Previous versions of this article misspelled the name of Tito Fojo, of the National Cancer Institute. This version has been corrected.
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Review of prostate cancer drug Provenge renews medical cost-benefit debate
Some fear the move will discourage pharmaceutical companies from developing new cancer drugs.
"It is extremely chilling if, after spending a huge sum of money, time and effort to get a drug through FDA approval, you'll then have to go through it all again to see if CMS will pay for it," said Allen S. Lichter, head of the American Society of Clinical Oncology. "Firing a shot across the bow like this is not the way to have an intelligent and meaningful discussion about how we start to address the complex issue of drug costs."
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 Provenge. 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.
To produce Provenge, doctors remove immune system cells from patients, expose the cells in the laboratory to a protein found on most prostate cancer cells and an immune system stimulator, and infuse the cells back into the patient in a month-long series of three treatments. In a study involving 512 patients with advanced prostate cancer, Provenge increased median survival from 21.7 months to 25.8 months.
"To charge $90,000 for four months, which comes out to $270,00 for a year of life, I think that's too expensive," said Tito Fojo of the National Cancer Institute. "A lot of people will say, 'It's my $100,000, and it's my four months.' Absolutely: A day is worth $1 million to some people. Unfortunately, we can't afford it as a society."
Others agreed, especially given the modest benefit.
"I'd like to think cost doesn't need to come up when it's a slam dunk," said H. Gilbert Welch of the Dartmouth Institute for Health Policy and Clinical Practice. "But when it's a close call like this, it certainly has to be a factor. That's $100,000 Medicare can't spend elsewhere."
But such commentary has caused widespread alarm among patients and advocates.
"The men most impacted by prostate cancer are African American men. If CMS doesn't approve this, then this treatment becomes an exclusive kind of treatment for men who can afford it out of pocket," said Thomas Farrington, president of the Prostate Health Education Network.
Others stressed that many men live far longer on the treatment and that even four months is extremely valuable to some.
"Whenever you are faced with a disease where you can lose your life, you really would like to extend it as much as you can," said Leibel B. Harelik, 61, a prostate cancer patient who is executive director of the Prostate Cancer Resource Center in Austin.
Company officials say the cost is not out of line with that of other cancer drugs. Each treatment with Provenge, which the company estimates cost nearly $1 billion to develop, is tailored to each patient.
"Because of that, we have higher costs associated with this product," said Mitchell H. Gold, Dendreon's chief executive. "Provenge is a unique new medicine that prolongs the lives of patients with late-stage prostate cancer. These patients need access to innovative new medicines."
Whatever the outcome on Provenge, many on both sides agreed that more debate over other new high-tech therapies was likely to come.
"At some point, if we keep paying these very high prices for treatments that provide very limited benefit, we're going to reach the point where we can no longer afford health care," said Alan Garber, a professor of medicine and economist at Stanford University. "Some say we're living through that right now."