Network News

X My Profile
View More Activity
Column Archive |  On Twitter: J Huget and MisFits  |  Fitness & Nutrition News  |  RSS Feeds RSS Feed
Posted at 7:00 AM ET, 11/17/2010

Medicare panel eyes cancer vaccine

By Rob Stein

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.

By Rob Stein  | November 17, 2010; 7:00 AM ET
Categories:  Cancer, Medical Technology, medicare, prostate cancer  
Save & Share:  Send E-mail   Facebook   Twitter   Digg   Yahoo Buzz   StumbleUpon   Technorati   Google Buzz   Previous: Schumer: FDA, FTC to act on caffeinated booze
Next: Gwyneth dances great on 'Glee,' despite osteopenia


Prostate cancer is a terrible disease that affects too many men each year. Help raise money and awareness by visiting

Posted by: omegarimmer611 | November 17, 2010 1:02 PM | Report abuse

Post a Comment

We encourage users to analyze, comment on and even challenge's articles, blogs, reviews and multimedia features.

User reviews and comments that include profanity or personal attacks or other inappropriate comments or material will be removed from the site. Additionally, entries that are unsigned or contain "signatures" by someone other than the actual author will be removed. Finally, we will take steps to block users who violate any of our posting standards, terms of use or privacy policies or any other policies governing this site. Please review the full rules governing commentaries and discussions.

characters remaining

RSS Feed
Subscribe to The Post

© 2010 The Washington Post Company