Doctors up pressure on Medicare on anemia drugs

By Kim Dixon

WASHINGTON (Reuters) - U.S. cancer doctors on Thursday plan to ratchet up pressure on the federal Medicare agency to reverse new limits on use of anemia drugs made by Amgen Inc. and Johnson & Johnson.

An official with the American Society of Clinical Oncology, a powerful lobby of cancer doctors, said they will formally ask that the U.S. Centers for Medicare and Medicaid re-open a final rule issued last month tightening usage and dosing for the drugs.

The erythropoiesis-stimulating agents are sold by Amgen Inc. as Epogen and Aranesp, and by Johnson & Johnson as Procrit, and are also known as EPO drugs.

"The proposal is unworkable and there is no evidence to support it at all," said Joseph Bailes, chair of the government relations panel at the American Society of Clinical Oncologists and a medical oncologist practicing in Houston.

Medicare issued the limits following months of heightened scrutiny of the drugs after they were linked to a higher heart attack and stroke risk when used at high doses. The drugs are the biggest single drug cost for Medicare -- Amgen earned $4 billion from its Aranesp alone last year.

But the cancer doctors group says the Medicare limits go too far.

The new limits are based on limited evidence on when to start the drugs, which are used to boost levels of oxygen-carrying hemoglobin in the blood during chemotherapy, according to the group.

The doctors also say the new rules are inconsistent with the U.S. Food and Drug Administration-approved label. For example, the rule allows only one dose increase of 25 percent, when studies show it can take up to 100 percent dose increase to achieve the intended hemoglobin levels, Bailes said.