Trends in Erythropoiesis-Stimulating Agent Use and Blood Transfusions for Chemotherapy-Induced Anemia Throughout FDA's Risk Evaluation and Mitigation Strategy Lifecycle

Amarilys Vega, Rongmei Zhang, Hui-Lee Wong, Michael Wernecke, Michael Alexander, Yuhui Feng, An-Chi Lo, Bradley Lufkin, Qin Ryan, Rima Izem, Thomas E MaCurdy, Jeffrey A Kelman, David J Graham
Pharmacoepidemiology and Drug Safety 2021 February 3

PURPOSE: Erythropoiesis-stimulating agent (ESA), indicated for treating some patients with chemotherapy-induced anemia (CIA), may increase risk of tumor progression and mortality.1-3 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, 308,742 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 <4 pp throughout the study period.

CONCLUSIONS: Medicare beneficiaries showed a substantive decrease in ESA administration after NCD, with minimal impact by the REMS and its removal. Small changes in RBC transfusion over the study period were likely due to a national secular trend.

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