Changes in Erythropoiesis Stimulating Agent Use Under a Risk Evaluation and Mitigation Strategy (REMS) Program

This interrupted time-series analysis of commercial insurance claims data found that implementation and enforcement of a REMS program for erythropoiesis stimulating agents did not produce statistically significant changes in initiation rates for darbepoetin alfa or epoetin alfa among cancer patients, nor did it significantly reduce inappropriate use in patients with hemoglobin above 10 g/dL. The findings raise concerns about the effectiveness of this REMS program in improving safe prescribing practices for these drugs.