UPDATE 2-Medicare medical chief sees no new ESA-drug evidence

(Adds further comments from Straube, others; context, byline)

By Kim Dixon

WASHINGTON, Oct 24 (Reuters) - Medicare, under fire for restricting payments for anemia drugs sold by Amgen Inc (AMGN.O) and Johnson & Johnson (JNJ.N), has received no new evidence to support reversing the policy, a top official said on Wednesday.

The U.S. Centers for Medicare and Medicaid Services (CMS) last month gave cancer doctors and their supporters 30 days to provide fresh evidence that the new policy tightening reimbursement for the best-selling drugs would harm patients.

CMS issued its restrictions after studies found the drugs are often overused, which can boost risk of heart problems and even death.

Barry Straube, the chief medical officer at CMS, told Reuters all three petitioners to the agency submitted responses, but none supported loosening the policy.

"We've made it very clear what would be required for us to reopen or reconsider the national coverage decision," he said.

The petitioners, including the American Society of Clinical Oncology, which represents cancer doctors, did not respond "to the questions with any evidence-based trials or information to be able to help us to deal with the reconsideration request," Straube said.

He said he considered the agency still in talks with the groups, though.

The drugs are erythropoietin-stimulating agents, also known as ESAs or Epo drugs. Aranesp is Amgen's best-selling drug, with sales of about $4.1 billion in 2006. Last year's sales of Procrit were $3.18 billion. Use has fallen sharply this year amid safety concerns.

CMS pays for care for the 43 million elderly and disabled people in the government's Medicare health insurance program. The drugs are the biggest prescription drug cost in Medicare, leading critics to charge the agency is putting cost over care.

"They'll say it's not based on cost, but no one really believes that," Johnson & Johnson's vice president of health policy in Washington, Kathy Buto, said in a recent interview.

A QUESTION OF EVIDENCE

Medicare got a boost to its stance last week when the U.S. Food and Drug Administration wrote a lawmaker that it "believes that the approved labeling and the (CMS) national coverage determination (NCD) are generally consistent in their recommendations regarding the use of ESAs in patients with cancer undergoing chemotherapy."

The companies and cancer groups have argued the policy clashes with the FDA-approved labeling.

The industry has conducted studies to get evidence to boost the dosing, trials which unintentionally led to the concern about heart risk. The companies, however, have not invested in studies about the benefits of lower dosing, analysts have said.

"Surprisingly, we haven't heard (from) the manufacturers in terms of a suggestion for a clinical trial," to prove their suggested dosing is safe, Straube said.

The Medicare policy requires doctors to stop treatment when hemoglobin reaches 10 grams per deciliter, while the companies and cancer groups largely support treating patients up to 12 grams per deciliter if they think it is appropriate.

(Editing by Brian Moss/Andre Grenon/Phil Berlowitz)