ASH Weighs in on Review of Medicare Coverage Policy for Erythropoietin-Stimulating Agents (ESAs)

April 25, 2007 – In March, the Centers for Medicare and Medicaid Services (CMS) announced plans to review the Medicare coverage policy for darbepoetin alfa and epoetin alfa after recent studies linked the treatments with increased risk for serious side effects. CMS will develop a National Coverage Determination (NCD) for uses of ESAs other than in dialysis, as well as a “monitoring policy” that requires a reduction in Medicare reimbursements for the treatments when the red blood cell counts of beneficiaries exceed a certain level. The review follows a March 9 announcement by the Food and Drug Administration (FDA) that manufacturers of the medications must include black box warnings on the labels to physicians and patients about the increased risk for serious side effects linked with the treatments. In addition, the FDA advised physicians that they should use only the lowest dose of the medications necessary to avoid the need for blood transfusions caused by anemia.

Based on the FDA safety alert, CMS issued instructions to local Medicare carriers to prohibit Medicare coverage of ESAs – Aranesp, Epogen, Procrit – when used for the treatment of the anemia of cancer. ESAs used for treatment of anemia due to chemotherapy would not be affected by this change in policy. Some Medicare Part B carriers immediately began to announce new local carrier decisions that require that ESAs should be used only in accordance with its approved product labeling.

What ASH Is Doing About This

• ASH continues to encourage coverage policies that assure patient safety and quality of care.
• ASH reviewed the latest studies concerning patient safety and worked with clinical and scientific experts to comment on the CMS policy as well as local carrier decisions. Of particular concern are restrictions in the use of ESAs for treatment of anemia in patients with hematologic malignancies not on chemotherapy. ASH’s comments indicate that there is data to support the use of ESAs in patients with anemia associated with low-risk myelodysplasia. ASH also recommended that the use of ESAs to treat anemic patients with hematologic malignancies requires further studies, and in the meantime, coverage of these patients should be on a case by case basis.
• ASH will be presenting comments to the FDA’s Oncologic Drugs Advisory Committee (ODAC) on May 10, 2007.
• ASH will be meeting with CMS officials to discuss the CMS proposed policy.
• ASH also is in the process of updating its guideline “Use of Epoetin in Patients with Cancer” to include other ESAs.

ASH will make information available to its members as it becomes available. In the meantime, please contact the ASH Government Relations and Practice Department at 202-776-0544 with any questions or comments.