Drug made in Colorado given another setback

Joyzelle Davis, Rocky Mountain News

Published March 6, 2007 at midnight

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Amgen’s Aranesp drug, which is manufactured in Longmont, won’t be covered to treat a certain type of anemia by at least one company that administers Medicare plans.

Noridian Administrative Services LLC, which administers Medicare plans in Colorado and some dozen other Western states, will no longer pay for Aranesp’s use in anemia of cancer, medical director William Mangold said. Aranesp’s use in anemia of cancer is’'t approved by the Food and Drug Administration, but insurers have typically covered this so-called off-label use if prescribing doctors deem it appropriate.

"The decision has been made that Noridian will not cover for that set of patients," Mangold told the Associated Press.

Noridian is one of 17 companies that administers Medicare plans, representing about 11 percent of the nation’s 41 million Medicare Part B recipients.

Noridian’s decision is the latest blow for Aranesp’s off-label use. The drug is approved by the FDA to treat chemotherapy-induced anemia and anemia in kidney diseases, and Amgen says Aranesp is safe and effective for those uses.

But recent clinical trials in cancer patients who aren't undergoing chemotherapy — the off-label use known as anemia of cancer — have shown negative results. In one trial, cancer patients on Aranesp had a higher risk of death than those on a fake treatment.

The FDA has scheduled an advisory committee meeting in May to discuss the use of Aranesp and other anti-anemia drugs in cancer patients.

David Polk, a spokesman for Thousand Oaks, Calif.-based Amgen, said the biotech company had hoped that Noridian would wait until the May meeting to make its decision but "wasn’t surprised" by the move. Noridian is the first company that administers Medicare plans to drop coverage, but other payers have also indicated that they’re reviewing whether they will continue to cover Aranesp for anemia of cancer.

Noridian's decision to stop coverage is based on a move last month by an influential drug-reference guide, USP DI, to stop recommending Aranesp as a treatment for anemia of cancer, Mangold said. Noridian and other Medicare carriers typically base their reimbursement policies partly on USP DI.

If more Medicare carriers decide to drop coverage, it could further threaten the estimated $500 million in annual Aranesp sales for use in anemia of cancer. Much of the rest of Aranesp’s $4.1 billion in worldwide sales last year were in approved uses such as chemotherapy-induced anemia.

Amgen’s 800-employee plant in Longmont manufactures both Aranesp and Epogen, another anemia drug that also has come under scrutiny in recent months. The two drugs accounted for nearly half of the biotech company’s revenue last year.

Amgen also has another plant in Boulder that makes other drugs, including rheumetoid arthritis drug Kineret.

Associated Press contributed to this report.

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