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Disparities in erythropoiesis-stimulating agent use after changes in medicare reimbursement and implementation of a risk evaluation and mitigation strategy

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Abstract

Introduction

The use of erythropoiesis-stimulating agents (ESAs) for treatment of chemotherapy-induced anemia (CIA) has been linked to potential negative health effects. Additionally, research has identified disparities in ESA utilization for CIA treatment. This study examines (1) health disparities in ESA use and (2) whether reimbursement (Medicare National Coverage Determination [NCD]) or regulatory (Risk Evaluation and Mitigation Strategy [REMS]) policies impacted disparities.

Methods

In a retrospective cohort study (2006–2018) among 1,747,889 patients with cancer in the United States receiving myelosuppressive chemotherapy at age ≥ 65 years, differences in ESA use for CIA were estimated using generalized estimating equation models, adjusting for policy periods, demographic characteristics, and clinical factors extracted from Medicare claims data.

Results

After controlling for covariates, ESA use was higher among Black, female, and urban patients in all policy periods, but these disparities decreased significantly following the NCD. The gap continued to close through the REMS period. Disparities in ESA use across geographic regions were modest, and ESA use disparities across socioeconomic characteristics (area deprivation index or dual Medicare/Medicaid eligibility) were not observed.

Conclusions

Being female, Black, or an urban resident was associated with higher ESA use for CIA in older patients with cancer. Both NCD and REMS implementation helped reduce disparities. REMS release was not observed to contribute to racial, sex, and rural–urban disparities in ESA use for CIA.

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Authors and Affiliations

  1. Office of Surveillance and Epidemiology, CDER, FDA, 10903 New Hampshire Ave., Silver Spring, MD, 20993-0002, USA

    Hui-Lee Wong, Amarilys Vega & David J. Graham

  2. Office of Biostatistics, CDER, FDA, Silver Spring, USA

    Rongmei Zhang

  3. Acumen LLC, Burlingame, USA

    Bradley Lufkin, Yuhui Feng, An-Chi Lo, Manzi Ngaiza, Michael Wernecke & Thomas E. MaCurdy

  4. Office of New Drugs, CDER, FDA, Silver Spring, USA

    Qin Ryan

  5. Department of Economics, Stanford University, Stanford, USA

    Thomas E. MaCurdy

  6. Centers for Medicare and Medicaid Services, Washington DC, USA

    Jeffrey A. Kelman

Authors
  1. Hui-Lee Wong
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Corresponding author

Correspondence to Hui-Lee Wong.

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Author contributions

Conceptualization: all authors; Methodology: Hui-Lee Wong, Rongmei Zhang, Bradley Lufkin, Yuhui Feng, An-Chi Lo, Manzi Ngaiza, Michael Wernecke, Qin Ryan, Amarilys Vega, David Graham; Resources: Hui-Lee Wong, Michael Wernecke, Thomas MaCurdy, David Graham; Formal analysis and investigation: All authors; Writing—original draft preparation: Hui-Lee Wong, Rongmei Zhang, Bradley Lufkin, Yuhui Feng, An-Chi Lo, Manzi Ngaiza, Michael Wernecke, Qin Ryan, Amarilys Vega, David Graham; Writing—review and editing: all authors; Study supervision: Hui-Lee Wong, Bradley Lufkin, Michael Wernecke, Thomas MaCurdy, David Graham.

Data availability

The datasets generated during and/or analyzed during the current study are not publicly available due to privacy and ethical restrictions.

Ethics approval

This is a retrospective observational study. No IRB approval is required.

Consent to participate

Not applicable.

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Not applicable.

Code availability

Not applicable.

Conflict of interest

The authors have no relevant financial or non-financial interests to disclose.

Funding

This study was funded through an intra-agency agreement between the Centers for Medicare & Medicaid Services and the US Food and Drug Administration.

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Wong, HL., Zhang, R., Lufkin, B. et al. Disparities in erythropoiesis-stimulating agent use after changes in medicare reimbursement and implementation of a risk evaluation and mitigation strategy. Drugs Ther Perspect 39, 29–39 (2023). https://doi.org/10.1007/s40267-022-00969-9

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