Unless it receives new evidence, the Medicare agency will not reverse its decision to cut reimbursements for best-selling anemia drugs such as Amgen Inc.'s Aranesp.
The US Centers for Medicare and Medicaid Services, the biggest purchaser of prescription drugs, made its position clear yesterday in a letter sent to physicians and others who sought to persuade the agency to reverse its stance.
Advocates had 30 days to deliver evidence to support a different conclusion than the one reached by the agency in its review of more than 800 publications and 2,600 comment letters.
The decision to cut reimbursement for a class of drugs known as erythropoiesis-stimulating agents, or ESAs, in some cancer patients was prompted by studies suggesting the drugs, which include Johnson & Johnson's Procrit, are overused and linked to an increased risk of stroke and heart attack.
Several Wall Street analysts said Medicare set a high bar for making any changes in its ruling.
The agency "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 and get reimbursed for patients on Medicare, the federal health plan for the nation's 43 million elderly and disabled.
In July, Medicare said it would reimburse only for cancer patients undergoing chemotherapy whose hemoglobin levels fall below 10 grams per deciliter of blood.
Doctor groups, including the American Society for Clinical Oncology, asked Medicare to reconsider the cancer decision, arguing it interfered with the practice of medicine and jeopardized patient care.
But the agency wants specific questions answered - among others, proof that patients undergoing chemotherapy require hemoglobin levels above 10 grams per deciliter. And it asked for evidence that the use of ESA therapy is superior to blood transfusions.
When rules were issued in July, Amgen said they have "no scientific basis" and are "incompatible with good clinical practice."
Executives at Amgen, the world's biggest biotechnology company, did not have a comment yesterday. J&J was not available for comment.
Aranesp and its predecessor, Epogen, had combined 2006 sales of $6.6 billion last year.
The drugs are also used to treat anemia in kidney disease patients. An expert panel to the FDA this month did not recommend significant changes to treatment guidelines in those patients.