Medicare panel eyes cancer vaccine
A panel of outside experts is meeting Wednesday to advise federal health officials about an expensive new vaccine recently approved to treat men with advanced prostate cancer.
The 14-member Medicare Evidence Development & Coverage Advisory Committee is meeting at the Centers for Medicare & Medicaid Services to review the scientific evidence for Provenge, which was approved in April.
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.
Those concerns have been heightened because the review comes after the bitter health-care reform debate, which was marked by accusations of 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 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.
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 is also not supposed to factor cost 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.
Provenge has long been the center of controversy. The FDA delayed Provenge's 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.
The committee will vote on nine questions about Provenge, including assessing the strength of the scientific evidence for how well it works and which patients are most likely to benefit.
| November 17, 2010; 7:00 AM ET
Categories: Cancer, Medical Technology, medicare, prostate cancer
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