Experience (HIV-PARSE) scale, and the MOSHIV scale. Criteria for evaluating the instruments included: comprehensiveness, respondent burden, internal
consistency of scales, test-retest reliability, clinical validity, and responsiveness to change. RESULTS: No instrument was found to be completely devoid of ceiling effects. Although none of the instruments demonstrated
perfect psychometric properties, overall, the MOS-HIV
instrument fared better than all its counterparts. The instrument has minimal respondent burden and has shown
evidence of internal consistency, test-retest reliability, validity, and is responsive to changes over time. The instrument has been widely used in clinical trials and has been
translated into 14 other languages, and translated forms
have been validated. CONCLUSIONS: The MOS-HIV
scale appears to be most optimal for HRQL measurement in clinical trials involving HIV patients.
PID23
PATTERNS OF ANTIBIOTIC USE AND COSTS
ASSOCIATED WITH EPISODES OF TREATMENT
FOR COMMON OUTPATIENT RESPIRATORYTRACT INFECTIONS: AN ANALYSIS OF
MANAGED-CARE DATA
Edelman-Lewis B1, Menzin J2, Boulanger L2, Leung M2,
Friedman M2, Hurley JS3, Harnett J4, Wilson J4
1
Focus Managed Research, Inc, Worcester, MA, USA; 2Boston
Health Economics, Inc, Waltham, MA, USA; 3Lovelace
Respiratory Research Institute, Albuquerque, NM, USA; 4Pfizer
Inc, New York, NY, USA
OBJECTIVE: The objective of this study was to understand the prescribing patterns and economic burden of
several common respiratory tract infections (RTIs) treated
in primary care. METHODS: Using eligibility and claims
data from the Lovelace Health Systems of Albuquerque,
New Mexico, we selected all outpatients treated with a
single antibiotic within 3 days of diagnosis between December 1997 and March 1999 for one of the following 4
RTIs: sinusitis, otitis media (OM), pharyngitis, and bronchitis. The patient’s index episode, the focus of this anal-
137
Abstracts
ysis, was defined as the first infection identified following
a gap of at least 30 days in antibiotic use. The treatment
episode ended when there were no additional antibiotics
prescribed or infection-related outpatient medical visits
for 21 consecutive days. The costs of antibiotics, visits,
and tests were documented over the course of the episode. RESULTS: A total of 30,562 patients (11,798 with
sinusitis, 5,636 with otitis media, 7,310 with pharyngitis,
and 5,818 with bronchitis) met the study inclusion criteria. For sinusitis, OM, and pharyngitis, penicillins were
the most widely prescribed antibiotics, followed by macrolides, sulfonamides, cephalosporins, penicillin/B-lactamase inhibitors, tetracyclines and fluroquinilones. Macrolides were the most commonly used antibiotic for
bronchitis (48% of patients). For patients requiring a
switch to a different antibiotic, macrolides were the most
frequent choice. The overall costs per episode were $97
for pharyngitis, $114 for both OM and sinusitis, and
$133 for bronchitis. The proportion of total costs related
to follow-up treatment ranged from 19% for pharyngitis
to 32% for OM. Antibiotics accounted for 19% (for
pharyngitis) to 29% (for sinusitis) of overall costs. CONCLUSIONS: The costs of treatment episodes for RTIs are
fairly substantial and vary by condition. While the initial
encounter accounts for the majority of the costs, the expenses associated with the need for additional treatment
are important to consider.
PID24
COST COMPARISON OF GATIFLOXACIN
VERSUS LEVOFLOXACIN IN THE TREATMENT
OF COMMUNITY-ACQUIRED PNEUMONIA IN
AN OUTPATIENT POPULATION
Bell TJ1, Loomis BR1, Mauskopf JA1, L’Italien GJ2,
Gallagher KM2
1
RTI, Research Triangle Park, NC, USA; 2Bristol-Myers Squibb,
Wallingford, CT, USA
OBJECTIVE: In addition to information about efficacy
and safety, decision-makers are interested in information
about the impact of new drug treatments on health care
costs. The objective is to determine the impact of using
gatifloxacin versus levofloxacin on total costs among
outpatient adults with community-acquired pneumonia
(CAP). METHODS: Patients were randomized to receive
either gatifloxacin (GAT) or levofloxacin (LEV) once
daily. Data were collected on efficacy, safety, and medical care resource use from 163 GAT and 176 LEV clinically evaluable patients. Medical care resource use information included the dose and duration of the study and
concomitant medications, duration of intensive care unit
(ICU) and non-ICU hospital stay, and number of outpatient physician visits. We used a multivariate regression
analysis to determine the impact of treatment on total
costs. The dependent variable was the logarithm of total
costs to adjust for the left skewness found in the cost
data. The regression analysis controlled for disease severity, admission to the hospital on the day of (or before)
randomization, and prognostic factors (including age,
presence of comorbidities, and a previous CAP episode
within the last 12 months). RESULTS: GAT achieved a
cure rate of 96% compared to 94% for LEV. Based on
results from the multivariate regression analysis, patients
in the GAT arm could expect total costs that were approximately 8% lower (on average) than the total costs
incurred by patients in the LEV arm. Patients admitted to
the hospital on the day of (or before) randomization
could expect total costs that were nearly 51 times higher.
Hospital admission on the day of (or before) randomization was the only statistically significant driver of expected total cost. CONCLUSION: GAT shows a trend to
be less costly and have a higher cure rate than LEV for
outpatients with CAP.
PID25
ECONOMIC EVALUATION OF MACROLIDES
AND FLUOROQUINOLONES FOR THE
TREATMENT OF RESPIRATORY TRACT
INFECTIONS
Lachaine J1, Laurier C1, Manzi P2
1
University of Montreal, Montreal, QC, Canada; 2Abbott
Laboratories Ltd, St-Laurent, QC, Canada
BACKGROUND: In the field of respiratory tract infections (RTI), concern about the efficiency of various treatments has increased with the introduction of newer antibiotics often associated with higher acquisition costs.
These include second-generation macrolides and fluoroquinolones, which constitute alternative strategies to
amoxicillin and erythromycin. OBJECTIVES: To evaluate, from a cost-efficacy standpoint, how these newer
agents compare with each other in the treatment of community acquired RTI in adults. METHODS: Cost-efficacy analyses were done using decision-analysis techniques based on efficacy and safety data of published
clinical trials. The analyses were performed from the perspective of a provincial third-party payer. Costs considered were those of antibiotics, physicians and pharmacists services and diagnostic procedures. RTI for which
analyses were performed are: bronchitis, community acquired pneumonia, otitis media, pharyngitis and sinusitis.
Specific antibiotics compared were: azithromycin, ciprofloxacin, clarithromycin, grepafloxacin, levofloxacin and
ofloxacin. RESULTS: Following a review of the literature
using Medline and Current Contents, 98 articles published between January 1986 and December 1999 met
the inclusion criteria and provided efficacy and safety
data for the analyses. Efficacy rates for each antibiotic
did not differ strikingly and various dosages did not necessarily have an impact on efficacy rates. Cost-efficacy
analyses indicate that, among the antibiotics studied, the
lowest cost-efficacy ratios were associated with either
azithromycin or clarithromycin at a dose of 250mg twice
daily. Azithromycin represented the preferred strategy for
the ambulatory treatment of community-acquired pneumonia and otitis media, while clarithromycin at a dose of
138
Abstracts
250 mg twice daily would be preferable for bronchitis,
pharyngitis and sinusitis. The studied fluoroquinolones
and clarithromycin at a dose of 500 mg twice daily were
dominated strategies for each of the studied RTI. CONCLUSION: From a cost-efficacy standpoint clarithromycin and azithromycin would be preferable to fluoroquinolones when an alternate strategy to amoxicillin or
erythromycin is needed.
PID26
PHARMACOECONOMIC EVALUATION OF
CEFUROXIME IN ABDOMINAL HYSTERECTOMY
Karpov O, Zaytsev A
Institute of Pharmacology, St-Petersburg Pavlov State Medical
University, St-Petersburg, Russia
OBJECTIVES: The prophylaxis of infection in hysterectomy is necessary because it decreases the amount of
postoperative complications. It has been shown that cefuroxime is an effective antibiotic for prevention of infectious complications after abdominal hysterectomy. It has
a bactericidal activity against most pathogens which can
lead to wound failure and prolonged the duration of hospitalization. But pharmacoeconomic evaluation is not performed in the numerous investigations. METHODS: 40
women were randomized in equal groups to receive cefuroxime 1,5 g i.v. before start of hysterectomy (group I)
and combination of ampicillin 4,0 g/day i.m. and gentamycin 5 mg/kg/day i.m. during 5 days after hysterectomy
(group II). The last method is commonly used in city gynecological departments. General condition, temperature,
pulse, condition of postoperative wounds, vaginal discharges were evaluated every day by means of a score
scale. The sum of scores was performed as total clinical
score (TCS). Cost-minimization analysis was performed
for evaluation of economic outcomes of the treatment.
RESULTS: Clinical efficacy of the studied regimens was
equal because the dynamic of TCS coincided in both
groups (100% and 95% accordingly). Condition of
wounds was excellent and pathogenic microorganisms
were not performed. But in group II were detected skin
rash (3 cases) and infectious infiltrate in the place of injection (1 case). Duration of hospitalization was similar
in both groups. But total cost in group I was less by
17.7% than in group II (p , 0.05) because acquisition
cost was more in group II. CONCLUSIONS: Prophylaxis
of infectious complications in hysterectomy by cefuroxime
is as effective as combination postoperative treatment
with ampicillin plus gentamycin. Cefuroxime has an economic advantage and less danger for patients. This simple method of prophylaxis indicates more compliance
and less cost and may be recommended for most cases of
hysterectomy.
PID27
DOES A DAY STILL MAKE A DIFFERENCE?
A DECISION ANALYSIS OF ADULT
STREPTOCOCCAL PHARYNGITIS
Rousculp MD
University of Alabama at Birmingham, Birmingham, AL, USA
OBJECTIVES: Adults presenting with acute sore throats
is one of the most common complaints encountered by
primary care clinicians, yet the proper management of
adult patients with pharyngitis is still somewhat controversial. This study proposes to identify the appropriate
clinical management of adult pharyngitis using both costbenefit analysis and cost-effectiveness analysis METHODS: Cost-Benefit Analysis and Cost-Effectiveness Analysis. Six management strategies were considered in these
analyses: empiric treatment, performing a rapid test, obtaining a bacterial culture, empiric treatment with a confirmatory bacterial culture, or a combination of the rapid
test with a bacterial culture of negative rapid tests. In addition, the study incorporates differing probabilities of
streptococcal disease based upon on previously published
symptomatically derived logistic regression scores. Using
an internet-based survey, information is collected on undergraduate and graduate students’ willingness-to-pay
and time trade-off of presented health states. RESULTS:
Preliminary results indicate that patients presenting with
3 or more indicative symptoms (3 days of fever .398C,
tender anterior cervical nodes, enlarged tonsils with purulent exudates, and lack of cough) should be treated empirically. Those adult patients that complain of only two
symptoms should be managed by a combination of a
rapid diagnostic test with a bacterial culture on those
rapid tests with negative results. CONCLUSIONS: This
study presents findings that should provide clinicians
with a better guide in the treatment of adult patients with
pharyngitis. Performing normative analyses of currently
accepted clinical management, the study employs adult’s
preferences as well as variation in severity of symptoms.
PID28
COMPARING DIFFERENCES IN CLINICAL
EFFECTIVENESS, NEPHROTOXICITY, AND
COST-EFFECTIVENESS OF AMINOGLYCOSIDE
THERAPY BETWEEN ALTERNATIVE
DOSING PROTOCOLS
Reynolds R1, Gupchup G2, Borrego M2, Raisch D2, Netravali S2
1
Lovelace Health Systems, Albuquerque, NM, USA; 2University
of New Mexico, Albuquerque, NM, USA
OBJECTIVE: The objective of this study was to develop
a pharmacoeconomic model which compared the difference in cost-effectiveness (CE) between a Multiple-dailydosing (MDD) protocol of aminoglycosides (AG) managed by a Clinical Pharmacokinetic Dosing Service (CPS)
and a protocol for Once-daily-dosing (ODD), from the
perspective of a Managed Care Organization. METHOD:
Event rates for both clinical effectiveness and aminogly-
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Abstracts
coside-associated-nephrotoxicity (ANN) for MDD were
determined by a retrospective chart review of 262 randomly sampled patients who received gentamicin for the
treatment of serious gram-negative bacterial infections
between January 1, 1990 and March 30, 1998. The incidence of ANN was 3.1%. Event rates for ODD protocol
for both clinical effectiveness and ANN were determined
to be 82.2% and 5.8%, respectively based on an extensive review of the current literature. Time-in-motion
studies were performed to determine personnel costs for
all nursing and pharmacy activities. Decision analysis
was used to determine the CE of the two protocols. RESULTS: The results were unexpected based on reports in
the literature predicting substantial cost savings with the
use of ODD programs. In the base case analysis the expected per patient cost value for MDD with CPS and
ODD protocols was $241 and $237 respectively. However,
MDD with CPS was determined to be more cost-effective
than ODD due to slightly increased rate of clinical effectiveness and a decrease in the rate of ANN (average CE
ratios 5 $281 versus $287, respectively). Both one-way
and two-way sensitivity analyses were performed by
varying the two key parameters of clinical effectiveness
and ANN. The model was robust to alterations in these
key parameters. CONCLUSION: This CE analysis questions the benefit of implementing an ODD program when
compared to a more traditional MDD protocol managed
by a CPS for aminoglycoside dosing.
MENTAL HEALTH
PMH1
SHOULD THE 51 ITEMS OF THE
SCHIZOPHRENIA OUTCOMES ASSESSMENT
PROJECT (SOAP-51) BE WEIGHTED?
Barr J1, Schumacher G1, Mason E1, Ohman S1, Goren J1,
Hanson A2
1
Northeastern University, Boston, MA, USA; 2Massachusetts
Department of Medical Assistance, Boston, MA, USA
OBJECTIVES: To determine if the 51 items in the
Schizophrenia Outcomes Assessment Project (SOAP-51)
instrument should be scored using weighted or unweighted items. METHODS: 193 community-based individuals with schizophrenia (average age 46.3yr, 46.6%
female) rated the importance of each item in the SOAP51 twice, 4 weeks apart, using a 10cm verbally anchored
(“not important to me” to “very important to me”), horizontal line with a numerical scale progressing in units of
10 from 0 (not)–100 (most). RESULTS: Results are
based on 180 valid and complete surveys in the first administration; there were also 171 in the second. The
items ranged from a low of 56.7 6 35.5 (How important
is it for you to have sexual relationships in your life?) to a
high of 89.1 6 18.4 (How important is it for you that
your medication helps you?): 1 item scored in the 50s, 2
in the 60s, 16 in the 70s, and 33 in the 80s. Six of 8 average item factor scores (self-concept, work/role, mental
health, medication effects, activities of daily living, and
physical functioning) had weights in the 80s ranging
from 80.4 6 18.7 to 85.1 6 13.3; however, two were in
the 70s: 79.1 6 15.5 (satisfaction) and 75.4 (interpersonal. There was no difference between the importance
weights of the 8 factors nor the 51 items (p . 0.05).
CONCLUSIONS: It is appropriate to use an unweighted
summary for calculating the factor scores in the SOAP51. It is apparent that in the SOAP item reduction process, items considered to be of import to the clients were
retained in the final instrument.
PMH2
TREATMENT COURSE AND CHARGES FOR
DEPRESSED PATIENTS TREATED WITH
SERTRALINE, VENLAFAXINE, AND
VENLAFAXINE XR IN THE MANAGED
CARE SETTING
Hirschfeld R1, Eaddy M2, Grudzinski A3
1
University of Texas Medical Branch, Galveston, TX, USA;
2
University of South Carolina, Columbia, SC, USA; 3Pfizer Inc,
New York, NY, USA
OBJECTIVES: Little information is available comparing
the treatment course and charges of newly diagnosed patients with depression treated with either sertraline
(SER), venlafaxine (VEN) or venlafaxine sustained-release
(VXR) in the managed care setting. This analysis aimed
to determine the impact on treatment course and depression-related charges of selecting SER, VEN or VXR as
first line pharmacotherapy for newly diagnosed patients.
METHODS: Retrospective intent-to-treat analysis of an
integrated database of medical and pharmacy charges
(PharMetric’s Integrated Outcomes database 07/98–06/99)
including patients aged 18–65 who were diagnosed with
depression [ICD-9: 296.2, 296.3, 300.4, 311] and who
initiated SER, VEN or VXR therapy within the same 30day period. Patients with documented previous mental
disorders/treatment were excluded. Depression-related
treatment charges for the 6-month period following treatment initiation were compared using log-linear regression. Cohorts were comparable with respect to prescribing physician (psychiatry vs. other). RESULTS: 19,129
patients were included in the analysis (SER 5 15,222;
VEN 5 1032; VXR 5 2875). VXR patients were more
likely to augment therapy compared to VEN or SER
(18% vs. 13% and 12%; p , 0.05). VEN patients were
more likely to switch to other medications than VXR or
SER (33% vs. 21% and 16%; p , 0.05). After controlling for differences in age, gender, managed care plan,
pre-treatment history of resource utilization, physician
specialty type, index RX year, and switching/augmentation, VEN and VXR patients incurred 13% and 30%
higher depression-related charges, respectively, than patients initiated on SER (p , 0.05 for both comparisons).
CONCLUSIONS: Treatment of depression with sertraline was associated with significantly less augmentation/
switching, and lower depression-related charges than ven-
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Abstracts
lafaxine or sustained release venlafaxine. The results of
this study lend insight useful in making prescribing/formulary decisions for patients with newly diagnosed depression.
PMH3
IS DEPRESSION THE MAJOR CAUSE OF
IMPAIRED QUALITY OF LIFE IN
SCHIZOPHRENIC PATIENTS?
Toumi M1, Pettersson Å1, Llorca PM2, Lançon C3, Aballéa S1
1
Lundbeck SA, Paris, France; 2CHU Sainte-Marie, ClermontFerrand, France; 3CHU Sainte Marguerite, Marseilles, France
OBJECTIVES: Schizophrenia is a complex and invalidating disease with a wide range of symptoms and often social exclusion. Patients’ quality of life is heavily impaired.
The associations between the different symptoms and the
QoL, as well as the possible impact of the patient management are still not well known. Our objective was to
study the associations between health status, quality of
life, general functioning and patient management in
schizophrenic patients. METHODS: 238 schizophrenic
patients were assessed in a cross sectional study with the
Lehman QoL scale, EuroQoL, SF-36, Calgary Depression
Scale, CGI, GAF and PANSS. At the same time the patient management was assessed. A progressive approach
using graphical chain models was adopted to determine
the strength of the associations between the different
variables. RESULTS: Depression was strongly associated
with the subjective dimensions of QoL, the utility of EuroQoL and with the mental health sub-score of SF-36.
The schizophrenic symptoms (PANSS) seem to have no
direct impact on the QoL, but only through their association to depression and impaired functioning (GAF).
Other factors that seem to have and impact on the QoL
are recent hospitalisation and the type of antipsychotic
drug prescribed, atypical antipsychotics seem more favourable compared to typical. CONCLUSIONS: Depression
seems to be the major factor impairing the quality of life
of schizophrenic patients.
PMH4
ASSESSMENT OF PATIENTS’ ATTITUDES
TOWARD ANTIPSYCHOTIC TREATMENT IN A
40-WEEK RANDOMIZED, CONTROLLED TRIAL
Dugar A, Stuelpner JE, Mackell JA, Miceli RJ
Pfizer Pharmaceuticals Group, Pfizer, Inc, New York, NY, USA
OBJECTIVES: Pharmacotherapy can reduce or prevent
symptom relapse among schizophrenics, thereby providing long-term benefits. Relapse is common following
noncompliance or discontinuation of antipsychotic medication, and dissatisfaction with medication may lead to
noncompliance resulting in symptom relapse and increased health care expenditures. We assessed how
schizophrenic patients view the use of antipsychotics.
METHODS: The Drug Attitude Inventory (DAI), com-
prised of 10 “yes/no” questions about efficacy, side effects and satisfaction, was used to characterize patients’
attitudes and subjective responses to antipsychotic treatment. The DAI was administered to subjects with chronic
or subchronic schizophrenia or schizoaffective disorder in
a forty-week, double-blind, randomized, parallel-group,
flexible-dose study of two regimens of ziprasidone (80 to
120 mg QD or 40 to 80 BID) and one regimen of haloperidol (5 to 20 mg daily). A score was calculated as the
sum of the responses to all questionnaire items, and the
subsets of six subjective and four attitudinal questions. A
categorical linear model was used to analyze the marginal
probabilities of favorable responses to the questions. RESULTS: For total, subjective and attitudinal items, DAI
scores at baseline were comparable between treatment
groups. Overall item response significantly favored ziprasidone at week 40 (p 5 0.0016; 7/10 questions showed a
higher percentage of positive responses for ziprasidone,
and the magnitude of differences per question ranged
from 114.2% to 23.7%). This difference was primarily
due to positive responses to the subjective questions (p 5
0.0006; 4/6 questions showed a higher percentage of positive responses for ziprasidone, and the magnitude of differences per question ranged from 114.2% to 23.2%).
CONCLUSIONS: Patients in the ziprasidone groups had
a significantly more positive attitude regarding their medication than those in the haloperidol group over 40 weeks
of treatment. These findings have implications for greater
patient compliance with ziprasidone treatment, which
may lead to decreases in relapse rates, hospitalizations,
and other health care resource use.
PMH5
FROM FIRST TO SECOND: IMPACT OF
PARTICIPANT CHARACTERISTICS ON THE
TIME TO FIRST SWITCH IN A
SCHIZOPHRENIA POPULATION
Russo P1, Vasey J2
1
The MEDSTAT Group, Inc, Washington, DC, USA; 2The
Pennsylvania State University, State College, PA, USA
OBJECTIVE: Examine which participant level factors
impact the time to switch from first- to second-generation agents among participants in the Schizophrenia Care
and Assessment Project (SCAP). METHODS: Baseline
data identified participants not receiving second generation agents (n 5 520). Accelerated failure time (AFT)
modeling (Weibull distribution error) applied. Number
of years between disease onset and study initiation included. Dependent variable: days between study initiation and first switch to second-generation. Right censoring addressed through dichotomous censor variable (1 5
switch during window). RESULTS: About one-fourth
(n 5 133) experienced switch (mean time to switch 5
171.08 days). Working hypothesis: persons with higher
side effect and symptom scores and lower functioning
would exhibit shorter time to switch. Persons with higher
side effect scores (AIMS) experienced longer interval until
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Abstracts
switch (1.08; p 5 0.01) and those with higher depression
scores (MADRS) experienced shorter time to switch
(0.97; p 5 0.02). Those receiving service through university hospital experienced longer interval (3.19; p 5 0.01).
The computed hazard rate (20.68) indicates the risk of
switch is decreasing over time. CONCLUSIONS: Findings indicate that symptoms and type of service delivery
site are significant in determining the switch from older
to newer agents. The shorter interval for those with
higher depression scores is expected and is probably reflective of clinical intervention aimed toward the amelioration of negative symptoms. Interestingly, the longer
interval for those with higher side effect scores was contrary to expectation and may indicate that the motivating
influence to change is more related to the presentation of
primary disease state, rather than the reduction of secondary symptoms associated with the first generation
medications. The longer interval for those receiving care
in a university hospital setting is perplexing since it is
usually expected that medication adjustment will occur
during hospital stays. Further investigation of this phenomenon may be aided by the inclusion of physician level
information, which is anticipated in upcoming analyses.
PMH6
CHANGE IN INSTRUMENTAL ACTIVITIES OF
DAILY LIVING ASSOCIATED WITH
ANTIDEPRESSANTS IN OLDER
DEPRESSED PATIENTS
Edell WS1, Mayo KW2, Bailey KL2, Sandoval RI2, Adams BE1,
Jensik SE1
1
Mental Health Outcomes, Lewisville, TX, USA; 2Pharmacia
Corporation, Peapack, NJ, USA
OBJECTIVES: While most current antidepressant agents,
such as SSRIs and dual action agents are reasonably effective in ameliorating depressive symptomatology in
older patients, less is known about their impact on concurrent instrumental activities of daily living (IADL’s).
This study examines change in IADL’s, such as the capacity to use the telephone, travel, shop, cook, do housework, handle money, or take medicine, from admission
to three-month post-discharge follow-up in geropsychiatric patients (age 55 and older) with major depression
(ICD-9-CM codes 296.20-296.36) treated with fluoxetine (n 5 77), mirtazapine (n 5 36), sertraline (n 5 145),
or venlaxafine (n 5 56). METHODS: Data were obtained from the CQI1SM Outcomes Measurement System, which tracked patients admitted to geropsychiatric
inpatient programs in 111 general hospitals across 33
states between 1997–1999. IADL’s were measured by selected items from the Duke OARS Multidimensional
Functional Assessment Questionnaire (Lawton & Brody,
1969). A Medication Usage Questionnaire was used to
track medications prescribed. One-way Analyses of Variance and if significant, Tukey’s pairwise comparisons
were used to compare medication groups. RESULTS: At
admission, patients exhibited moderate to severe inability
to independently carry out IADL’s (Mean score of 14 to
15 out of 21). Medication groups were indistinguishable
on change scores in overall IADL’s from time of admission to follow-up. On average, patients showed no
change in their ability to carry out IADL’s during this
time period, despite an improvement in level of depression, as measured by the collateral version of the Geriatric Depression Scale (Nitcher, Burke, Roccaforte, &
Wengel, 1993). CONCLUSIONS: Antidepressant agents
in this analysis were associated with modest improvement in IADL’s as assessed by the Duke OARS Multidemsional Functional Assessment in Older Adults. New
treatment modalities that improve IADL’s along with depressive symptomatology in older patients would be beneficial. Further controlled studies are needed to better understand these findings.
PMH7
CHANGE IN MALADAPTIVE BEHAVIORS
ASSOCIATED WITH ANTIDEPRESSANTS IN
OLDER DEPRESSED PATIENTS
Jensik SE1, Mayo KW2, Bailey KL2, Sandoval RI2, Edell WS1,
Adams BE1
1
Mental Health Outcomes, Lewisville, TX, USA; 2Pharmacia
Corporation, Peapack, NJ, USA
OBJECTIVES: Numerous antidepressant agents are
available to treat geropsychiatric patients with depression. While most current agents are reasonably effective
in ameliorating depressive symptomatology, less is known
about the impact of these agents on concurrent maladaptive behaviors. This study examines change in sixteen
such behaviors from admission to discharge to threemonth post-discharge follow-up in geropsychiatric patients (age 55 and older) with major depression (ICD-9CM codes 296.20-296.36) treated with fluoxetine (n 5
292), mirtazapine (n 5 288), sertraline (n 5 744), or venlaxafine (n 5 289). METHODS: Data were obtained
from the CQI1SM Outcomes Measurement System,
which tracked patients admitted to geropsychiatric inpatient programs in 111 general hospitals across 33 states
between 1997–1999. Maladaptive behaviors were measured by the Psychogeriatric Dependency Rating Scale
(PGDRS) (Wilkinson & Graham-White, 1980) and a
Medication Usage Questionnaire was used to track medications prescribed at admission, discharge, and followup. One-way Analyses of Variance and if significant,
Tukey’s pairwise comparisons were used to compare
medication groups. RESULTS: At admission, patients exhibited mild to moderate evidence of maladaptive behaviors (Mean PGDRS overall score of 20 out of 48). Medication groups were indistinguishable on change scores in
overall maladaptive behaviors from time of admission to
discharge (average length of stay around 16 days), discharge to follow-up, or admission to follow-up. On average, patients showed a very modest improvement (1–2
points) on the PGDRS from admission to discharge,
modest decline from discharge to follow-up (0–2 points),
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Abstracts
and no change to modest improvement from admission
to follow-up (0–1 points). CONCLUSIONS: Antidepressant agents in this analysis were associated with modest
improvement in maladaptive behavior as assessed by the
PDGRS. New treatment modalities that improve maladaptive behavior along with depressive symptomatology
in older patients would be beneficial. Further controlled
studies are needed to better understand these findings.
PMH8
IMPACT OF CURRENT ANTIDEPRESSANTS ON
COGNITION IN OLDER PATIENTS
WITH DEPRESSION
Adams BE1, Mayo KW2, Sandoval RI2, Bailey KL2, Jensik SE1,
Edell WS1
1
Mental Health Outcomes, Lewisville, TX, USA; 2Pharmacia
Corporation, Peapack, NJ, USA
OBJECTIVES: An array of antidepressant agents are
available in the treatment of geropsychiatric patients with
depression. While most current agents, such as the selective serotonin reuptake inhibitors (SSRI’s) (e.g., fluoxetine; sertraline) and agents acting upon both serotonin
and norepinephrine (e.g., mirtazapine; venlaxafine), are
reasonably effective in ameliorating depressive symptomatology, less is known about the impact of these agents
on other common areas of deficit in older depressed patients, such as cognition. This study examines change in
cognitive functioning in geropsychiatric patients (age 55
and older) with major depression (ICD-9-CM codes
296.20-296.36) treated with fluoxetine (n 5 269), mirtazapine (n 5 275), sertraline (n 5 713), or venlaxafine
(n 5 259). METHODS: Data were obtained from the
CQI1SM Outcomes Measurement System, a Joint Commission of Accredited Hospital Organizations (JCAHO)
ORYX accepted performance improvement system,
which tracked patients admitted to geropsychiatric inpatient programs in 111 general hospitals across 33 states
between 1997–1999. Cognitive functioning was measured at admission and discharge using the Mini-Mental
State Examination (MMSE) (Folstein, Folstein, & McHugh,
1975). A Medication Usage Questionnaire was used to
track medications prescribed to patients just prior to admission and at discharge. One-way Analyses of Variance
and if significant, Tukey’s pairwise comparisons, were
used to compare medication groups. RESULTS: At admission, patients exhibited moderate evidence of cognitive impairment (Mean MMSE score of 21 out of 30).
Medication groups were indistinguishable on change
scores in cognitive functioning from time of admission to
discharge (average length of stay around 16 days). The
average change score on the MMSE was 1.1 to 1.6 points,
suggesting very mild improvement. CONCLUSIONS: Antidepressant agents in this analysis were associated with
modest improvement in cognitive functioning as assessed
by the MMSE. New treatment modalities that improve
cognition along with depressive symptomatology in older
patients would be beneficial.
PMH9
HEALTH CARE UTILIZATION AND COSTS IN
SCHIZOPHRENIC PATIENTS TAKING
RISPERIDONE VERSUS OLANZAPINE IN A
VETERANS ADMINISTRATION POPULATION
Shermock KM1, Fuller MA2, Secic M1, Laich JS2, Durkin MB3
1
The Cleveland Clinic Foundation, Cleveland, OH, USA; 2Louis
Stokes Department of Veterans Affairs Medical Center,
Brecksville, OH, USA; 3Janssen Pharmaceutica, Titusville, NJ,
USA
OBJECTIVES: To compare the change in health care utilization and costs from one year before (preperiod) and
one year after (postperiod) starting treatment with risperidone or olanzapine in schizophrenia patients in a
Veterans Administration population. METHODS: Patients with a diagnosis of schizophrenia (ICD-9 CM code
295) in the preperiod, who had an initial prescription for
risperidone or olanzapine dispensed between 3/97 and
3/99, were included. Patients who received any atypical
antipsychotic in the preperiod were excluded. Comparisons of average change in utilization and cost from the
preperiod to the postperiod were made between the
groups for: inpatient hospitalizations, outpatient clinic
visits, medications, and total health care cost. Analysis of
covariance was used to analyze the data using age, gender, and race as covariates. RESULTS: 304 patients in
the olanzapine group and 344 in the risperidone group
were included. The olanzapine group had significantly
more inpatient admissions per patient (0.09 vs. 20.24,
p 5 0.026), longer inpatient lengths of stay (4.3 days
vs. 24.2 days, p 5 0.004), and higher cost of inpatient
admissions ($2735 vs. 2$3226, p 5 0.003) than the risperidone group. There was a significantly lower cost of
antipsychotic for the risperidone group than for the olanzapine group ($650 vs. $1660, p , 0.001). The mean
daily doses were 3.4 mg of risperidone and 12.0 mg of
olanzapine. The olanzapine group also had a significantly
higher change in cost for all drugs ($1492 vs. $683, p ,
0.001) and all health care costs ($5,665 vs. 2$1,167, p ,
0.001) than the risperidone group. CONCLUSIONS:
The changes in total health care costs, number, length of
stay, and cost of inpatient admissions, and medication
costs for risperidone-treated patients were significantly
lower compared with olanzapine-treated patients.
PMH10
HEALTH OUTCOMES OF CHILDHOOD
ATTENTION-DEFICIT/HYPERACTIVITY
DISORDER (ADHD): HEALTH CARE USE AND
WORK STATUS OF CAREGIVERS
Noe L1, Hankin CS2
1
Ovation Research Group, Highland Park, IL, USA; 2ALZA
Corporation, Mountain View, CA, USA
OBJECTIVES: Attention-deficit/hyperactivity disorder
(ADHD) is the most commonly diagnosed psychiatric
disorder among children in the US. However, the social
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Abstracts
and economic costs of ADHD are not well understood.
We sought to examine the impact of childhood ADHD
on caregivers’ work status and work productivity, and
patients’ health care use. METHODS: We conducted a
telephone survey of 154 caregivers of ADHD-diagnosed
children. Caregivers were identified from membership in
CHADD (Children and Adults with Attention-Deficit/
Hyperactivity Disorder). RESULTS: The mean number
of ADHD-diagnosed children per caregiver was 1.3
(range 1–4); 60% of children were in 6th grade or lower.
The reported mean number of prior year ADHD-related
visits to pediatricians, psychiatrists, psychologists, and
counselors was 2.0, 3.7, 2.9, and 6.6 visits, respectively.
In the 3 months prior to telephone survey, 18% of visits
were for unscheduled emergencies—63% of caregivers
reported some change in their work status as a result of
their child’s ADHD. Of these, 15% changed type of job,
46% reduced hours worked per week, and 11% stopped
working completely. During the 4 weeks prior to survey,
caregivers reported having lost an average of 0.8 days
from work and being 25% less productive, for an average
of 2.4 days attributed to their child’s ADHD—this is
equivalent to 39 days reduced caregiver productivity per
year. CONCLUSIONS: Childhood ADHD adversely affects caregiver work status and work productivity.
ADHD also results in frequent unscheduled emergency
visits. Effective disease management of childhood ADHD
may ultimately mitigate substantial costs borne by employers and health care systems.
PMH11
SCHIZOPHRENIA CARE AND ASSESSMENT
PROGRAM (SCAP): THE IMPACT OF CLINICAL
SYNDROME, ANTIPSYCHOTIC MEDICATION
TREATMENT AND ADHERENCE ON
OUTPATIENT PSYCHIATRIC UTILIZATION
Russo P, Smith M
The MEDSTAT Group, Inc, Washington, DC, USA
OBJECTIVE: To examine the impact of clinical syndrome, type of medication and adherence on outpatient
utilization. METHODS: Baseline data predicted 6-month
outpatient utilization (n 5 985). Psychotherapy, clinic
visits (specimen collection), and total number of outpatient visits were examined. Presence of medication (15
first-generation; 5 novel; both) was coded. Adherence reflected the 4-weeks prior to assessment. Clinical syndrome variables: deficit, hallucinations/delusions, and
disorganization. Negative binomial regression (adjusted
standard errors). RESULTS: Psychotherapy Visits: Positive effect observed for higher hallucinations/delusions
and use of both first- and second-generations. Clinic Visits: The probability of visit was positively impacted by
higher disorganization, adherence, education less than
high school graduation, and CHAMPUS. Negative effect
noted for use of novel agents and having Medicare only.
Number of visits higher for those with higher disorganization. Total Outpatient Visits: Positive effect observed
for adherence at both periods and treatment with novel
agents alone or in combination with first-generation
agents. The clinical syndrome variables did not achieve
significance. CONCLUSIONS: The positive correlation
of medication adherence at both baseline and 6 months
with clinic visits and total visits is an important driver in
outpatient services utilization. The type of medication
positively impacts the number of visits, however, a negative association was observed between type of medication
and the probability of a clinic visit. It may be possible
that some persons using novel agents achieve improvement through outpatient medication management (psychotherapy visits) and may require less frequent clinic
visits (for specimen collection), suggesting that the favorable adverse event profile of second-generation agents
may promote community functioning. Positive symptoms
and disorganization drive the occurrence and number of
visits while the presence of deficit syndrome did not
achieve significance. These findings suggest that as treatment costs vary by method, payers could benefit by assessing clinical syndrome in order to estimate diseaserelated payments accurately.
PMH12
PREVALENCE OF COMORBID ANXIETY AND
DEPRESSION AMONG PATIENTS PRESCRIBED
SSRI MONOTHERAPY
Grotzinger KM, Chang LL
GlaxoSmithKline PLC, Collegeville, PA, USA
OBJECTIVE: To examine the distribution of mental
health conditions comorbid to depression, especially anxiety, among patients treated for 1–6 months or 7–12
months with an SSRI. METHODS: The study comprised
a retrospective review of integrated medical and pharmacy claims from a national managed care organization.
Continuously enrolled patients between the ages of 18
and 65 years were identified from the 1.9M claims underlying six IPA model plans for 1997–1998. Patients placed
on SSRI therapy following a 4 month period without
drugs were stratified according to underlying mental
health conditions and length of SSRI monotherapy. RESULTS: Overall, between 47% and 52% of patients
placed on SSRI monotherapy had a history of depression;
an additional 5–12% had histories of anxiety without depression. Greater proportions of patients for whom paroxetine was prescribed rather than either fluoxetine or
sertraline had anxiety comorbid to depression in the year
prior to initiating drug therapy(11.5%, 6.5%, 7.9%, respectively)(Chi-square ,.001). The 40 or more percent of
patients without depression or anxiety in their histories—
12 months preceding initiation of drug therapy and
month of initiation—but treated with SSRIs often had diagnoses for other mental health conditions, specifically
neurotic disorders, affective psychoses, nondependent
abuse of drugs and adjustment reaction. These diagnoses
patterns persisted when patients were subset according to
persistence of therapy, i.e., SSRI therapy for greater or
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Abstracts
fewer than 6 months. CONCLUSIONS: These results
support the common belief that physicians differentially
prescribe SSRIs according to comorbid symptoms. Observed differences in the prevalence of diagnoses across
SSRI therapies are consistent with differences in the range
of approved indications across drugs and preferential
prescribing of paroxetine for patients with comorbid
anxiety disorders.
PMH13
PRE-TREATMENT PATIENT DIFFERENCES:
CHOICE OF DRUG THERAPY
WITHIN SCHIZOPHRENIA
Gibson PJ, Loosbrock DL
Eli Lilly and Company, Indianapolis, IN, USA
OBJECTIVE: To examine pre-treatment differences in
characteristics of patients with schizophrenia treated
with olanzapine and risperidone, as reported in epidemiologic studies. METHOD: All 15 non-randomized studies with olanzapine and risperidone cited in Medline or
presented at major conferences (APA, ECNP, WPA,
ISPOR) through 1999 were included. The direction, magnitude, and statistical significance from all comparisons
of pre-treatment characteristics for schizophrenia patients initiating therapy on olanzapine or risperidone are
summarized. RESULTS: Several studies found olanzapine
patients were more likely to be younger and male. One of
six studies found younger mean age at onset, though
prior duration of illness results had no consistent direction. Other specific comparisons were included in only
one or two studies. History of hospital admission results
were mixed, though olanzapine patients had significantly
higher prior hospitalization costs in the one study with
that measure. Patients initiated on olanzapine were more
likely to have prior use of clozapine, depot antipsychotics, and/or antidepressants, whereas patients initiated on
risperidone were more likely to have anticholinergic use
at therapy start. In one study, patients initiated on olanzapine had mean CGI scores and/or GAF scores indicative of greater severity. CONCLUSIONS: When evaluated, significant pre-treatment patient differences were
often found. Physicians may be choosing olanzapine therapy for more complicated schizophrenic patients, indicated by prior hospitalization cost, medication use, and
clinical assessment scores.
PMH14
DEFICIT SYNDROME AND DRUG USE
PATTERNS IN COMMUNITY-BASED
SCHIZOPHRENIA CARE
Russo P1, Kirkpatrick B2
1
The MEDSTAT Group, Inc, Washington, DC, USA; 2University
of Maryland Psychiatric Research Center, Baltimore, MD, USA
OBJECTIVE: To determine how deficit syndrome relates
to patterns of antipsychotic drug use among persons with
schizophrenia receiving community-based care. METHODS: Study participants were enrolled in the US Schizophrenia Care and Assessment Program (SCAP). Data
were obtained from participants who completed the baseline and 6-month assessments and were using antipsychotic medications at baseline (n 5 1019). Presence of
deficit syndrome was assigned based on proxy methods
using clinical data (Kirkpatrick B., et al., 1989). Antipsychotics were categorized as first-generation, second-generation, or other. Few participants received antipsychotics in the ‘other’ category (2%) and were not included in
these analyses. Baseline characteristics and the presence
of deficit syndrome were used to predict two outcomes:
(1) the likelihood of receiving first-generation antipsychotics at the initial assessment, and (2) the likelihood of
switching from one antipsychotic class to another between assessments. Covariates included demographic
(gender, race, age, marital status, education, insurance),
clinical (GAF, hallucinations/delusions, disorganization),
medication adherence, and site variables. Logistic regression was applied. RESULTS: Deficit syndrome was not
significantly related to use of a 1st-generation agent at
baseline. A positive association was found for African
Americans (.0004), lower hallucination/delusion scores
(.02), and several site indicators (,.05) ( Orlando, Denver, Baltimore, and San Diego). The probability of
switching antipsychotic classes between assessments was
significantly related to one site indicator (.01) (Orlando);
weak evidence (.08) of lower GAF scores being associated with a switch was observed. The presence of deficit
syndrome did not achieve significance in either model.
CONCLUSIONS: The deficit syndrome has been studied
extensively in its relation to neurological function and
course of illness. In the SCAP population of patients receiving community-based care at diverse settings, we do
not find a relation between deficit syndrome and two
measures of antipsychotic drug assignment. Further research may include evaluation of the relationship between deficit syndrome and drug assignment patterns
over time.
PMH15
A RETROSPECTIVE ECONOMIC EVALUATION
OF OLANZAPINE VERSUS RISPERIDONE IN THE
TREATMENT OF SCHIZOPHRENIA
Zhao Z
Eli Lilly and Company, Indianapolis, IN, USA
OBJECTIVES: The purpose of this study was to assess
the one-year direct schizophrenia-related treatment costs,
mental health care costs and total health care costs for
patients diagnosed with schizophrenia and initiating therapy with either olanzapine or risperidone. METHODS: A
retrospective analysis of the integrated medical and pharmacy claims of a large, geographically diverse, commercially insured population was conducted. A previously
validated algorithm to identify schizophrenics was used
for patient selection. The confirmed schizophrenia pa-
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Abstracts
tients who began treatment with either olanzapine or risperidone were included. Treatment course and associated
schizophrenia-related, mental health care and total health
care costs during the subsequent 12-month period were
examined using univariate and multivariate methods.
RESULTS: Nine hundred eighty-five (985) patients initiated on risperidone and 348 initiated on olanzapine met
inclusion criteria. The mean dose was 4.02 and 10.49 for
risperidone and olanzapine patients, respectively. Patients
taking olanzapine versus risperidone stayed on therapy
longer during the 12-month observation period (217 days
versus 181 days, p , 0.0001). Although pharmaceutical
costs were significantly higher for olanzapine patients,
their medical costs were significantly lower than those on
risperidone. After adjusting for differences in patient demographics, disease severity and comorbidities, olanzapine patients had significantly lower mental health care
costs including drug costs ($1,827 less, p , 0.05) and
lower total health care costs ($1,834 less, p , 0.05). The
schizophrenia-related costs (including drug costs) were
not statistically significantly different, though numerically the risperidone patients incurred $740 more per patient than patients on olanzapine (p 5 0.26). CONCLUSIONS: The findings in this study suggest that the initial
selection of atypical antipsychotic for the treatment of
schizophrenia matters, as olanzapine offset its acquisition
cost by reducing medical costs and demonstrated significant mental and total health care cost savings over risperidone.
PMH16
USE OF RASCH MODELS FOR VALIDATION OF
INSTRUMENTS USED IN MENTAL
HEALTH EVALUATION
Lançon C1, Toumi M2, Pettersson Å2, Aballéa S2, Fournier A2
1
CHU Sainte Marguerite, Marseilles, France; 2Lundbeck SA,
Paris, France
OBJECTIVES: The Positive And Negative Syndrome
Scale (PANSS) and Calgary Depression Scale for Schizophrenics (CDSS) are widely used in the evaluation of
schizophrenia. Their internal validity have already been
evaluated with classical methods (multitrait and confirmatory analyses). During the last two decades, Item Response Theory has been developed to deal with latent
traits. As part of it, Rasch models are commonly used in
Quality of Life research but not yet for other outcome
questionnaires. METHODS: 458 schizophrenic patients
were evaluated with the PANSS and CDSS. Rasch models
for polytomous items were fitted to the data in order to
assess: 1) unidimensionality of the CDSS and the PANSS
subscales, i.e. their ability to measure one latent trait (degree of depression/degree of positive, negative, general
schizophrenic symptoms); infit and outfit statistics were
used and residuals studied; 2) invariance of comparisons,
implying that the parameter characterizing an item does
not depend on the latent trait distribution of the population; item parameters estimates were compared for two
subgroups of the population. RESULTS: Unidimensionality and invariance of comparisons are globally satisfactory for the CDSS, although the appropriateness of two
items (items four and seven) may be questionable. Results
do not support the three-dimensional structure for the
PANSS, which is commonly used as the reference. CONCLUSIONS: Further investigation of the factorial structure of PANSS (e.g five-factors structures, which have
been proposed by several authors) is necessary. Rasch
models provide a powerful approach to evaluate internal
validity of mental health scales, enabling to investigate
invariance of comparisons, which constitutes the major
distinction from classical methods.
PMH17
TYPICAL AND ATYPICAL ANTIPSYCHOTICS IN
THE TREATMENT OF SCHIZOPHRENIA:
ASSESSMENT OF CLINICAL AND ECONOMIC
OUTCOMES USING A MARKOV MODEL
Neeser K1, Schramm W1, Brandt A1, Höffler J2, Jürgens T3,
Mast O3
1
Institute for Medical Informatics and Biostatistics (IMIB),
Riehen, Switzerland; 2Westfälische Klinik für Psychiatrie,
Gütersloh, Germany; 3Bayer Vital GmbH, Leverkusen, Germany
OBJECTIVES: Health economic assessment of cost-effectiveness parameters for the comparison of typical (Haloperidol), partially atypical depot (Flupentixol) and atypical neuroleptics (Olanzapin, Risperidon) in the treatment
of schizophrenia from the perspective of German health
insurance. METHODS: A published markov model was
rebuilt and calibrated with DATA®, taking into consideration relapse rates, extrapyramidal symptoms (EPS)
and other prognostic symptoms. All data were derived
from published sources where available. Besides the comparison of monotherapy, a stepwise treatment scenario
was simulated, starting with three months Olanzapin
treatment followed by Flupentixol. Over the 5-year simulation period cumulated complication rates (percentage
of relapse, positive and negative symptoms), patient related outcomes (Brief Psychiatric Rating Score “BPRS”)
and cost parameters (medication, EPS-cost and total
costs) were assessed. A cost-effectiveness analysis was
performed. RESULTS: Olanzapin/Flupentixol in combination had the lowest relapse rate (42.9 %), followed by
Flupentixol (44.4%), Olanzapin (44.8%), Risperidon
(48.0 %) and Haloperidol (57.6%). Olanzapin treatment
showed the highest BPRS score (3.13), followed by Risperidon (3.07), Olanzapin/Flupentixol (2.52), Flupentixol (2.42) and Haloperidol (2.37). The most cost-effective treatment measured by cost in DEM per relapse free
patient was Olanzapin/Flupentixol (200,000), followed
by Olanzapin (211,000), Flupentixol (212,000), Risperidon (231,000) and Haloperidol (287,000). The best costeffectiveness (expressed in DEM/BPRS) was observed in
Olanzapin (37,100), followed by Risperidon (39,100),
Olanzapin/Flupentixol (45,500), Flupentixol (48,600)
and Haloperidol (51,400). Total 5-year drug cost (DEM)
146
Abstracts
were 24,600, 26,800, 3,800, 2,700 and 3,210 respectively. CONCLUSIONS: In terms of relapse rates Olanzapin and Flupentixol lead to better clinical outcome and
better cost-effectiveness results as compared to alternative typical or atypical neuroleptic therapy. With Olanzapin and Risperidon most favorable BPRS scores were
achieved. Flupentixol depot as monotherapy or following
initial Olanzapin treatment is a cost-effective alternative
to atypical neuroleptics at low drug cost and low relapse
rates.
PMH18
HEALTH CARE UTILIZATION IN PATIENTS
WITH TREATMENT RESISTANT DEPRESSION
Crown WH1, Ling DCY1, Finkelstein SN2, Berndt ER2,
White AS1
1
The MEDSTAT Group, Cambridge, MA, USA; 2Massachusetts
Institute of Technology, Cambridge, MA, USA
OBJECTIVES: Approximately one-half of patients with
an episode of major depression will have a recurrent episode during their lifetime. Recent studies indicate that approximately 20% of depressed patients are resistant to
traditional antidepressant treatments. This study utilizes
medical and prescription claims data from the 1995–
1998 MarketScan® Databases to profile the characteristics and health care utilization of patients with treatmentresistant depression. METHODS: Depression-diagnosed
patients with adequate antidepressant dosing and treatment duration are selected. Patients are classified as treatment-resistant if they have switched/augmented their initial medication with other antidepressants twice, or if
they have switched/augmented their initial medication
and have claims for depression-related hospitalizations or
suicide attempts. Depression-diagnosed patients meeting
selection criteria but not classified as treatment-resistant
by the above criteria are used as a comparison group.
RESULTS: Patients with treatment-resistant depression
are at least twice as likely to be diagnosed with bipolar
disorder, at least 1.5 times as likely to be diagnosed with
comorbid anxiety disorders, and at least 1.5 times as
likely to be diagnosed with substance-related disorders
than the comparison group (p-values ,0.01). Patients
with treatment-resistant depression have 30% higher
mean number of psychiatric diagnostic groupings (PDG)
and 9% higher mean number of major diagnostic categories (MDC) than the comparison group (p-values ,0.01).
Furthermore, patients with treatment-resistant depression are at least twice as likely to be hospitalized (depression and non-depression related), and have 41% more
outpatient visits than the comparison group (p-values
,0.01). Finally, patients with treatment-resistant depression use 2 to 3 times more psychotropic medications (in
addition to antidepressants) than the comparison group
(p-values ,0.01). CONCLUSIONS: Treatment-resistant
patients are higher utilizers of both depression-related
and general medical services. This finding underscores
the importance of early identification and effective treat-
ment of treatment-resistant patients to prevent future depressive episodes and to mitigate health care utilization.
PMH19
RISK OF HOSPITALIZATION FOR PATIENTS
WITH BIPOLAR DISORDER
Ling DCY1, Bresnahan BW2, White AS1, Neslusan CA2,
Crown WH1
1
The MEDSTAT Group, Cambridge, MA, USA; 2R.W. Johnson
Pharmaceutical Research Institute, Raritan, NJ, USA
OBJECTIVES: Health care utilization for patients with
bipolar disorder has received limited attention. This
study utilizes medical and prescription claims data from
the 1998 to mid-2000 MarketScan Databases to examine
the risks of hospitalization, a major cost driver in treating
bipolar patients. Hospitalizations are associated with a
relapse of bipolar symptoms (often due to treatment ineffectiveness or discontinuation). METHODS: Bipolar patients are identified using diagnosis codes and prescription drug claims. An ‘intent-to-treat’ framework for
classifying drug cohorts by initial bipolar prescription is
used. Prescription claims are studied over a minimum of
a six-month time period to analyze drug use patterns
(e.g., switching and augmenting treatment). Descriptive
profiles of the bipolar patients are presented. Cox proportional hazard models are used to examine the relationships among observable patient characteristics, drug
choice, drug use patterns, and hospitalizations. This
method accounts for the potential bias in parameter estimates due to data censoring. RESULTS: Among patients
with at least 6-months of follow-up data (n 5 6,536), the
mean age is 43 years old and 63.3% are female. The
majority of patients are initially observed on antimanic
medications, with lesser percentages on other common
pharmacological therapies (typical and atypical antipsychotics, and antiepileptics). During the 6-month followup, 14.5% of patients have at least one hospitalization
and 7.2% have at least one bipolar-related hospitalization. During a 12-month follow-up, 23.3% have at least
one hospitalization of any type and 11.5% have at least
one bipolar-related hospitalization. The unadjusted risk
of hospitalization increases over time, at a decreasing
rate. CONCLUSION: The high incidence of hospitalization demonstrates the need for effective treatment options. This study also illustrates the importance of accounting for censored data to obtain unbiased estimates
of factors associated with the risk of hospitalization.
PMH20
DOSING OF BENZODIAZEPINE HYPNOTICS IN
ELDERLY PATIENTS
Young JK, Schultz D, Foster D, Heller S
Solucient, Ann Arbor, MI, USA
OBJECTIVES: Use of benzodiazepines in elderly patients
has been associated with adverse outcomes including mo-
147
Abstracts
tor vehicle accidents and hip fractures from falls. Evidence exists showing greater risk of adverse outcomes
with higher doses of these drugs regardless of drug halflife. Initial administration of lower doses to elderly and
debilitated patients is generally recommended for benzodiazepine hypnotics. We analyzed whether these recommendations are generally followed when prescribing
these drugs to inpatients. METHODS: Demographic and
hospital information for all patients receiving flurazepam, triazolam, or temazepam between January 1998
and June 2000 was extracted from Solucient’s Projected
Inpatient International Classification of Clinical Services
(pICCS) database. This database contains demographic,
hospital, clinical, and detailed service level information
for inpatients from over 150 short-term, non-federal, US
hospitals. The percent of elderly patients (over age 65) receiving the recommended dose was determined. The relationship of patient age, hospital teaching status, bed size,
and geographic region on the likelihood of following dosing recommendations was analyzed. RESULTS: We extracted information for 14,929 inpatients receiving flurazepam, 8,147 inpatients receiving triazolam, and 125,625
patients receiving temazepam. Among elderly patients receiving one of these drugs, 72.1% of patients receiving
flurazepam, 49.8% of patients receiving temazepam, and
7.1% of patients receiving triazolam received the recommended dose. For all three drugs, patient age was directly
correlated with the likelihood of receiving the recommended dose. There was no consistent relationship between teaching status, hospital bed size, or geographic region and the likelihood of receiving the recommended
dose, although teaching hospitals were much more likely
than non-teaching hospitals to provide the recommended
dose for temazepam and triazolam (OR 5.3 CI 4.9–5.8
for temazepam; OR 2.7 CI 2.2–3.2 for triazolam). CONCLUSIONS: Many elderly inpatients are prescribed higher
than recommended doses of hypnotic benzodiazepines,
suggesting need for systemic interventions to avert adverse outcomes.
PMH21
QUALITY OF LIFE OF NON-INSTITUTIONAL
CAREGIVERS OF SCHIZOPHRENIC PATIENTS:
CONTRIBUTION OF QUALITATIVE
INTERVIEWS TO QUESTIONNAIRE
GENERATION
Auquier P1, Simeoni MC1, Azorin JM2, Lançon C2, Toumi M3
1
Public Health Department, Marseilles, France; 2CHU Sainte
Marguerite, Marseilles, France; 3Lundbeck SA, Paris, France
OBJECTIVES: The detrimental effects of hospitalisation
and developments in psychopharmaceutical, psychotherapeutic and social treatments led to deinstitutionalization. Proxies of patients, relatives or friends, have had to
learn to cope with caregiving tasks. Facilitating the coping of the caregivers should ensure a better quality of
caregiving, notably in terms of therapeutical observance.
An exhaustive literature review found 9 instruments for
caregivers of schizophrenic patients. Five of them are self
administered, but none of those covering mental, psychological and social fields have been widely validated and
accepted within the scientific community, none are available in French. We report the first step of development of
a specific, multidimensional, self-administered instrument measuring the quality of life of non-institutional
caregivers of schizophrenic patients. METHODS: Faceto-face interviews were conducted with non-institutional
caregivers of schizophrenic patients. Their content was
analysed to generate a large number of candidate items
covering all-important aspects of caregivers’ quality of
life. Eighteen interviews were performed: 11 mothers and
7 fathers aged from 48 years to 71. RESULTS: Content
analysis identified topics covering mental (worrying,
emotional over-involvement, and suffering, guilt, fair of
stigma, of future, loneliness, disillusion, anxiety, feeling
of usefulness, self esteem . . . ) physical (fatigue, disruption of sleep . . . ) and social (relationships with the patient, friends, relatives, health workers, occupation, leisure . . . ) fields. Negative as well as positive impact was
identified. CONCLUSIONS: These results were compared
to the domains described in the literature. This step led to
the generation of about 100 questions and the validity of
this questionnaire will be studied on 400 caregivers.
PMH22
PATTERNS OF ANTIDEPRESSANT USE AND
HEALTH CARE COSTS IN DEPRESSED PATIENTS
WHO RECEIVED SSRI THERAPY
Wade SW1, Berzon R2, Patton MP1, Koch P3, Batra D1
1
Protocare Sciences, Santa Monica, CA, USA; 2Boehringer
Ingelheim, Ridgefield, CT, USA; 3Boehringer Ingelheim GmbH,
Ingelheim am Rhein, Germany
OBJECTIVES: To assess differences in the health care resource use of patients who received selective serotonin
reuptake inhibitor (SSRI) antidepressants. METHODS:
Retrospective analysis of administrative medical claims
from 1/97–12/99 was conducted using Protocare Sciences’ Managed Care Database. Patients were categorized as early discontinued or continued (,6 months vs.
>6 months therapy), then as non-switched or switched
(one agent vs. .one agent). Total health care costs were
compared across these categories. RESULTS: Under half
(48%) of the 11,119 SSRI users studied continued antidepressant therapy for at least 6 months. Two-thirds of all
patients received monotherapy; 19% switched agents
(44% of switches were in the first three months of therapy); 15% used multiple agents. Eight percent of patients
who discontinued early had switched agents within the
specified 6 month period; 90% of these switches occurred
in the first three months. For patients who continued therapy for >6 months, the average total health care charges
per patient per month (PPPM) during the first three therapy
months were $906 (switch by third month), $568 (switch
by sixth month), $496 (switch by twelfth month) and $375
(switch after twelfth month). PPPM charges in the first six
148
Abstracts
therapy months ranged from $452–$921 for discontinued
patients and from $423–$483 for non-switched, continued patients. CONCLUSIONS: Patients who discontinued
SSRI therapy early tended to have higher costs than patients who continued therapy. It is unclear whether these
increased costs stem from treatment of medication side
effects or increased utilization related to lack of efficacy
of the initial antidepressant. Alternatively, early switchers
may simply be more clinically complex patients.
PMH23
DEINSTITUTIONALIZATION OF
SCHIZOPHRENIC PATIENTS:
COST-CONSEQUENCES AND POLICY
IMPLICATION OF INTENSIVE CASE
MANAGEMENT VERSUS STANDARD
CASE MANAGEMENT
Llorca PM1, Toumi M2, Hansen K2, Barré S2, François C2
1
CHU Sainte-Marie, Clermont-Ferrand, France; 2Lundbeck SA,
Paris, France
OBJECTIVES: In France a large part of acute hospitalisation beds are occupied by long-term hospitalisation of
schizophrenic patients. A model was developed to compare Intensive Case Management (ICM) to Standard Case
Management (SCM) for long-term hospitalised chronic
schizophrenic patients. METHODS: A model was used
to evaluate the number of patients that are either successfully dechronized, experiencing failure, or are readmitted
to hospital within a year for a cohort of 100 chronic
schizophrenic patients. With these figures, it was possible
to estimate the needs in terms of number of beds and employees in the catchment area of Clermont-Ferrand in
France, for the 1st, 2nd and 3rd year after the ICM strategy have been implemented. RESULTS: At the beginning
of the first year, 100 hospitalisation beds, 30 nurses, 10
psychologists and 5 psychiatrists were needed. After 1
year these numbers were respectively reduced to 50, 15,
10 and 2.5 due to the success of the ICM strategy. This
positive trend is also recorded for the second year of implementation. At the end of the 3rd year a steady point
level is nevertheless reached with the model, due to the
fact that there will always be patients that can not be
dechronized; the numbers at this point will be 11 beds, 3
nurses, 1 psychologist and a half-time psychiatrist. CONCLUSIONS: Due to the important caseload of ICM, it remains more costly than SCM at implementation, but will
reduce cost from year 1, and be less costly than SCM
from year 3. This model can therefore evaluate the economic impact of creating a dechronization unit in a
catchment area and make budgetary prevision for largescale implementation of ICM in France.
PMH24
THE COST OF ACUTE HOSPITALIZATION FOR
ANOREXIA NERVOSA AND BULIMIA
O’Brien JA, Patrick AR
Caro Research Institute, Concord, MA, USA
BACKGROUND: It has been reported that approximately 1% of young women have anorexia nervosa and
4% bulimia. Managing eating disorders requires a multidisciplinary approach including acute hospitalization,
when necessary. This study was undertaken to assess the
cost of acute hospital care for these disorders. METHODS: Inpatient cost estimates, adjusted for medical inflation and cost-to-charge ratios, were developed using data
from all-payer 1998 discharge databases from five states,
supplemented with national fee schedules. ICD9 codes
were used to identify those with a principal diagnosis of
anorexia (307.1) or bulimia (307.51). Cases where both
diagnoses were coded are excluded from results reported
here. Log transformation was used to address highly
skewed distributions. Length-of-stay (LOS), disposition
and psychiatric unit care (PSYU) were also examined.
Hospital costs (i.e., accommodation, ancillary, physician)
are reported in 2000 US$. RESULTS: The state databases
yielded 641 cases of anorexia and 326 of bulimia. The
overwhelming majority (.96%) were females. For anorexia: the mean age was 25 years (45% ,20 years); mean
LOS was 13; 24% received care in a PSYU; 87% were
discharged home; 7% went to a rehab or mental health
facility (MHF) and 3% left against medical advice
(AMA). For bulimia, the mean age was 27 years (25%
,20 years); mean LOS was 9; 39% received care in a
PSYU; 90% were discharged home; 4% to rehab or
MHF; 3% left AMA. The mean total cost per hospital
stay was $12,390 for anorexia and $9,120 for bulimia.
On average, the number of annual admissions was 1.6
and 1.2 for anorexia and bulimia, respectively. Managed
care was the largest primary payer. CONCLUSIONS: Although hospitalization is not the primary site of medical
care for managing serious eating disorders, it’s sometimes
required. We believe that this information provides an essential piece in understanding the economic consequences
of these conditions.
PMH25
A MODEL COMPARING OLANZAPINE AND
ZIPRASIDONE IN PATIENTS
WITH SCHIZOPHRENIA
Alexeyeva I1, Mauskopf J1, Earnshaw S1, Gibson PJ2,
Ascher-Svanum H2, Ramsey JL2
1
RTI-Health Solutions, Research Triangle Park, NC, USA; 2Eli
Lilly and Company, Indianapolis, IN, USA
OBJECTIVE: To estimate and compare the efficacy,
treatment-emergent adverse events, costs and outcomes
of olanzapine and ziprasidone for treatment of schizophrenia. METHODS: A decision-analytic model was
used to determine outcomes for patients treated over a
1-year period. Model parameters were based on clinical
trial data and published medical literature. Data from
different trials were compared only when patient populations were similar. Comparative studies were available
for weight gain and cardiovascular events. For essential
parameters with no relevant study results, assumptions
were made that the medications would be similar. RE-
149
Abstracts
SULTS: Compared to patients treated with ziprasidone,
data seem to suggest that olanzapine patients had a
higher response rate, a higher incidence of weight gain,
and a lower incidence of QTc prolongation. Total medical cost was higher for ziprasidone patients when the
medication cost of ziprasidone was assumed to be more
than half the price than that of olanzapine. The olanzapine group’s costs were more sensitive to changes in drug
costs, whereas the ziprasidone group’s costs were more
sensitive to the response rate of the medication used for
those patients not responsive to ziprasidone. CONCLUSIONS: Compared to ziprasidone patients, olanzapine
patients may have a higher response rate, a higher incidence of weight gain, and a lower incidence of QTc prolongation, with lower total costs as long as ziprasidone is
more than half the price of olanzapine.
PMH26
OUTPATIENT ANTIPSYCHOTIC USE:
COMPARING ATYPICAL AND CONVENTIONAL
ANTIPSYCHOTIC ADHERENCE USING A
NATIONAL RETAIL PHARMACY DATA BASE
Vanelli MR
Adheris, Inc, Woburn, MA, USA
OBJECTIVES: We report on trends in medication adherence for patients who received conventional and atypical
antipsychotics under routine outpatient care during a
9-month period in 1998–9. METHODS: Refill records
were analyzed for over 25,000 patients at a national retail pharmacy chain. Persistence was defined as a patient’s possession of medication at 30 day intervals from
a patient’s initial prescription. Persistence was taken as a
proxy for medication adherence. RESULTS: The percentage of patients adhering to therapy at nine months was
44.4% for atypical agents; 47.6% for conventional
agents; and 71.1% for clozapine. CONCLUSIONS: Improved clozapine adherence was associated with a closely
supervised medication administration process that ensured patient tracking and frequent and sustained patient-provider contact. Atypical agents, with their improved side-effect profile relative to conventional agents,
were not associated with better adherence. These results
suggest that improved side-effect profiles alone may not
insure higher levels of medication adherence and that improved medication administration processes may facilitate higher levels of outpatient medication adherence for
patients with major mental illness.
PMH27
COST-UTILITY ANALYSIS OF QUETIAPINE
COMPARED TO RISPERIDONE IN THE
TREATMENT OF PATIENTS WITH
SCHIZOPHRENIA OR OTHER
PSYCHOTIC DISORDERS
Simons WR1, Meddis D2
1
Global Health Economics & Outcomes Research, Short Hills,
NJ, USA; 2AstraZeneca, Macclesfield, Cheshire, UK
OBJECTIVE: Comparative cost-effectiveness was assessed in an open-label, randomized trial (QUEST) that
compared the efficacy and safety of quetiapine with risperidone in a outpatient population with schizophrenia
or other psychotic disorders. METHOD: Based on the
overall Positive And Negative Syndrome Scale (PANSS)
scores, patients in QUEST were categorized into one of
three health states—mild (PANSS <74.5), moderate
(PANSS .74.5 and <106.5), or severe (PANSS score
.106.5)—at baseline and at 2 months and 4 months.
Utilities and expected utilities from baseline were calculated. RESULTS: At baseline, 297 (54.0%), 206 (37.5%),
and 47 (8.5%) quetiapine patients, had mild, moderate
or severe symptoms compared to 102 (59.0%), 55
(31.8%), and 16 (9.2%) in the risperidone group. For patients in the mild or moderate states at baseline, improvements were seen in both treatment groups. For severe patients, more quetiapine patients improved: 21.2% versus
7.7% in the mild state and 60.6% versus 30.8% in the
moderate state (p 5 0.020) at 2 months and 46.9% versus 0.0% in the mild state and 40.6% versus 62.5% in
the moderate state (p 5 0.023) at 4 months. Overall,
when weighted by utilities, quetiapine treated patients attained greater gains in health state utilities at each followup visit for the mild (0.61 6 0.069), moderate (0.36 6
0.073) and severe (0.29 6 0.071) states. At 2-months,
quetiapine patients enjoyed a gain of 0.239 from their
baseline level compared to 0.175 for the risperidone
group. At 4-months, the gains were 0.329 versus 0.184
for the quetiapine and risperidone groups (p , 0.05). Average daily doses were 253.9mg quetiapine and 4.4mg
risperidone, yielding average daily costs to US consumers
of $6.38 and $7.85. At average retail costs to consumers
in the US, quetiapine reduces costs by $1.47/day or
$536.55 annually. CONCLUSION: Patients with schizophrenia or other psychotic disorders, treatment with quetiapine resulted in significant effectiveness and cost savings compared with risperidone.
PMH28
DEPRESSION AND HOMELESSNESS,
A FRENCH INITIATIVE
Emmanuelli X1, Hassin J1, Smadja C2, Taieb C2
1
Samu Social de Paris, Paris, France; 2PharmacoEconomics
Programs, Pierre Fabre SA, Boulogne Billancourt, France
CONTEXT: So-called chronic depression, a limiting factor in terms of social reinsertion, must be diagnosed to
enable its management and to prevent a decline towards
a profound, desocialised state. OBJECTIVE: To determine the incidence of depression in populations of the
homeless, who are users of the Samu Social de Paris—
Paris Social Emergencies Unit—(SSP). METHOD: Once
an individual had been assessed and a response found to
his or her need, it was suggested that patients calling the
SSP free-phone number should agree to complete the
CES-D questionnaire. Developed in the US by Randloff
(1977), this questionnaire enables the detection of depressive symptoms in a given population. Its use over the
150
Abstracts
telephone has been validated. RESULTS: Mean age: 43
years. Sex ratio: 84% men, 16% women, this being in
line with the ratio of users of the SSP. In 54% of our sample, the period of homelessness was longer than 2 years;
92% were single, 64% had maintained contacts with
their family and 36% declared they had no income. 70%
of those questioned had a score of 17 or higher on the
CES-D scale, indicative of depressive symptoms, mean
score: 22.4; the prevalence of possible depression was
69% and that of probable was 60%. Although no significant difference was seen in terms of the duration of
homelessness, two peaks were nonetheless observed: at
28 for those on the street for more than one month and
less than 6 months, and 22.8 for those homeless for more
than two years. CONCLUSION: By “turning the spotlight” on a poorly understood population, this study provides relevant results, which demonstrate the need to act
very rapidly to help these populations living in considerable need, before the homeless sink into a state of permanent poverty.
PMH29
COST ANALYSIS OF OLANZAPINE VERSUS
RISPERIDONE IN THE TREATMENT OF
UNCONTROLLED SCHIZOPHRENIA
Zhao Z
Eli Lilly and Company, Indianapolis, IN, USA
OBJECTIVES: This study compares the one-year direct
schizophrenia-related treatment costs, mental health care
costs and total health care costs of uncontrolled schizophrenia patients initiated on olanzapine versus risperidone. METHODS: The integrated medical and pharmacy
claims of a large, geographically diverse, commercially
insured population were used to conduct this analysis.
Patients who initiated treatment with either olanzapine
or risperidone and had one inpatient or two outpatient
services for schizophrenia within 30 days prior to initiation of drug of interest were included in this analysis.
Treatment course and associated schizophrenia-related,
mental health care and total health care costs during the
subsequent 12-month period were examined using univariate and multivariate methods. RESULTS: Four hundred thirty-one (431) patients initiated on risperidone
and 142 initiated on olanzapine met inclusion criteria.
The mean dose was 4.34 and 11 for risperidone and
olanzapine patients, respectively. During the one-year period after initiation of drug of interest, olanzapine patients (compared with risperidone patients) were less
likely to be hospitalized and had shorter mean length of
hospital stays for schizophrenia-related causes, mental
health care causes and all causes. Although pharmaceutical costs were significantly higher, medical costs were significantly lower for patients on olanzapine compared to
those on risperidone. Univariate and multivariate analyses (controlling for potential confounding factors such as
patient demographics, disease severity and comorbidities)
consistently demonstrated that olanzapine patients had
significantly lower schizophrenia-related costs ($2,839 less,
p , 0.05), lower mental health care costs ($3,744 less, p ,
0.005) and lower total health care costs ($4,674 less, p ,
0.001) than those patients initiated on risperidone. CONCLUSIONS: The findings revealed significant differences
between olanzapine and risperidone in the treatment of
uncontrolled schizophrenics in clinical practice. Olanzapine patients incurred lower costs (lower schizophreniarelated, mental health care and total health care costs).
The lower costs were inpatient driven by fewer hospitalizations and shorter length of hospital stays in the olanzapine treatment group.
PMH30
DIFFERENCES IN HEALTH CARE
EXPENDITURES AMONG PATIENTS TREATED
FOR DEPRESSION WITH OR
WITHOUT ANXIETY
Crown W1, Wan GJ2, Berndt ER3, Finkelstein SN3, Ling D1
1
The MEDSTAT Group, Cambridge, MA, USA; 2Wyeth-Ayerst
Pharmaceuticals, St. Davids, PA, USA; 3Massachusetts Institute
of Technology, Cambridge, MA, USA
OBJECTIVE: To compare health care expenditures of
treatment with SNRIs and SSRIs in depressed patients
with or without anxiety. METHOD: Using administrative claims from the MEDSTAT MarketScan database,
we identified patients with a new episode of depression
enrolled in a participating health plan from 1994 to
1998. Patients included for analysis had both a diagnosis
of depression (ICD-9-CM criteria) and a prescription for
either an SNRI (venlafaxine [n 5 290], venlafaxine XR
[n 5 63]) or an SSRI (fluoxetine [n 5 2854], paroxetine
[n 5 1772], sertraline [n 5 2580], fluvoxamine [n 5
124]) antidepressant. RESULTS: The SNRIs (n 5 353)
had lower inpatient non–mental health costs ($206 vs
$472; P 5 0.02) and lower antidepressant medication
costs ($302 vs $338; P 5 0.01) compared with the SSRIs
(n 5 7330). In particular, venlafaxine (n 5 290) costs
were lower than fluoxetine (n 5 2854) costs ($281 vs
$395; P , 0.05). Among patients with depression and
anxiety, SNRIs (n 5 219) had lower inpatient non–mental health costs ($273 vs $635; P 5 0.04) and lower antidepressant medication costs ($304 vs $350; P 5 0.01)
than SSRIs (n 5 4351). Among depressed patients without anxiety, SNRIs (n 5 134) had lower inpatient non–
mental health costs ($96 vs $234; P 5 0.05) and lower
inpatient mental health costs among users of inpatient
mental health services ($2,301 vs $4,847; P 5 0.02) relative to SSRIs (n 5 2979). CONCLUSION: Patients receiving SNRIs appear to have lower health care expenditures in some areas compared with SSRIs among depressed
patients with or without anxiety. Further research is
needed to determine whether patients treated with SNRIs
can be shown to accrue more favorable economic benefits over time relative to patients treated with SSRIs.
151
Abstracts
PMH31
PHARMACOECONOMIC EVALUATION OF THE
TREATMENT WITH OLANZAPINE IN
“REVOLVING DOOR”
SCHIZOPHRENIC PATIENTS
Gurovich I, Lyubov E, Shmukler A
The Moscow Research Institute of Psychiatry of the Russian
Federation, Moscow, Russia
OBJECTIVES: We aimed to evaluate the clinical, societal
and economic outcomes of olanzapine treatment compared to treatment with standard antipsychotics in outpatients with multiple schizophrenic episodes and subsequent yearly rehospitalizations. METHODS: The present
study comprised two stages. Within the first (clinical)
stage a mirror image 24-week cost-effectiveness study
was performed. Data were evaluated from 30 schizophrenic patients (ICD-10). Drug efficacy assessment included PANSS. Social functioning was evaluated with the
original checklist. Economic analysis based on resource
utilization data. Within the second stàge a Markov simulation model over a hypothetical 5-year period has been
developed to compare the overall costs and cost-effectiveness of olanzapine with those of standard treatment. RESULTS: During the maintenance phase of the study,
olanzapine-treated patients achieved a statistically significant greater improvement than ones treated with standard antipsychotics on overall measures of effectiveness.
In spite of high acquisition cost of olanzapine, total medical costs were not significantly more (nearly 10 %). Incremental cost-effectiveness ratio for olanzapine of 5 roubles (1998 values) per disability-free day gained over the
trial period. The direct cost per patient was calculated to
be 56000 roubles higher for 5-year` therapy with olanzapine. However the net savings per olanzapine-treated patient was 40.000 roubles from societal perspective by significantly increasing productivity and producing more
time in a disability-free state. The results of analysis were
not robust in a sensitivity analysis, including variations in
the frequency, duration and/or cost of hospitalization
and/or acquisition cost of olanzapine. CONCLUSIONS:
Olanzapine offered an economically justifiable therapeutic option in the long-term management of the special
subpopulation of patients with frequent rehospitalizations.
PMH32
BARRIERS TO THE USE OF MEDICATIONS TO
TREAT ALCOHOLISM
Mark TL1, Kranzler HR2, Poole VH1, Hagen CA3, McLeod C3,
Crosse SE3
1
The MEDSTAT Group, Washington, DC, USA; 2University of
Connecticut School of Medicine, Farmington, CT, USA;
3
Westat, Rockville, MD, USA
In December 1994, naltrexone, marketed under the
brand name Revia, became the first adjunctive medication in almost 50 years approved by the FDA for treat-
ment of alcoholism. Despite the evidence of its efficacy in
randomized clinical trials, the use of naltrexone is not
widespread. OBJECTIVE: To identify possible barriers
to the use of naltrexone and other new medications in the
treatment of alcoholism. METHODS: Focus groups were
conducted in Washington, DC. The first comprised physicians who treat substance abuse, recruited nationally
through a professional association and physician consultant referrals. The second comprised individuals who had
been treated for alcoholism in the past three years and
were in recovery, recruited locally through a newspaper
advertisement. The physician group was taped and transcribed; the patient group was not taped in order to protect confidentiality. RESULTS: Public and provider lack
of information were identified as key reasons why naltrexone has not been used more widely. Patients also
pointed out medication side effects, the philosophy of Alcoholics Anonymous (AA), the high price of naltrexone,
and stigma as barriers. In addition, physicians noted lack
of evidence of efficacy in practice, difficulty measuring efficacy in practice, lack of physician time for patient management, patient reluctance to take medication, uncertainty in identifying appropriate patients for naltrexone,
and lack of knowledge of and attitudes toward the use of
medications among counselors as barriers. The findings
will be used to inform the design of a national survey of
providers. CONCLUSIONS: The findings suggest that
physicians will not adopt innovations based solely on the
clinical literature. While millions of dollars have been invested in the development of new alcoholism medications, licensing medications may not result in significant
changes in treatment without educational and marketing
efforts to promote the medications through the diverse
members of the alcoholism treatment community.
PMH33
OLANZAPINE VERSUS RISPERIDONE IN THE
TREATMENT OF SCHIZOPHRENIA:
A COMPARISON OF COSTS AMONG
TEXAS MEDICAID PATIENTS
Rascati KL1, Johnsrud M1, Crismon ML1, Barber BL2, Lage MJ2
1
The Center for Pharmacoeconomic Studies—The University
of Texas, Austin, TX, USA; 2Eli Lilly and Co, Indianapolis, IN,
USA
OBJECTIVE: The purpose of this retrospective study is
to examine both schizophrenia-related direct costs and
total (schizophrenia plus non-schizophrenia) direct costs
among Texas Medicaid patients who have been diagnosed with a schizophrenic disorder and have been initiated on one of two atypical antipsychotics (olanzapine or
risperidone). METHODS: Services and prescription utilization and cost data were retrieved for 3,072 patients
with schizophrenia who were initiated on olanzapine or
risperidone between 1997 and 1998. Each patient was
followed for one year from initiation of therapy. Multivariate analysis was used to control for a wide range of
factors (drug choice, patient demographics, pre-utiliza-
152
Abstracts
tion costs, region, health conditions, and treatment patterns) that may influence schizophrenia-related costs and
total costs. Estimation was conducted via a two-stage instrumental variable model. RESULTS: The mean unadjusted total schizophrenia-related cost per patient per
year was $4,973, and the total unadjusted health care
cost per patient per year was $7,335. Although the daily
drug costs associated with olanzapine were higher than
risperidone, and patients taking olanzapine on average
stayed on therapy longer than those taking risperidone,
when looking at total schizophrenia-related costs (services plus prescription utilization), there was no significant difference between drug groups (olanzapine $81
lower, p 5 0.7534). Additionally, when total health care
costs were analyzed, there was no significant difference in
drug groups (olanzapine $530 lower, p 5 0.1050). Sensitivity analyses found similar results. CONCLUSION:
This naturalistic study used data from a Texas Medicaid
population to examine the schizophrenia-related costs
(and total costs) for patients who received olanzapine
versus risperidone. No differences in direct costs were
found for patients receiving olanzapine versus risperidone.
PMH34
SWITCHING AND AUGMENTATION OF
ANTIDEPRESSANTS IN OLDER
DEPRESSED PATIENTS
Adams BE1, Jensik SE1, Mayo KW2, Bailey KL2, Sandoval RI2,
Edell WS1
1
Mental Health Outcomes, Lewisville, TX, USA; 2Pharmacia
Corporation, Peapack, NJ, USA
Newer antidepressants are often prescribed to geriatric
patients with depression because older agents often have
side effects that may be problematic in the elderly. Less
well-understood are the prescribing patterns of clinicians
when such first-line agents are switched or augmented.
OBJECTIVE: To examine switching and augmentation
patterns used during the inpatient and post-discharge period in geriatric patients with major depression (ICD-9CM codes 296.20-296.36) treated initially with fluoxetine, mirtazapine, sertraline, or venlaxafine. METHOD:
Data were obtained from the CQI1SM Outcomes Measurement System, an ORYX (JCAHO) accepted performance improvement system, which tracked patients admitted to geropsychiatric inpatient programs in 111
general hospitals across 33 states between 1997–1999. A
Medication Usage Questionnaire was used to track medications prescribed just prior to admission, at time of discharge, and at three-month post-discharge follow-up.
RESULTS: From admission to discharge, over one-third
to one-half (37.4–52.1%) of patients switched or augmented specific antidepressant agent. Switching and augmenting rates decreased somewhat from discharge to follow-up (10.5–29.6%) and from admission to follow-up
(30.5–38.9%). Remarkably, over twenty distinct antidepressant agents were used when switching occurred, and
fifteen distinct antidepressant agents were used to augment the initial antidepressant agent. CONCLUSIONS:
A significant number of patients do not appear to improve adequately on their agent of first choice. The great
variety of treatment combinations suggests there is no
clearly preferred treatment strategy for partial and nonresponders. Practice guidelines for treatment strategies to
augment and switch in older patients with depression
would be beneficial for both clinicians and patients.
PMH35
PATTERNS OF ANTIDEPRESSANT AND
ANTIPSYCHOTIC MEDICATION USE IN
MEDICAID, 1995–1999
Gregorian R, Gemmen E
The Lewin Group, Falls Church, VA, USA
OBJECTIVES: This study sought to: 1) analyze trends in
utilization of antidepressant and antipsychotic medications in Medicaid between 1995 and 1999; 2) gauge
the utilization and diffusion of new generation, branded
antidepressants and antipsychotics during this period.
METHODS: The study was based on a time-series analysis of quarterly, state-level, Medicaid pharmaceutical
claims, as administered by HCFA. Data from 45 states
were suitable for analysis. RESULTS: In 1998, antidepressants and antipsychotics accounted for 9% of Medicaid prescriptions, but 19% of expenditures. From 1995
to 1998, Medicaid prescriptions for antidepressant and
antipsychotic medications grew by 40% and 20%, respectively; corresponding expenditures grew by 96% and
160%. The growth rate in both prescriptions and expenditures for antidepressants and antipsychotics outpaces
that observed in Medicaid pharmacy benefits as a whole
by more than two-fold. In 1995, new generation antidepressants and antipsychotics accounted for 44% and
17.5% of all prescriptions for Medicaid antidepressants
and antipsychotics, respectively. By 1998, these new generation drugs had accounted for 62% and 51% of all
Medicaid prescriptions for antidepressants and antipsychotics. CONCLUSIONS: Antidepressants and antipsychotics account for a large proportion of Medicaid pharmaceutical prescriptions and reimbursements. The total
Medicaid market for antidepressants and antipsychotics
grew dramatically over this four-year period. The impact
of newer antidepressants and antipsychotics on expenditures is disproportionate to the number of prescriptions
for these agents. New generation antidepressants and antipsychotics have been accepted into common use within
Medicaid programs. Increased Medicaid expenditures for
antidepressants have been driven both by the uptake of
new generation agents and by increased overall prescription volume. Increased Medicaid expenditures for antipsychotics have been driven by increased utilization of
atypical antipsychotics. Utilization of new-generation antidepressants and antipsychotics varies among the states;
not all states have adopted new generation agents as
quickly as others.
153
Abstracts
PMH36
DOSING OF BENZODIAZEPINE HYPNOTICS IN
ELDERLY PATIENTS
Young JK, Schultz D, Foster D, Heller S
Solucient, Ann Arbor, MI, USA
OBJECTIVES: Use of benzodiazepines in elderly patients
has been associated with adverse outcomes including motor vehicle accidents and hip fractures from falls. Evidence exists showing greater risk of adverse outcomes
with higher doses of these drugs regardless of drug halflife. Initial administration of lower doses to elderly and
debilitated patients is generally recommended for benzodiazepine hypnotics. We analyzed whether these recommendations are generally followed when prescribing
these drugs to inpatients. METHODS: Demographic and
hospital information for all patients receiving flurazepam, triazolam, or temazepam between January 1998
and June 2000 was extracted from Solucient’s Projected
Inpatient International Classification of Clinical Services
(pICCS) database. This database contains demographic,
hospital, clinical, and detailed service level information
for inpatients from over 150 short-term, non-federal, US
hospitals. The percent of elderly patients (over age 65) receiving the recommended dose was determined. The relationship of patient age, hospital teaching status, bed size,
and geographic region on the likelihood of following dosing recommendations was analyzed. RESULTS: We extracted information for 14,929 inpatients receiving flurazepam, 8,147 inpatients receiving triazolam, and 125,625
patients receiving temazepam. Among elderly patients receiving one of these drugs, 72.1% of patients receiving
flurazepam, 49.8% of patients receiving temazepam, and
7.1% of patients receiving triazolam received the recommended dose. For all three drugs, patient age was directly
correlated with the likelihood of receiving the recommended dose. There was no consistent relationship between teaching status, hospital bed size, or geographic region and the likelihood of receiving the recommended
dose, although teaching hospitals were much more likely
than non-teaching hospitals to provide the recommended
dose for temazepam and triazolam (OR 5.3 CI 4.9–5.8
for temazepam; OR 2.7 CI 2.2–3.2 for triazolam). CONCLUSIONS: Many elderly inpatients are prescribed higher
than recommended doses of hypnotic benzodiazepines,
suggesting need for systemic interventions to avert adverse outcomes.
PAIN & NEUROLOGIC DISORDERS
PPN1
AN INTERNET STUDY OF WTP FOR MIGRAINE
PHARMACOTHERAPIES
Lenert LA, Minh C, Jackson C
University of California–San Diego, San Diego, CA, USA
BACKGROUND: There are a wide range of therapeutic
options for migraine headaches that have different costs
and benefits, and little is known about the cost-effectiveness of specific therapies. OBJECTIVE: Assess patients’
preferences for outcomes of treatment of migraine headache based on their marginal willingness to pay (WTP)
for treatment attributes. METHODS: In an Internetbased study, we used computer software to measure importance ratings of attributes of pharmacological migraine therapies, then elicited their WTP for an ideal drug
(one that was 100% effective, worked quickly, and had
no adverse effects) and for “less than ideal” drugs with
relatively poor performance in one specific attribute of
performance. Patients: 429 self-identified migraineurs recruited via an Internet web site. RESULTS: A high proportion of patients in the study had symptoms consistent
with migraine etiology of headache (91% in enrollees,
99% of patients providing WTP ratings). Expert review
confirmed a large proportion of symptom profiles as being consistent with migraine (90% of the first 109 enrollees). Median WTP for an ideal migraine therapy was
4.1% of estimated monthly income or $130 (US), and
was associated with severity of pain, frequency of headaches, and the types of medications used in the past.
WTP was reduced when pharmaceuticals offered less
benefit (median reductions of a $75 per month for 50%
chance of causing a rebound headache; $62 for rendering
user unable to work, $50 for a two-hour delay in effect;
and $15 for failure to relieve nausea). Reductions in WTP
were largely consistent with importance ratings for attributes except for “speed of relief,” which was more
highly valued. CONCLUSIONS: Elicitation of patients’
WTP for specific attributes of a therapy appears to be a
feasible method to quantify patients’ preferences for outcomes. Further work is needed to compare this approach
to traditional methods for measurement of WTP.
PPN2
USE OF GALANTAMINE IN THE NETHERLANDS
FOR THE TREATMENT OF MILD TO MODERATE
ALZHEIMER’S DISEASE
Caro J1, Salas M1, Getsios D1, Mehnert A2, for the AHEAD
Study Group
1
Caro Research Institute, Concord, MA, USA; 2Janssen
Research Foundation, Beerse, Belgium
OBJECTIVES: To estimate the costs and long-term
health effects of using galantamine in Dutch patients with
mild to moderate Alzheimer’s disease (AD). METHODS:
A pharmacoeconomic model was developed. It consists
of two components: an initial module based on two galantamine clinical trials and a subsequent module that
uses trial results and equations derived from recently
published data to forecast the time until patients require
full time care (FTC) or die. The analyses compare treatment with galantamine 24 mg to no pharmacologic treatment. Cost estimates were based on resource use profiles
of patients with AD in the Netherlands and are reported
in 1998 guilders (NLG) determined from the perspective
of a comprehensive care payer. Future costs are dis-
154
Abstracts
counted at a 5% annual rate. Extensive sensitivity analyses were conducted. RESULTS: Over the decade of analysis, a net saving of NLG 3,050 was estimated. The cost
of galantamine makes up 5.0% of the total. The model
predicts that patients treated with galantamine are expected to spend 10.0% less time receiving home-based
FTC and 9.9% less time in a nursing home compared to
untreated patients. For every hundred patients starting
treatment on galantamine 17.8 person-years of FTC are
avoided (14.3 discounted). Secondary analyses of the effect of galantamine on behavioral symptoms estimated an
increment in total savings of NLG 4,903. Sensitivity analyses run on key model parameters showed results to be
robust. CONCLUSION: On average, treatment with galantamine not only provides a considerable health benefit
but is also expected to yield savings in the costs associated with mild to moderate AD in the Netherlands.
PPN3
THE IMPACT OF DEMENTIA ON CAREGIVER
QUALITY OF LIFE
Gold KF1, Botteman MF1, Kemp R2, Kittner B2, Pashos CL1
1
Abt Associates Clinical Trials, Bethesda, MD, USA; 2Aventis,
Bridgewater, NJ, USA
BACKGROUND: The prevalence of Alzheimer’s disease
(AD) and vascular dementia (VD) is expected to rise substantially in the coming decades. As well, the impact of
these conditions on caregiver burden and quality of life
(QOL) is also expected to increase. OBJECTIVES: To (1)
determine how the characteristics of patients and their
caregivers affects caregiver’s QOL, and (2) identify subsets of caregivers disproportionately affected by their patient’s disease. METHODS: Data were collected crosssectionally at baseline on 912 pairs of AD/VD patients
and their primary caregivers as part of a multinational
prospective longitudinal clinical trial. Patient and caregiver demographics, patient CDR and DAD scores were
collected, as were caregiver EuroQol (EQ-5D) scores and
time spent on caregiving activities. Univariate and multivariate analyses were conducted to determine patient and
caregiver characteristics that were particularly associated
with low caregiver QOL. RESULTS: Patient severity as
measured by CDR score was moderately related to caregiver EuroQol score (p , .05). Specifically, caregiver EuroQol scores were .84, .78, .76, and .74 for questionable,
mild, moderate, and severe dementia (on the CDR), respectively. In a main-effects only regression model, a
4-point and a 7-point reduction in caregiver’s EuroQol
score was associated with the caregiver being a women
and being a spouse/partner of the patient, respectively.
When an interaction term between these two variables
was introduced into the regression, the main effects of
caregiver gender and being a spouse/partner of the patient became insignificant. However, the interaction
term, being a woman spouse caring for a patient, was associated with a significant 12-point reduction in EuroQol
score. CONCLUSIONS: Worse caregiver QOL is associated with more severe patient disease stage and with being a woman caring for a demented spouse. Interventions
should thus be planned with special consideration given
this potentially more vulnerable set of caregivers.
PPN4
UTILITY ASSESSMENTS OF OPIOID
TREATMENT IN THE US, CANADA AND
AUSTRALIA FOR PATIENTS WITH CHRONIC
NON-MALIGNANT PAIN
Schmier J1, Palmer C1, Ingham M2, Mathur S1, Dodd S3,
Gourlay G4
1
MEDTAP International Inc, Bethesda, MD, USA; 2JanssenOrtho Inc, Toronto, ON, Canada; 3Janssen Pharmaceutica,
Titusville, NJ, USA; 4Flinders Medical Centre, Bedford Park,
Australia
BACKGROUND: Optimal treatment for chronic nonmalignant pain (CNMP) is largely a function of patient
preferences in balancing pain control with treatment tolerability. OBJECTIVE: To estimate utilities for health
states associated with CNMP and its treatment with opioids. METHODS: 96 CNMP patients (31 Canadian, 33
US, 32 Australian) completed the SF-36TM and assessed
health state descriptions and their own current health using the visual analog scale and computer-assisted adaptive conjoint analysis (ACA). The health state descriptions included combinations of: presence/absence of 7
side effects (3 severity levels for each); pain control (5 severity levels); and 2 opioid administration routes. RESULTS: On average, subjects were 47 (613) years, white
(95%), female (63%), not living alone (74%), and unemployed (74%). Approximately 75% of subjects in each
country were currently experiencing mild to moderate
pain; most had arthritic or low back pain. All SF-36TM
subscale scores by country were significantly lower than
US age- and gender-equivalent norms (p , 0.05). Mean
utilities did not vary substantially between oral vs. transdermal opioid administration. Overall, mean (6SE) utilities ranged from a maximum of 0.87 6 0.02 (no pain or
side effects) to a minimum of 0.18 6 0.02 (uncontrolled
pain with severe respiratory depression or severe vomiting). Mean utilities for controlled pain with moderate
side effects ranged from 0.62 6 0.02 (mood changes,
vomiting, or respiratory depression) to 0.74 6 0.02
(sweating). Uncontrolled pain without side effects (0.64 6
0.02) was preferred to well-controlled pain with severe
side effects (range: 0.41 6 0.03 [mood changes, vomiting, or respiratory depression] to 0.54 6 0.03 [sweating]). CONCLUSIONS: Results indicate a patient preference for opioid therapy that causes fewer side effects.
Although pain may be extremely debilitating, tolerating
pain to avoid opioid side effects may be preferable to
controlling pain and experiencing certain opioid side effects. Opioid side effects combined with poorly-controlled pain may result in very low health utility.
155
Abstracts
PPN5
COMPARISON OF COSTS AND
COST-EFFECTIVENESS OF OXCARBAZEPINE
AND SODIUM VALPROATE FOR
NEW/RECENT ONSET PARTIAL SEIZURES
Bazalo G1, Sachdeo R2, Graham S3, Chang S3, Cohen A3
1
Bazalo Consulting, Scottsdale, AZ, USA; 2Robert Wood
Johnson Medical School, New Brunswick, NJ, USA; 3Novartis
Pharmaceuticals, East Hanover, NJ, USA
OBJECTIVE: to determine the comparative costs and
cost-effectiveness of oxcarbazepine and sodium valproate
in the treatment of new and recent onset partial epileptic
seizures. METHODS: Low, moderate and high dose
maintenance regimens were determined for each drug
based upon prescription audit information captured in
the prescribing physician’s office. Unit drug costs based
on wholesale acquisition costs were then used to compute
a daily drug cost for each dosage level. A decision-analysis model using a Monte Carlo simulation was developed
to evaluate the cost-effectiveness of oxcarbazepine and
sodium valproate. The model contained the computed
daily drug costs along with direct payer costs associated
with initiation and maintenance of therapy, treatment of
adverse events and switching from one drug to another
due to poor seizure control or adverse events. The probabilities of maintaining seizure control and of experiencing
adverse events were obtained from double-blind clinical
trials comparing oxcarbazepine and sodium valproate.
RESULTS: The average daily drug costs weighted over
the three dosage levels were $4.72 ($1.49 to $7.66) for
oxcarbazepine and $3.17 ($2.45 to $3.87) for sodium
valproate. Total one year costs for oxcarbazepine, including costs of adverse events and costs of switching drugs
due to poor seizure control or adverse events were
$3,511 for oxcarbazepine and $5,931 for sodium valproate. The computed number of months on initial therapy was 9.95 for oxcarbazepine and 9.66 for sodium valproate. The analysis was carried out to four years using
the same probabilities for adverse events and seizure control. The four-year costs were $17,949 and $23,144 with
25.8 and 24.3 months of therapy for oxcarbazepine and
sodium valproate respectively. CONCLUSION: These
findings suggest that oxcarbazepine results in lower expected total costs compared to sodium valproate when
drug costs, evaluation and management, adverse events
and costs of switching therapies are taken into account.
PPN6
VALIDATION OF THE 24 HOUR HEADACHE
DISABILITY QUESTIONNAIRE (DISQ-24) IN A
SAMPLE OF HEADACHE SUFFERERS
Runken MC, Kwong W, Davis K, Batenhorst A
GlaxoSmithKline, Inc, Research Triangle Park, NC, USA
OBJECTIVES: The Disq-24 was developed to measure
headache disability on a 24-hour basis and was first utilized in a sample of migraine subjects who experienced
chronic daily headaches. The purpose of this study was to
evaluate this instrument’s psychometric properties.
METHODS: The Disq-24 is a 14-item questionnaire with
a 6-point Likert-type scale that measures disability with
regards to three hypothesized dimensions: family/social
(4-item), work activities (5-item), and emotions/feelings
(5-item). This instrument was administered in a prospective, multicenter, randomized, double-blind, placebocontrolled, parallel group trial of 170 transformed migraine sufferers. Four scaling assumptions of summated
rating scales (equal variances, equal weights, item-internal consistency and discriminant validity) and scale-level
reliability were examined using the baseline data. RESULTS: The means and standard deviations of items
within each scale were similar. However, item evaluation
demonstrated a floor effect in all items ranging from
22% to 66%. Item internal consistency was generally
high and ranged from 0.62 to 0.90. Cronbach’s alpha
ranged from 0.93 to 0.95 for the three dimensions and
was 0.97 for the total score, exceeding the generally acceptable criteria of 0.70. Although each item was highly
correlated with the hypothesized scale, the item-scale correlations did not discriminate significantly with other
scales. CONCLUSIONS: Although the Disq-24 satisfied
the equal variance, equal weights, and internal consistency assumptions of summated rating scales, item discriminant validity was not supported in the above analysis. This lack of support could be due to the small sample
size and/or the existence of a unidimensional structure.
The validity of the instrument warrants further testing in
a headache population which is not restricted to chronic
daily headache patients.
PPN7
A MODEL FOR PREDICTING THE INCIDENCE
OF MIGRAINE IN THE IDAHO
MEDICAID POPULATION
Shaw J1, Joish V1, Cady PS2
1
The University of Arizona, Tucson, AZ, USA; 2Idaho State
University, Pocatello, ID, USA
BACKGROUND: Migraine headache affects approximately 9 million Americans. It is a chronic disease and is
often associated with a high rate of disability. OBJECTIVE: The purpose of this research was to develop a
model for predicting the incident number of migraine
cases in the Idaho Medicaid population over a 5-year period. METHODS: Incident migraine cases between January 1994 and December 1998 were identified from the
Idaho Medicaid claims database using migraine-specific
ICD-9-CM codes or migraine-specific pharmacy claims.
Data were collected on the total number of new migraine
cases according to age, race, gender, and year. A negative
binomial model was developed to predict incident migraine cases from the other variables. All model independents were treated as categorical variables. Two hundred
sixty-six Medicaid recipients between the ages of 5 and
104 were included in the analysis. RESULTS: A test for
156
Abstracts
overdispersion revealed that use of a negative binomial
model was appropriate. Age, race, gender, and year were
all determined to be significant effects by likelihood-ratio
test. The greatest incidence of migraine was observed
among persons 30–34 years of age. Controlling for other
effects, the incidence of migraine fell with increasing age
.34 or decreasing age ,30. The estimated mean number
of new cases was greater among Caucasians than nonCaucasians (46.2 vs. 3.7) and was greater among females
than males (41.9 vs. 8.0). The estimated incidence of migraine was lowest in 1994 and generally rose each year
from 1996 onward. Using a pseudo-R2 measure developed by Nagelkerke, the model explained 87.2% of the
variance in incident migraine cases. CONCLUSIONS:
The findings of this investigation with regard to age, race,
and gender are consistent with those of previous studies.
Our estimates for the impact of time on the incidence of
migraine suggest that costs associated with migraine
treatment will continue to rise for the Idaho Medicaid
program.
PPN8
PSYCHOMETRIC EVALUATION OF WIDELY
USED PAIN MEASURES FOR PURPOSE OF
COMPUTERIZED DYNAMIC PAIN ASSESSMENT
Zhao JH1, Ware JE1, Kosinski M1, Bjorner JB2,
Turner-Bowker D1
1
QualityMetric, Lincoln, RI, USA; 2National Institute of
Occupational Health, Copenhagen, Denmark
OBJECTIVES: The aim of this study was to test the unidimensionality of 65 items from nine widely used pain
questionnaires in preparation for computerized adaptive
pain assessment. METHODS: Random samples of adults
were contacted on the internet (N 5 782) and telephone
(N 5 750). 65 items were selected mainly from Brief Pain
Inventory, MOS Pain Measures, Oswestry Low Back
Pain Disability Questionnaire, NottingHam Health Profile, McGill Pain Questionnaire, Health Disability Index,
Migraine-Specific Questionnaire, Aberdeen Back Pain
Scale, and Headache Impact Test. Mplus software was
used to perform confirmatory and exploratory factor
analyses of polychoric correlations among the items.
Model was examined through eigenvalue analysis, interfactor correlations, and root mean square residuals. RESULTS: Confirmatory factor loadings ranged from 0.53
to 0.92 with 90% of them higher than 0.7. Three factors
were rotated to an oblique solution. Examination of exploratory factor analysis revealed two subdimensions of
pain based upon item content: pain severity and pain impact. The third dimension observed in the three-factor solution, interpreted as current pain, was defined by questions without recall period. Eigenvalue analyses showed
that the first factor explained more than 65 percent of the
total variance in all pain item scores. Three factors explained 74% of the variance. The interfactor correlations
were high, ranged from 0.64 to 0.67. Root mean square
residuals were low, 0.07 for one-factor solution and
0.05, 0.03 for two- and three-factor solution respectively.
CONCLUSION: Most items from widely used questionnaires measure one single underlying construct of pain
sufficiently to meet the assumption of Item Response
Theory. Items selected will be calibrated on a standard
metric to estimate scores at patient’s specific pain level.
Further investigation on the application of IRT methods
and computer technology in pain assessment is warranted.
PPN9
HOW IS PAIN FELT ACROSS COUNTRIES? THE
SHORT-FORM MCGILL PAIN QUESTIONNAIRE
(SF-MPQ) IN 10 LANGUAGES
Conway K1, Uzun V1, Alacoque J1, Abetz L2, Melzack R3,
Plante M4
1
Mapi Research Institute, Lyon, France; 2Mapi Values,
Macclessfield, UK; 3McGill University, Montreal, QC, Canada;
4
Pfizer Inc, Ann Arbor, MI, USA
OBJECTIVES: Measuring Health-Related Quality of Life
(HRQoL) has become a vital part of assessing pain in international studies. The SF-MPQ is one of the most
widely used tests for the measurement of pain. It consists
of 15 descriptors (11 sensory; 4 affective) rated on an intensity scale from 0 (none) to 3 (severe), a Present Pain
Intensity (PPI) Index and a visual analogue scale (VAS).
Prior to use in international trials the measure underwent
linguistic validation in 10 languages. METHODS: A
HRQoL specialist coordinated the translation process in
each target country using the following methodology: 1)
two forward translations by professional translators, native speakers of the target language and fluent in English;
2) comparison and reconciliation of the translations by a
HRQoL specialist and translators; 3) backward translation by a native English speaker; 4) comparison of the
source and backward versions; 5) comprehension test in
a sample target population and finalization. RESULTS:
Linguistic and conceptual issues emerged during the translation process. The adjective “aching” was redundant in
most languages, equivalents were found such as “discomforting”/“not very intense”. The adjective “tender” used
alone was not found descriptive; the equivalent “sensitive
to touch” was therefore preferred. The term “punishing”
was found to have a strong religious connotation, the notions of “violent” or “torturing” were used instead. Concerning the PPI Index, the terms used to describe pain
had an affective component such as “distressing”, “horrible”. An intensity scale was favored in translations.
CONCLUSIONS: A rigorous translation methodology of
the original SF-MPQ was performed to ensure conceptual
equivalence and acceptability of translations. The issues
encountered during linguistic validation highlight the
value of international input in instrument design. Future
psychometric testing will be conducted to ensure reliability and validity of each translation, appropriateness of
the questionnaire in each country, and comparability of
data across countries.
157
Abstracts
PPN10
SURVIVAL AND NURSING HOME FREE
SURVIVAL (NHFS) OF AD PATIENTS
Wu EQ, Hay J
University of Southern California, Los Angeles, CA, USA
OBJECTIVE: To model survival and NHFS of Alzheimer
Disease (AD) patients. To justify the Mini-Mental Status
Examination (MMSE) score as an important predictor of
patient survival and nursing home utilization. METHODS: Survival models were applied to analyze the Minimum Uniform Data Set (MUDS), developed and maintained by Alzheimer Research Centers of California
(ARCC). The study sample included 3150 AD patients,
who enrolled in ARCC between Oct. 1992 and Jan.
1999. Cox regression models with and without timedependent covariates were used in the analysis. Results
were adjusted by comorbidities. RESULTS: The MMSE
score was shown to be a strong predictor of both AD patients’ survival and NHFS. One-unit increase of MMSE
score (on a 30-point scale) corresponds to a 5.5% hazard
reduction. That is to say, if a patient’s 5-year survival
probability is 0.500, with his MMSE score increased by
one unit, the probability will be increased to 0.520. One
unit increase of MMSE also corresponds to 6.4% hazard
reduction in future nursing home utilization, which
means a NHFS probability of 0.500 will be increased to
0.523. Female, black, and Hispanic had higher survival
probability. Older age, longer education, and history of
major psychosis in patient’s primary relatives caused
lower survival rate. Marriage and female gender increased NHFS; high value in Body mass index decreased
NHFS. All the above results were significant at 0.01 or
0.05 level. CONCLUSIONS: The study showed MMSE
was a strong predictor of patient survival and NHFS.
Further study should be conducted to explore the possibility that MMSE score can be used as a clinical indicator
for treating AD patients. It is also interesting that, older
age doesn’t have significant impact on NHFS although it
is a strong predictor of survival. On the other hand, marriage has a significant impact on NHFS, but not on survival.
PPN11
THE MIGRAINE IN FRANCE IN 2000:
EPIDEMIOLOGICAL DATA
Henry P1, Auray JP2, Duru G2, Chazot G3, Dartigues JF4,
Lanteri-Minet M5, Lucas C6, Pradalier A7, El Hasnaoui A8,
Gaudin AF8
1
Hopital Pellegrin, Bordeaux, France; 2Université Claude
Bernard, Lyon, France; 3Hopital Cardio Vasculaire et
Neurologique, Bron, France; 4Université Bordeaux II, Bordeaux,
France; 5CHU de Nice, Nice, France; 6Hospital Roger Salengro,
Lille, France; 7Hopital Louis Mourier, Colombes, France;
8
Laboratoire Glaxo Wellcome, Marly le Roi, France
OBJECTIVE: A French national epidemiological study
on migraine was presented 10 years ago at the Migraine
trust. It was the first study to cover an entire country
(HENRY P. et al.: Migraine prevalence in France. In New
advances in headache research: 2. Ed. Clifford Rose 1991
Smith Gordon—pp. : 11–14). This study has provided
also data on the burden of migraine in terms of its economic and social impact. We would like today to update
the data. METHODS: 1486 persons, aged over 15 and
suffering from headaches were randomly selected from a
large representative sample of the French population.
They were asked to complete a questionnaire, which allowed discriminating sufferers of migraine according to
IHS criteria. RESULTS: Among the 1486 headache sufferers, we find 880 migrainous people (1-1, 1-2 and 1-7
IHS criteria), 454 without migrainous headache and 152
with chronic daily headache. If we compare the results of
the certain migraine group (1-1 and 1-2 IHS) we find that
they are identical (8,1% (1989) versus 8,2% (1999)).
However, if we include the migrainous disorder group
fulfilling all criteria but one (1-7 IHS), the prevalence rate
for migraine headache in France between 1989 and 1999
seems to show a clear increase, rising from 12,1% to
17,3% because of less restrictive criteria than those applied ten years ago. Regarding the prevalence in general
population for chronic daily headache the rate is around
3% with 1,8% for men and 3,9% for women in 1999.
PPN12
DIFFERENCES IN HEALTH-RELATED QUALITY
OF LIFE BETWEEN MIGRAINEURS WITH AND
WITHOUT PROPHYLACTIC MEDICATION USE
Girts TK, Lofland JH, O’Connor JP
Thomas Jefferson University, Philadelphia, PA, USA
In a previous study, sumatriptan therapy was associated
with improvements in Health Related Quality of Life
(HRQoL). Using the same population, the present study
explores additional changes in HRQoL between patients
who did and did not receive migraine prophylaxis medication. OBJECTIVES: To compare the difference in
HRQoL of migraineurs who did and did not receive migraine prophylactic medication. METHODS: A retrospective database analysis was conducted using pharmacy claims and HRQoL data. Study patients were from
a managed care organization, were diagnosed with migraine, and were initiated on sumatriptan (baseline). The
SF-36 and Migraine-Specific Quality of Life Questionnaire-Version 1.0 (MSQ) surveys were administered at
baseline, 3 and 6 months after initiation of sumatriptan.
Patients were identified for the prophylaxis group if they
received any medication from a previously developed list
of possible migraine prophylaxis medications: 1) within
30 days prior to baseline and 2) at least 4 out of the 6
months after baseline. A two-way repeated measures
ANOVA was performed comparing differences in HRQoL
between the groups from baseline to 6 months. RESULTS:
Of 178 patients, 40 were in the prophylaxis group and
138 in the non-prophylaxis group. Statistically significant
increases were found in the MSQ Role Function-Restric-
158
Abstracts
tive, and the SF-36 Role-Physical, Bodily Pain domains in
the non-prophylaxis group compared with the prophylaxis group (p-value ,0.05). A statistically significant increase was found in the SF-36 Physical Functioning
domain in the prophylaxis group compared with the nonprophylaxis group (p-value ,0.05). CONCLUSION: Although sumatriptan has been shown to improve HRQoL
of migraineurs, concurrent use of prophylaxis medication
for migraineurs shows mixed results of any additional
benefit in HRQoL.
ing home associated with donepezil treatment may have
important health care cost-saving implications.
PPN14
A PROGNOSTIC MODEL TO PREDICT
QUALITY OF LIFE CHANCES AFTER
SUBARACHNOID HEMORRHAGE
Toth K1, Szende A2, Contreraz M1, Machovich A1, Futo J1,
Nyari I1
1
National Institute of Neurosurgery, Budapest, Hungary;
2
AstraZeneca, Torokbalint, Hungary
PPN13
DELAYS IN NURSING HOME PLACEMENT FOR
PATIENTS WITH ALZHEIMER’S DISEASE
ASSOCIATED WITH TREATMENT WITH
DONEPEZIL MAY HAVE HEALTH CARE
COST-SAVING IMPLICATIONS
Provenzano G1, Duttagupta S2, McRae T2, Mastey V2, Ellis B1,
Ieni J3
1
Battelle Centers for Public Health Research and Evaluation,
Arlington, VA, USA; 2Pfizer Pharmaceuticals Group, Pfizer Inc,
New York, NY, USA; 3Eisai Inc, Teaneck, NJ, USA
OBJECTIVES: Donepezil, an anti-dementia drug, has
been associated with delays in nursing home placement
(NHP) for patients with Alzheimer’s disease (AD). This
analysis explores the health care cost-saving implications
of such treatment. METHODS: Information on the dates
and reasons for NHP was obtained through follow-up interviews with caregivers and chart reviews of 763 AD patients who participated in three randomized, double-blind,
placebo-controlled clinical trials and two subsequent openlabel studies of donepezil. Patients were categorized according to their experiences in utilizing donepezil during
the clinical trials and extension studies. Cox proportional
hazards models (adjusted for age, gender, baseline MiniMental Status Examination scores, caregiver status and
post clinical study use of cholinesterase inhibitors) were
used to estimate adjusted survival functions from which
median times to NHP were estimated for each donepezil
use category. Analyses of the relationship between donepezil use and time to NHP were completed for both first
dementia-related placement (data reported here) and for
permanent placement (data similar). Standard nursing
home cost data were applied to these results. RESULTS:
For the least exposure group (dose ,5 mg/day and/or
used drug for less than 8 weeks total; n 5 95), the median time to first dementia-related NHP was 43 months.
Compared with this group, patients who received at least
5 mg/day of donepezil for 8 weeks or more had a significantly (p , 0.05) longer time to first dementia-related
NHP. For patients who received donepezil for at least 36
weeks (12 weeks of double blind and 24 weeks of openlabel treatment, for example), the median time was 73
months to first dementia-related NHP (RR 5 0.458, p ,
0.01). CONCLUSIONS: Because nursing home care has
been reported as the principal cost driver in the care of
AD patients, these delays to the time of entry into a nurs-
OBJECTIVES: Traditionally, mainly survival chances are
considered at clinical decisions before major operations.
This study looked at the potential ability of the most
commonly used pre-operation estimators to predict health
related quality of life of subarachnoid hemorrhage (SAH)
patients one year after surgery. METHODS: 173 patients
underwent intracranial aneurysm surgery within 72
hours after SAH at the National Institute of Neurosurgery in 1998 and1999. Before surgery health status assessment included Hunt-Hess (HH) grade as a measure of
neurological status, ASA physical status score, and CT
examination that determines the presence of intracerebral
hemorrhage (ICH) and Fisher scale. 12 months after the
surgery, patients were interviewed either by phone or
post by using the EQ-5D generic quality of life questionnaire. The relationship between the pre-operation health
status/risk estimators and one-year QoL values was examined by differences in mean EQ-5Dindex values and
by developing a regression model. F-statistics and student-t tests have been used to test statistical significance.
RESULTS: Patients with ICH had lower EQ-5D index
values (0.32 vs. 0.70, p , 0.001). Patients with Fisher
scores .3 had lower QoL than those with scores below
(0.35 vs. 0.68, p , 0.001). HH grade .3 lead to lower
QoL values (0.05 vs. 0.66, p , 0.001). Patients with ASA
scores .2 had also significantly lower QoL (0.18 vs.
0.66, p , 0.001). Due to similar meaning and high correlation between ICH status and Fisher score, Fisher score
was dropped from the prognostic model. Regression
model included: EQ-5Dindex 5 1.04 8V 0.38fx(ASA .
2) 8V 0.24fxICH 8V 0.30fx(HH . 3) 8V 0.006fxAGE.
The overall model showed an R2 5 0.412, and p-value
,0.001. P-values for individual coefficients were 0.0001,
0.0001, 0.0001, 0.002, and 0.012, respectively. CONCLUSIONS: Pre-operation health status/risk assessment
can predict future quality of life to an important extent.
It is argued that QoL chances should also be considered
in addition to survival chances. These results can be useful in sub-group analyses in modeling studies.
159
Abstracts
PPN15
MULTIPLE PAIN RELIEF ASSESSMENT IN
WOMEN UNDERGOING NATURAL VERSUS
EPIDURAL DELIVERY WITH ROPIVACAIN
OR BUPIVACAIN
Szende A1, Kincses ZS2, Zimanyi M3, Kadar Z4, Zorenyi G1
1
AstraZeneca, Torokbalint, Hungary; 2Semmelweis University,
Budapest, Hungary; 3Albert Szentgyorgyi Medical University,
Szeged, Hungary, 4Diosgyor City Hospital, Diosgyor, Hungary
OBJECTIVES: To compare level of pain and pain relief
by using different outcome measurement techniques in
women undergoing natural and epidural delivery. To
identify the relationship between categorical self-assessment and continuos VAS measures in painless delivery.
METHODS: 300 women at 10 centres in Hungary undergoing natural, epidural (ropivacain), or epidural
(bupivacain) delivery were involved in this non-randomized, open study. To avoid selection bias, patients were
recruited consecutively and natural delivery patients
came from centres where epidural delivery was not offered. Pain was measured by 10cm visual analogue scale
and by categorical self-assessment questions before pain
relief, at 15, 30 minutes, and then hourly afterwards. Patient’s preferred choice for possible future delivery was
also recorded. ANOVA method was used to test statistical significance. RESULTS: Initial average pain level
measured by VAS was 6.9 cm. Initial pain level did not
differ across groups. Changes in pain between the two
epidural groups were not statistically significant. Decrease in VAS scores was 3.3, 5.3, and 5.1 cm at 15, 30,
and 60 minutes after drug administration, respectively.
Changes assessed by patients as some, good, and excellent pain relief was associated with an average change of
1.80; 3.75; and 5.67 cm in VAS, respectively. Good or
excellent pain relief was experienced in 91% of epidural
patients. All of the epidural group and 70% of the natural group would choose painless delivery at a possible future occasion. Most reasons related to decreased pain,
less tiredness, better compliance with doctors, and more
attention to the baby. P values were less than 0.05. CONCLUSIONS: Large decrease in pain level can be achieved
in epidural groups at small additional costs and this is reflected in patients’ preferences. Validation of the VAS
method in painless delivery by assessment of importance
of change can be highly useful in future VAS studies.
PPN16
ECONOMIC BURDEN AND LOSS IN QUALITY OF
LIFE DUE TO LOW BACK PAIN
Szende A1, Lovas K2, Szebenyi B3, Bàlint G3, Héjj G3
1
AstraZeneca, Torokbalint, Hungary; 2Semmelweis University,
Budapest, Hungary; 3National Institute of Rheumatology and
Physiotherapy, Budapest, Hungary
OBJECTIVES: Low back pain is a common health problem in the population but its impact on quality of life and
societal costs is not well identified yet. The objective of
this study was to measure quality of life and costs related
to LBP and to understand the relationship among these
measurements. METHODS: 87 LBP patients (56 females) of mean age of 55 were recruited within a musculoskeletal study in both primary care and rheumatology outpatient settings in Hungary in 2000. Patients
filled in the generic EQ-5D quality of life and the disease
specific Oswestry questionnaires and reported health care
utilization. Mean quality of life and utilization values
were analysed and correlation coefficients between different measurements were reported. RESULTS: Average
EQ-5Dindex, EQ-5Dvas, and Oswestry score were 0.48;
0.52; 40, respectively. QoL did not differ significantly
across sub-diagnoses (i.e. discopathia, lumboischialgia,
osteoporosis, spondylitis ankylopoetica, and other) groups
of LBP. Average annual number of physiotherapy and
spa/pool treatment occasions was 8.9 and 2, respectively.
Average number of GP and specialist visits were 7.5 and
4. Patients spent a mean of 2.9 days in hospital and they
spent 12.7 days in bed due to LBP. Active workers reported 16.6 days spent on sick leave. Statistically significant correlation was observed between EQ-5Dindex and
EQ-5Dvas; EQ-5Dindex and Oswestry; EQ-5Dvas and
Oswestry; days in bed and EQ-5Dindex; days in bed and
EQ-5Dvas; days in bed and Oswestry. Corresponding
correlation coefficients were 0.71; 20.74; 20.67; 20.55;
20.36; 0.4 (p , 0.01). CONCLUSIONS: Results showed
that LBP leads to substantial loss in quality of life, important direct medical costs, and substantial productivity
costs among active patients. Different health status measures correlated strongly to each other but the most important cost driver, i.e. days on sick leave did not show
any correlation with these.
PPN17
ADDRESSING PARADOXES IN ECONOMIC
EVALUATIONS (EES). AN EXAMPLE USING
MOTOR NEURON DISEASE (MND)
Bose UK1, Burrell A1, Ward J2
1
Aventis Pharma, West Malling, UK; 2Evidence Research Unit,
Macclesfield, UK
BACKGROUND: MND results in progressive degeneration of the motor neurons, with intellect remaining
largely unaffected. Average life expectancy from diagnosis to death is 2–5 years. Riluzole is the only treatment
which has been shown to extend life in MND, though its
cost-effectiveness has been questioned. In recent years,
there has been a large increase in the number of EEs.
Many have been criticised due to methodological deficiencies. Using MND as an example, it is clear that EEs
can provide either valuable or misleading information in
a decision-making context. METHODS: Systematic search
for, and critical appraisal of, available EEs of riluzole
therapy for MND. RESULTS: The methodological quality of the six identified studies was variable. The study
with the greatest validity concluded that riluzole is a cost-
160
Abstracts
effective intervention. Flaws in other studies related to
the identification and measurement of costs, and to the
extrapolation of benefits. Overall there was a range in the
estimates of cost-effectiveness. For example, Messori et al
(1999) calculated the incremental cost per life year gained
to be approximately £41,000, whereas analysis by Tavakoli, et al. (1999) used Markov modeling to incorporate
the importance of implications on quality of life in the remaining months. This methodology revealed that the
incremental cost per life year gained was £8,587, and
therefore identified riluzole as a cost-effective therapy.
CONCLUSION: Clear presentation and use of perspective and relevant disease end-points are vital in economic
evaluation to avoid paradoxes in results of studies assessing similar interventions. For therapies such as riluzole,
where length of life and quality of life are key variables,
different end-points can provide contradictory results.
PPN18
COST SAVINGS IN MIGRAINE ASSOCIATED
WITH LESS CHEST PAIN ON NEW
TRIPTAN THERAPY
Wang JT, Barr CE, Torigoe Y, Wang EI, Rowland CR,
Goldfarb SD
Pharmacia, Peapack, NJ, USA
OBJECTIVES: To build an economic model estimating
the costs of care for chest pain in migraine patients when
treated with almotriptan instead of sumatriptan. METHODS: We conducted a population-based retrospective cohort study from the MEDSTAT Marketscan database.
Patients were continuously enrolled for any two consecutive years between 1996 and 1998 and had a first prescription for oral sumatriptan between July 1, 1996 and
June 30, 1998. Exclusion criteria included contraindications or risk factors for coronary artery disease. The
baseline and treatment periods were defined as five
months before and after the date of the first prescription
minus 15 days (since most patients receive samples). Patients with chest pain-related diagnoses and procedures
were compared between periods using the McNemar test.
The cost of chest pain-related care was used to build a
model estimating costs based on rates of chest pain from
clinical trials. RESULTS: Of 1,759 patients meeting inclusion criteria, 369 were excluded. The final cohort of
1,390 migraine patients showed a statistically significant
increase in the number experiencing chest pain after
treatment with sumatriptan (compared to the baseline period) from 110 to 158 (p 5 0.003), a 43.6% increase. Associated costs increased from $22,713 to $30,234. The
model estimated annual cost savings of $11,215 per
1,000 patients for migraine treated with almotriptan instead of sumatriptan due to lower rates of chest pain
(0.3% vs. 2.2%, p 5 0.004). CONCLUSIONS: Direct
medical cost savings are predicted for health plans from
migraine patients switched from sumatriptan to almotriptan based on the lower rate of chest pain.
PPN19
COMPARISON OF HUI2 AND HUI3 SCORES FOR
PATIENTS WITH ALZHEIMER’S DISEASE
Niwata S, Yamada Y, Ikegami N
Keio University School of Medicine, Tokyo, Japan
OBJECTIVES: To examine the difference between the
Japanese versions of the Health Utilities Index (HUI)
Mark2 and the HUI Mark3 scores of patients with Alzheimer’s Disease (AD) in order to undertake the pharmacoeconomic evaluation of AD drugs. METHODS: We
conducted a cross-sectional study of AD patients at four
sites (three in outpatient and one in institutional settings)
using the combined HUI2/HUI3 questionnaire. For those
who were not able to make self-evaluations, proxy evaluations were made by caregivers in outpatient settings and
by the nursing staff in institutional settings. Severity of
dementia was measured by Clinical Dementia Rating
(CDR). RESULTS: With the HUI2, the mean (SD) utility
scores of the 63 outpatients with mild AD (n 5 19), moderate AD (n 5 29), and severe AD (n 5 12) were
0.61(0.16), 0.50(0.25), 0.38(0.18), respectively. The corresponding scores with HUI3 were 0.33(0.23), 0.17(0.29),
and 0.02(0.25), respectively. For inpatient (n 5 12), it
was 0.37(0.21) for those with severe AD (n 5 10) with
the HUI2, and 0.04 (0.20) with the HUI3. The single
scores for each attribute of the HUI2 and 3 tended to decrease as the CDR level became more severe. CONCLUSIONS: Compared with the HUI2, the HUI3 yields significantly lower global utility scores for patients with
AD. Based on our results, there appears to be a need to
further evaluate the validity of the HUI2 and HUI3.
PPN20
ESTIMATED RESOURCE USE AND COST OF
MITOXANTRONE VS PLACEBO IN PATIENTS
WITH PROGRESSIVE-RELAPSING AND
SECONDARY-PROGRESSIVE MULTIPLE
SCLEROSIS: RESULTS FROM THE MIMS TRIAL
Durgin TL, Wanke LA, Goodkin D, Ghalie R
Immunex Corporation, Seattle, WA, USA
OBJECTIVE: To evaluate the pharmacoeconomics of
mitoxantrone (m) therapy in patients with progressiverelapsing and secondary-progressive multiple sclerosis
(MS). METHODS: The MIMS trial showed that m improves several outcomes in patients with progressiverelapsing and secondary-progressive multiple sclerosis
(MS). Patients receiving m 12 mg/m2 every three months
had fewer relapses and hospitalizations, less progression
of neurologic disability, and improved quality of life and
functionality. A pharmacoeconomic analysis was undertaken to compare resource consumption in the m and
placebo (p) groups. Major cost drivers were identified as
follows: drug therapy, including acquisition, administration, and monitoring (primarily m, IV corticosteroids,
and antibiotics); hospitalizations (5 days/occurrence);
physician visits (1/relapse); days lost from work (2/docu-
161
Abstracts
mented relapse, 3 additional for relapse requiring IV corticosteroids, and 7/hospitalization). Standard costs were
assigned as follows: m ($1000/cycle); IV corticosteroids
used to treat relapses ($1250/occurrence); antibiotics
used to treat infections ($300/occurrence); hospitalizations ($1850/day); physician visits ($100/occurrence);
wages ($160/day). RESULTS: A cost-minimization analysis was done and the cost per patient per year was found
to be as follows: m therapy (m 5 $4000, p 5 $0); IV corticosteroid therapy (m 5 $250, p 5 $750); antibiotic
therapy (m 5 $96, p 5 $39); hospitalization (m 5
$1850, p 5 $3145); physician visits (m 5 $40, p 5
$100); lost wages (m 5 $448, p 5 $989). The total annual cost per patient was $6684 in the m group and
$5023 in the p group. The annual cost of m ($4000) was
substantially offset by a reduction in other costs associated with p for a total annual incremental m cost of
$1661. CONCLUSIONS: MS is a chronic, debilitating
disease associated with considerable costs. Pharmacoeconomic analyses suggest that m compares favorably with
other disease-modifying therapies for MS. Additional
data will be presented using remaining direct and indirect
cost drivers. The results of cost-effectiveness analyses incorporating patient outcome measures will also be presented.
treated by triptans. Of the 5.65% of patients using triptans, we found 4.23% were migraine sufferers, 0.2% had
tension-type headache and 1.2% had chronic daily headache. We found that 2.96% of the general population
were chronic daily headache patients (n 5 152). Of these,
18 patients were triptans abusers (11.8%). CONCLUSION: This study confirmed that triptans use by migraine
patients is very low in France in general population.
Overuse of triptans seems to be low in comparison with
other drugs.
PPN22
OBJECTIVE: GRIM 200 is an epidemiology survey on
migraine that was performed in France in 2000, ten years
after the first one (GRIM). The goal of this study was to
estimate the evolution of epidemiological data since ten
years, and to assess the impact of triptans on the disease
management and social repercussions of migraine.
METHODS: The survey was carried out by I.S.L, a national institute, on a representative sample of 10,585 subjects in France aged 15 years and older according to the
quota method. There were 2 successive home interviews.
Persons suffering from headache were selected during the
first interview, or screening. They were then contacted
for a second interview with a validated questionnaire for
diagnosis of migraine. This questionnaire was the same
used in 1989 with supplementary questions concerning
triptans. RESULTS: We found a 8.2% prevalence of certain migraines (1-1 and 1-2 IHS) and a 17.3% prevalence
of certain migraines and migraine disorder (1-7 IHS).
Only 5.65% of headache sufferers (n 5 1486) were
SE
E
PP
N
5
PPN21
MIGRAINE IN FRANCE IN 2000 :
THERAPEUTICAL DATA
Lucas C1, Lanteri-Minet M2, Auray JP3, Duru G3, Chazot G4,
Dartigues JF5, Henry P6, Pradalier A7, El Hasnaoui A8,
Gaudin AF8
1
Hospital Roger Salengro, Lille, France; 2CHU de Nice, Nice,
France; 3Université Claude Bernard, Lyon, France; 4Hopital
Cardio Vasculaire et Neurologique, Bron, France; 5Université
Bordeaux II, Bordeaux, France; 6Hopital Pellegrin, Bordeaux,
France; 7Hopital Louis Mourier, Colombes, France; 8Laboratoire
Glaxo Wellcome, Marly le Roi, France
162
Abstracts
URINARY & KIDNEY DISORDERS
PUR1
HEALTH STATUS OF ELDERLY
DIALYSIS PATIENTS
Boening AJ1, Chapman MM1, Brown RH2, Zager PG2, Meyer KB1
1
New England Medical Center, Boston, MA, USA; 2Dialysis
Clinics, Inc, Albuquerque, NM, USA
OBJECTIVES: The elderly comprise approximately half
of new patients undergoing dialysis, an expensive, lifesaving treatment. We report the health status of 3 elderly age
groups, including novel information about patients >85
years, hypothesizing that as age increases health status
will decrease. METHODS: This retrospective analysis reports on 6154 patients treated by one dialysis chain
(48.4% male, 61.5% white, 39.1% diabetes as primary
diagnosis). Health status is reported by a single administration of the SF-36 between 10/30/90 and 10/30/00. RESULTS: Although not statistically significant at p , .01,
with increasing age, there are trends to lower Physical
Function and Role Physical scores. The Physical Component Score shows a statistically significant difference between groups 1 and 2. Group 3, the very elderly, are not
significantly different from groups 1 or 2. Other scales
show no change. CONCLUSIONS: As hypothesized,
physical health of dialysis patients appears vulnerable to
age. However, other domains of health status remain robust. The very elderly receiving dialysis maintain their
mental health when compared to patients in the 2 younger
age groups. (See table below.)
study using the General Practice Research Database
(GPRD) containing medical records from 550 of 686
general practices in the UK. The baseline period included
the year in which a patient’s first OAB symptom or diagnosis record occurred and the following year. The followup period was six years. A total of 9,706 patients, aged
40 years or older met the criteria. Transition rates from
frequency/urgency to incontinence, and from urge incontinence to frequency/urgency were calculated. Logistic regression was used to examine the impact of risk factors
on symptom transition, and its effect on a patient’s risk
of depression and accidental fall. RESULTS: Of female
patients with OAB, 23.4% had “frequency/urgency” at
baseline and developed “incontinence” in the follow-up
period—potentially reflecting progression of the condition. Factors associated with progression of OAB included older patients (70 to 90 years), female gender, urgency, accidental falls, multiple sclerosis, and epilepsy.
Controlling for these factors, patients with progression
showed an increased risk of depression and accidental
fall compared to patients who had no change in symptoms (adjusted odds ratios 1.44 and 1.35, respectively;
p 5 0.0001 for both). CONCLUSION: OAB appears to
be a progressive disease. A significant proportion of patients progressed from “dry” to “wet” symptoms. This
may imply that some patients with OAB, if left untreated, will develop progression of OAB over time. The
risks of depression and accidental falls were significantly
increased in those patients whose OAB condition worsened. Further research is required to determine whether
treatment can prevent, reduce, or delay the progression
of OAB syndrome.
PUR2
PUR3
EVIDENCE OF DISEASE PROGRESSION IN
ADULT PATIENTS WITH AN OVERACTIVE
BLADDER (OAB)
Zhou Z1, Barr CE1, Torigoe Y1, Williamson TE1, Shah J2
1
Pharmacia, Peapack, NJ, USA; 2Institute of Urology, London, UK
PERSISTENCE OF THERAPY WITH DRUGS FOR
OVERACTIVE BLADDER
Zhou Z, Barr CE, Torigoe Y, Williamson TE
Pharmacia, Peapack, NJ, USA
OBJECTIVES. This study examined patterns of transition of bladder symptoms in adult patients with an overactive bladder, identified risk factors for such transitions,
and assessed the impact of symptom transition on patient
outcomes of depression and accidental falls. METHODS:
This study was a retrospective, population based cohort
OBJECTIVE: This study evaluates the real world persistency of therapy for overactive bladder (OAB), comparing tolterodine, oxybutynin and flavoxate head-to-head
in a large sample extracted from a US drug claim database. Clinical trials have shown tolterodine has equal efficacy to oxybutynin in reduction of OAB symptoms and
Table for PUR1 Mean SF-36 SCORE (SD)
1652
Physical
1 Function
Role
Physical
Bodily Pain
General
Health
Vitality
Social
Function
Role
Emotional
Mental
Health
Group 1 36.9 (27.8) 29.3 (37.9) 58.5 (29.0) 43.2 (20.1) 42.7 (22.8) 62.8 (28.8) 55.7 (43.6) 69.2 (20.0)
65–74
n 5 3687 n 5 3609 n 5 3674 n 5 3587 n 5 3635 n 5 3687 n 5 3577 n 5 3621
Group 2 32.4 (26.2) 26.8 (36.4) 58.1 (28.4) 44.2 (20.0) 40.8 (22.4) 61.3 (30.0) 54.2 (43.9) 69.5 (20.1)
75–84
n 5 2117 n 5 2059 n 5 2111 n 5 2073 n 5 2098 n 5 2119 n 5 2038 n 5 2089
Group 3 30.0 (27.1) 26.8 (37.5) 58.7 (58.7) 46.8 (21.1) 42.1 (23.0) 63.5 (30.1) 53.6 (44.5) 71.5 (19.1)
>85
n 5 267
n 5 257
n 5 266
n 5 254
n 5 261
n 5 267
n 5 257
n 5 258
* 5 p , .01
Physical
Component
Score*
Mental
Component
Score
31.8 (10.1)
n 5 3445
30.9 (9.4)
n 5 1957
30.7 (10.0)
n 5 244
48.3 (11.3)
n 5 3445
48.4 (11.6)
n 5 1957
49.5 (11.0)
n 5 244
163
Abstracts
a significantly better side-effect profile. METHOD: A
longitudinal study was conducted using drug claims from
PCS Health Systems. The study cohort consists of 4602
“naïve tolterodine users”, 7291 “naïve oxybutynin users” and 2127 “naive flavoxate users.” Survival analysis
was used to estimate the “persistence rate”—defined as
the proportion of patients who are still on a drug treatment during or after a defined period of continuous treatment for the drug. A Cox-regression model was used to
assess the net effect of using tolterodine or oxybutynin on
the persistence of drug therapy controlling for differences
in the patients’ demographics, comorbid conditions, and
other factors. RESULTS: The persistence on tolterodine
was 30% higher than that on oxybutynin on continuous
treatment periods of 31–60 days, and 90% higher for
301–360 days of therapy. The persistence on tolterodine
was 430% higher than that on flavoxate for treatment
periods of 30–60 days and 340% higher for 301–360
days of therapy. The average length of continuous treatment for naive tolterodine users was the longest of the
three drugs: 143(3.9) days compared to 91(2.6) days for
oxybutynin and 41(4.6) days for flavoxate. The adjusted
odds-ratio of terminating drug treatment for tolterodine
vs. oxybutynin users was 0.66 (p . 0.001). CONCLUSIONS: Patients using tolterodine were significantly more
likely to continue their treatment than those choosing
other OAB drugs. The better persistence for tolterodine
users should result in longer symptom relief for patients,
particularly for those who are in need of long-term treatment but are distressed by side effects.
PUR4
ANALYSIS OF COMORBIDITY IN OVERACTIVE
BLADDER AND URINARY INCONTINENCE IN A
MANAGED CARE ORGANIZATION
Juzba M, White TJ, Chang EY
Prescription Solutions, Costa Mesa, CA, USA
OBJECTIVE: The primary objectives of this study are to
examine the costs of overactive bladder and urinary incontinence (OAB/UI) and evaluate for the presence of depression and falls and fractures as comorbid conditions
from a managed care perspective. METHOD: Retrospective computerized claims records from a managed care
organization were analyzed. Patients were included if
they had an ICD-9 code consistent with OAB or UI, were
under treatment and were continuously eligible between
1/1/99 and 12/31/99 (N 5 445). Randomly sampled control patients from the general membership were matched
on age and gender with the OAB/UI group at a ratio of
5:1 (N 5 2,220). Diagnoses of depression and of falls,
fractures and contusions were collected and a Charlson
comorbidity index was developed for all study patients.
Depression-related costs and falls & fracture-related
costs included those directly related to treatment. RESULTS: Seventeen (0.77%) of the control patients had a
diagnosis of depression compared to 2.02% of the OAB/UI
patients (P , 0.0001). Of the OAB/UI patients, 13.93%
were diagnosed with a fall or fracture compared to 8.11%
of the control patients (P , 0.0001). The mean Charlson
score of the OAB/UI group was 0.51 (SD 1.10) compared
to 0.37 (SD 1.00) for the control group (P , 0.01). The
mean cost of treating depression was $33 (SD $605) for
the control group and $42 (SD $138) for the OAB/UI
group (P , 0.0001). The average cost of treating falls &
fractures was $154 (SD $1,922) for the control group
and $434 (SD $4,946) for the OAB/UI group (P , 0.0001).
CONCLUSION: Compared to the general population, patients with a diagnosis of OAB/UI are significantly more
likely to experience a fall or fracture or experience depression. They also tend to have a significantly higher
burden of comorbidity. The average cost of fall & fracture treatment and treatment of depression is significantly higher among OAB/UI patients.
PUR5
THE IMPACT OF PHARMACOTHERAPY ON
OVERACTIVE BLADDER SYMPTOM
IMPROVEMENT AND RESOURCE UTILIZATION
Pashos CL1, Grossman M1, Bull S2
1
Abt Associates Clinical Trials, Cambridge, MA, USA; 2Alza
Corporation, Mountain View, CA, USA
OBJECTIVES: To examine the effects of drug treatment
on overactive bladder (OAB) symptom improvement and
resource utilization. METHODS: We conducted an observational study of 217 OAB patients enrolled by 31
physicians nationwide. One hundred twenty-two patients
have been tracked through 3 months to determine symptom improvement, change(s) in treatment, and resource
utilization. The impact of medication on OAB symptom
improvement was modeled using stepwise logistic regression adjusting for patient age, sex, symptom duration,
symptom severity, incontinence, frequency of leakage accidents, and frequency of urinations. RESULTS: Participants averaged 60.7 years old (S.D. 5 15.7), 85.2% were
female, and the mean duration of OAB symptoms was
8.1 years. On average, patients experienced 11.0 urinations per day (S.D. 5 4.7) and 2.2 accidents per day
(S.D. 5 3.4). Treatment with medication increased the
odds of symptom improvement by four-fold (odds ratio
(O.R.) 5 4.3, 95% confidence interval (CI) 1.8–9.9). Patients with incontinence were significantly more likely to
report improvement in symptoms compared with patients with urinary frequency alone (O.R. 5 3.2, 95%CI
1.2–8.4). Nineteen of 72 (26%) patients not started on
medication at baseline began medication within the first
3 months, consuming an average of 1.16 office visits per
patient. In contrast, 11 of 50 patients (22%) who were
started on medication at baseline discontinued within the
first 3 months, consuming an average of 0.64 office visits
per patient. Patients staying on medication (39/50, 78%)
consumed on average the fewest office visits per patient
(0.15), while patients who managed symptoms without
medication (53/72, 73%) consumed an average of 0.26
office visits. CONCLUSIONS: Pharmacotherapy signifi-
164
Abstracts
cantly improves OAB symptoms and is associated with less
office visit utilization. Thus, initiating patients on medication, rather than trying a step-wise care approach, may
be a cost-effective means to manage symptoms of OAB.
PUR6
THE RELIABILITY AND VALIDITY OF A NEW
OAB-SPECIFIC HRQL QUESTIONNAIRE (OAB-Q)
Coyne K1, Abrams P2, Revicki D1, Herzog R3, Hunt T4
1
MEDTAP International Inc, Bethesda, MD, USA; 2Bristol
Urological Institute, Bristol, UK; 3University of Michigan, Ann
Arbor, MI, USA; 4Pharmacia, Peapack, NJ, USA
OBJECTIVES: Most health-related quality-of-life (HRQL)
bladder questionnaires address the impact of incontinence;
however, OAB includes frequency and urgency symptoms without incontinence. Thus, a questionnaire was
developed to assess the impact of OAB on HRQL in patients with and without incontinence. METHODS: The
61-item self-administered OAB-q contains a symptom
and HRQL scale. Both the OAB-q and the SF-36 were
completed by participants recruited from: 1) a community sample who screened positive for OAB in a telephone survey and participated in a clinical validation
study (n 5 254); 2) a clinical study for those seeking
treatment for OAB symptoms (baseline)(n 5 736). Item
analysis and exploratory factor analysis (EFA) were performed to assess factor structure. Psychometric evaluation was conducted to assess internal reliability and validity. RESULTS: Of the 911 participants, the clinical
diagnoses were: normal 5 130, OAB with incontinence
(OAB-I) 5 552, OAB without incontinence (OAB-C) 5
229. Mean age 5 59.5; 74.4% were women. EFA revealed 1 domain for symptom distress and 4 domains for
HRQL: coping, concern/emotional, sleep and social interactions. Both OAB-I and OAB-C participants reported
significantly greater symptom distress and HRQL impact
than normals. Significant differences between OAB-I and
OAB-C participants were present in all OAB-q subscales
except sleep where both groups were highly affected. Internal consistency reliability of the symptom distress scale
was 0.86 and the HRQL subscales ranged from 0.88–
0.94. The OAB-q subscales correlated moderately well
with the SF-36 subscales (r 5 0.17–0.52) providing validity evidence. The OAB-q was reduced to 34 items: 8
symptom distress and 26 HRQL items. CONCLUSIONS:
The OAB-q is a reliable and valid instrument that can
discriminate between clinically-diagnosed normal, OAB-I
and OAB-C participants. As the first OAB-specific
HRQL questionnaire, the OAB-q demonstrates that OAB
with and without incontinence causes significant symptom distress and has a negative impact on HRQL.
PUR7
CLINICAL CORRELATES WITH
HEALTH-RELATED QUALITY OF LIFE SCORES
AND SUBSCALES AMONG CONSULTING AND
NON-CONSULTING INDIVIDUALS WITH
STRESS URINARY INCONTINENCE
Rao S, Bowman L, Buesching D
Eli Lilly and Company, Indianapolis, IN, USA
OBJECTIVES: To measure clinical parameters and
health-related quality of life using the incontinence quality of life (I-QOL) instrument among consulting and
non-consulting stress urinary incontinence (SUI) patients.
METHODS: The I-QOL is a self-administered instrument that contains 22 items yielding a total score as well
as three subscale scores (avoidance and limiting behaviors, psychosocial and social embarrassment). Physicians
and consulting patients were identified in the UK, Germany, France, Italy, Netherlands and the US. Study participants completed questionnaires to obtain diagnostic
and treatment information for patients and to also gather
details on demographics, symptoms and quality of life.
The non-consulting patients (those who did not consult a
doctor) were also asked to complete questionnaires regarding their symptoms and quality of life. Statistical
analysis included t-tests and multiple regressions, adjusting for multiple comparisons using Hochberg’s method.
The analysis consisted of associations between I-QOL
measures and treatment variables, diagnostic tests and severity of symptoms among consulting and non-consulting
SUI patients. RESULTS: A sample of 2174 SUI consulting patients and 809 SUI non-consulting patients participated. Multivariate analysis showed that pad use among
consulting patients was a predictor of the psychosocial
subscale score (t 5 23.52, p , 0.01) whereas leakage
during exercise predicted the avoidance and limiting behaviors subscale scores among non-consulting SUI patients (t 5 24.47, p , 0.05). The non-consulting SUI patients were younger than the consulting SUI patients (t 5
28.99, p , 0.0001). There were no statistically significant differences in employment and marital status between the two groups. CONCLUSIONS: There were differences in association between the I-QOL subscores and
symptom severity among consulting and non-consulting
SUI patients. There was a significant age difference between the non-consulting and consulting SUI patients.
Evaluation of I-QOL differences between consulting and
non-consulting patients will require additional study.
PUR8
THE INFLUENCE OF RACE ON SF-36 SCORES OF
DIALYSIS PATIENTS
Boening AJ1, Chapman MM1, Brown RH2, Zager PG2, Meyer KB1
1
New England Medical Center, Boston, MA, USA; 2Dialysis
Clinics Inc, Albuquerque, NM, USA
OBJECTIVES: African-Americans represent one-third of
dialysis patients and are known to live longer than Cau-
165
Abstracts
casian dialysis patients. Previous reports suggest they also
have better health status. The health status of AfricanAmericans and Caucasians has not been compared using
the SF-36. We hypothesize that SF-36 scores for AfricanAmericans will be better than for Caucasians. METHODS: This retrospective analysis compares 6509 AfricanAmericans (mean age 55 years, 48% male, 34% diabetes
as primary diagnosis) to 7715 white patients (mean age
60 years, 56% male, 37% diabetes as primary diagnosis)
from one dialysis chain. Health status is measured by a
single administration of the SF-36 between 10/30/90 and
10/30/00. Clinical variables are assessed. RESULTS: For
all domains except Role Emotional, African-Americans
report better health status, despite univariate analysis
showing significantly worse hematocrit, dialysis adequacy (Kt/V), creatinine, hypertension, and socioeconomic
status (all: p , .01). CONCLUSIONS: Despite worse results on clinical parameters and lower socioeconomic status, African-American dialysis patients report better SF36 scores than Caucasians. Health status has been shown
to be an independent predictor of dialysis patient survival.
Our results may partially explain the increase in survival
observed for African-American dialysis patients. Further
investigation is necessary to determine if these differences
remain after case-mix adjustment. (See table below.)
were identified. Eligible infants were required to be continuously enrolled in the plan during the birth hospitalization, have complete claims histories, and have prescription drug benefits. A secondary analysis of resource
utilization during the first 30 days post-initial hospital
discharge was conducted among surviving infants who
were continuously enrolled during that 30 day period.
Costs reflect payments by the plan, patient deductibles,
and co-payments for all covered medical services. RESULTS: In 1998, 1,208 births to enrollees were premature and eligible for study; 28% were multiple births.
Twenty-one infants (1.7%) died during the birth hospitalization. The total direct medical cost of the birth hospitalization was $35.5 million. During the first 30 days
post discharge, 133 (12.4%) of the remaining eligible infants (n 5 1,076) had claims for inpatient services. Total
direct cost of all covered medical services during this period was an additional $1.2 million. CONCLUSION:
Even in a relatively low risk population, the direct medical costs associated with premature birth were very high
(nearly $37 million for about 1,000 infants) and need for
acute medical care continued in the first month post-discharge. Appropriate medical management of this high
risk population may be cost-effective.
WOMEN’S & MEN’S HEALTH
A COST-MINIMIZATION ANALYSIS COMPARING
MIRENA® WITH ORAL CONTRACEPTIVES
Menard G, Pineau M, Laplante S
Berlex Canada Inc, Lachine, QC, Canada
PWM2
PWM1
PREMATURE BIRTH AND RESOURCE
UTILIZATION IN A LARGE EMPLOYMENT
BASED INDEPENDENT PRACTICE
ASSOCIATION (IPA)
Harley CR1, Leader S2
1
Ingenix Pharmaceutical Services, Eden Prairie, MN, USA;
2
MedImmune Inc, Gaithersburg, MD, USA
OBJECTIVES: While premature birth is one of the costliest hospital events, the total direct medical cost of care
associated with the birth of a premature infant has not
been documented from a societal perspective. METHODS: Retrospective analysis of administrative claims
data from a large, employment based IPA covering a total
of 3 million members in 1998 was conducted. All infants
born in calendar year 1998 with a birth diagnosis of prematurity (,38 weeks gestation) and low birth weight
(,2500 grams) [ICD 9-CM codes 765.0x and 765.1x]
OBJECTIVES: To validate the economic advantages of
Mirena, a new hormone releasing contraceptive system
that can be inserted in the uterus for 5 years, compared to
oral contraceptives (OC) in Canada. Mirena and OC offer equivalent contraceptive efficacy with a similar safety
profile. METHODS: A cost-minimization analysis with a
third-party payer perspective and a 5-year horizon. Three
major scenarios were analysed. In the first scenario, only
the drug acquisition cost of both treatments was used.
Mean cost of OC was calculated based on the amount reimbursed in the April 2000 list of the Régie de l’assurance-maladie du Québec (RAMQ). In the second scenario, the pharmacy’s dispensing fee (Quebec RAMQ
fee) was added. In the third scenario, real-life conditions
of use of Mirena were applied, i.e. an expulsion rate of
Table for PUR8
Physical
Function*
Role
Physical*
Bodily
Pain*
General
Health*
Vitality*
Social
Function*
Role
Emotional
Mental
Health*
African46.9 (28.8) 37.3 (40.4) 60.3 (28.5) 45.3 (20.6) 49.5 (22.1) 66.1 (27.9) 58.7 (43.1) 69.8 (20.1)
American n 5 6427 n 5 6283 n 5 6401 n 5 6235 n 5 6332 n 5 6416 n 5 6216 n 5 6302
Caucasian
41.6 (29.5) 29.1 (37.7) 57.0 (28.2) 41.3 (21.0) 40.3 (22.8) 61.1 (29.1) 57.6 (43.4) 67.7 (21.0)
n 5 7655 n 5 7512 n 5 7614 n 5 7536 n 5 7590 n 5 7660 n 5 7458 n 5 7569
*p , .01
Physical
Mental
Component Component
Score*
Score*
34.9 (10.3)
n 5 5981
32.4 (10.5)
n 5 7264
48.6 (11.3)
n 5 5981
47.2 (11.7)
n 5 7264
166
Abstracts
6% and estimated continuation rate of 56% and 65% after 5 years. Sensitivity analysis was performed on OC
cost using the lowest and highest costs from the RAMQ
list. Discounting was performed at 0%, 3% and 5% over
65 time-periods (13 cycles 3 5 years) for OC. No discount rate was applied to Mirena since acquisition cost is
paid once at treatment start. RESULTS: The mean cost of
an OC is determined to be $11 per cycle, while drug acquisition cost of Mirena is $290. All scenarios favour
Mirena. With a 5% discount rate, Mirena offered a mean
saving of $346 over 5 years. When the pharmacist’s dispensing fee was included Mirena offered a mean saving
of $750. In real life conditions, with a 5% discount rate,
the use of Mirena resulted in a mean saving of at least
30% (i.e., between $194 and $221). CONCLUSION:
Mirena represents a less expensive alternative to longterm contraception when compared to OC and this, in all
proposed scenarios.
PWM3
ERECTILE DYSFUNCTION: A PROSPECTIVE
STUDY OF PATIENTS SEEKING THERAPY
Jackson-Kline SE1, Shepherd MD2, Divers EC3, Lawson KA2,
Rascati KL2, Rosen RC4
1
Health Outcomes Consultant, Devon, PA, USA; 2The
University of Texas, Austin, TX, USA; 3AstraZeneca, Wayne,
PA, USA; 4The University of Medicine and Dentistry of New
Jersey, Piscataway, NJ, USA
OBJECTIVES: To describe erectile dysfunction (ED) patient demographics, comorbidities, treatment seeking behavior, and patient-reported use and outcomes of therapy. METHODS: A self-administered questionnaire was
developed and pilot tested. The final survey instrument
included selected demographics, questions regarding
when patients first experienced ED symptoms, when patients first sought treatment for ED, patients’ experience
with ED treatments, patients’ rating of how well a particular ED therapy worked, and comorbid conditions. Patients evaluated their experience with ED therapies on a
Likert-type scale. RESULTS: During May and June of
1997, 285 questionnaires were given to patients while
they waited to see their urologist for ED treatment. A total of 59.4 percent (n 5 168) of respondents (n 5 283)
listed “Caucasian, White” as their race. Age of the survey
respondents ranged from 31 to 82 years with a mean age
of 59.5 years (sd 5 11.2). A total of 27.1 percent of survey respondents completed 4 years or more of college. A
total of 31.4 percent of respondents reported 1996
household income of $30,001–$50,000. A total of 58.1
percent (n 5 165) of the respondents listed “Married/
long-term partner” as their marital status. A total of 76.5
percent (n 5 218) of respondents reported currently being treated by a physician for health problems in addition
to ED. Respondents reported a mean of 2.9 years (sd 5
5.1 years, range5, 1 year to 34 years) between first noticing the symptoms of ED and seeking professional medical treatment for those symptoms. A total of 239
(83.9%) respondents reported having tried at least one
therapy option to treat their ED. The ED therapy mentioned most often was “an injectable drug” with a mean
rating of 3.8 (sd 5 1.2). CONCLUSION: This multi-site,
prospective study gives insight into patient demographics, comorbidities, experience with ED and its treatment
and allows a better understanding of therapy health outcomes for this important medical condition.
PWM4
PHARMACIST-INITIATED EMERGENCY
CONTRACEPTION IN BRITISH COLUMBIA
Fielding D, Soon J, Levine M, Ensom M
The University of British Columbia, Vancouver, BC, Canada
BACKGROUND: As of December 1 2000, the Province
of British Columbia launched a program of expanded access to emergency contraceptive pills (ECPs) authorizing
pharmacists with special training to provide ECPs to
women without a prescription from their physicians. OBJECTIVES: To determine whether the expanded access
program (EAP) will increase the utilization of ECPs and
reduce pregnancy and abortion rates among women in
B.C. METHODS: This research utilizes a province-wide
prescription database (PharmaNet) that documents prescription transactions for all residents. PharmaNet data
will be linked, in a manner insuring researchers are
blinded to patient identity, to information in other provincial health-care databases including physician visits,
hospitalizations, and birth and abortion records. Data for
all women with an index prescription for an ECP from a
pharmacist or a physician for the 2-year period prior to
and for the 2-year period after initiation of the EAP will
be included in the analyses. RESULTS: Four weeks after
the program launch, 50% of the province’s 2400 pharmacists have been certified and half of those are registered providers. Currently, 340 of the province’s 760
community pharmacies have one or more pharmacists
certified and registered to prescribe ECPs. To date, 316
patients (mean age 26 years; range, 15 to 48) have received pharmacist-initiated ECPs in 19 of the province’s
20 health regions; 58% of the pharmacist-initiated ECP
prescriptions occurred on weeknights or weekends; the
average interval between unprotected intercourse and arrival in the pharmacy has been 24 hours; and 53% of the
women stated that the reason for need was due to birth
control failure. At time of presentation, these data will be
updated for the first five months of this study. CONCLUSIONS: Despite limited publicity to date, participation by pharmacists and access by women have been notable during the first four weeks of the program.
167
Abstracts
PWM5
HEALTH CARE USE ATTRIBUTABLE TO
PROSTATE NON-SELECTIVE ALPHA-1
ANTAGONIST INITIATION FOR BENIGN
PROSTATIC HYPERPLASIA (BPH)
Chrischilles EA1, Rubenstein LM1, Gilden D2, Shah H3
1
University of Iowa, Iowa City, IA, USA; 2Jen Associates, Inc,
Cambridge, MA, USA; 3Boehringer Ingelheim Pharmaceuticals,
Inc, Ridgefield, CT, USA
OBJECTIVE: The prescription of prostate non-selective
alpha-1 antagonists (terazosin, doxazosin, prazosin) may
require extra health care visits for dose titration and for
monitoring treatment safety and effectiveness. From a
retrospective cohort study using pension related fee-forservice supplementary Medigap health claims data, we
estimated the impact of alpha-1 antagonist initiation on
health care use and costs for men with BPH. METHODS:
Claims data from a two year period included medical and
prescription drug information for 53,824 men with BPH.
We compared men who initiated alpha-1 antagonists
with a random sample of nonusers. Inpatient and outpatient costs were calculated as the sum of the Medicare
paid amount, the Medigap co-pay amount, and the Medigap deductible amount. Comparisons used generalized estimating equation (GEE) or Poisson regression methods to
estimate the change from four months pre- to four months
post-initiation and an imputed date for non-users. This period coincided with the recommended time for treatment titration and a period of increased hypotensive event risk in
this population. RESULTS: Adjusting for baseline health
care use, age, and co-morbidity, alpha-1 antagonist initiators had a mean of 4.2 more physician visits post-initiation
than men who did not initiate among those who did not
use other antihypertensives and 5.8 more visits among men
who did use antihypertensives (p , 0.05). The corresponding adjusted difference in cost of physician visits was $176
per man for those who did not use other antihypertensives
and $267 for those who did use other antihypertensives (p
, 0.05). Initiation was also significantly associated with an
increase of 0.15 hospital stays per 1,000 person-days
among non-users of other antihypertensives and an increase of 0.24 hospital stays per 1,000 person-days among
users of other antihypertensives. CONCLUSION: The increased number of physician visits, hospital stays, and physician visit costs post-initiation should be considered in
cost-effectiveness analyses of BPH treatments.
PWM6
COST-EFFECTIVENESS OF INTRAVAGINAL
PROSTAGLANDIN E2 GEL AND INTRAVAGINAL
MISOPROSTOL FOR PREINDUCTION
CERVICAL RIPENING
Gagne AL, Daneshfar S
Northeastern University, Boston, MA, USA
OBJECTIVES: To compare the cost-effectiveness of intravaginal prostaglandin E2 gel and intravaginal miso-
prostol tablets for preinduction cervical ripening. METHODS: This study was a modeled cost-effectiveness analysis
from the hospital perspective. A decision analysis was
used to estimated costs and percentage of women achieving vaginal delivery with either intravaginal prostaglandin E2 or intravaginal misoprostol. Costs were assessed
in 1999 dollars and obtained from Brigham and Women’s
Hospital in Boston, Massachusetts. Probabilities and percentage of patients achieving vaginal delivery within 24
hours were obtained by meta-analysis of published trails.
Health resoursed used for the rate of delivery after each
dose of the study agents were obtained through an expert
physician pane. RESULTS: The primary outcome measures were direct medical costs, in 1999 dollars, and effect was measured as percentage of patients achieving
successful cervical ripening, leading to labor induction
and vaginal delivery before use of an alternative method.
The meta-analysis included a total of 9 trials incorporating 1,056 patients. Direct medical costs for prostaglandin
E2 was $1,852.14 and $1,941.51 for misoprostol. Eightyfive percent of patients receiving misoprostol and 71% of
patients receiving prostaglandin E2 achieved vaginal delivery before the use of an alternative method. CONCLUSION: Though misoprostol is less expensive per
dose compared to prostaglandin E2, the overall treatment
costs are higher when encompassing costs associated with
adverse effects. Therefore, an incremental cost analysis
demonstrates that if the hospital is willing to pay $638
more per patient, there will be a 1% greater chance of
achieving vaginal delivery.
PWM7
THE EFFECT AND ECONOMIC IMPACT OF
STANDARDIZED ORDERS ON THE PREVENTION
AND TREATMENT OF PONV IN HOSPITALIZED
GYNECOLOGICAL SURGERY PATIENTS
Marra C, St. Pierre E, Frighetto L
Vancouver General Hospital, Vancouver, BC, Canada
OBJECTIVES: The risk of post-operative nausea and
vomiting (PONV) following gynecological surgery remains high despite effective prophylactic medications.
Thus, the objectives of this study were to determine if
standardized orders for the prophylaxis and treatment of
PONV in gynecological surgery patients: 1) reduce
PONV occurrence; 2) reduce total costs; and 3) influence
the choice of medications used for PONV prophylaxis
and treatment. METHODS: A retrospective design was
employed in which a random sample of 200 patients was
selected from each of the two 6 month phases before
(pre) and after (post) the implementation of standardized
orders for PONV prophylaxis and treatment. The primary outcome was the occurrence of any PONV episode.
Logistic regression was used to adjust for potential confounding factors. RESULTS: Characteristics were similar
except for surgical and anesthesia length between phases.
The proportion of patients receiving PONV prophylaxis
increased from 31% (pre) to 47% (post, p 5 0.002).
168
Abstracts
There was a reduction in the risk of a PONV event in the
post phase (OR 5 0.67, 95% CI 0.67 to 0.97, p 5 0.04).
The risk of PONV was significantly reduced with the administration of prophylactic medications (OR 5 0.46,
95% CI 0.46 to 0.67). There was a reduction in the mean
number of PONV episodes in the post phase (1.81
events) versus the pre phase (1.47 events, p 5 0.02). A reduction in mean PONV management costs was observed
in the post phase ($8.31, SD 8.50) as compared to the
pre-phase ($10.23, SD 8.25, p 5 0.02). For mean prophylactic costs, these were significantly higher in the
post-implementation phase when compared to the preimplementation phase ($1.64, SD 3.36 vs. $0.91, SD
2.43, p 5 0.013). Univariate sensitivity analyses revealed
that the economic results were sensitive to several parameters. CONCLUSION: The implementation of pre-printed
order forms for PONV prophylaxis and treatment appears
to be an effective and economically attractive strategy.
PWM8
QUALITY OF LIFE IN POST-MENOPAUSAL
WOMEN IN FIVE EUROPEAN COUNTRIES
Piercy J1, Zoellner Y2, Kay S3, Abetz L1, Alt J4, Schaefer M2
1
Mapi Values, Macclesfield, UK; 2Humboldt University, Berlin,
Germany; 3Adelphi Group Products, Macclesfield, UK; 4 Solvay
Pharmaceuticals, Hanover, Germany
OBJECTIVES: Whilst differences between Caucasian,
African and Asian menopausal women have been well
documented, the aim of this study is to explore the relationship between menopause, HRT use and aspects of
quality of life (QoL) across five European countries.
METHODS: A large-scale observational study of
women’s health in France, Germany, Italy, Poland, UK
was conducted with 7806 women, aged 45–65, and consulting gynecologists or primary care physicians (n 5
530). QoL was assessed with the Women’s Health Questionnaire (vasomotor, depressed mood and sexual behavior scales). RESULTS: Mean age (range 52.5 to 54.7) and
time since menopause were similar across all countries.
Findings suggested differential use of HRT across Europe
(current or lapsed): high in Germany (68%), low in
France (50%) and Italy (49%) (chi-square 5 139, P ,
0.001). We compared aspects of QoL between users and
non-users (stratified by time since menopause). Within 5
years of menopause HRT users experienced: significantly
fewer vasomotor symptoms than non-HRT users across
all countries (z 5 215,9 p , 0.001); significantly less depression (z 5 210.5, P , 0.001) across all countries except the UK, and significantly better sexual functioning in
Italy and Germany (z 5 27.6, p , 0.001). For women
experiencing menopause over 5 years ago, HRT users
had better scores in sexual (z 5 212.2, P , 0.001) and
mood (z 5 23.0, P < 0.002) domains than non-users in
all countries, but no differences were observed for vasomotor symptoms. CONCLUSIONS: Within 5 years of
menopause, HRT improves those aspects of menopausal
symptoms which are most important to women at that
time in their lives (vasomotor symptoms, mood) irrespective of country. After 5 years, across countries, the impact of vasomotor symptoms on women naturally decreases and thus HRT users no longer experience a
benefit over non-users. However, the benefits of HRT on
sexual functioning and mood continue. These findings
suggest that pooling European WHQ data may be appropriate.
NO SPECIFIC OR MULTIPLE
DISEASES-HEALTH POLICY
PHP1
THE ECONOMICS OF PARALLEL TRADE IN
PHARMACEUTICALS: EXPERIENCES
FROM SWEDEN
Persson UB, Anell A
IHE, The Swedish Institute for Health Economics, Lund,
Sweden
OBJECTIVES: To analyse the impact of parallel trade of
pharmaceuticals on welfare and innovation in the long
run and to estimate the impact of costs for pharmaceuticals in some therapeutic areas in the short run. METHODS: Identify arguments for and against parallel trade by
use of literature review and by interviewing agens involved in parallel trade of pharmaceuticals. Official data
of prices and sales of pharmaceuticals are used to estimate the impact of parallel trade on the drug bill. RESULTS: In Europe the principle of free trade and the
harmonization of registration requirements for pharmaceuticals tend to force price convergence across markets,
i.e. a uniform ‘Euro price’. Parallel trade have reduced
annual costs for pharmaceuticals for treating ulcer related diseases by about 19 percent and for the treatment
of inhaled steroids of about 8 percent in Sweden. These
cost savings are compared with the excess costs for the
distribution and storage of parallel-imported products.
Comparison shows net cost savings for the ulcer related
diseases and inhaled steroids in the short run. CONCLUSIONS: There is a conflict between the principle of free
trade and the principle of intellectual property rights
(e.g., patent, brand-names, etc.). The purpose of intellectual property rights is to provide economic incentives for
the innovative industry to develop new medicines. New
medicines are products with relatively high R&D costs,
difficult to finance without patent protection and price
discrimination.
PHP2
ATTITUDE OF PHYSICIANS TOWARD
FORMULARIES AND SERVICES PROVIDED
BY PHARMACIST
Sansgiry SS1, Hayes DJ1, Rice GK2, Nadrash AT1,
Erickson KE1, Bui MU1
1
University of Houston, Houston, TX, USA; 2Kelsey-Seybold
Clinic, Houston, TX, USA
169
Abstracts
OBJECTIVE: This study evaluated attitude of physicians
toward formularies as well as services provided by the
pharmacy department in a large independent practice association (IPA). METHODS: Surveys (n 5 280) were
sent to all practitioners in the IPA. The survey requested
information on physician use of and satisfaction with the
existing printed formulary quick list, their satisfaction
with the pharmacy services, and their attitude towards
formularies in general using a five-point strongly agreestrongly disagree scale. We received 90 completed surveys with a response rate of 32%. RESULTS: Majority of
respondents were staff physicians (87%). Around 31%
indicated pediatrics as their specialization followed by
family medicine (17%) and internal medicine (17%).
Practitioners who indicated that they had received the
formulary quick list (37%) were highly satisfied (3.44 6
0.84) with it. Practitioners were very satisfied with the
performance (4.27 6 0.79), interaction (4.35 6 0.81),
and services offered (4.21 6 0.79) by the pharmacies.
Their attitude towards pharmacist playing a more active
role in patient care was positive (3.54 6 0.98). However,
their attitude towards formularies in general was negative. They agreed that formularies increased the amount
of time spent making drug choices (4.01 6 1.1), limited
access to the best medicines for patients (3.63 6 0.88),
resulted in less-effective medicines (3.01 6 0.99), compromised the quality of drugs prescribed (3.36 6 0.92),
and reduced the opportunities to offer the best medication for patients (3.43 6 0.82). CONCLUSION: Physicians had negative attitude towards formularies in general. However, they were satisfied with the services
offered by pharmacists, and they were positive towards
more patient care involvement by the pharmacists. Physicians were also satisfied with the formulary quick list offered by the pharmacy department. A plan was developed
to provide practitioners with an interactive, intranetbased reference of medications that would assist in prescribing decisions.
PHP3
PHARMACOECONOMIC FELLOWSHIPS:
STRUCTURE, PROCESS, AND OUTCOMES
Maio V, Lofland JH, Girts TK
Thomas Jefferson University, Philadelphia, PA, USA
The escalating demand for pharmacoeconomic research
has exceeded the supply of available researchers. Postgraduate pharmacoeconomic fellowships emerged to
train and produce quality independent researchers to
meet these growing educational needs. However, even after more than ten years in existence, the effectiveness of
these programs has not been formally evaluated. In order
to determine their effectiveness, first, a set of measures
for pharmacoeconomic fellowship programs needs to be
developed. OBJECTIVE: To construct a framework to
examine the potential structure, process, and outcome
measures for pharmacoeconomic fellowship programs.
METHODS: Using the Donabedian model, we discuss
the structures, processes, and outcomes of pharmacoeconomic fellowship programs. RESULTS: We begin by focusing on the structure of these programs, including facilities, qualification of the teaching staff, and operations of
the institution. The types of settings involved in pharmacoeconomic fellowships are illustrated, and the experience and skills of preceptors and fellowship applicants
are defined. The processes of pharmacoeconomic fellowships are reviewed, and the different characteristics of
these programs such as the research and the educational
components are discussed. Potential outcome measures
of pharmacoeconomic fellowship programs are discussed. CONCLUSION: A framework for examining the
structure, process, and outcome measures for pharmacoeconomic fellowship programs is given. Measures evaluating the outcomes of fellowship programs need to be developed. Further research is needed to determine the
effectiveness of pharmacoeconomic fellowship programs.
PHP4
DEVELOPING A COMPREHENSIVE
PERFORMANCE MEASUREMENT DATA SET FOR
PHARMACEUTICAL BENEFIT
MANAGEMENT PROGRAMS
Long SR1, Hatzmann MH1, Chawla AJ2
1
The MEDSTAT Group, Washington, DC, USA; 2Genentech,
South San Francisco, CA, USA
Pharmaceutical benefit management (PBM) programs are
key to the provision of prescription drugs among those
enrolled in health plans. A recent survey of HMOs revealed 600 of 604 HMOs had a drug benefit; and only 57
HMOs of the 600 with a drug benefit did not provide
prescription drug coverage through a PBM (PBMI, 2000).
Several proposals have advocated use of PBMs to administer outpatient prescription drug benefits for Medicare
enrollees. Thus, the demand for accountability and a
means to evaluate performance of PBM programs is
growing; yet a set of standardized indicators for evaluating PBM performance does not yet exist. OBJECTIVE:
Explore the array of functions performed by PBMs and
measures used to evaluate PBM performance. Recommend additional measures that should be considered toward development of a comprehensive measurement set
for evaluating PBM activities. METHODS: MEDLINE
and web searches were conducted to develop a summary
of PBM functions and existing PBM-related indicators.
Measures used in other performance measurement activities that could be modified to assess PBM performance
also were identified. RESULTS: PBM activities fall into
four major categories: (1) administrative and management, (2) drug use control, (3) cost containment, and (4)
disease management. Monitoring costs and savings of using drug management programs is the main focus of PBM
performance measurement to date. Several entities have
participated in efforts to develop measures for evaluating
pharmaceutical care, but none has defined a comprehensive set of performance measures. Additional measures
170
Abstracts
that could be included in a comprehensive measurement
set, falling into the four major categories of PBM activities,
are suggested. CONCLUSIONS: A standardized, comprehensive set of performance indicators should be developed
to enable public and private sector purchasing organizations to evaluate PBM services and the impact of these
activities on quality of care and consumer satisfaction.
PHP5
POLISH GUIDELINES FOR CONDUCTING
PHARMACOECONOMIC EVALUATIONS IN
COMPARISON TO INTERNATIONAL HEALTH
ECONOMIC GUIDELINES
Orlewska E1, Mierzejewski P2
1
Medical University of Warsaw, Warsaw, Poland; 2Ministry of
Health, Warsaw, Poland
OBJECTIVES: Poland is the next European country,
which is in the process of drafting country-specific guidelines for economic evaluation of pharmaceuticals. The
aim of the study was to compare Polish pharmacoeconomic guidelines with international health economic
guidelines, highlighting areas of agreement and dissent.
METHODS: Existing documents from 18 countries were
reviewed, analyzed and a comparison was undertaken.
The following topics were considered: objective, use of
pharmacoeconomic analyses, responsibility in their conduct and target audience, methodology and ethical code
of practice while conducting and publishing results of
pharmacoeconomic analysis. The explanation of differences was taken. RESULTS: For a number of issues recommendations are consistent between Poland and other
countries. For the purpose of the Polish pharmacoeconomic research guidelines, the Canadian, Australian,
Dutch and Belgian guidelines have, in some parts, been
specially adopted to the Polish situation. In some parts it
was possible to combine certain aspects; in the other, due
to the unique local circumstances, there was a need to develop the methodological guidelines on a pure national
level. For example there is a lack of consensus concerning
costing and utility measurement. CONCLUSIONS: The
guidelines for conducting pharmacoeconomic evaluations
are linked to existing health care system and approaches
to the pricing and reimbursement of pharmaceuticals.
This is the purpose of differences between international
health economic guidelines. To reach an optimal degree
of the use of pharmacoeconomic studies in decision-making process it is essential to take into account local situation and create country-specific guidelines.
PHP6
ACTIVITIES, FUNCTIONS AND STRUCTURE OF
PHARMACY AND THERAPEUTICS COMMITTEES
IN ISRAELI HOSPITALS
Rotem R1, Reuveni H2, Goldberg A2
1
Sokoka Meidcal Centre, Beer-Sheba, Israel; 2Ben-Gurion
University, Beer-Sheba, Israel
OBJECTIVES: The pharmacoeconomic litrature shows
that one of the means available to HMOs for wisely using the medical budget is the Pharmacy and Therapeutics
Committee (PTC). The present procedure for the hospital
PTCs was written by the Ministry of Health in 1978. The
aim of the study was to investigate the Israeli hospitals
PTCs work. METHODS: This study was based upon a
questionnarire which included subjects from the PTCs
procedure and also subjects that the PTC dealt with in
the late nineties. The questionnarire was sent in October
1999 to 51 hospitals. The information was processed on
Excel software. RESULTS: Hospital responses were 41/
51 (80.4%). Thirty one hospitals reported having PTC
and answered the questionnaire, ten hospitals reported
not-having PTC at all. The PTCs chairperson appointed
is a department director as demanded by the Ministry
Procedure by 12 (41%) of the hospitals, the deputy chairperson nomination matched by 2 (7%) hospitals, organizer of the PTC nomination matched by 20 (69%) of the
hospitals. The attending doctors specialities are: intern,
pediatrics, surgery, gynecology, infection diseases, anesthesiology and mental health. Nine (31%) hospitals reported having a PTC procedure, 28 (97%) hospitals are
checking requests for enlarging the local formulary and
just 25 (86%) recommend of formulary reduction; 20
(69%) hospital PTCs recommended 50 guidelines to the
local management and 28 of them were addopted. CONCLUSION: From the returned questionaries it seems that
no PTC keeps the entire procedure. In 1999, the local
PTCs reported adding 494 medicines and decreasing 48,
which means a total of 446 medicines added. One hundred seventy nine members of PTCs formed 50 guidelines; 28 of them were accepted by the local management.
There is no control of the Ministry of Health on the PTCs
procedures implementation; the procedure has not been
upgraded since 1978 and it is not familiar to most of the
hospitals.
PHP7
APPLICATION OF HEALTH ECONOMICS IN THE
CANADIAN PHARMACEUTICAL INDUSTRY
Hirji Z1, Rindress DE2, Welner SA2
1
University of British Columbia, Vancouver, BC, Canada;
2
BioMedCom Consultants Inc, Montreal, QC, Canada
OBJECTIVES: The field of health economics (HE) has
undergone vast growth over the last decade. One continually evolving main factor is the motivation for performing HE studies, in particular in Canada because of changing requirements for provincial formulary submissions.
The objective of this study was to determine how HE
data is being applied by the Canadian pharmaceutical industry to date. METHODS: A survey was sent to key
personnel working in HE in the Canadian pharmaceutical industry and followed-up. Data from returned surveys
were compiled in a database, tabulated, and evaluated.
RESULTS: Twenty-one (84%) of 25 surveys sent to companies reporting previous experience with HE were re-
171
Abstracts
turned; 90% of these companies were firms with more
than 100 full-time employees. Of the respondents, 67%
currently have a department or unit whose sole responsibility is HE, up from 12% reported in a previous study
for 1995. The application of HE information by Canadian pharmaceutical companies is most often for provincial formulary submissions (100%), marketing (86%)
and pricing (81%). It is also used by 62% of respondents
for internal training and medical education programs.
Relatively few Canadian companies apply HE information to managed care decision-making (38%) and patient
education (24%). Health economic research data was
published by 3/4 of the respondents in the form of scientific posters or conference presentations and by 2/3 in the
biomedical, peer-reviewed literature. Ninety percent of
respondents cited plans for new HE studies in Canada
within the next year. CONCLUSION: Canadian companies have expanded their use of HE data in recent years.
The focus has shifted from preferential internal use (pricing and marketing) to more external purposes such as
provincial and hospital formulary submissions. Health
economic research data also find a place in training
within pharmaceutical companies and in medical education.
PHP8
PRACTICE USE OF PHARMACOECONOMICS
DATA IN HOSPITAL FORMULARY DECISIONS
Odedina FT1, Sullivan JL2, Nash R1, Clemmons CD1
1
Florida A&M University, Tallahassee, FL, USA; 2Pharmacia
Corporation, Tampa, FL, USA
OBJECTIVES: The use of formulary system can ensure
high quality and control cost if the formulary decision is
based on appropriate clinical and economic considerations. We explored use of pharmacoeconomic data in
hospitals for formulary decisions. METHODS: Study design was cross-sectional telephone survey using a structured survey instrument. Participants were pharmacists
who are P&T committee members of Florida hospitals.
RESULTS: Data were collected from 73 hospitals. Most
hospitals make formulary decisions at the local level
(82%). Thirty-three percent indicate that pharmacoeconomic data is used “all the time” when formulary decisions are made with only six percent stating that it is
rarely or never used. Pharmacoeconomic data is rated by
62% of participants to be “very important” in formulary
decisions. The usual sources of pharmacoeconomic data
listed by participants are in-house data (73%), published
literature (55%), and pharmaceutical industry studies
(15%). When asked to rank order 10 criteria in making
formulary decisions, the mean ratings of participants suggested the following order of importance: Efficacy, Toxicity, Side Effects, Acquisition Cost, Costs weighed by
Benefits, Extent of Drug Monitoring, Availability of Oral
Therapy, In-house data, Average Hospital LOS, Avoiding
use of Home Infusion. Most participants reported that
someone with pharmacoeconomic skills is employed by
the hospital (one has a Masters degree, one has residency
training, 31 with practical experience and 15 have informal training). Based on a pharmacoeconomic case study
comparing a new drug B to a current drug A, most of the
participants would add drug B to the formulary if it is a
new class of drug with no pre-existing resistance, has the
advantage of reduced IV use, or has a consistent reduction in hospital LOS. CONCLUSIONS: Results of this
study confirms that most hospitals consider pharmacoeconomic data invaluable in formulary decisions.
PHP9
COMPARISON OF TECHNOLOGY ASSESSMENT
IN LARGE MEDICAL GROUPS AND HEALTH
MAINTENANCE ORGANIZATIONS (HMOS)
Wise S1, Donohue TF2
1
Genentech, Inc, South San Francisco, CA, USA; 2Boston
Market Strategies, Inc, Lynnfield, MA, USA
OBJECTIVES: This analysis compares the characteristics
and processes of technology assessment (TA) in large
medical groups and HMOs. METHODS: The survey
populations were large medical groups and large HMOs
(at financial risk for lives .100,000). Mail and telephone
questionnaires were implemented. RESULTS: Survey response rate among medical groups was 54% (39/73). Response rate among HMOs was 43% (41/96). In responding medical groups, TA involves physicians (100%),
finance staff (85%), and quality improvement staff
(77%). In responding HMOs, medical functions (91%)
and pharmacy functions (83%) participate in TA. Medical groups most frequently conduct TA when technology
is adopted into clinical practice (88% of respondents)
and use TA to help develop guidelines (84%). HMOs
conduct TA throughout the product lifecycle and use TA
for coverage determinations. Medical groups and HMOs
conduct TA on injectable biotechnology products more
than any other type of drug. 44% of medical group respondents and 90% of HMO respondents seek outside
assistance for TA, with the Agency for Health care Research and Quality (AHRQ) as a leading source for medical groups and private TA vendors as leading sources for
HMOs. Both medical groups and HMOs consider expert
opinion and peer-reviewed journals as the most valuable
information sources. CONCLUSIONS: The need to manage legal and financial risk while focusing on clinical
practice and patient care drives TA in medical groups. A
need to define legally defensible benefits drives TA in
HMOs.
PHP10
THE POTENTIAL BENEFITS AND DRAWBACKS
OF ALLOWING DIRECT-TO-CONSUMER
ADVERTISING OF PHARMACEUTICALS
IN EUROPE
Dickson AJ
Consultant Health Economist, Northallerton, UK
172
Abstracts
Whether to legalise direct-to-consumer advertising
(DTCA), the authorised advertising of prescription drugs
direct to the consumer, within the European Union (EU)
is often discussed. But how would allowing DTCA help
EU governments looking for solutions to rising costs, rising patient expectations, loss of public confidence and
ageing populations? This poster summarises the main arguments for and against the EU legalising DTCA. OBJECTIVES: To explore the arguments for and against allowing the use of DTCA in EU states; to determine the
validity of the propounded arguments, by evaluating actual data which highlights the effects of introducing
DTCA in the US and New Zealand. METHODS: Using
PubMed and a within-literature search, a literature review of published information on the arguments for and
against DTCA, and DTCA’s associated costs was undertaken. RESULTS: Advocates believe DTCA will enable
the pharmaceutical industry to significantly improve the
effectiveness of its marketing campaigns. DTCA’s opponents argue that health care providers’ ability to ration
health care based on clinical need will be destroyed. US
data indicates that DTCA rose 38.5% in 1999 to
$US1.8bn, whilst in New Zealand expenditure rose
47.1% in 2000 to $US21.5m. DTCA has caused US retail
spending on prescriptions to soar. Yet in New Zealand
DTCA is credited with improving awareness, choice and
treatment of previously neglected conditions. CONCLUSIONS: DTCA’s ability to allow the pharmaceutical industry to connect with its ultimate consumers (patients)
would lead to increased strains on European health systems. But, the increased awareness that DTCA will bring
to currently neglected conditions (such as osteoarthritis
in men) could lead to huge benefits to patients quality-oflives and help refocus changing health systems towards
patients needs. As such, DTCA could be part of the solution to Europe’s health care crisis, but its introduction
will bring to EU states as many headaches as it solves.
PHP11
USE OF THE ANDERSEN HEALTH CARE
SERVICES UTILIZATION BEHAVIORAL MODEL
TO UNDERSTAND THE RELATIONSHIP
BETWEEN HEALTH INSURANCE COVERAGE
AND HEALTH CARE SERVICES UTILIZATION
AMONG THE ELDERLY
Yang M, Barner JC
The University of Texas, Austin, TX, USA
OBJECTIVES: The purpose of this study was to determine the relationship between health insurance coverage
(Medicare, Medicaid, other public, employer-sponsored,
and other private) and health care services utilization
(i.e., physician visits, hospitalizations, and the ability to
get needed prescription medications) among the elderly.
METHODS: The 1996 National Health Interview Survey
and its supplements were utilized as the data sources.
Elderly persons (.65 years) who had Medicare coverage
(N 5 27,727,536) were included in the study. The
Andersen Health Care Services Utilization Behavioral
Model provided the study framework and was used to
understand the effect of health insurance coverage on
health care services utilization while controlling for other
variables. The framework models the relationship between predisposing (age, gender, living status, race, and
education), enabling (income, health insurance coverage,
usual source of care, geographic location, and out-of-pocket
spending), and need for care (health status, activity limitation, restricted bed days, and comorbidities) factors
and health care services utilization. RESULTS: Elderly
persons with additional public health insurance coverage
(Medicare plus Medicaid or Medicare plus other public
health insurance) had significantly more physician visits
than those with Medicare only (p 5 0.0159 and 0.0258,
respectively). Elderly persons who had Medicare plus
other public health insurance and Medicare plus other
private health insurance were significantly more likely to
be hospitalized than those who had Medicare only (p 5
0.0341 and 0.0327, respectively). Elderly persons with
Medicare plus employer-sponsored insurance were more
likely to get needed prescription medication(s) (p 5
0.0076) than those with Medicare only. CONCLUSIONS: Elderly persons who had additional health insurance coverage (i.e., in addition to Medicare) were more
likely to have more physician visits, hospitalizations, and
they were more likely to obtain needed prescription medications. Additional health insurance coverage may be
beneficial in increasing access to health care services
among the elderly.
PHP12
ACUTE CARE ELDERLY UNITS: THEIR
PREVALENCE, CHARACTERISTICS
AND DETERMINANTS
Jayadevappa R, Raziano DB, Samakur M, Lavizzo-Mourey R
University of Pennsylvania, Philadelphia, PA, USA
BACKGROUND: The acutely ill hospitalized elderly patients face the risk of functional decline and poor quality
care. To improve the outcomes of hospitalization, various intervention models have been used. However, the
contributors to the functional loss and quality of care are
interrelated and warrant a multidimensional intervention. The Acute Care for Elders (ACE) unit is a one such
promising model of care for elderly to minimize adverse
outcomes of hospitalization. OBJECTIVE: To analyze
the determinants, prevalence and characteristics of ACE
units. METHODS: We surveyed all established Geriatric
Medicine Divisions (n 5 100) across US to determine
presence of ACE unit. Data on demographics, resource,
structure, administration, and patient care was obtained
via a questionnaire. Hospital data regarding number of
beds, revenue, number of medicare inpatients, and average length of stay was obtained from Annual Survey data
of the American Hospital Association. Descriptive analysis and step-wise logistic regression were used to analyze
the characteristics and determinants of ACE units. RE-
173
Abstracts
SULTS: Of the 82 responding geriatric divisions, 15 had
an active ACE unit. Average daily census on ACE units
ranged from 5 to 25, average length of stay was 5.2 days
and the average nurse to patient ratio was 1:6. Community dwelling was the most common pre-admission living
setting. Two most common admitting diagnoses were
congestive heart failure and pneumonia. T-test showed
significant difference (,.05) between hospitals with ACE
unit and hospitals without, with respect to number of
beds and total revenue. The step-wise logistic regression
indicated that total hospital revenue was the only significant factor in determining the presence of an ACE unit.
CONCLUSIONS: Thus, application of the ACE unit
model remains modest given the paucity of information
regarding its long and short-term benefits and cost-effectiveness. Further research in this direction can facilitate
informed policy decisions.
PHP13
INDICES FOR EVALUATION OF DRUG
COST/UTILIZATION: EVERY SILVER LINING
HAS A GRAY CLOUD
Valuck RJ
University of Colorado School of Pharmacy, Denver, CO, USA
OBJECTIVE: Given the high cost of pharmaceuticals,
particularly “blockbuster” drugs such as the COX-II inhibitors, the issue of value-for-dollar is an increasingly
important one for managed care decision-makers. Due to
the complexity of conducting full economic evaluations,
it is often tempting to try to reduce such analyses to the
most simplistic methods possible—either by assuming
equal effectiveness of two drugs and performing a costminimization analysis, or by using an index of drug cost/
utilization such as DDD (number of defined daily doses
of a drug used in a population), PMPM (per member per
month cost/utilization), PPPM (per patient per month
cost/utilization), ADC (average daily cost of drug therapy), or DACON (daily average consumption of a drug
in a population). If a partial economic evaluation based
on drug cost/utilization is necessary or preferred, decision-makers should bear in mind the relative strengths
and limitations of these approaches prior to making
policy decisions. The objectives of this paper are: (1) to
describe several indices of drug cost/utilization, (2) to discuss their strengths and limitations, (3) to provide
illustrations of their use, and (4) to offer suggestions for
appropriate interpretation. METHODS: Using numerical
examples focusing on COX-II inhibitors, several indices
of drug cost/utilization are described and compared, including DDD, PMPM, PPPM, ADC, and DACON. General limitations and assumptions of “partial” economic
evaluations based solely upon cost/utilization data are
discussed, including assumptions of equal effectiveness,
compliance, continuation and safety; as well as confounding by indication, severity of illness and time on
market. RESULTS: Depending upon the index used, results (data) on drug cost/utilization for COX-II inhibitors
vary. CONCLUSION: Numerous indices are used to describe and evaluate drug cost/utilization. Each has its
own strengths and limitations, and must be interpreted in
the appropriate context to best inform pharmaceutical
policy decision-making.
PHP14
COST ANALYSIS OF PHARMACEUTICAL
SERVICES IN A TEACHING INSTITUTION
Bussières JF, Lebel D
Montreal University, Sainte-Justine Hospital, Montréal, QC,
Canada
OBJECTIVES: The study purpose was to describe and
quantify annual costs of pharmaceutical services per category (5) and clienteles (5) in a 452 bed mother and child
teaching institution. METHODS: Based on a daily diary
completed by each pharmacist, we calculated costs of
pharmaceutical services in five categories in 1999–2000:
distribution, management, clinical, teaching and research.
Pharmacists were requested to provide a description of
their activities, including the number of new patients/follow-up, verbal and written requests and number/type of
interventions. Costs ratios were calculated. RESULTS:
1999–2000 fiscal year showed 21,330 admissions, 115,961
patient-days and 275,000 outpatient visits. Pharmacists
represented 47% of total worked hours. Pharmacists’ total hours reported represented 89,6 % of accounting
data. Hours were dedicated to distribution (53%), clinical (29%), management (12%), teaching (5%) and research (1%) services. Pharmacists answered 26 491 questions while providing 26 065 interventions among 5
clienteles (intensive care, pediatrics, multi-specialties,
mother and child and haematology/oncology). We calculated a ratio of interventions/worked hours with an average of 0,61 (min 0,015–max 1,35). An analysis of these
differences will be provided. Pharmacists’ total annual
costs represented $1,453,000.00 CDN including social
benefits. Assuming our pharmacy model optimizes the
number of potential interventions in our setting and that
100 % of pharmacist’s paid time is required to materialize them, we calculated an average cost of $54.92 CDN/
intervention (min $24.80 CDN–max $2,233.00 CDN).
Differences were calculated between 1998–1999 and
1999–2000 showing an average of 104% difference (min
68%–max 197%). Differences can be explained by pharmacist expertise evolution, management decisions and
changes in activity volumes. CONCLUSION: There are
little data available to allow benchmarking in the costs of
pharmaceutical services. Further studies are required to
identify the most useful ratios to monitor such costs as
well as relevant outcomes.
174
Abstracts
PHP15
A SURVEY OF PUBLIC HOSPITAL PHARMACISTS
IN SINGAPORE ON THEIR VIEWS ABOUT
‘THE FORMULARY’ AND ITS
DECISION-MAKING PROCESS
Roy A, Li SC
National University of Singapore, Singapore, Singapore
OUR PREMISE: If the expectation is “A formulary must
help control drug costs but not just promote cheap drugs
(i.e., compromise on quality of care)”, there clearly exists
a need for pharmacoeconomics in formulary decisionmaking. OBJECTIVES: To understand if such expectation and need exist in Singapore, and how confident
pharmacists would be if asked to use pharmacoeconomics to aid their decision-making. METHOD: After having
obtained consent from the respective pharmacy managers, survey forms were circulated to all pharmacists in the
5 major public hospitals of Singapore. If after 2–3 weeks,
the response rate was lower than 50% a reminder (via
e-mail) and a second circulation of the questionnaire was
made. In the event of any clarification(s) being required,
the respondent was contacted over phone. RESULTS
AND CONCLUSION: With a response rate that ranged
from 50% to 85% in the individual hospitals and an
overall average of z64% (70 of 110 identified pharmacists responded) our findings delineated the following
picture in Singapore. Formulary restriction is the best
method to control drug costs (57%). However, it should
not be a list of cheapest alternatives (90 %) but should
ideally promote the use of the best drug (71%) while also
controlling the hospital budget (57%). Though what factors are involved in the current formulary decision-making process are not known (49% have no knowledge),
drug effectiveness (64%) as opposed to acquisition cost
(5%) will be considered as the most important factor by
the pharmacists if they were to decide on the formulary.
However, only 1% felt very confident about being able to
use pharmacoeconomics to aid their decision-making, if
asked to do so. There is therefore, a definite but unstated
need for use of pharmacoeconomics in the formulary setting; however, there is clearly a lack of capability to fulfill
the need.
PHP16
THE VALUE OF VARIOUS FORMS OF EVIDENCE
IN DRUG FORMULARY DECISION MAKING
Morris L1, Aikin K2
1
Louis A. Morris & Associates, Dix Hills, NY, USA; 2Food and
Drug Administration, Rockville, MD, USA
INTRODUCTION: The study examined the perceived
value of different forms of evidence (i.e., randomized
controlled trials and retrospective cohort analyses study
designs) among physicians and pharmacists (N 5 780).
Research participants read three abstracts (for each of
three fictitious drugs) that varied type of claim (cost,
cost-effectiveness, and effectiveness) and study design.
They rated the perceived value of the study in determining formulary recommendations on seven items. METHODS: Factor analysis was used to derive weights for a
single measure of value that ranged from 0.735 (low
value) to 5.145 (high value). RESULTS: Four-way ANOVAs indicated that cost-effectiveness (mean 5 3.19) and
effectiveness (mean 5 3.11) data were of more value than
cost data (mean 5 2.84, p , .0001). Also, formularyaffiliated physicians (mean 5 3.10) found the studies to
be of more value than hospital pharmacy directors (mean 5
2.93, p , .02). A significant two-way interaction indicated that pharmacy directors valued retrospective cohort analyses more than randomized trials regardless of
type of claim. In contrast, physicians valued randomized
trials more than retrospective cohort analyses (p , .001).
Manipulation checks indicated some difficulty identifying
the purpose of individual studies. While most respondents could correctly identify cost-effectiveness and effectiveness studies (between 77% and 92% correctly identified these studies), there was confusion regarding cost
studies. Almost half of the participants (between 42%
and 57%) characterized these studies (which were described as “cost-minimization” analyses) as cost-effectiveness studies. Pharmacy directors (49%) were more
likely to mischaracterize the cost-minimization studies
compared to the physician groups (approximately 40%
of these groups) (chi square 5 20.29, p , .02). CONCLUSIONS: The results suggest that the multidisciplinary make-up of formulary committees is important to
assure the incorporation of multiple forms of evidence in
decision-making. Also, more attention to the study design
is essential to evaluate the value of various forms of evidence for formulary decisions.
PHP17
PATIENT OUTCOMES IN THE SEDATED
ICU PATIENT
Kamath T1, Hopefl A2, Chaikledkaew U1, Johnson KA1
1
University of Southern California, Los Angeles, CA, USA;
2
AmeriNet, St. Louis, MO, USA
OBJECTIVE: This study compares patient outcomes in
the mechanically ventilated ICU patient by patient demographics, hospital characteristics and drug therapy. METHODS: Data collected from 42 hospitals included patient
demographics, disease severity, sedatives/analgesics administered, hospital type/size, days hospitalized and discharge status. RESULTS: 622 patients were studied (48%
female, mean APACHE score 5 21.7, 31% with care
plans). Only 50% of patient episodes for ICU sedation
greater than 24 hours were treated with lorazepam
(guideline recommended drug for long-term sedation).
94% of patients received recommended analgesics. Patients in community hospitals had fewer ICU days (9.31
versus 11.05) and total hospital days (14.14 versus
16.96) compared to teaching hospitals. Patients receiving
midazolam or orazepam had shorter hospital stays (13.7
and 15.5 days respectively) compared to propofol pa-
175
Abstracts
tients. Patients receiving midazolam had higher mortality rates (31.7%) compared to patients on lorazepam
(29.2%). However, these results were not confirmed
when controlling for disease severity and other factors.
Multivariate regression analysis revealed that type of sedative/analgesic drug treatment and whether the hospital
had a care plan were not associated with shorter ICU and
total hospital stays when controlling for patient demographics and disease severity. In fact, patients admitted to
hospitals with care plans had longer total hospital stays.
More severe patients had shorter total hospital stays,
probably due to higher mortality. Higher mortality was
associated with older patients and higher disease severity.
CONCLUSION: There is much discussion about treatment guidelines and use of care plans to improve quality
of care and reduce hospitalization costs. In this study, the
type of sedation and analgesia treatment in mechanically
ventilated ICU patients and whether the patient had a
care plan did not influence days in ICU or mortality.
Whether following treatment guidelines and care plans
reduces total costs, needs further evaluation.
PHP18
A MODEL FOR COMPARING COSTS
ASSOCIATED WITH PRESCRIPTION
WASTAGE WITH APPLICATION TO VA
PRESCRIPTION DATA
Walton SM, Johnson NE, Arondekar BV, Schumock GT
University of Illinois at Chicago, Chicago, IL, USA
OBJECTIVE: The objective of this study was to determine the frequency and cost of prescription switches for
90-day vs. 30-day outpatient prescriptions dispensed by a
VA pharmacy and to develop a model to determine the
prescription fill policy with the lowest total costs.
METHODS: VA outpatient prescription records for one
year for simvastatin and lovastatin (30 or 90-days) were
analyzed to determine the frequency, quantity and cost of
medication wasted due to medication switches. The
quantity wasted was defined as the difference between
the quantity dispensed and the quantity of drug used before changing to a new drug or dosage. Differences in dispensing costs for a given time-period were also included.
Sensitivity analyses were conducted for quantity wasted,
drug costs, and dispensing costs. RESULTS: A total of
16,990 prescriptions were analyzed. The quantity and
costs of medication wasted were higher for 90-day prescriptions than for 30-day prescriptions. However, average costs to the VA pharmacy were $2.45 higher per prescription for the 30-day supply because of additional
dispensing costs for the 30-day fill. The model and sensitivity analyses show that a 90-day supply policy results in
lower total pharmacy costs under several scenarios. Only
in the case of high drug costs was the 30-day policy favorable to the 90-day policy in terms of total costs.
CONCLUSION: Prescriptions given in a 90-day supply
resulted in lower total costs. The projected cost savings of
having a 90-day versus a 30-day policy would hold true
for prescriptions with similar drug costs and similar rates
of wastage that result from changes that physicians make
to patients’ prescriptions. In addition, the model provides
a flexible framework for pharmacy administrators to assess refill policies in terms of excess or unnecessary cost
for different classes of drugs, given patient and/or physician behavior.
PHP19
USING FINANCIAL RATIOS TO COMPARE
PHARMACY SPENDING IN THE DEPARTMENT
OF VETERANS AFFAIRS
Sampson JM
VA Medical Center, Alexandria, LA, USA
OBJECTIVE: To understand how pharmacy spending
varies across the VA Medical Centers in the United States.
Pharmacy costs continue to rise. From 1990 to 1994
pharmacy expenditures were reported to be 6% of the total Veteran’s Health Association (VHA) budget. In 1995
and 1996 it was 7%. In 1997 it was 8% and in 1998 it
was 9%. Then in 1999 it went to 11%. Future projections
are for a continued increase in budget spending. METHODS: Ratios of yearly Pharmacy to Medical Center expenditures were compared. These ratios were ranked and
compared with geographical location. The years of 1997
and 1998 were studied. RESULTS: The majority of the
highest ratios were located in the Midwest, Soutwest, and
Southern regions of the United States. CONCLUSIONS:
Financial ratios can demonstrate variations in expenditures and identify areas that may require further inquiry.
PHP20
THE LAG BETWEEN EFFECTIVENESS AND
COST-EFFECTIVENESS EVIDENCE OF NEW
DRUGS AND DECISION-MAKING IN
HEALTH CARE
Stoykova BA, Drummond M, Kleijnen J
University of York, York, UK
BACKGROUND: A new drug is approved for use if its
effectiveness has been demonstrated. Recently decisionmakers in a number of countries have begun to account
for both the effectiveness and cost-effectiveness of new
drugs. However, cost-effectiveness evidence lags behind
the effectiveness data. OBJECTIVE: To explore the timeliness of delivering cost-effectiveness information about
new drugs with established effectiveness and significant
financial impact. METHODS: New drugs were identified, based on guidance documents and reports published
by the National Institute for Clinical Excellence of England and Wales, and the following data were collected:
dates of publication of first effectiveness and cost-effectiveness evidence, methodology of the cost-effectiveness
analysis, funding of the research, etc. RESULTS: Guidance documents for the following new drugs/drug groups
have been published by NICE by the end of 2000: tax-
176
Abstracts
anes for ovarian and breast cancer, proton pump inhibitors in the treatment of dyspepsia, glycoprotein IIb/IIIa
inhibitors, methylphenidate for hyperactivity in childhood, zanamivir, and rosiglitazone for type II Diabetes
Mellitus. The analysis of the evidence shows that the effectiveness of these drugs has been demonstrated in the
last 12 years. However, cost-effectiveness evidence has
been published for 70% of the drugs with an average delay of 3 years (range 0–10). The cost-effectiveness of
those, introduced after 1995 (80% of all included drugs/
drug groups), has been demonstrated using models only,
if at all. CONCLUSIONS: Cost-effectiveness evidence is
produced with a lag behind the effectiveness evidence. As
a result, decision-makers are in a position of awaiting
sound evidence while issuing guidance based on current
inconclusive research results. The cost to society is discussed, and establishing the cost-effectiveness of new
drugs alongside RCTs at an earlier stage of their development is suggested.
PHP21
SINGLE EUROPEAN-LEVEL
COST-EFFECTIVENESS ANALYSIS: OVER THE
FOURTH HURDLE AND INTO THE DITCH?
Hutton J1, Nuijten M2, Chambers M1
1
MEDTAP International Inc, London, UK, 2MEDTAP
International, Jisp, Netherlands
BACKGROUND: As more European governments require economic data to support reimbursement applications the potential burden of multiple economic evaluations is being seen as a problem by industry. Placing
responsibility for cost-effectiveness assessment at the European level using standardised methods has been proposed as a solution. OBJECTIVE: To review the feasibility of a European level cost-effectiveness test for new
drugs, from conceptual, practical and political viewpoints. METHODS: The issues are examined first from
the theoretical perspective—does a European level economic evaluation have any inherent logic. Secondly, the
practical issues of how such an evaluation might be conducted are examined. Could it be based on a phase III
clinical trial? The political issues relate to who would regulate the production of such cost-effectiveness data; who
would use the data to assist in what decision(s)? Different
regulatory models are assessed using the analogy of drug
licensing. DISCUSSION: The position generally taken by
economists is that a generalised cost-effectiveness result is
neither possible nor useful. Differences in the price structures, treatment patterns and provider incentives between
systems make generalisations of cost-effectiveness of
questionable relevance. How fast will European integration produce a single health market? Moves towards a
single European price for each drug are relevant as in the
willingness of European states to allow the EU to play a
bigger role in health care financing and organisation.
Will countries accept each others’ assessments or will an
EU agency like EMEA be required? CONCLUSIONS:
Long-term political and economic changes may well create a true European market in which cost-effectiveness at
the European level will have meaning and relevance.
Meanwhile, individual country health care systems seem
more concerned with short-term budget impact when
making new drugs available. The pharmaceutical industry should not anticipate a reduction in the overall demand for locally targeted economic information.
PHP22
PATIENT ADHERENCE TO DRUG THERAPY IN A
THREE-TIER COPAYMENT STRUCTURE
Hutchison S
AdvancePCS, Scottsdale, AZ, USA
BACKGROUND: The three-tier copayment plan is designed to reduce the cost of pharmacy benefits to the insurer or payer while maintaining patient choice. Because
the patient pays a larger portion of the cost of middleand high-tier drugs, some have argued that this plan design may adversely impact patient drug utilization for
chronic medications. OBJECTIVE: To determine whether
a three-tier copayment structure adversely affects patient
drug utilization for middle- and upper-tier drugs for diabetes and depression. METHODS: We conducted a longitudinal, retrospective claims database study using claims
data from a national pharmaceutical benefits management
company. Claims for two chronic conditions, depression
and oral diabetes, were examined for patients on three-tier
copayment plans and for patients on an open formulary
plan with the same copayment for every drug. Average
rates of patient adherence, number of prescriptions filled,
and days of therapy were calculated. RESULTS: There
were statistically significant differences in rates of patient
adherence, number of prescriptions filled, days of therapy,
amount of copay, and payer costs among patients using
drugs in the lower, middle, or upper tier of the three-tier
structure. In addition, average patient adherence, number
of prescriptions filled, and days of therapy did differ significantly for patients on an open formulary compared to patients on a three-tier copayment structure. These differences were largely a function of sample size, and may be of
little practical utility.CONCLUSIONS: The larger patient
copayment for medications in the middle and upper tiers
of a three-tier copayment structure have only a minimal
impact on drug utilization in the antidepressant and oral
diabetes drug categories. Further research is needed to determine whether these findings would be replicated when
applied to other therapeutic classes.
PHP23
DRUG REIMBURSEMENT PROGRAM FOR
INDIGENT PATIENTS: AN ECONOMIC IMPACT
ON THE HOSPTAL ADMINISTRATION BUDGET
Nguyen AB1, Arbuckle R2, Anderson RW2, Sansgiry SS1
1
University of Houston, Houston, TX, USA; 2The University of
Texas MD Anderson Cancer Center, Houston, TX, USA
177
Abstracts
All patients are entitled to equal access to health care resources. The Department of Pharmacoeconomics at University of Texas MD Anderson Cancer Center (UTMDACC) administers a Patient Assistance Program (PAP)
that provides assistance to indigent patients with free
pharmaceuticals for their therapy. Drug cost is recovered
through a drug reimbursement program offered by pharmaceutical companies. OBJECTIVE: The objective of
this report is to examine trends in drug cost savings to indigent patients at UTMDACC using the PAP model.
METHODS: A retrospective study using data from September 1996 to August 2000 was conducted to determine
the value of the program. Patients were enrolled in this
program if they qualified based on the Financial Classification Scale. Uninsured patients as well as under-insured
patients were considered in this study. Data was analyzed
to evaluate the trend in cost savings for the three fiscal
years. RESULTS: Over $334 million was spent on drug
cost over the period. There was an average increase of
22% per year in drug cost. The indigent patients accounted for 9% of the total patient population at UTMDACC. An estimated $33 million was spent on drugs for
indigent patients during that period. The PAP system recovered a total of $16.8 million; $4.1M (1997), $4.3M
(1998), $3.5M (1999), and $4.9M (2000). This accounts
for 51% in drug cost recovery through this program. The
fluctuation in cost saving was attributed to changes in the
number of programs, number of patients enrolled, and
product mix. CONCLUSION: The PAP system has provided free drugs to patients without financial resources
and reduced the economic burden of this population on
the health care institution. The program has created
goodwill between the pharmaceutical companies, the
health care institution, the patients and the community.
nal instrument consisted of 12 questions: 2 categorical
addressing memory of the experience and 10 referred to
characteristics of anxiety. In phase 3, two groups of critically ill patients were administered the questionnaire: 1)
sedated only and 2) sedated and pharmacologically paralyzed. The questionnaire was administered twice for reliability. Questionnaire results were compared to subjective and objective sedation monitoring tools for validity.
Calculated sample size was 20 for each group. RESULTS:
During six months, 21 patients consented to participate.
Twelve patients died and nine patients (6 sedated, 3 sedated/paralyzed) were administered questionnaires. Five
patients (3 sedated, 2 sedated/paralyzed) did not remember the intensive care unit experience. Two of three patients in the sedated group who answered the questionnaire found it difficult to remember over time. One
sedated/paralyzed patient who answered the questionnaire received a sedative without amnesic properties and
felt anxious during therapy. The distressful feeling of this
patient was comparable to findings of the objective sedation tool. CONCLUSIONS: Mortality in this critically ill
patient population was high. Due to amnestic properties
of sedatives most patients did not remember the experience. Of patients who remembered, their memory deteriorated over time. Based on lessons learned, it may require
2–3 years to achieve the necessary sample size.
NO SPECIFIC OR MULTIPLE DISEASES-QUALITY
OF LIFE & PREFERENCE-BASED MEASURES
INTRODUCTION: The ERIQA Group aims to create
guidance for European regulatory authorities on the assessment of the quality of HRQL studies in clinical trials
and to evaluate the validity of HRQL claims. OBJECTIVES: To identify disease or drugs in which a formal
HRQL assessment is recommended. To identify measures
and methods recommended. To evaluate the reliability of
recommendations across documents. METHODS: Informations were searched on the EMEA website (www.
eudra.org/emea.html). A research was performed with
the two key words: “Quality of life” and “QoL”. All the
documents retrieved were reviewed. RESULTS: 133 documents were retrieved excluding duplicates (129: Quality
of Life, 25: QoL). 19 documents derived from the Efficacy Working Parties (EWP) including nine notes for
guidance (Weight Control, Cancer, Chronic Peripheral
Arterial Occlusive Disease, Cardiac Failure, Stable Angina Pectoris, Antiarrythmics, Parkinson, Alzheimer,
Multiple Sclerosis), concept paper (3), points to consider
(5) and position statements (2). Only one document was
a note for guidance for ICH. 104 European Public Assessment Report (EPAR) were retrieved, representing 26
products. Nine miscellaneous documents were found in-
PQP1
LESSONS LEARNED FROM DEVELOPING A
PSYCHOMETRICALLY BASED SEDATION
QUESTIONNAIRE IN PHARMACOLOGICALLY
PARALYZED CRITICALLY ILL PATIENTS
Kane SL, Dasta JF, Pathak DS
The Ohio State University, Columbus, OH, USA
OBJECTIVE: To share lessons learned from developing a
reliable and valid questionnaire for adequacy of sedation
in pharmacologically paralyzed critically ill patients.
METHODS: In phase 1, seven experts listed 21 characteristics describing anxiety in pharmacologically paralyzed patients. In phase 2, two scenarios were created illustrating the experience of paralysis: one with and one
without receiving a sedative. A convenience sample of 30
people evaluated scenarios to determine the importance
of characteristics obtained from phase 1 using a fivepoint scale. Items were reduced to the 10 most important
characteristics (mean >3). Based on these results, the fi-
PQP2
ROLE OF HEALTH RELATED QUALITY OF LIFE
OUTCOMES IN THE EUROPEAN DRUG
REGULATORY PROCESS: A REVIEW OF THE
EMEA DOCUMENTS
Acquadro C, Staniek V, for the ERIQA Group
Mapi Research Institute, Lyon, France
178
Abstracts
cluding minute reports, workshop, letters (5), assessment/
opinion (2) from the CPMP and 2 documents were produced by the CVMP. CONCLUSIONS: The recommendations from the EMEA are vague in most cases, too generic, inconsistent between each other and reveal in some
cases a lack of knowledge of the field. These recommendations are not up-dated and do not exist in relevant diseases (HIV/AIDS, HBP). Nevertheless, recommendations
do exist showing a real interest in HRQL and recognition
of HRQL as a valuable endpoint (mainly secondary).
PQP3
DEFINING CLINICALLY MEANINGFUL CHANGE
IN HEALTH-RELATED QUALITY OF LIFE
Crosby RD1, Kolotkin RL2, Williams GR3
1
Neuropsychiatric Research Institute, Fargo, ND, USA; 2Duke
Medical Center, Durham, NC, USA; 3Knoll Pharmaceuticals,
Mount Olive, NJ, USA
OBJECTIVES: This paper reviews current approaches to
defining clinically meaningful change in health-related
quality of life (HRQOL). METHODS: Definitions of
clinically meaningful change are discussed. Psychometric
properties of HRQOL instruments necessary for identifying clinically meaningful change are identified. Two broad
methods for identifying clinically meaningful change are
contrasted: anchor-based methods and distribution-based
methods. Anchor-based methods include forced-choice
paradigms, global change ratings, receiver operating characteristic techniques, goal attainment scaling and external event methods. Distribution-based methods include
individual effect size, the Guyatt responsiveness index,
the Jacobson-Traux reliable-change index (and subsequent
variations), standard error of measurement, and hierarchical linear modeling. Strategies for validating clinically
meaningful change measures are discussed. RESULTS:
Anchor-based and distribution-based methods have both
advantages and limitations, and neither appears superior
to the other. Anchor-based methods provide a source for
external validation, but are dependent on the specific anchors being used. Distribution-based methods provide a
statistical basis for decision-making, but may vary on the
basis of sample characteristics. CONCLUSIONS: The use
of multiple methods to define clinically meaningful change
is strongly recommended. Factors to consider in defining
clinically meaningful change include the severity of the
baseline value, the direction of change, and the importance of the change to the individual.
PQP4
CROSS-CULTURAL VARIATIONS IN SF-12
SCORES AMONG INDIVIDUALS WITH VARIOUS
HEALTH CONDITIONS
Bolge SC, Eschmann B, Donohue JA
Consumer Health Sciences, Princeton, NJ, USA
OBJECTIVE: To examine the cross-cultural differences
of health-related quality of life among people with various health conditions across four countries. METHODS:
Analyses were based on 12-page questionnaires mailed to
adults in 2000. A total of 38,677 responses were received
from France, Germany, Great Britain, and the US Results
were subsequently weighted and projected to the national
populations of these four countries. Weighting was based
on gender, age, and region for the European countries
and gender, age, race, and region for the US Participants
reported whether they were diagnosed with the following: arthritis, asthma, depression, diabetes, GERD, high
blood pressure, high cholesterol, migraines, nasal allergies, or osteoporosis. Physical and mental health status
were defined by summary measures of the SF-12 scale.
RESULTS: The French reported lower mental health status but better physical health status than people in Germany, Great Britain, and the US, regardless of diagnosed
health conditions. The opposite was found among arthritis, asthma, and GERD sufferers in Germany, who reported the best mental health status but the lowest physical health. Respondents from Great Britain and the US
generally reported SF-12 scores that fell between those of
France and Germany, with three notable exceptions.
Among people diagnosed with depression, those in the
US reported better mental health status. Among people
diagnosed with high blood pressure or high cholesterol,
those in Great Britain reported the lowest physical health
status. CONCLUSION: Self-reported quality of life varied by country regardless of condition. Researchers
should consider cross-cultural variations in self-reported
quality of life measures when conducting multinational
trials. Collapsing data could obscure effects.
PQP5
TRANSLATING SF-36 SCORES INTO
PREFERENCES: AN EXAMINATION OF THE
PERFORMANCE OF TWO
PREDICTIVE EQUATIONS
Meletiche DM, Roberts CS, Lofland JH
Thomas Jefferson University, Philadelphia, PA, USA
Despite widespread use of the SF-36, its use in cost-utility
analyses has been precluded by its inability to measure
patient preferences. To overcome this obstacle, various
investigators have derived equations to estimate preference scores from the SF-36. OBJECTIVE: To compare
two methods of estimating preference values from SF-36
scores. METHODS: A convenience sample of patients
completed the SF-36 and EuroQol during their initial
visit to a specialty headache center. Preference scores
were estimated from the SF-36 using two equations, one
developed by Fryback and the other by Brazier. The performance of each equation was assessed by calculating
the correlation coefficient between the estimates and actual preference scores from the EuroQol. Mean preference scores from each method were compared using oneway repeated measures ANOVA. RESULTS: Forty-seven
179
Abstracts
patients were enrolled; 45 completed the EuroQol and
SF-36. Mean preferences estimated by the Brazier and
Fryback equations were 0.815 (SD: 0.110, Range: 0.497–
0.971) and 0.655 (SD: 0.060, Range: 0.511–0.791). The
mean EuroQol score was 0.553 (SD: 0.347, Range:
20.239–1.000). The correlation coefficient between predicted preferences from Brazier and Fryback’s equations
and the EuroQol were 0.613 and 0.494, respectively. The
mean preference scores produced by the three methods
were significantly different (F 5 24.59, p 5 0.0001) and
both of the predictive equations yielded significantly
higher mean values (p , 0.05) than the EuroQol. CONCLUSIONS: Both equations to estimate a single, preference-based index from the SF-36 produced higher mean
scores and a narrower range of values than the EuroQol.
Preferences produced by the Brazier equation were more
highly correlated with EuroQol scores than preferences
from the Fryback equation. The Fryback equation also
produced a wider range of scores. Continued development and validation of predictive equations is needed in
order to use SF-36 scores in cost-utility analyses.
PQP6
HEALTH UTILITIES INDEX MARK 3:
AGREEMENT BETWEEN RATERS AND
BETWEEN MODALITIES OF ADMINISTRATION
Verrips G1, den Ouden A1, Bonsel G2, Gemke R3, Paneth N4,
Verloove-Vanhorick S1
1
TNO Prevention and Health, Leiden, Netherlands; 2Academic
Medical Center, Amsterdam, Netherlands; 3Free University
Medical Center, Amsterdam, Netherlands; 4Michigan State
University, East Lansing, MI, USA
OBJECTIVES: The aim of this study was to evaluate inter-rater and inter-modality agreement in assessing health
status using the Health Utilities Index Mark 3 (HUI3).
METHODS: A random sample from a Dutch cohort of
14-year-old Very Low Birth Weight children and their
parents were invited to participate in a HUI3 face-to-face
(n 5 150) or telephone interview (n 5 150). All 300 participants were also sent a HUI3 questionnaire by mail.
Response rate was 68%. RESULTS: Inter-rater and intermodality agreement were high for the physical HUI3
attributes and poor for the psychological attributes. Children and parents reported more dysfunction in the psychological attributes when interviewed than when completing the mailed questionnaire. High agreement on the
physical attributes may have resulted from the fact that
hardly any dysfunction was reported in these attributes,
and poor agreement in the psychological attributes may
have been a result of the fact that in these attributes much
more dysfunction was reported. CONCLUSIONS: In
measuring children’s health status using the HUI3, the results and their interpretation vary with the source of information and the modality of administration. For maximum comparability between studies, written self-report
questionnaires seem the preferred option.
PQP7
IS COMPLIANCE WITH DRUG TREATMENT
CORRELATED WITH HEALTH RELATED
QUALITY OF LIFE?
Côté I1, Farris KB2, Feeny DH3
1
Institute of Health Economics, Edmonton, AB, Canada;
2
University of Iowa, Iowa City, IA, USA; 3Univeristy of Alberta,
Edmonton, AB, Canada
OBJECTIVES: Compliance with drug treatment and
health related quality of life (HRQL) are two distinct
concepts. However, we might expect a weak positive relationship between the two, i.e. higher compliance is associated with higher HRQL. The purpose of this study
was to assess the relationship between compliance and
HRQL. METHODS: HRQL was measured using the
physical (PCS) and mental (MCS) component summary
measures of the MOS Short-Form 12 (SF-12). Compliance was assessed using Morisky’s instrument. Three longitudinal datasets were used to investigate the relationship. One dataset (n 5 100) included hypertensive
patients aged between 34 and 80 years. Another dataset
(n 5 199) covered high risk community-dwelling individuals between 27 and 93 years of age. In this dataset, 43%
reported taking medication to control blood pressure.
The third dataset (n 5 365) consisted of elderly patients,
of whom 57% reported taking medication for pain relief
and 47% to control blood pressure. There are two observations per patient in the first dataset and three per patient in the other two. In all datasets, patients were taking
at least one prescribed medication. Correlation coefficients established the relationship between PCS, MCS
and compliance. RESULTS: In all datasets, MCS was
positively correlated to compliance. PCS was positively
correlated to compliance in the hypertensive and the elderly populations and was negatively correlated to compliance in the high risk population. Correlation between
compliance and PCS range from 0.00 (p 5 0.96) to 0.09
(p 5 0.03). Correlation between compliance and MCS
range from 0.01 (p 5 0.90) to 0.21 (p 5 0.00). CONCLUSIONS: Correlation between PCS, MCS and compliance was in general positive but typically small or negligible. Further research is needed to establish the relationship
between compliance and HRQL.
PQP8
EVALUATING BIAS INTRODUCED BY
ANNUALIZING UTILIZATION AND
COST MEASURES
Zodet M, de Lissovoy G
MEDTAP International Inc, Bethesda, MD, USA
OBJECTIVES: Administrative databases are often used
to investigate patterns of health care resource use and expenditure over time for particular conditions in order to
project future costs and to evaluate the cost-effectiveness
of interventions. Duration of the period of observation
typically varies across individuals due to differences in
180
Abstracts
enrollment/disenrollment dates, timing of the index event,
and the database time span. Projecting expenditure on an
annual or per member per month basis requires standardizing these periods of observation. We evaluate bias introduced by a simple method for annualizing utilization
and cost measures. METHODS: We investigated resource
use and costs surrounding an index event; hospital admission with a primary diagnosis of heart failure. For
each patient, claims data were available for a pre-event
and post-event period ranging from 6 to 24 months. We
standardized periods to one year pre- and post-event by
first tabulating counts and costs for the actual period observed. We then multiplied these values by the ratio of
365 days to actual days in the period such that values for
periods shorter than 365 days were inflated and longer
than 365 days deflated. To determine whether this adjustment biased the magnitude of annualized values, we
estimated a regression model with annualized cost and
adjustment ratio as dependent and independent variables
respectively. RESULTS: For the pre-event period, there
was no significant association between annualized cost
and adjustment factor (p 5 0.72, R2 5 0.00014, p 5
0.012) indicating absence of bias. While bias was observed in the post-event adjustment factor (p 5 0.005),
the low model explanatory power (R2 5 0.00869) and
lack of correlation (Pearson correlation coefficient 0.093)
suggest minimal impact on the magnitude of annualized
estimates. CONCLUSION: We find that a simple approach
to standardization was reasonably robust. We compare
advantages and disadvantages with more complex regression-based methods.
PQP9
QUALITY OF LIFE OF PATIENTS WITH
FABRY DISEASE
Botteman MF1, Pastores GM2, Gold KF1, Yeh J1, Ali J1,
Aliski W3, Pashos CL1
1
Abt Associates Clinical Trials, Bethesda, MD, USA; 2New York
University School of Medicine, New York, NY, USA;
3
Transkaryotic Therapies Inc, Cambridge, MA, USA
BACKGROUND: Fabry disease (FD) is a rare genetic
disorder of metabolism due to a deficiency of a lysosomal
enzyme (alpha-galactosidase A) and the resultant accumulation of globotriasylceramide in the cerebrovascular
and cardiovascular systems, kidney, and liver. Symptoms
become manifest during childhood or adolescence and
progress to include episodes of extremity pains, renal failure, cardiomyopathy, and/or strokes. OBJECTIVES: To
better understand quality of life (QOL) in FD patients
relative to disease progression, and normatively, compared to other chronic diseases. METHODS: Data were
collected prospectively from a sample of 85 FD patients
contacted through the Fabry Support and Information
Group. Subjects responded to a survey that included the
SF-36, a symptoms checklist, and extensive demographic
questions. Information about SF-36 performance for
other populations was collected from the literature. Data
on 53 males are reported here. RESULTS: Patients with
FD have substantially lower QOL across all domains
compared to the 25th percentile of the general male population, as well as that observed for patients with Gaucher disease, renal disease, and stroke. There is also a very
substantial decrease in QOL from early adulthood through
middle age (data not shown here). CONCLUSIONS: These
data suggest that FD places an increasing and unusually
heavy QOL burden on patients, especially related to general health, physical role and vitality. Research is currently underway to determine whether enzyme replacement therapy can alleviate this burden. (See table below.)
PQP10
NEGATIVE AFFECTIVITY: A SIGNIFICANT
CONTAMINANT OF PATIENT REPORTED
HEALTH RELATED QUALITY OF LIFE
INSTRUMENTS (SF-36)
Reed PJ1, Moore DD2
1
University of Tennessee Health Science Center, Memphis, TN,
USA; 2Clemson University, Clemson, SC, USA
Negative affectivity (NA) has been shown to be strongly
and consistently correlated to patient reported, subjective
health indicators. Therefore, subjective health indicators
may or may not give an accurate assessment of the individual’s true health status. NA can be expected to act as a
general nuisance factor in health research, one that taps
organically spurious variance. The pervasive influence of
NA may confound the results and complicate the interpretation of health related quality of life instruments,
such as the SF-36. OBJECTIVE: The purpose of this
study was to evaluate the potential influence of NA on
the MOS SF-36. METHODS: We used Structural Equa-
Table for PQP9
SF-36 Scores
Physical Function
Role Physical
Bodily Pain
General Health
Vitality
Social Functioning
Role Emotional
Mental Health
FD Males
General US Male Population
(25th Percentile)
Gaucher Disease
(Untreated)
Stroke
Renal Disease
(Hemodialysis)
52
28
49
28
35
56
53
63
80
75
62
62
50
75
67
68
67
52
65
51
42
71
64
65
65
54
75
64
55
86
80
80
82
68
70
51
59
75
75
69
181
Abstracts
tion Modeling (SEM) techniques to evaluate the SF-36
and the impact of NA on the Mental and Physical Components in a sample taken from the 1990 National Survey of Functional Health Status (NHS). RESULTS: The
percent of shared variance of the Physical Health and
Mental Health indicators and the Physical and Mental
Health factors combined are physical function (.0603),
role physical (.0817), bodily pain (.0720), health perception (.0600), role emotional (.0486), vitality (.0756), general mental health (.5207) and social function (.0811).
General mental health (GMH) indicators are virtually
identical to NA indicators. The percent of shared variance of the NA/GMH factor and Physical Health and
Mental Health is .4422 and .9781 respectively. CONCLUSIONS: The present results suggest that about 47
percent of Physical Health and 98 percent of Mental
Health is due to the influence of NA/GMH. This may account for the lack of discriminative ability, shown in previous studies, of the Mental Health factor and Mental
Component Scale Score.
PQP11
THE HEALTH AND WORK QUESTIONNAIRE
(HWQ): AN INSTRUMENT FOR ASSESSING
WORKPLACE PRODUCTIVITY IN RELATION TO
WORKER HEALTH
Shikiar R1, Rentz AM2, Halpern MT3, Khan ZM4
1
MEDTAP International, Seattle, WA, USA; 2MEDTAP
Intertnational Inc, Bethesda, MD, USA; 3Charles River
Associates, Washington, DC, USA; 4GlaxoSmithKline,
Research Triangle Park, NC, USA
OBJECTIVE: Recently, interest has increased in productivity loss associated with medical conditions or health
behaviors that do not preclude attendance at work (e.g.,
migraine, smoking). Commonly, productivity loss is subjectively assessed (asking workers directly to report on
the productivity impacts of their medical conditions or
health behaviors) which may be problematic because certain illnesses or health behaviors are viewed as socially
undesirable. We describe the initial validation of a new
instrument, the Health and Work Questionnaire (HWQ)
that can be used in studies of worker health and productivity. METHOD: The HWQ consists of 24 items assessing work quality, quantity, efficiency, and related factors.
To minimize “social desirability” tendencies on the part
of respondents, they are asked to rate their work quality,
quantity, and efficiency from their supervisor’s and their
co-worker’s perspectives as well as their own. All items
have ten-point response scales. The initial questionnaire
was pretested by 30 subjects. Based on subject feedback,
no wording changes were deemed necessary. The HWQ
was administered to 294 employees of a major US airline
and was completed at baseline and at three subsequent
monthly intervals. Validation included comparisons with
two objective productivity measures collected by the airline: Time Lost, the average time a reservation agent is
unavailable between calls; and Total Performance Points,
the performance measure used for quarterly employee
evaluation. RESULTS: Six subscales were identified by
factor analyses: productivity, concentration/focus, supervisor relations, impatience/irritability, work satisfaction, and
non-work satisfaction. Internal consistency reliability values were high for all scales (0.84–0.96), with the exception
of impatience/irritability, displaying adequate reliability
(0.72). All HWQ scale scores correlated significantly with
the Time Lost measure; two scales correlated significantly
with the performance measure. The significant correlations
were all modest (0.12 to 0.22). CONCLUSIONS: With
other measures, the HWQ may be a useful instrument in
assessing group differences and evaluating the impact of
health interventions on work-place productivity.
NO SPECIFIC OR MULTIPLE DISEASESMETHODOLOGICAL ADVANCES
PMA1
METHODOLOGICAL ADVANCES IN THE
ASSESSMENT OF QUALITY OF LIFE IN
CLINICAL TRIALS
Hufford MR
Invivodata, Inc, Pittsburgh, PA, USA
Pharmaceutical science has moved away from focusing
exclusively on the impact of medications on physiological
parameters to a focus that includes the subject’s quality
of life (QoL). To date, QoL assessment has relied exclusively on global summaries that ask subjects to recall,
summarize, and evaluate their subjective QoL. New science-based methods using handheld technology to gather
QoL data can lead to more valid, reliable, and timely
QoL data. Many of the components of QoL, from subjective well-being to objective functioning, derive from an
interest in understanding a subject’s daily and momentary experiences. Rather than relying on broad summaries of experience, a ‘bottoms-up’ approach to QoL assessment directly measures subjects’ momentary QoL in
real-time, in the real-world. Until recently, researchers
did not have an efficient way to collect valid momentary
QoL data from subjects in their natural environment. Recent methodological advances in the science of patient
experience, termed Ecological Momentary Assessment
(EMA), make it possible to collect real-time QoL data
from subjects using electronic patient experience diaries.
This ‘bottoms-up’ approach using EMA methods extends
existing QoL measures by providing a unique perspective
on the extent to which subjects’ evaluations of various
moments in their lives reflect QoL changes over time. Recent empirical evidence suggests that this ‘bottoms-up’
approach may enhance the sensitivity of QoL assessment
in clinical trials. The new perspective EMA provides on
momentary patient experience represents a promising
methodological advancement in the study of QoL. In
combination with standard written assessments of QoL,
EMA data can provide a new perspective on the relationship between medication effects and QoL.
182
Abstracts
PMA2
DEVELOPMENT OF COST-EFFECTIVE
WEB-BASED OUTCOMES RESEARCH STUDIES
AND DISEASE MANAGEMENT PROGRAMS
Ambegaonkar AJ, Day D
Pfizer, Inc, Alexandria, VA, USA
Innovations in information technology are rapidly changing the health care market. With more and more clinical
trials being conducted and managed on the web, the Internet provides an opportunity for conducting effective
multi-center outcomes research studies and developing
disease management programs. OBJECTIVES: This research describes the development of a web-driven application for ongoing collection, analysis, and reporting of
outcomes research data. In addition, the web application
was developed to gain experience in provision of benchmarking reports to health care providers conducting disease management programs. METHODS: Given current
privacy regulations a multi-level security system with error checking was developed to assure integrity of data entering the system. Through integration of several programming languages (Visual Basic Script, Java Script, and
HTML) into web-based active server pages, a method for
immediate data collection, summary, and on-demand reporting was successfully developed. The system was deployed remotely via an Internet Service Provider. A prospective multi-site (10) hospital based infectious disease
study of fungal risk and treatment patterns; and a retrospective lipid/cardiology clinic based study of patient care
was conducted using the above technology. RESULTS:
For expenditures of less than $1,000, secure web applications were developed that provided electronic data capture of all study variables. The customizability of the program allowed for developing applications for differing
disease states thereby reducing set-up costs and improving
efficiency. Simultaneous multi-site training and minimal
data entry errors further reduced costs. The applications
also provided real-time reports that enhanced patientcare and reported practice patterns that highlighted national and regional variations. CONCLUSIONS: The
success of these studies has demonstrated the utility of
the internet in providing health care practitioners with a
cost-effective tool for efficiently conducting multi-center
outcomes research and disease management. Considering
the increasing popularity and access to the Internet, this
research has significant implications for outcomes research and disease management.
PMA3
DOES WHERE YOU LIVE AFFECT IF AND HOW
YOU DISCOUNT FUTURE COSTS AND
BENEFITS IN ECONOMIC EVALUATION?
SHOULD IT?
Faulkner LA1, Gafni A2, O’Brien BJ1
1
Centre for Evaluation of Medicines, St Joseph’s Hospital,
McMaster University, Hamilton, ON, Canada; 2McMaster
University, Hamilton, ON, Canada
OBJECTIVES: An accepted practice with unresolved issues in economic evaluation is the discounting of future
costs and benefits. Many people conducting evaluations
view discounting as a technical matter and look to guidelines for the proper rate. Therefore, we ask three questions about international guidelines: 1) what discount
rate(s) are recommended; 2) do they differ for costs and
health outcomes; 3) what is the underlying theory for discounting and rationale for the rate(s)? METHODS: We
review recommendations about discounting in international guidelines according to underlying theory used to
recommend discounting, suggested rates, rationale for
particular rates, whether a different rate was suggested
for health outcomes, and what literature was cited. RESULTS/CONCLUSION: Australia, Canada, and Ontario
recommend discounting costs and health outcomes at
5%, the US 3%, New Zealand 10%, and the Netherlands
4%, while the UK recommends 6% for costs and 1.5%
for health outcomes. Most countries recognize the controversy, yet remain unconvinced that health outcomes
should be discounted at different rates. While the primary stated underlying theory for discounting is time
preference, the rationale (if provided) for the particular
rates recommended varies across countries. Most often, it
relies on empirical estimates of government bond rates
and/or notions of international consistency reflecting potentially conflicting principles. Implicit appeals to measure pure time preference also exist; however, this may
not be measurable if time and health are inextricably
linked. Furthermore, some health outcome measures may
already include individuals’ time preferences potentially
leading to double discounting. Implications will be discussed.
PMA4
AN ECONOMIC PROOF AND APPLICATION
THAT FORMULARY RESTRICTIONS WITHIN
DRUG CLASSES ALWAYS RESULT IN
HIGHER COSTS
Simons WR
Global Health Economics & Outcomes Research, Inc, Short
Hills, NJ, USA
Pharmaceutical benefit providers use restrictive formularies to control health care expenditures for drugs. One
type of restriction requires the use of one drug before the
use of another drug within the same drug. OBJECTIVE:
Test the hypothesis that restrictive formularies lower expenditures for pharmaceuticals. METHOD: We use expected utility theory to derive equations for the restrictive
and unrestrictive formulary cases where the equations
take into account effectiveness (i.e., the probability of
attaining treatment goal and not attaining goal), alternatives if treatment fails and costs of each scenario. Administrative costs are assumed zero. We prove mathematically that restrictive formularies within drug classes
always cost more. Moreover, even if all drugs in the therapeutic class are equal in effectiveness and equal in cost,
183
Abstracts
the restrictive formulary will still always be more costly
than the unrestrictive one. We then allow effectiveness
and costs to vary and derive equation to calculate the
cost of a restrictive formulary in those cases. We derive
the equations for patients with various distributions of
baseline severity. Last, we apply the equations and actual
effectiveness and cost data to the case of atypical antipsychotics where Ontario and British Columbia Provincial formularies have mandated that risperidone be prescribed before quetiapine or olanzapine. RESULT: The
cost of the restrictive status would range from $0.87–
0.97 per patient per day with mild symptoms treated
with risperidone, $2.65–3.30 for patients with moderate
symptoms and $5.14–5.73 for patients with severe symptoms. The range depends on effectiveness rates. Even if
all drug costs were equal and the efficacy rates were all
80 percent, the cost per patient per day for the restrictive
status of quetiapine would be $0.66–0.71, $1.12–1.41,
$1.67–2.26 for risperidone patient with mild moderate
and severe symptoms. CONCLUSION: To our knowledge this is the first proof and practical application. Restrictions were removed in both provinces.
PMA5
A RISK ADJUSTMENT METHODOLOGY FOR
CLAIMS DATA
Wilson P, Yuan Y, Dowse BT
IMS Health, Plymouth Meeting, PA, USA
OBJECTIVES: To develop a risk adjusted outcomes measurement system that compensates for the lack of clinical
information in the claims data by dividing diseases into
different stages according to the severity at various stages
of the disease progression and the presence of other conditions and procedures coded in the claims database.
METHODS: The data sources used were Medicare and
a large employer’s claims databases, which covered approximately 12 million and 130 thousand hospitalizations per year respectively. Rigorous data validation
processes were applied to ensure data validity. Our methodology was based on the research completed by JS Gonnella, et.al,, (1987) “A Clinically Based Approach to
Measurement of Disease Severity”, sponsored by National Center for Health Services Research, which classified diseases and combinations of diseases into different
stages according to severity. Our risk adjustment system
applied this approach to the principle diagnosis, secondary diagnoses and procedures coded in the claims data, to
derive severity measurements for each hospitalization. In
addition, we adjusted for the number of body systems involved, patient age, gender and other factors. Outcomes
measurement included mortality, potentially avoidable
complications, length of hospital stay, total charges and
total cost. For each DRG group, logistic regression and
multiple regression models were developed from the
Medicare claims data to create risk adjusted norms.
Models were checked for statistical and clinical validity.
RESULTS: The model outputs were applied to the large
employer’s claims data to score each patient for each outcome measurement. The results allowed for multi-dimensional comparisons on quality measurements and resource utilization measurements for all the hospitals in
the large employer’s database. CONCLUSIONS: The
uniqueness of our methodology was that it adjusted for
severity of diseases at various stages and combinations of
diseases and number of body systems involved. It provided a more accurate means for risk adjustment than
currently available.
PMA6
THE REDUCTION OF SAMPLE SIZE FOR A
COST-EFFECTIVENESS TRIAL USING A
NEW METHOD: THE EIGHT CASES IN JAPAN
Kamae I, Yanagisawa S, Nakahara N
Kobe University, Kobe, Japan
At ISPOR’s Third Annual European Conference, we presented a new formula that can naturally extend the traditional formula for sample-size calculation of a clinical
trial, considering the cost-effectiveness ratios for two regimens A and B. OBJECTIVE: According to the formula,
to explore applicability and validity of such a theoretical
framework in real clinical trials, and then show the benefit which the new formula brings in terms of designing a
prospective cost-effectiveness trial. METHODS: We
searched and reviewed the published Japanese articles
these ten years that reported socioeconomic evaluation of
pharmaceuticals based on a clinical trial for two regimens: a new treatment and an old one. Subsequently we
assessed the applicability and the validity of our formula
in the context of such reviewed articles, and then if the
formula could be applied, we calculated two sample
sizes: considering effect only vs. cost-effectiveness. RESULTS: We reviewed eighteen Japanese articles which
conducted cost-effectiveness analysis using modeling or
retrospective cost evaluation after clinical trials except
one prospective study. Of these eight were selected as applicable for our formula. In all of them we found that the
sample size for one regimen, considering effect only vs.
cost-effectiveness, can be reduced such as 1534 to 5 at
the best, and 632 to 319 at the worst ratio. CONCLUSION: In the eight published Japanese studies, the sample
size of each clinical trial considering effect only could actually be reduced if such studies are to be designed in advance as a prospective cost-effectiveness trial considering
the difference of the cost-effectiveness ratios of two regimens.
PMA7
CONTROLLING FOR BIASES FROM
MEASUREMENT ERRORS IN HEALTH
OUTCOMES RESEARCH USING STRUCTURAL
EQUATION MODELING
Shi J, McCombs J, Hay J, Nichol M, Chou CP, Hsiao C
University of Southern California, Los Angeles, CA, USA
184
Abstracts
OBJECTIVES: Measurement errors in independent variables may lead to attenuated estimates of their effects and
may contaminate estimates for other covariates in conventional linear regression models (LRM). However, the
direction and magnitude of these biases are difficult to
determine theoretically. Measurement error is a serious
problem in health services research as health status is a
latent variable that can only be measured with error using proxy variables. This study empirically evaluated the
validity of LRM models in health outcomes research.
METHODS: SEMs with a latent health construct are
proposed and compared with LRM models to examine
the bias of measurement errors in general health status
using data from a study of the impact of pharmacist’s
consultation on both health outcomes and costs (KP/USC
study). Perceived health status at a given time point was
modeled as a latent variable measured by the multiple
scales of the SF-36. RESULTS: The latent health construct with multiple scales of the SF-36 and its SEMs for
health outcomes and costs are empirically supported by
the KP/USC data. SEM estimations of the latent health
construct in both the measurement model and the structural model were all statistically significant with expected
signs. As predicted, LRM estimates for the SF-36 scales
were attenuated. However, there is no strong evidence
that LRM estimations of treatment effect were contaminated by the measurement errors in the SF-36 or that the
simultaneity between health outcomes and costs. CONCLUSIONS: Measurement errors in health status variables may result in attenuated estimates of health status
effects on patient outcomes. Fortunately, careful study
design can eliminate the contamination of treatment effect estimates due to errors in measuring health status.
Moreover, SEM methods can be used to control both attenuation and resonation biases.
PMA8
DEVELOPMENT OF A CHRONIC DISEASE
INDICATOR USING A MANAGED
CARE POPULATION
Malone DC1, Raebel MA2,3
1
University of Arizona, Tucson, AZ, USA; 2Kaiser Permanente
of Colorado, Denver, CO, USA; 3University of Colorado
School of Pharmacy, Denver, CO, USA
OBJECTIVES: Accurate determination of disease prevalence in large patient populations is difficult. The objective of this research was to use pharmacy data to develop
an index that estimates the presence and number of
chronic diseases in a managed care population. METHODS: An expert panel evaluated 246 specific medication
classes as to their likelihood to be indicative of a chronic
disease. Those classes identified were then compared
against medical records from two random samples of
persons 18 years of age or older continuously enrolled for
at least one year in a health maintenance organization.
One sample was drawn from all eligible persons (n 5
137), while the other sample was restricted to individuals
50 years of age or greater (n 5 138). A cumulative number of chronic conditions was designated the chronic disease index (CDI). Sensitivity and specificity were calculated for those conditions with prevalence greater than
10% based upon medical record review. RESULTS: The
expert panel designated 54 drug classes as containing
medications used to treat chronic conditions. A total of
5640 medications were dispensed over a 1 year period for
the 275 subjects. The average total number of chronic
conditions via medical record review was 2.89 1 2.07,
compared to 1.33 1 1.21 chronic conditions estimated
by medication use. The CDI correlated well with the
number of chronic conditions found via record review
(r 5 0.735, p , 0.0001). The specificity of pharmacy
records to indicate the presence of hypertension, dyslipidemia, depression, and diabetes was 79.9%, 99.0%,
90.2%, and 99.6%, respectively. The sensitivity was
90.9%, 49.9%, 77.5%, and 62.2% for hypertension,
dyslipidemia, depression, and diabetes, respectively. CONCLUSIONS: The CDI correlates well with documented
chronic conditions. Pharmacy data can be useful in identifying persons with diagnoses of hypertension, dyslipidemia, depression, and diabetes.
PMA9
BAYESIAN OR CLASSICAL DESIGN AND
ANALYSIS: DOES IT MAKE A DIFFERENCE??
Bloom BS
University of Pennsylvania, Philadelphia, PA, USA
INTRODUCTION: The utility of research results is measured primarily by its effects on decisions. Underpinning
research are methods appropriate to the question or hypothesis. The role of Classical and Bayesian approaches
remains in dispute in health services research. The goal of
this study was to determine if results differ when both
analytic techniques are used with the same dataset.
METHOD: We searched MEDLINE and related databases for English-language articles published 1 January
1978 through 31 August 1999. We combined Bayesian
and Classical statistics search terms, and their variants,
with randomized control trials (RCTs) and meta analyses. RESULTS: Searches found 18 studies in 14 publications that met all criteria for review—9 RCTs, 8 meta-analyses and 1 epidemiological estimate. Statistical analyses
using both methods agreed in 5 RCTs, 4 meta-analyses,
and for the epidemiological estimates. For 4 RCTs where
results disagreed, Classical analysis the experimental intervention was efficacious compared to the control and
Bayesian reanalysis concluded the experimental intervention was not proven efficacious. Classical meta-analyses
of the four studies where results disagreed concluded the
experimental intervention was not better than the control; Bayesian reanalysis concluded the intervention was
efficacious. CONCLUSION: The conventional wisdom
that Classical and Bayesian methods will give similar answers is not supported by this study. Disagreement on
many fundamental beliefs between Classical and Baye-
185
Abstracts
sian statistics means continuing debate. One way to resolve this debate is for proponents of each technique to
decide together the circumstances for use of each method
and analytic framework. If the experts do not agree on
the methodological requirements, other decision-makers
likely will force their own views, driven mainly by other
pressures like cost control.
PMA10
DESCRIPTION OF COST/EFFECTIVENESS
RATIO DISTRIBUTIONS
Kim S, Moeschberger M, Pathak D
The Ohio State University, Columbus, OH, USA
BACKGROUND: Health economic evaluation systematically analyzes all inputs and outputs of treatment, and
suggests the most effective alternatives for given resources. Results of a cost-effectiveness analysis are summarized in a series of cost-effectiveness (C/E) ratios. Little
is known about the distributions of C/E ratio estimates.
Hence, there is a lack of statistical tests for the C/E ratios.
OBJECTIVE: This study is to describe the characteristics
of C/E ratio distribution. Since the cost and effect distributions frequently follow the normal, lognormal, and
gamma distributions, the ratio distributions are formed
by some combination of them. METHODS: In describing
the ratio distribution, the probability density functions
(PDF) of the ratio distributions are derived if they exist. If
the closed form of the PDF does not exist, the ratio distributions are presented graphically. RESULTS: First, the
ratio distributions take on a variety of shapes depending
on the coefficient of variation of their denominator distribution. Most of the time, the ratio distributions have the
bell shape with, or without, a heavy right tail. However,
the ratio distribution could even be bimodal if the coefficient of variation of denominator was very large. Second,
the correlation between numerator and denominator of
the C/E ratio significantly affects the distribution shapes
and locations. Since the numerator and denominator are
allowed to be correlated, this derived PDF is more general and practical than the Cauchy distribution. Third,
the ratio distributions formed from the combination of
gamma and lognormal distributions are all skewed to the
right. CONCLUSIONS: The C/E ratio distributions are
not always bell shape nor symmetric. The ratio distributions take on a variety of shapes depending on the coefficient of variation of their denominator distribution and
the correlation coefficients between numerator and denominators.
PMA11
COMPARISON OF STATISTICAL TESTS FOR THE
COST/EFFECTIVENESS RATIOS
Kim S, Moeschberger M, Pathak D
The Ohio State University, Columbus, OH, USA
BACKGROUND: Results of a cost-effectiveness analysis
are summarized in a series of cost-effectiveness (C/E) ratios. As with other statistics, the C/E ratio is subject to
sampling variation. However, constructing a confidence
interval for the cost-effectiveness ratio is complicated because both numerator and denominator of the ratio are
stochastic in nature. Several statistical methods have been
proposed lately, yet, the systematic method of handling
uncertainty is generally underdeveloped in economic evaluation. OBJECTIVE: This study is to compare the statistical methods proposed in constructing confidence intervals for the various ratio distributions, for the various
correlation coefficients between numerator and denominator, for the various coefficient of variations, and the
various sample sizes. METHODS: The ratio distributions
are formed from the combinations of normal, log normal, and gamma distributions, which frequently arise in
cost-effective studies. In evaluation the performance of
statistical methods, a simulation study was conducted for
the various ratio distributions. For each sample, the confidence intervals were constructed by five statistical procedures; the Box, Taylor’s, Fieller’s, bootstrap, and jackknife methods. RESULTS: First, since the ratio distributions
are largely dependent on the distribution of its denominator, none of the statistical tests work if the mean of denominator is close to zero. Second, if the sample size is
small, none of the statistical tests perform well enough regardless of correlation and coefficient of variation. Third,
for the large sample size, all methods, except the box
method, constructed the confidence interval well. Among
them, Fieller’s method is the first choice of selection for
the estimation of the confidence interval. CONCLUSION: None of the statistical tests work if the mean of
denominator is close to zero. This is problematic for Incremental Cost-effectiveness Ratio (ICER). If the “net effect” of the new procedure is insignificant, then the statistical test for the ICER is not stable.
PMA12
RELATIONSHIP BETWEEN NONPARAMETRIC
RECEIVER OPERATING CHARACTERISTIC
ANALYSIS AND A LIKELIHOOD-RATIO TEST
FOR MODEL SELECTION: I. A MONTE CARLO
SIMULATION USING CONTINUOUS DATA
Shaw JW, Horrace W, Coons SJ
The University of Arizona, Tucson, AZ, USA
BACKGROUND: Receiver operating characteristic (ROC)
analysis is frequently used to assess the accuracy of diagnostic tests. The area under an ROC curve (AUC) is indicative of the extent to which a measure correctly classifies true-positive and true-negative subjects. DeLong et
al. (Biometrics 1988; 44: 837–845) have proposed a
method for comparing nonparametric ROC curves derived from the same set of cases. In a small study using
data from a naturalistic investigation, DeLong’s test
yielded results that were consistent with those of a likelihood-ratio test for model selection developed by Vuong
186
Abstracts
(Econometrica 1989; 57: 307–333). OBJECTIVE: To
confirm our previous findings, a Monte Carlo simulation
was undertaken to assess the relative performance of DeLong’s and Vuong’s tests in samples of varying sizes.
METHODS: One thousand observations were randomly
generated for a Bernoulli dependent variable and 11 normally distributed independent variables. Bootstrapped estimates for AUC and logistic regression model log-likelihood (LL) were derived using 500 replications of sample
size 10, 25, 50, 100, 175, 250, and 500. At each sample
size, predictors were compared on the basis of AUC using
DeLong’s test and model LL using Vuong’s test. The random number seed was set so that identical samples were
compared with each test. RESULTS: In general, the two
tests yielded similar statistical conclusions. The observed
power of Vuong’s test was slightly less than that of DeLong’s test. There were only two cases in which the tests
yielded different results, and these occurred in small samples. CONCLUSIONS: Though slightly less powerful
than DeLong’s test, Vuong’s test may be applied in cases
where the dependent variable has more than two levels. It
is also easier and takes much less time to perform than
DeLong’s test. Given these advantages, Vuong’s test may
be preferred to ROC-based tests in larger samples.
PMA13
RELATIONSHIP BETWEEN NONPARAMETRIC
RECEIVER OPERATING CHARACTERISTIC
ANALYSIS AND A LIKELIHOOD-RATIO TEST
FOR MODEL SELECTION: II. A MONTE CARLO
SIMULATION USING DISCRETE DATA
Shaw JW, Shahriar J, Horrace W
The University of Arizona, Tucson, AZ, USA
BACKGROUND: In a simulation using continuous data,
we compared the performance of DeLong’s test for nonparametric receiver operating characteristic (ROC) curves
(Biometrics 1988; 44: 837–845) with that of Vuong’s test
for model selection (Econometrica 1989; 57: 307–333).
Both tests were found to yield similar results regardless of
sample size. Diagnostic tests are often measured on an ordinal rating scale, and nonparametric methods tend to
underestimate the area under the ROC curve (AUC) when
used with discrete data. Thus, it was conceivable that
level of measurement might influence the performance of
DeLong’s test. OBJECTIVE: A second Monte Carlo simulation was performed to determine whether DeLong’s
and Vuong’s tests behave differently when used with discrete data. METHODS: One thousand observations were
randomly generated for a Bernoulli dependent variable
and 11 binomial independent variables. The independents were generated such that realizations were integers
ranging from 1–10. Bootstrapped estimates for AUC and
logistic regression model log-likelihood (LL) were derived
using 1000 replications of sample size 10, 25, 50, 100,
175, 250, and 500. At each sample size, predictors were
compared on the basis of AUC using DeLong’s test and
model LL using Vuong’s test. The random number seed
was set so that identical samples were compared with
each test. RESULTS: In general, the two tests yielded
similar statistical conclusions. Asymptotically, the observed power of Vuong’s test was greater than that of DeLong’s test. In smaller samples, however, Vuong’s test
was slightly less powerful. The results of the two tests diverged in only three cases in small samples. CONCLUSIONS: The results of this analysis correspond to those of
our simulation using continuous data. Though slightly
less powerful than DeLong’s test, Vuong’s test is more
flexible and is less time consuming. Given the results of
both simulations, Vuong’s test appears to present a useful
alternative to ROC analysis for comparing the accuracy
of diagnostic tests.
PMA14
BAYESIAN DECISION ANALYSIS IN OUTCOME
STUDIES WITH SMALL NUMBERS OF EVENTS: A
SIMULATION BASED PREDICTION APPROACH
Wang J, Davey P, MacDonald T
University of Dundee, Dundee, Scotland
BACKGROUND: Decisions are often based on relative
risk and their asymptotic properties, which is not reliable
when the number of events is small. Moreover, clinical
decision-making primarily depends on individual risk of
adverse outcome rather than relative risk. Bayesian decision analysis predicts individual outcome, is valid for
small samples and can include decision-maker’s prior
knowledge into the analysis. METHOD: We analysed
data about gastrointestinal adverse events of medium and
high doses of ibuprofen in a population of 46,249 patients. We used a Bayesian method based on expected
utility with a utility function EFF 2 q L(No. Events).
Where EFF is the efficiency, L is a quadratic function representing the risk of Adverse Outcome and q represents
relative importance of the risk. Bayesian value of information (VOI) of additional observations of a particular
subgroup was calculated. Markov Chain Monte Carlo
procedure and software BUGS were used to fit a Poisson
regression model to adjust for confounders. RESULT:
There were 1 and 5 G.I. events in high and medium dose
groups (relative risks, RR 5.26 and 2.36 respectively).
The Bayesian mean log-RR between high and medium
was 0.41 (95%CI 22.72, 2.58). Assuming that the
higher dose had 20% higher efficiency, we found that
medium dose is preferable when q is larger than 15. VOI
of additional observations was calculated for a range of q
and showed that additional observations of the higher
dose would be most valuable. For example, when q 5 50
the VOI of an additional subgroup of 1000 person-years
exposure was 15% for high doses but only 3% for medium doses. CONCLUSION: In comparison with the
classical approach for drug safety or other outcome studies, Bayesian methods provides much more information
to assist decision-making, especially when the number of
events is small.
187
Abstracts
PMA15
CONDUCTING PHARMACOECONOMIC
RESEARCH IN THE ABSENCE OF
COUNTRY-SPECIFIC DATA
Miller B1, Rosner AJ2, Becker DL2
1
Pharmacia Canada, Mississauga, ON, Canada; 2Innovus
Research Inc, Burlington, ON, Canada
In an ideal world, appropriate pharmacoeconomic evidence would be collected to meet the needs of the local
reimbursement environment. Unfortunately, due to clinical research limitations and time constraints, we are often
faced with a lack of the necessary data. OBJECTIVE: Using an anti-infective as our case study, we present an approach that we developed to overcome the challenge of
creating an economic argument for Canadian hospital
setting in the absence of country-specific data. METHODS: Our methodology involved a multi-step approach:
(i) hospital formulary committee members were consulted to identify the submission requirements; (ii) a
panel of experts were surveyed to understand local treatment patterns; (iii) the survey results were used in a case
modeling exercise to determine the applicability of the
randomized clinical trial (RCT) protocol to the Canadian
environment; and (iv) a chart review was undertaken to
validate results of the case modeling exercise. RESULTS:
Hospital formulary committees preferred Canadian-specific evidence of a new product’s economic value. Committee members were generally unfamiliar with pharmacoeconomic concepts and preferred that a complicated
economic model not be used. Results of the expert survey
indicated that there are important differences between
the RCT protocol and Canadian treatment patterns.
These differences include restrictive inclusion/exclusion
criteria, an excess of protocol-driven tests and procedures, and treatment strategies that are not necessarily reflective of real-life. The case modeling exercise allowed
for a structured method to hypothesize on the real-world
impact of the product. An ongoing chart review will be
used to confirm these hypotheses. CONCLUSIONS: It is
anticipated that issues surrounding the absence of country-specific data will continue to plague researchers for
the foreseeable future. Use of this multi-step approach
provides a rigorous method for making conclusions in
the absence of locally acquired evidence.
betics. METHODS: The panel consisted of 7 physicians
(three family physicians, two internists and two endocrinologists) who were randomly selected from a pool of
high-volume prescribers. The panel was contacted by
phone and upon acceptance, they were mailed a 63-item
questionnaire cover clinical criteria for treatment management, adherence to diabetes guidelines, decision rules
for failure treatment, resource use and tests requested for
drug-naïve and previously treated patients. The questionnaire was developed based on literature review and pilottested between two clinicians for appropriateness. The
ratings were done using a 5-item Likert scale ranging
from “strongly agree” to “strongly disagree”. RESULTS:
All participating physicians completed the questionnaire.
Endocrinologists and internists follow the American Diabetes Association guidelines (ADA). Only two family
physicians use the ADA guidelines. The main assumptions for the pharmacoeconomic model coincided with
the experts’ opinion, such as the initial treatment for a
drug-naïve type 2 diabetic patient is monotherapy and after its failure an increased dose followed by addition of
another treatment is recommended. Treatment adjustment is based on glycosylated hemoglobin, post-prandial
glucose or fasting plasma glucose. For any treatment
changes, patient should visit physician office but they are
not usually hospitalized. The presence of side effects is an
indication to decrease the dose. Number and type of laboratory tests are independent of drug-naïve status. There
are no differences in the criteria used for treatment selection and treatment changes between drug-naïve patients
and previously treated patients. Furthermore experts do
not recommend switching medications. CONCLUSIONS:
An expert panel is a useful tool to assess model assumptions.
PMA17
THE EUROPEAN SERVICE MAPPING SCHEDULE
(ESMS): A NEW INSTRUMENT FOR MENTAL
HEALTH SERVICES RESEARCH, RESULTS OF A
FRENCH STUDY
Azorin JM1, Goudemand M2, Toumi M3, Johnson S4,
Pettersson Å3
1
CHU Sainte Marguerite, Marseilles, France; 2Centre
Hospitaliser USNB, Lille, France; 3Lundbeck SA, Paris, France;
4
Whittington Hospital, Department of Psychiatry & Behavioural
Sciences, London, UK
PMA16
CONFIRMATION OF THE DECISION RULES AND
ASSUMPTIONS FOR A MODEL OF DIABETES
TREATMENT USING AN EXPERT PANEL
Caro J1, Salas M1, Ward A1, Sung J2, Shah A2
1
Caro Research Institute, Concord, MA, USA; 2Novartis
Pharmaceuticals Corporation, East Hanover, NJ, USA
OBJECTIVE: To assess systematically, using a panel of
physician experts, the assumptions made for a pharmacoeconomic model regarding the indications, treatment initiation and decision rules for management of type 2 dia-
OBJECTIVES: When comparing patient management
and patient outcomes, the available services within a
catchment area appear to be a major confounding factor.
The ESMS aims to classify services and measure their activity in a standardized way, which opens new opportunities to adjust for service offer. The ESMS allows to map
the services available in a set of catchment areas and to
identify different profiles. In addition we evaluate the accuracy of the French standardized classification of mental
health services and the applicability of the instrument in
France. METHODS: 171 services in 24 catchment areas
188
Abstracts
were involved in the study, which focused on the French
public mental health care system. Each service was classified according to the ESMS and data were collected on
service use. The data for each catchment area were aggregated in residential use, structured day activities, continuous out patient care and emergency out patient care, then
a cluster analysis was performed. The ESMS classification of the services based on function was compared to
the official French description of services. RESULTS:
Four classes were identified: Class 1 high activity in all
services, class 2 low activity in all services, class 3 low activity in continuous ambulatory care, class 4 high activity
in continuous ambulatory care. The ESMS confirmed the
consistency between the French official description of the
services’ missions and the actual activity. 10% of the services had at least one additional “non official” function.
The study showed that the ESMS was adapted for use in
France, but it requires expert supervision for large-scale
implementation. CONCLUSIONS: The ESMS proves to
be useful not only in mental health service research, but
can also bring the possibility to adjust for the catchment
area’s service profile in outcomes research.
PMA18
THE AVANDIA WORLDWIDE AWARENESS
REGISTRY (AWARE®): AN INTERNET-BASED
PROGRAM FOR EVALUATION OF CLINICAL,
HUMANISTIC AND ECONOMIC OUTCOMES OF
PATIENTS WITH TYPE 2 DIABETES
Bakst A1, Meletiche DM1, Arnold R2, Harjono H2, Najib M2,
Cobitz A1
1
GlaxoSmithKline, Collegeville, PA, USA; 2Pharmacon
International, Inc, New York, NY, USA
AWARe® is an Internet-based database designed to capture clinical and humanistic outcomes from diabetes
practice settings around the world. The main goal of
AWARe® is to better understand how patients with type
2 diabetes respond to different treatments in a naturalistic environment. OBJECTIVE: To describe an innovative
method of collecting clinical, humanistic and economic
outcomes of patients with type 2 diabetes in a “real
world” practice setting. METHODS: The data collection
methods involve the electronic linkage of clinical information and humanistic outcomes of patients with type 2
diabetes. Patients at least 18 years of age who are maintained on oral antidiabetic therapy are eligible to participate in AWARe®. As providers enter patients’ clinical information into the patient’s electronic medical record, the
data elements of interest are automatically transmitted to
a secure Internet site (Pharmacon EB-HealthTM) where the
data are stored and continuously updated. Data collected
in AWARe® include: demographic information, prescription use, HbA1c, fasting plasma glucose, total cholesterol, triglycerides, LDL, HDL, blood pressure, liver
function tests, the SF-36, and the Diabetes and Treatment
Satisfaction Questionnaire (DTSQ). Every six months,
participants use hand-held devices to complete the elec-
tronic versions of the SF-36 and the DTSQ. The results
from these surveys are instantaneously transmitted via
wireless technology to EB-HealthTM. CONCLUSION:
AWARe® permits immediate retrieval of clinical and humanistic information from an Internet-based registry. Information on the patient’s clinical progress may be continuously transmitted to EB-HealthTM, allowing researchers,
clinicians and administrators to perform “real time”
analyses of the clinical effectiveness of antidiabetic therapy, as well as to determine its impact on patients’ quality of life and satisfaction with treatment. As AWARe® is
expanded to sites around the US and throughout the
world, it will provide valuable information on the impact
of the different treatments for type 2 diabetes on patients’
clinical, humanistic and economic outcomes.
CONTRIBUTED
WORKSHOP
PRESENTATIONS
WW1
METHODOLOGICAL COMPLEXITIES IN USING
ADMINISTRATIVE CLAIMS DATABASES TO
EVALUATE QUALITY OF CARE FOR
ATTENTION-DEFICIT/HYPERACTIVITY
DISORDER
Hankin CS1, Wright AT2
1
ALZA Corporation, Mountain View, CA, USA; 2Advance PCS,
Hunt Valley, MD, USA
OBJECTIVES: Attention-deficit/hyperactivity disorder
(ADHD) is one of the most prevalent of childhood mental disorders, and represents the most common reason
children are referred to mental health providers.
PARTICIPANTS WHO WOULD BENEFIT: Researchers who use large-scale administrative databases to evaluate quality of care for mental disorders and associated
patient outcomes. Purchasers of health care who provide
health services to patients with psychiatric disorders.
The presence of the disorder is associated with substantial health resource utilization and costs. Although evidence-based guidelines for the pharmacologic treatment
of ADHD are widely available, little is known about variation in provider prescribing practices, patient compliance, and attendant patient health outcomes. This is especially problematic because psychostimulants, commonly
prescribed for ADHD as a daily regimen, are frequently
taken solely on an “as needed” basis to improve behaviors during school hours. We are currently conducting a
program of research using large-scale, national, integrated pharmacy benefits and medical claims databases
to examine the quality of ADHD pharmacologic care, patient compliance, and associated patient outcomes. The
objectives of this workshop are to discuss the complexi-