WASHINGTON (AP) - Medicare advisers on Wednesday supported the effectiveness of the prostate cancer drug Provenge, an innovative therapy that has prompted questions about the cost of medical care and the government's role in paying for it.
The vote by a 14-member panel of outside experts amounts to a recommendation that Medicare pay for Provenge, which costs $93,000 per patient and extends life an average of four months.
The Centers for Medicare and Medicaid Services will make a final decision on the drug in March, and a positive ruling would make the drug available to tens of thousands of seniors diagnosed with prostate cancer. Most analysts expect Medicare to pay for the drug, giving drugmaker Dendreon Corp. a blockbuster product worth up to $2 billion in sales per year.
The agency already pays for other innovative cancer drugs from companies such as Genentech and Eli Lilly that have similar price tags and survival benefits.
Medicare is legally prohibited from considering price when deciding whether to pay for a new treatment, and the agency's decision to review Provenge prompted outrage from some patient groups who said the drug should be paid for immediately.
But experts say that as health care costs climb, both public and private insurance providers are being forced to demand better evidence for new drugs' benefits.
"CMS will never admit that cost is a part of the reason they opened up the national coverage decision, but I think it definitely is," said David Blaszczak, a Potomac Research Group analyst who previously worked for the agency. "If this product was only $200 we wouldn't be going through this process."
The Food and Drug Administration approved Provenge in April as the first cancer drug that uses the body's own immune system to fight the disease, offering an alternative to chemotherapy drugs that attack cancerous and healthy cells at the same time.
Most observers expected Medicare to pay for it immediately, as it does with most drugs. But Medicare officials said in June they would conduct their own review, triggering protests from patient groups.
"We believe that if the FDA approves a treatment option, that Medicare and insurance companies should provide unrestricted access," said Tom Kirk, president of US Too International, a prostate cancer advocacy group, in a petition to Medicare officials.
Medicare officials say cost has nothing to do with its review, and point out they have conducted similar reviews of four other cancer drugs in recent years.
Instead, the agency's review is aimed at clearing up bureaucratic confusion among Medicare carriers across the country, some of whom already pay for Provenge, while others do not, CMS spokesman Don McLeod said.
"When this happens, we frequently look at creating a national policy to clear up the conflict," McLeod said. "What we're doing is not unusual."
Dan Mendelson, president of Avalere Health consultants, says Medicare's review of Provenge is primarily a signal to drugmakers that the agency will not automatically pay for drugs just because they have been cleared by the FDA. Medicare officials want to see more data on how drugs work in the more than 47 million seniors covered by the program.
"It is an important and valid thing for the government to seek further evidence about how a medicine works in the Medicare population, but this is coming out at a very politically charged time," said Mendelson, who worked on health care issues in the Clinton administration.
Earlier this month, Republicans swept Democrats out of power in the House of Representatives and state capitals, in part by campaigning against President Obama's health care overhaul passed in March. The plan is designed to cover 30 million additional Americans while reducing health care costs in the long run. But Republicans have vowed to repeal the law, which they've called a "government takeover" that will ration care for patients.
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