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FDA defends Medicare anaemia drug policy

Medicare's reimbursement limits on US payments for Amgen's and Johnson & Johnson's (J&J) anaemia drugs are "generally consistent" with FDA recommendations, according to a statement release by the agency on 16 October 2007.

Medicare's reimbursement limits on US payments for Amgen's and Johnson & Johnson's (J&J) anaemia drugs are "generally consistent" with FDA recommendations, according to a statement release by the agency on 16 October 2007.

The letter, which was addressed to California Democrat, Pete Stark, said: "The FDA believes that the approved labelling and the national coverage determination are generally consistent in their recommendations regarding the use of ESAs in patients with cancer undergoing chemotherapy."

Medicare has already announced that it would restrict payments for the anaemia drugs, Amgen's Aranesp and J&J's Procrit, when given to cancer patients. The move followed concerns that the drugs were overused and may be linked to a higher risk of heart attack, stroke and death.

Aranesp, which is an erythropoietin-stimulating agent (ESA), is Amgen's top-selling treatment, with FY06 sales of approximately USD 4.1bn, while Procrit racked up sales of USD 3.2bn. Use of both drugs has fallen sharply amid safety concerns.

The Centers for Medicare & Medicaid Services (CMS) decided it would only pay for the drugs in cancer patients undergoing chemotherapy when haemoglobin levels dropped below a certain level in patient's blood.

Amgen and the American Society of Clinical Oncology have approached the CMS to get it to reconsider. Both groups said that the limits interfere with the practice of medicine and jeopardised care.

Spokesperson for Amgen, Kelley Davenport, 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."

Johnson & Johnson's Procrit manufacturing unit Ortho Biotech disagreed with the FDA's conclusion that the CMS ruling is consistent with the approved label for the drugs. The Medicare policy requires doctors to stop treatment when haemoglobin reaches 10 grams per decilitre, while the FDA-approved labelling permits doctors to treat patients up to 12 grams per decilitre if appropriate.

30th September 2008

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