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 review coverage of the medications for uses 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 erythropoietin stimulating agents (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.
ASH has been active in responding to Medicare and the FDA and encouraging coverage policies that assure patient safety. The ASH Committee on Practice’s Subcommittee on Reimbursement 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 potential restrictions in the use of ESAs for treatment of anemia in patients with hematologic malignancies not on chemotherapy. ASH indicated to CMS that there are data to support the use of ESAs in patients with anemia associated with low-risk myelodysplasia. ASH also recommended that use of ESAs to treat anemic patients with hematologic malignancies requires further studies, and, in the meantime, coverage for these patients should be on a case-by-case basis.
ASH also is in the process of updating its practice guideline, "Use of Epoetin in Patients with Cancer." In early May, ASH will be working with the FDA’s Oncologic Drugs Advisory Committee, which is scheduled to review additional trial data on ESAs.
