By Kim Dixon and Lisa Richwine
WASHINGTON (Reuters) - A senior Medicare official said the case for restricting payments for anemia drugs sold by Amgen Inc (AMGN.O: Quote, Profile, Research, Stock Buzz) and Johnson & Johnson (JNJ.N: Quote, Profile, Research, Stock Buzz) has become stronger since the agency made its controversial decision.
The U.S. Centers for Medicare and Medicaid Services (CMS) is reviewing its decision to restrict payment in certain cancer patients following a storm of criticism from cancer doctors and the drugmakers to restrict payment for the drugs.
Mounting evidence, including two studies casting more doubt on the drugs' safety, backs the original policy, Dr. Barry Straube, the chief medical officer at CMS, told the Reuters Regulation Summit on Friday.
"I think that our national coverage decision has been shown, with even more evidence coming out since we made it, to have been the right thing to do," Straube said.
The drugs are one of the biggest prescription costs for Medicare, the U.S. insurance plan for about 43 million elderly and disabled. So-called erythropoietin-stimulating agents, Amgen's Aranesp earned about $3.6 billion in 2007 sales, and J&J's Procrit had 1.7 billion in 2007 sales.
CMS issued its payment restrictions in 2007 after four large studies raised safety concerns and the Food and Drug Administration added its strongest warning to the drugs' labels, based on studies that suggested a higher risk of death and other adverse events.
A J&J spokeswoman said "there are other studies CMS should take into account," and that the drugs are safe when used according to the label. Amgen was not available for comment.
FDA MEETING KEY
The FDA holds a hearing next month to consider two recent studies that suggested the drugs pose more serious risks for some cancer patients.
Straube said a likely discussion item will be rejecting use of the drugs at all for chemotherapy-induced anemia.
"I think that FDA is clearly thinking through all of its options," he said, citing meetings with staffers. "One severe option, depending on what the evidence is, is that they clearly could consider removing ESAs for some of the indications they are being given now."
The payment issue revolves around the level of a patient's hemoglobin the treatment should start. The agency is struggling with whether there can be exceptions to the current policy in certain patients.
The American Society of Clinical Oncology, which represents cancer doctors, and the drugs' makers, are continuing to submit new evidence to bolster their argument that the restrictions will boost the risk of blood transfusions, he said.
FERVENT REACTION
Straube said he has seen no convincing evidence to support reversing the decision. A recent poll released by cancer and blood doctors suggesting doctors believe the policy is leading to more blood transfusions will have little sway, he said. Continued...
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