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Posted at 5:04 PM ET, 11/17/2010

Medicare panel endorses prostate cancer vaccine

By Rob Stein

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.


Costly cancer treatments (NIH)

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.

By Rob Stein  | November 17, 2010; 5:04 PM ET
Categories:  Cancer, Medical Technology, medical costs, medicare, prostate cancer  
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Comments

How about it, all you fiscal conservatives - should Medicare pick the $93,000 tab, not to cure a cancer, but to extend some people's life by an average of 4 months?

Posted by: j3hess | November 17, 2010 7:36 PM | Report abuse

This is an obscene decision that needs reversed. It's past stupidity into the surreal. Four months lifespan for $93,000 when so many people have nothing? These people need placed in Hospice care which is far more appropriate for the terminally ill. A palliative treatment that only prolongs the inevitable at this excessive cost should only be available at private pay options. Even better let me guess the AMA backed the decision. I would expect nothing less from the AMA.

Posted by: Desertdiva1 | November 17, 2010 8:48 PM | Report abuse

If the drug is so worthless that it costs $93k and only -maybe- gives people 3-4 months, well it seems pretty useless. That's just not a very long time. I don't want to discourage people, but the ROI on this drug sucks. It's an exceptionally poor value for the cost.

Medicare shouldn't be peeing away money on this. If people want to pay for it privately they can go for it, but the drug is a giant rip off. It's a shame investment in research can't be structured in such a way that the outcomes don't require such ludicrous pricing, but I suppose finances aren't their forte.

In any case they need to go back to the lab and come up with something more effective at a far, far lower cost. Say X10 lower, then they'll have actually accomplished something useful. However, bottom line is I have to call BS on this 3-4 month thing, it's just weak results, they need to do better.

Please note, it's not that I don't think investors should be compensated, it's that the way they're being compensated in this case is ludicrous. That's the part that needs to change.

Posted by: Nymous | November 17, 2010 9:38 PM | Report abuse

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Posted by: lizhiyong120 | November 17, 2010 10:06 PM | Report abuse

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Posted by: lizhiyong120 | November 17, 2010 10:07 PM | Report abuse

In response to the comments of Desertdiva1 and Nymous. There is more to this issue. First, the four month extension of life you have both fixated on is an average. I understand that many men in the study lived longer than that. Second, and far more important, is the fact that this drug triggers the body's own immune system to fight cancer and is the first such vaccine that seems to work. Is it perfect? No. But it has proved the concept. If the drug is covered, it will create a strong incentive to develop follow-ons that will improve on the effectiveness. In my opinion, what would really be stupid would be to cut off the incentives to exploit this advance right when we are on the doorstep of something that will help a lot of people.

Posted by: walkamile | November 18, 2010 10:20 AM | Report abuse

It would be ridiculous to have this drug paid for by medicare even if they dropped it to 3,000.00. Not if it only can give you a maybe 4 month extension of your problems. And why isnt some one looking into that 93,000.00 price gouge. They cant expect to make up R&D costs in the first 100 cases. Or do they.

Posted by: HawkCW4 | November 22, 2010 2:15 PM | Report abuse

I am on my 3rd line of prostate cancer chemotherapy treatment, and it is a very expensive line. I was against chemotherapy from the start but an oncologist talked me into it and my wife also swayed my decision although her motivation was her love for me.
The expensive chemo drugs are not working and my PSA is now rising to dangerous levels; meanwhile the drug companies are profiteering from my misfortune. Of course if the drugs don't work there is no refund for all the money my medical insurance paid for the drugs, and I feel that my disease is bleeding the health care system.
I have seen reports that claim that cures are not sought by drug companies, but that the companies prefer to develop expensive maintenance drugs to elevate their profit margins.
That human beings would do this to other human beings is indeed a sin, but when money and greed is involved there seems to be no holds barred.
I have no fear of dying as it is inevitable, but I hate dying with such a bad feeling for humanity and with such disgust for the drug company's business practices. It is not the medical community I loath, but the greedy drug companies and corrupt politicians that they have in their pockets.

Posted by: sferguson14 | November 24, 2010 11:12 PM | Report abuse

I am on my 3rd line of prostate cancer chemotherapy treatment, and it is a very expensive line. I was against chemotherapy from the start but an oncologist talked me into it. My wife also swayed my decision although her motivation was her love for me.
The expensive chemo drugs are not working and my PSA is now rising to dangerous levels; meanwhile the drug companies are profiteering from my misfortune. Of course if the drugs don't work there is no refund for all the money my medical insurance paid for the drugs, and I feel that my disease is bleeding the health care system and is just one example of why so many people are without medical care due to the high cost of medical insurance.
I have seen reports that claim that cures are not sought by drug companies, but that the companies prefer to develop expensive maintenance drugs to elevate their profit margins.
That human beings would do this to other human beings is indeed a sin, but when money and greed is involved there seems to be no holds barred.
I have no fear of dying as it is inevitable, but I hate dying with such a bad feeling for humanity and with such disgust for the business practices of the drug company's. It is not the medical community I loath, but the greedy drug companies and corrupt politicians that they have in their pockets.
The simplest and cheapest solution for me would be euthanasia, but this humane treatment of a person dying of cancer is outlawed in America, meanwhile the development of expensive, debilitating, and often ineffective drugs for immense profit is applauded and politically supported.

Posted by: sferguson14 | November 24, 2010 11:26 PM | Report abuse

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