FDA Letter Supports CMS Decision On Medicare Coverage Of Anemia Drugs

Main Category: Medicare / Medicaid / SCHIP
Also Included In: Regulatory Affairs / Drug Approvals;  Blood / Hematology
Article Date: 18 Oct 2007 - 8:00 PST

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FDA officials in a letter dated Oct. 12 said that the agency supports a recent decision by CMS that will limit Medicare coverage for use of anemia medications -- Aranesp, manufactured by Amgen, and Procrit, manufactured by Johnson & Johnson -- in cancer patients, CQ HealthBeat reports (Reichard, CQ HealthBeat, 10/16). According to a 61-page "national coverage determination" announced in July, Medicare will cover the medications, synthetic forms of the protein erythropoietin, to treat anemia caused by chemotherapy but not anemia caused by cancer.

Under the decision, Medicare will cover the medications to treat anemia in cancer patients whose hemoglobin levels decrease to less than 10 grams per deciliter of blood. The decision will allow local Medicare contractors to determine whether to cover the medications to treat patients with myelodysplastic syndrome, a condition that can lead to leukemia (Kaiser Daily Health Policy Report, 10/2). The letter, released on Tuesday by Reps. Pete Stark (D-Calif.) and Henry Waxman (D-Calif.), said that the decision is "generally consistent" with information on recommended use of the medications in cancer patients (Bloomberg/Los Angeles Times, 10/17).

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In a statement, Stark said, "The FDA letter confirms ... Medicare's new national coverage determination is consistent with the FDA's recommendations and scientific research," adding, "Excessive use" of such drugs "increases the risk of tumor progression in cancer patients. Medicare's action will prevent excessive use and protect patients' lives." Waxman said, "Clearly, the FDA letter confirms that the Medicare coverage decision is appropriately based on science."

Amgen and J&J have lobbied Congress to reverse the decision and have collected signatures from majorities in the House and Senate in support of the move. In a statement, Amgen said, "Amgen continues to urge CMS to quickly respond to the oncology community's collective concerns by allowing patients access to the medicines their doctors believe are a critical part of their cancer care" (CQ HealthBeat, 10/16).

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