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Provenge®

Posted by medconsumers on April 5, 2011

Should Medicare spare no expense in extending the lives of elderly people with incurable advanced cancer? Should cost-effectiveness be taken into consideration when approving a drug that works—sort of—but is extremely expensive?

Such questions are crucial to sustaining our currently unsustainable medical care system. But they were studiously avoided last month when Medicare announced that it would pay for Provenge, the controversial drug/vaccine for advanced prostate cancer. Rationing would, of course, be the outcry, but as someone has already pointed out, “It is irrational to think that we can have a medical care system that avoids rationing.”

It also seems irrational to approve a drug for symptomless cancer when the drug itself has a list of distressing symptoms (side effects), according to the company’s official website. Medicare approval was very specific regarding who should receive Provenge: “Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer.” Translation: this drug is proven effective only for men with minimal or no symptoms of advanced prostate cancer that did not respond to chemical castration, aka androgen deprivation therapy.

Here’s the backstory for Provenge, which has been controversial for over three years. The drug/vaccine costs about $93,000, delivered as three intravenous infusions approximately 2 weeks apart. It has been shown to extend life for about four months compared with a placebo. Another way of putting the same information: In the trial conducted for FDA approval, men with advanced prostate cancer who received no treatment lived a median of about 26 months; the men who received the drug/vaccine lived a median of about 30 months.

High hopes were pinned on Provenge by groups representing men with prostate cancer largely because it is a vaccine. It is not a vaccine for prevention; rather it is a vaccine for men who already have prostate cancer. Provenge stimulates the body’s immune system to resist the disease…at least for a short period of time. The voices of patient advocacy were heard loud and clear three years ago when the FDA decided not to approve Provenge for any stage of prostate cancer because effectiveness was uncertain. The advocacy groups generally wanted blanket approval for Provenge. Researchers and policy makers, on the other hand, know from experience that once a high-profile drug like Provenge is approved, it will be prescribed for earlier stages of prostate cancer. Knowing this is likely to happen, Medicare has issued a statement that Provenge should be prescribed for earlier stages of prostate cancer only in the context of a clinical trial. I think we can count on it being ignored, despite the fact that the evidence supporting Provenge’s use for earlier stages of prostate cancer has been described as “virtually nil”.

The cancer patients’ understandable need for hope and extended survival has become the driving force behind the demand for FDA approval whether the scientific evidence is weak, strong, or non-existent. But does it make sense to demand a blank check for anything the drug companies put on the market? And why would a drug company go back to the lab and come up with a more effective drug when it can make lots of money on one that’s only marginally effective?

Though not a chemotherapy drug, Provenge is emblematic of new cancer drugs with extremely high cost and effectiveness so miniscule that one British blogger wrote, only half in jest: “We doctors will have to start measuring chemotherapy’s effect on survival with stopwatches.”

Can we have a national conversation about these issues that is rational? No, is the obvious answer, but it is worth considering the options before you ever develop a terminal condition. Last summer the New England Journal of Medicine published a study that defies conventional wisdom about aggressive treatment for advanced cancer. It showed people with terminal lung cancer who chose early, palliative care offered by hospice had a better quality of remaining life and, surprisingly, a longer life than those given the standard aggressive treatment at the end of life. Click here

Maryann Napoli, Center for Medical Consumers©

3 Responses to “Provenge®”

  1. that’s the correct article. I noticed that it focused on the very sick, which is not true of all end stage kidney patients. Although many do suffer from heart disease and diabetes, some end stage patients only have kidney disease. Are we to use age as a factor when deciding who gets what type of care? Then who decides who is “too old”?

  2. this conversation includes not only cancer treatments but things like dialysis and kidney transplant. A recent news article questioned whether “older patients” should be on dialysis or if, because of costs, they should be “encouraged” to accept end of life care. There was even some suggested wordage to make it more attractive. Kidney dialysis and transplant is entirely paid for by Medicare, regardless of age. The article suggested that it was originally intended to keep younger people working, which I find very hard to believe.

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