Correction to This Article
Previous versions of this article misspelled the name of Tito Fojo, of the National Cancer Institute. This version has been corrected.

Review of prostate cancer drug Provenge renews medical cost-benefit debate

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By Rob Stein
Washington Post Staff Writer
Monday, November 8, 2010; 7:53 AM

Federal officials are conducting an unusual review to determine whether the government should pay for an expensive new vaccine for treating prostate cancer, rekindling debate over whether some therapies are too costly.

The Centers for Medicare & Medicaid Services, which dictate what treatments the massive federal health-insurance program for the elderly will cover, is running a "national coverage analysis" of Provenge, the first vaccine approved for treating any cancer. The treatment costs $93,000 a patient and has been shown to extend patients' lives by about four months.

Although Medicare is not supposed to take cost into consideration when making such rulings, the decision to launch a formal examination has raised concerns among cancer experts, drug companies, lawmakers, prostate cancer patients and advocacy groups.

Provenge, which was approved for advanced prostate cancer in April, is the latest in a series of new high-priced cancer treatments that appear to eke out only a few more months of life, prompting alarm about their cost.

"This absolutely is the opening salvo in the drive to save money in the health-care system," said Skip Lockwood, who heads Zero - the Project to End Prostate Cancer, a Washington-based lobbying group. "If the cost wasn't a consideration, this wouldn't even be under discussion."

Those concerns have been heightened because the review comes after the bitter health-care reform debate, which was marked by accusations about rationing and "death panels." The appointment of Donald M. Berwick to head Medicare only intensified anxieties. President Obama sidestepped a Senate battle by naming Berwick, who has advocated for scrutinizing costs, when Congress was in recess in July.

Because men tend to be elderly when they get diagnoses of advanced prostate cancer, Medicare's decision will have a major effect on Provenge's availability. Regional Medicare providers paying for Provenge would have to stop. Private insurers also tend to follow Medicare's lead.

Medicare officials, who are convening a panel of outside advisers to vet the issue at a public hearing Nov. 17, say Provenge's price tag isn't an issue. But Berwick and other officials declined to discuss the rationale for the review.

"Certainly no one in the Medicare program would publicly state that the price tag would have anything to do with Medicare looking at it. But they are human beings, too. They notice things like that," said Sean Tunis, director of the Center for Medical Technology Policy and a former chief medical officer at Medicare. Tunis said, though, that other factors, such as the special nature of the therapy and lingering questions about its effectiveness, were probably playing a more crucial role.

The review comes as the Food and Drug Administration considers withdrawing an approval for another expensive cancer treatment- Avastin for metastatic breast cancer - which triggered a similar debate even though the FDA too is not supposed to factor costs into its analyses.

Medicare usually covers new cancer drugs once they have been approved by the FDA. The decision in June to scrutinize Provenge prompted several members of Congress to question the action. Supporters have inundated the agency with hundreds of thousands of comments.

"I don't want to blame Obamacare, but it just kind of figures that people are taking a look at what the cost-benefit ratios are and all that sort of stuff," said David Dykes, 69, of Lorton, a retired federal employee who was hoping to try Provenge. "That may sound pretty good to the people who want to cut costs, but it doesn't sound too good to me. This is something that could extend my life. I'd like to give that a shot."


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