The Food and Drug Administration no longer requires certification of doctors and hospitals to prescribe epoetin alfa (Procrit, Epogen) or darbepoetin alfa (Aranesp) for chemotherapy anemia.
A Risk Evaluation and Mitigation Strategy (REMS) program was put in place in 2011 to make sure that the benefits of erythropoiesis-stimulating agents (ESAs) outweighed the risks when prescribed. Under the program, providers were required to become certified in the ESA REMS and to demonstrate that each patient had received counseling on the benefits and risks of the therapies prior to use.
Amgen’s prescriber surveys demonstrated “acceptable knowledge” of the need to counsel patients about the risks. Utilization data indicated “appropriate prescribing” as an alternative to transfusion.
In addition, in an evaluation of the impact of multiple regulatory actions, the FDA determined that full implementation of the ESA REMS in 2011 had minimal impact on trends in ESA utilization metrics, the FDA wrote.
The FDA concluded that regulatory actions and label changes – and the cut in payments for nonrenal indications from the Center for Medicare & Medicaid Services – were enough to reduce overuse in chemotherapy.
However, while the REMS is no longer necessary, the FDA says serious risks of shortened overall survival and/or increased risk of tumor progression or recurrence associated with these drugs remain and health care providers should continue to discuss the risks and benefits of using ESAs with each patient before initiating use.