FDA Supports CMS Decision On Medicare Coverage Of Anemia Drugs

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Anemia Drugs

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 formsof the protein erythropoietin, to treat anemia caused by chemotherapybut not anemia caused by cancer.

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Under the decision, Medicarewill cover the medications to treat anemia in cancer patients whosehemoglobin levels decrease to less than 10 grams per deciliter ofblood. The decision will allow local Medicare contractors to determinewhether to cover the medications to treat patients with myelodysplasticsyndrome, 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 "generallyconsistent" with information on recommended use of the medications incancer patients (Bloomberg/Los Angeles Times, 10/17).

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In a statement, Stark said, "The FDA letter confirms ... Medicare's newnational coverage determination is consistent with the FDA'srecommendations and scientific research," adding, "Excessive use" ofsuch 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 theMedicare coverage decision is appropriately based on science."

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

Reprinted with permission from kaisernetwork.org. Youcan view the entire Kaiser DailyHealth Policy Report, search the archives, and sign up for email deliveryat kaisernetwork.org/email. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, afree service of The Henry J. Kaiser Family Foundation.

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