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

Area of Science:

• Oncology
• Pharmacovigilance
• Health Services Research

Background:

• Risk Evaluation and Mitigation Strategy (REMS) programs aim to ensure safe drug use.
• The effectiveness of REMS programs in achieving their safety goals is debated.
• Specific REMS programs target drugs with known risks, like erythropoiesis-stimulating agents (ESAs) in cancer patients.

Purpose of the Study:

• To evaluate the impact of a REMS program on the initiation of darbepoetin alfa and epoetin alfa.
• To assess changes in ESA initiation among adult cancer patients after REMS implementation and enforcement.
• To determine if the REMS program reduced inappropriate ESA use in cancer patients.

Main Methods:

• Utilized claims data from a large US commercial insurance company.
• Conducted interrupted time-series analyses to assess trends before and after REMS implementation and enforcement.
• Analyzed initiation rates and inappropriate use of darbepoetin alfa and epoetin alfa in adult cancer patients.

Main Results:

• Monthly ESA initiations decreased for both darbepoetin alfa and epoetin alfa over the study period.
• No statistically significant changes in ESA initiation levels or slopes were observed post-REMS implementation or enforcement.
• Changes in inappropriate ESA initiation rates were not statistically significant between the study periods.

Conclusions:

• REMS program implementation and enforcement were not associated with significant changes in ESA initiation.
• The findings suggest that certain REMS programs may not consistently enhance patient safety as intended.
• Further research is needed to understand the real-world impact of REMS on drug safety and utilization.