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Medicare Wants Proof for Amgen, J&J Anemia Drugs

The U.S. Medicare agency said Monday that, unless it receives new evidence, it will not reverse a decision to cut payments for certain uses of anemia drugs, including Amgen's Aranesp.

The U.S. Centers for Medicare and Medicaid Services (CMS) made its position clear in a letter sent to physicians and others who sought to persuade the agency to change its mind.

CMS gave advocates 30 days to deliver proof to support a different conclusion than reached by the agency in its review of more than 800 publications and 2,600 comment letters.

The decision by the government earlier this year to cut reimbursement of a class of drugs known as erythropoiesis-stimulating agents, or ESAs, in some cancer patients was prompted by concerns the drugs, which include Johnson & Johnson's Procrit, are overused and linked to an increased risk of stroke and heart attack.

The drugs are given to boost oxygen-carrying hemoglobin in the blood to combat anemia and avoid blood transfusions.

CMS said it would only reimburse for cancer patients undergoing chemotherapy whose hemoglobin levels fell below 10 grams per deciliter.

Doctor groups, including the American Society for Clinical Oncology, had asked Medicare to reconsider.

But in its letter, the agency wanted specific questions answered -- among others, proof that patients undergoing chemotherapy require hemoglobin levels above 10 grams per deciliter. And it asked for evidence that use of ESA therapy is superior to blood transfusion for maintaining that 10 gram per deciliter level.

CMS runs Medicare, the health insurance plan for the nation's 43 million elderly, a large buyer of the drug.

At the time the final rules were issued in July, Amgen said they have "no scientific basis" and are "incompatible with good clinical practice."

Executives at the world's biggest biotech company did not have an immediate comment.

Aranesp and and its predecessor, Epogen, had combined 2006 sales of $6.6 billion last year, nearly half of its total revenue. Procrit sales make up a much smaller slice of sales for J&J, a more diversified health care conglomerate.

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