Medicare to keep limits on anemia drugs

The U.S. Medicare agency said Monday that, unless it received new evidence, it would not reverse a decision to cut reimbursement for bestselling anemia drugs such as Amgen Inc.’s Aranesp.

The U.S. Centers for Medicare and Medicaid Services, or CMS, the biggest purchaser of prescription drugs, made its position clear in a letter sent to physicians and others who sought to persuade the agency to reverse its stance.

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

The decision by the government this year to cut reimbursement of a class of drugs known as erythropoiesis-stimulating agents in some cancer patients was prompted by studies suggesting the drugs -- which include Johnson & Johnson’s Procrit -- were overused and linked to an increased risk of stroke and heart attack.

Several Wall Street analysts said Medicare had set a high bar for making any changes to its ruling.

“CMS is digging in its heels, making any [coverage] change unlikely,� Jefferies & Co. analyst Adam Walsh wrote in an investor note.

The drugs are given to boost oxygen-carrying hemoglobin in the blood to combat anemia and avoid blood transfusions. Doctors and cancer centers buy the drugs from manufacturers and get reimbursed for patients on Medicare, the federal health plan for the nation’s 43 million elderly and disabled.

CMS said in July that it would reimburse only 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 the cancer decision, saying it interfered with the practice of medicine and jeopardized patient care.

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 the drugs was superior to blood transfusions for maintaining that 10-gram-per-deciliter level.

When the final rules were issued in July, Amgen said they had “no scientific basis� and were “incompatible with good clinical practice.�

Amgen said in a statement that the CMS coverage decision had resulted in a different standard of care for Medicare beneficiaries versus privately insured patients, who the company said were still being treated according to current clinical guidelines.

“This government policy undermines clinical judgment, effectively removes physicians’ ability to make decisions and is unreasonable and impractical,� Amgen said.

Amgen added that multiple parties involved in the debate had presented CMS with arguments showing the agency “materially misinterpreted existing evidence.� Consequently, Amgen said CMS “has already received answers to a number of the questions� posed in its letter Monday.

J&J; was not available for comment.

Aranesp and its predecessor, Epogen, had combined sales of $6.6 billion last year, nearly half of Amgen’s total revenue.

Procrit sales make up a much smaller slice of sales for J&J;, a more diversified healthcare conglomerate.

The drugs are also used to treat anemia in kidney disease patients. A Food and Drug Administration expert panel this month did not recommend significant changes to treatment guidelines in those patients.

A CMS spokesman said the agency was not considering changing its kidney disease reimbursement policy.

Shares of Amgen fell 13 cents to $55.29.