Medicare panel endorses prostate cancer vaccine
A panel of experts Wednesday endorsed an expensive new vaccine recently approved to treat men with advanced prostate cancer.
In a series of votes, the 14-member Medicare Evidence Development and Coverage Advisory Committee said that there did appear to be sufficient evidence that Provenge, which was approved in April, could help extend the lives of patients with advanced prostate cancer.
Medicare's decision to launch an official review of Provenge rekindled debate over whether some treatments are too costly.
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 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.
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. Private insurers also tend to follow Medicare's lead.
Medicare officials say Provenge's price tag isn't an issue, and some outside experts say the agency may be motivated more by questions about the vaccine's effectiveness and concerns that it may be used "off-label" for uses not specifically approved by the Food and Drug Administration.
In fact, the committee voted that there was inadequate evidence Provenge would help other kinds of patients, such as those who were either sicker than those studied to get Provenge approved or those who were not as sick.
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.
The committee did not actually vote on whether Provenge should be covered. Officials at the Center for Medicare and Medicaid Services will use the committee's advice to make that decision.
Provenge has long been the center of controversy. The FDA delayed its approval in 2007. The rejection triggered outrage among patients, advocates and investors in Dendreon, the Seattle company that developed the drug. The campaign to win Provenge's approval included anonymous death threats, accusations of conflicts of interest, protests, congressional lobbying and vitriolic Internet postings.
Prostate cancer strikes 192,000 men in the United States each year and kills about 27,000. The only therapies are surgery, radiation, hormones and the chemotherapy drug Taxotere.
Unlike standard vaccines, which are given before someone gets sick to stimulate their immune system to fight off infections, Provenge is a "therapeutic vaccine," designed to attack cancer cells in the body.
| November 17, 2010; 5:04 PM ET
Categories: Cancer, Medical Technology, medical costs, medicare, prostate cancer
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