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Risk Evaluation Mitigation Strategy (REMS) for ESAs Will Impact Oncology Practices

On February 16, 2010, the U.S. Food and Drug Administration (FDA) announced that Erythropoiesis Stimulating Agents (ESAs) will now be prescribed and dispensed to patients under a Risk Evaluation Mitigation Strategy (REMS).  This FDA regulation is intended to minimize the risks associated with these agents and was developed because of recent safety concerns associated with the use of ESAs, including the risk of increased tumor growth, decreased survival, and increased cardiovascular side effects.  Amgen Inc. manufactures both epoetin alfa (PROCRIT®, Centocor Ortho Biotech, Inc., and EPOGEN®, Amgen Inc.) and darbepoetin alfa (ARANESP®, Amgen Inc.) and is required by the FDA to oversee and monitor health care professionals and hospitals to ensure they are fully compliant with all requirements of the REMS provisions.

As part of the REMS requirements, all patients receiving ESAs must be provided with an FDA-approved Medication Guide that explains how to use the drug safely.  Additionally, health care providers and hospitals will also need to meet certain requirements in order to prescribe and dispense ESAs to patients with cancer.  To ensure these provisions are met, the APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) Oncology Program was created.  Under this program, health care providers who wish to prescribe an ESA to patients with cancer must:

  • Register and maintain active enrollment in the ESA APPRISE program
  • Complete a special training module
  • Discuss the risks, benefits, and FDA-approved uses of ESAs with patients before beginning treatment
  • Document this discussion with written acknowledgment from the patient
  • Re-enroll in the APPRISE program every three years

The APPRISE Oncology Program does not apply to ESAs used for anemia in patients without cancer (e.g., nephrology).  Enrollment in the APPRISE Oncology Program will begin on March 24, 2010.  Physicians and other providers seeking to enroll in the ESA APPRISE Oncology Program should contact their local Amgen or Centocor Ortho Biotech Products field representative or visit the ESA APPRISE Oncology Program website.  Physicians and hospitals will have 12 months to enroll in the program before facing restrictions on prescribing and dispensing.

To help physicians stay current on REMS programs that affect oncology and supportive care medications, NCCN offers a REMS resource page. NCCN will also be hosting a policy summit focusing on REMS on May 7, 2010.  At this summit, NCCN will present its recommendations surrounding REMS issues to multiple stakeholders, including the FDA and REMS developers, as well as provide practical advice to providers concerning the best practices for navigating REMS.  The real-world recommendations will aim to assure patient safety while balancing issues concerning barriers to medications and provider workload. 

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