A $93,000 cancer treatment: Worth the price?Provenge is the first 'cancer vaccine' to hit the market, but comes with a price tag of $93,000. Patients require just one treatment, which comes in three infusions over the course of a month.
By: Christopher Snowbeck, Pioneer Press (St. Paul) / MCT
Sid Thompson no longer suffers from constant pain.
He goes out to dinner weekly with his granddaughters and regularly has lunch with golfing buddies.
The 70-year-old runs errands with his wife, happily greets guests in his Minnetonka, Minn., home and has experienced a dramatic improvement in physical health compared with the way he felt in December.
At that point, after about a year's worth of chemotherapy, Thompson told his doctor he'd rather face death than continue with treatments for his advanced prostate cancer.
That's when Thompson got access to a new drug treatment called Provenge -- a therapy that has generated both remarkable success stories and considerable controversy.
'Eight to 10 weeks after I had this treatment, the results to me were incredible,' Thompson said. 'I had had a lot of pain in my hips and shoulders and back from the prostate cancer. ... But the whole thing disappeared.'
Provenge is the first 'cancer vaccine' to hit the market, but comes with a price tag of $93,000. Patients require just one treatment, which comes in three infusions over the course of a month.
In the spring, U.S. regulators approved Provenge for use in patients like Thompson, and the University of Minnesota is one of the few medical centers in the country that currently can provide the complex treatment.
In the most definitive study thus far of Provenge, patients experienced a median survival benefit of about four months. Put another way, the median
survival time for those who took the drug was about 26 months compared with about 22 months for those who received a placebo.
The results were strong enough for regulators in April to approve Provenge for use in the U.S. But the limited duration of the benefit has made Provenge the latest treatment to raise fundamental questions about the costs and benefits of modern medicine.
'If every patient lived only four months longer, I don't think it would be worth it,' said Dr. Robert Kratzke, a cancer expert at the University of Minnesota. 'But there is a subset of patients -- that we can't predict -- who seem to benefit for a dramatically longer period, both symptomatically and in terms of survival.'
Kratzke said he's been told of one patient treated at the Mayo Clinic, for example, who lived for 10 years. Mayo officials did not respond to questions about the claim, but doctors at the Rochester hospital in 2004 published a study mentioning a Provenge patient who was cancer-free for more than four years.
Provenge is the latest in a series of highly complex medications that fall into a group known as 'specialty drugs.' A hodgepodge of medications that doctors prescribe to treat everything from multiple sclerosis and hemophilia to hepatitis C and rheumatoid arthritis, specialty drugs are produced through a much more complex process than traditional medications.
That process -- and the considerable research behind the medications -- makes specialty drugs expensive. Dendreon Corp., the Seattle-based company that makes Provenge, reportedly spent about $1 billion developing the treatment.
In 2009, the average annual cost for just one specialty medication was $32,735, up more than 10 percent from the previous year, according to research from Stephen Schondelmeyer, an expert on pharmaceuticals at the Prime Institute at the University of Minnesota.
For the 12 months ending in March, the U.S. market in specialty pharmaceuticals was worth just over $62 billion, according to IMS Health, a health care information firm based in Norwalk, Conn. Cancer therapies accounted for about one-third of the specialty drug sales during the period -- the single largest therapeutic class -- and the value of specialty cancer drug sales more than doubled from 2004 to 2010, according to IMS Health.
The manufacturing process for Provenge illustrates the vast distance between specialty drugs and the typical bottle of pills on the pharmacy shelf.
Through a process called leukapheresis, doctors circulate a patient's blood outside the body through a machine that collects white blood cells. At the U, collection typically occurs on a Monday and the white blood cells are then promptly shipped to a Provenge manufacturing center in Maryland.
The white blood cells are challenged in a lab with prostate-cancer-specific proteins through a process that's designed to rev up the immune system -- the intent is to transform the white blood cells into cancer-fighting cells. Three days after first being collected, the cells are shipped back to the Twin Cities and infused into patients almost immediately.
"This is the first time ever that in one of the four major cancers ... that there's been an effective, proven immunotherapy that's gotten to market," said Kratzke, the cancer expert at the U. "It's extremely significant."
In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed in the U.S. and about 27,000 men died from the disease. But Provenge is a treatment option for very few prostate cancer patients.
Regulators say the drug is indicated only for patients with minimal or no symptoms where the cancer has spread to other parts of the body and is resistant to standard hormone treatment. Because that's a narrow band of patients, health insurers say they aren't overly worried about the cost of Provenge -- at least for now.
"If Provenge use was expanded to a broader population of prostate cancer patients, it would have a noticeable effect on cost trends," said James McManus, a spokesman for Eagan-based Blue Cross and Blue Shield of Minnesota.
Blue Cross and Bloomington-based HealthPartners are among the private insurers covering the cost of Provenge, one of several newer drugs that offer treatment advances at steep prices. It's the broader trend -- not any one treatment -- that raises a concern, said Dr. George Isham, the chief health officer at HealthPartners.
"There are more and more of these newer drugs coming in that are very, very expensive," said Isham. "That's going to be a social problem in terms of how we can afford that."
In recent months, Dendreon's stock price has fluctuated over news that the federal Medicare health insurance program is initiating a review of whether it should pay for patients to have the drug. Some stock analysts have greeted the reports with dismay, while others have said a Medicare review was expected.
In the meantime, Dendreon officials stress that the Medicare review does not limit patient access to Provenge. Many Medicare contractors across the country have provided the treatment, the company notes, and their decisions will stand until Medicare completes its review next year.
Another challenge for the company is beefing up its production capabilities. Because additional manufacturing centers won't be running until next year, Dendreon limited the launch of Provenge to about 50 medical centers in the U.S.
While some medical centers have talked about needing to run lotteries or use other means to control access to the limited supply of Provenge, that hasn't been an issue at the University of Minnesota, said Kratzke. Since the drug was approved for use, about 40 patients either have received the treatment at the U or are in the process of doing so.
Among prostate cancer patients, Provenge has been a widely watched medicine for years. Back in 2007, an advisory committee to the Food and Drug Administration recommended approval for Provenge, but the agency instead asked for Dendreon to study the treatment in more patients.
Some prostate cancer patients were outraged by the decision. Patient groups rallied outside the FDA in opposition to the decision and filed a lawsuit alleging that the agency's decision was influenced by conflicts of interest. There were even reports of death threats against advisory panel members who voted against approval for Provenge.
Even with FDA approval of the drug this year, hints of controversy remain.
Dr. Steven Miles, an internal medicine physician at the U, said he worries that broad use of the drug might not be justified, given the results of studies thus far. Noting that the final approval study for Provenge included only about 730 patients, Miles asked: "Is that enough to justify approving this drug for use in millions of people, especially for such a modest effect?"
The price of Provenge is especially striking considering that, according to a study published this year, the current cost of care for men with prostate cancer has been estimated at about $1,800 per month.
"The high cost (of Provenge) may affect use," wrote Dr. Dan Longo, a deputy editor at the New England Journal of Medicine.
But the focus on the drug's cost seems misplaced to patients like Thompson.
A retired stockbroker, Thompson was first diagnosed with prostate cancer in 2004. He managed the disease with radiation treatments and medications until the cancer reasserted itself in 2008.
While on chemotherapy, Thompson lost his appetite, suffered equilibrium problems and had no energy. The bed was his best friend, he said, and it was a struggle just to walk to the kitchen. He received Provenge as part of a study just prior to its approval.
"There was no quality of life," Thompson says of his time on chemotherapy. "If Provenge costs $100,000 for a one-time treatment, and you're on chemotherapy for 14 months and it's $10,000 or $12,000 per month, it's more costly for chemotherapy."
Thompson is not free of his cancer, and he occasionally has pain for a few days in different parts of his body. But he now has a measure of optimism that wasn't there last year.
"I think as we get further into this method of treatment, the cost will decrease," Thompson said. "The other thing is, I really think it's on the threshold of something that can be used for all kinds of cancers in the future."
Distributed by McClatchy-Tribune Information Services.