Amgen Criticizes Medicare’s Anemia Drug Coverage Policy
Amgen on Wednesday criticized part of a final decision announced on Monday by CMS that will limit Medicare coverage for anemia medications -- Aranesp and Epogen, manufactured by the company, and Procrit, manufactured by Johnson & Johnson -- in cancer patients, Reuters/New York Times reports (Reuters/New York Times, 8/2).
According to the 61-page "national coverage determination," Medicare will cover the medications, synthetic forms of the protein erythropoietin, to treat anemia caused by chemotherapy but not anemia caused by cancer. In addition, under the decision, Medicare will cover the anemia medications in cancer patients whose hemoglobin levels decrease to less than 10 grams per deciliter of blood. The decision also will allow local Medicare contractors to determine whether to cover the anemia medications for use in patients with myelodysplastic syndrome, a condition that can lead to leukemia (California Healthline, 7/31).
Amgen said that the provision under which Medicare will not cover the anemia medications in cancer patients whose hemoglobin levels are higher than 10 grams per deciliter of blood might increase the need for transfusions and compromise quality of care, as many physicians seek to maintain hemoglobin levels of 11 to 12 grams per deciliter in patients.
In addition, the provision contradicts recommendations on the use of the medications approved by FDA, as well as a recommendation from the agency's Oncologic Drugs Advisory Committee, and guidelines from the American Society of Clinical Oncology and the American Society of Hematology.
Roger Perlmutter, executive vice president for global research and development for Amgen, said, "In our view, restricting coverage in this way is unreasonable, impractical and unworkable" (Reuters/New York Times, 8/2). He added, "The coverage restrictions placed on the FDA-approved indication have no scientific basis and are incompatible with good clinical practice" (Costello, Los Angeles Times, 8/2).