FDA Discontinues ESA APPRISE Risk Evaluation and Mitigation Strategy Program

What happened to the ESA APPRISE program? Why were these changes made? — Name withheld on request

The erythropoiesis stimulating agent (ESA) APPRISE program was initiated in 2010 for the ESAs on the market in the United States: epoetin alfa (Epogen, Procrit) and darbepoetin alfa (Aranesp). ESA APPRISE was a risk evaluation and mitigation strategy (REMS) program created to ensure that the benefits outweighed the risks when ESAs are used to minimize red blood cell transfusions in patients with cancer and chemotherapy-induced anemia.

The specific risks this program addressed included shortened overall survival and increased likelihood of tumor progression and recurrence in patients with cancer. Specifically, the program was concerned with ensuring that patients and providers were aware of the risks inherent with using these agents and that their use in this population was in accordance with current clinical guidelines.

In April 2017, the Food and Drug Administration (FDA) ended the ESA APPRISE REMS program after determining that healthcare providers understood the previously mentioned risks and were prescribing these agents appropriately according to current clinical guidelines.¹ This action was due to changes in both the prescribing information and the Centers for Medicare and Medicaid (CMS) reimbursement guidelines for ESAs. As such, the FDA deemed that the certifications and other requirements of the ESA APPRISE program provided no additional educational benefit.

However, although the ESA APPRISE program is no longer required when using ESAs in patients with cancer, the risks associated with these agents remains the same.

Reference

1. Information on erythropoiesis-stimulating agents (ESA) epoetin alfa (marketed as Procrit, Epogen), darbepoietin alfa (marketed as Aranesp). U.S. Food and Drug Administration; https://www.fda.gov/Drugs/DrugSafety/ucm109375.htm. Last updated March 13, 2017. Accessed November 1, 2017.