CMS panel doubts data on ESAs for transplants

A Medicare advisory panel isn't convinced that high-tech anemia drugs really benefit kidney patients awaiting transplants. In a meeting yesterday, the expert committee said there isn't enough evidence to justify using the drugs to raise patients' hemoglobin levels more than previously advised, Reuters reports. "The connection is just not there," said panel vice chairman Saty Satya-Murti, a physician and health policy consultant.

Amgen, which markets Aranesp and Epogen, had presented data to support more aggressive use, saying it would prevent potentially harmful blood transfusions and improve patients' chances for successful transplants. Amgen's Reshma Kewalramani said a critical Centers for Medicare and Medicaid Services review excluded some important studies and the agency was downplaying potential complications from blood transfusions. "The data are there and the evidence are very clear in this regard," she told the news service, referring to patient sensitivity from transfusions and their "negative impact on graft access and transplant survival."

But according to that CMS review, the evidence isn't sufficient to show that the drugs can actually forestall the need for blood transfusions or that they improve transplant outcomes. University of Connecticut professor C. Michael White, who presented that analysis of clinical data at the panel meeting, found the evidence lacking. "The data is generally weak and the strength of the evidence is low to insufficient," he said.

Complicating matters is the question of safety; high doses of the drugs have been linked with a potential increase in heart risks, and safety issues prompted changes in Medicare coverage of the drugs for cancer patients. But doctors and patient advocates at the meeting urged CMS to keep reimbursement rules flexible so that they can decide how to use them in individual patients. CMS will take the panel's views into account when it issues draft guidance on the drugs in March; final guidelines are expected in June.

- read the Reuters story

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