1. Trends in <scp>Erythropoiesis‐stimulating</scp> agent use and blood transfusions for <scp>chemotherapy‐induced</scp> anemia throughout <scp>FDA</scp> 's risk evaluation and mitigation strategy lifecycle
- Author
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Jeffrey A. Kelman, Bradley Lufkin, Hui-Lee Wong, Thomas E. MaCurdy, Rima Izem, David J. Graham, An-Chi Lo, Amarilys Vega, Qin Ryan, Rongmei Zhang, Yuhui Feng, Michael Wernecke, and Michael Alexander
- Subjects
medicine.medical_specialty ,Chemotherapy ,Epidemiology ,business.industry ,medicine.drug_class ,Anemia ,medicine.medical_treatment ,Retrospective cohort study ,Erythropoiesis-stimulating agent ,medicine.disease ,030226 pharmacology & pharmacy ,Risk evaluation ,03 medical and health sciences ,0302 clinical medicine ,Erythropoietin ,hemic and lymphatic diseases ,Concomitant ,Emergency medicine ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,business ,Medicaid ,medicine.drug - Abstract
PURPOSE Erythropoiesis-stimulating agents (ESAs), indicated for treating some patients with chemotherapy-induced anemia (CIA), may increase the risk of tumor progression and mortality. FDA required a Risk Evaluation and Mitigation Strategy (REMS) to mitigate these risks. We assessed REMS impact on ESA administration and red blood cell (RBC) transfusion as surrogate metrics for REMS effectiveness. METHODS Retrospective cohort study including data from January 1, 2006 to December 31, 2018 for beneficiaries ≥65 years enrolled in Centers for Medicare & Medicaid Services (CMS) Medicare Parts A/B with a cancer diagnosis; patients with other indications for ESA use were excluded. Study time was divided into five periods demarcated by issuance of CMS National Coverage Determination (NCD) (Pre-NCD, Pre-REMS) and REMS milestones (Grace Period, REMS, post-REMS). Study outcomes were monthly proportion of chemotherapy episodes (CTEs) with concomitant ESA administration, with post-CTE ESA administration, and with RBC transfusions. RESULTS Of 1 778 855 beneficiaries treated with CT, 308742 received concomitant ESA for CIA. The proportion of CTEs with concomitant and post-CTE ESA administration decreased Pre-REMS (9.0 percentage points [pp] and 3.5 pp, respectively). There were no significant post-REMS changes in the proportion of CTEs with concomitant (0.0 pp) and post-CTE ESA administration (0.1 pp). Fluctuation in RBC transfusions was
- Published
- 2021