Amgen Criticizes Part Of Medicare Decision On Payments For Anemia Treatment

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Amgen on Wednesday criticized part of a final decision announced on Monday by CMSthat will limit Medicare coverage for anemia medications -- Aranesp andEpogen, 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 proteinerythropoietin, to treat anemia caused by chemotherapy but not anemiacaused by cancer. In addition, under the decision, Medicare will coverthe anemia medications in cancer patients whose hemoglobin levelsdecrease to less than 10 grams per deciliter of blood. The decisionalso will allow local Medicare contractors to determine whether tocover the anemia medications for use in patients with myelodysplasticsyndrome, a condition that can lead to leukemia (Kaiser Daily Health Policy Report, 7/31).

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Amgensaid that the provision under which Medicare will not cover the anemiamedications in cancer patients whose hemoglobin levels are higher than10 grams per deciliter of blood might increase the need fortransfusions and compromise quality of care, as many physicians seek tomaintain 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.

RogerPerlmutter, executive vice president for global research anddevelopment for Amgen, said, "In our view, restricting coverage in thisway is unreasonable, impractical and unworkable" (Reuters/New York Times,8/2). He added, "The coverage restrictions placed on the FDA-approvedindication have no scientific basis and are incompatible with goodclinical practice" (Costello, Los Angeles Times, 8/2).

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Reprinted with permission fromkaisernetwork.org.You can view the entire KaiserDaily Health Policy Report, search the archives, andsign up for email delivery at kaisernetwork.org/email. The Kaiser Daily Health Policy Report is published forkaisernetwork.org,a free service of The Henry J. Kaiser Family Foundation.

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