WASHINGTON (AP) — Medicare officials said Wednesday that the program will pay the $93,000 cost of prostate cancer drug Provenge, an innovative therapy that typically gives men suffering from an incurable stage of the disease an extra four months to live.
The Centers for Medicare and Medicaid said the
biotech drug made by Dendreon Corp. is a "reasonable and necessary"
medicine. The decision ensures that millions of men would be able to afford the
drug through the government-backed health care coverage. With government
reimbursement, analysts estimate Provenge could rack up $1 billion in sales
next year. The decision, which will be finalized by June 30, is important for
Dendreon because most prostate cancer patients are 65 or older.
Medicare is legally prohibited from considering
price when deciding whether to pay for a new treatment. The Food and Drug
Administration approved Provenge last April and in most cases Medicare
automatically covers drugs cleared by the agency. But Medicare's decision to
review Provenge last year prompted outrage from some patients and doctors who
said the government was looking for a reason to avoid reimbursing for the
pricey drug.
The infused drug is a first-of-a-kind treatment in
that each dose is customized to work with a patient's immune system.
Seattle-based Dendreon says Provenge's price reflects the more than $1 billion
spent researching and developing the drug. And prostate cancer patients point
out that the median survival time with Provenge is double that of chemotherapy,
which is about two months and is marked by significant side effects.
"It's impossible to put a dollar figure on a
human life, especially when you're talking about a drug that has such mild side
effects," said Jim Kiefert, a prostate cancer patient and advocate who was
part of the Provenge study. "Of all the treatments I've had — with
surgery, radiation and hormone treatment — Provenge had fewer side effects than
any of them."
But bioethicists who study health care decisions
say Medicare's ruling on Provenge mirrors the bias of the overall U.S. health
system, which emphasizes expensive treatments over basic medical care. Health
care costs account for nearly one fifth of the U.S. economy, more than any
other country.
"We tend to put our health care dollars into
very high-tech interventions that produce very marginal improvements,"
said Dr. Steven Miles, a professor at the University of Minnesota's Center for
Bioethics. "The problem is that we have created a health care system that
is uniquely inadequate in terms of access to primary health care, which is
where you get the most bang for your buck."
A growing number of biologically engineered cancer
drugs are being priced in the $100,000 range, including therapies from Roche and
Eli Lilly & Co. Last week, Bristol-Myers Squibb Co. received approval for a
new melanoma drug that will be priced at roughly $120,000 per patient.
Provenge is the first FDA-approved cancer drug that
uses the body's own immune system to fight the disease, offering an alternative
to chemotherapy drugs that attack cancerous and healthy cells at the same time.
The treatment is intended for men whose prostate cancer has spread elsewhere in
the body and is not responding to hormone therapy or radiation.
Each regimen of Provenge must be tailored to the
immune system of the patient using a time-consuming formulation process.
Doctors collect special blood cells from each patient that help the immune
system recognize cancer as a threat. The cells are mixed with a protein found
on most prostate cancer cells and another substance to rev up the immune
system, and then given back to the patient as three infusions two weeks apart.
Industry observers say much of the scrutiny of
Provenge stems from the current political climate, as voters push lawmakers to
cut the deficit and rein in government spending. At the same time, the new
health care reform law has stoked debate about how much say the government
should have in approving coverage of medical treatments.
Republicans have accused the acting chief of
Medicare, Dr. Donald Berwick, of advocating health care rationing, based on
statements he made as a professor at Harvard University. President Obama
appointed Berwick to the post last year, but Senate Republicans have opposed
his confirmation and have urged Obama to nominate someone else.
Dr. Sean Tunis, a former Medicare official, called
Wednesday's decision a case of "the dog that didn't bark."
"You could almost guess that this would be
outcome before they even started. So why raise all the anxiety and subject
yourself to all the criticism of rationing?" said Tunis, who is director
of the Center for Medical Technology Policy in Baltimore.
Medicare officials have said the agency's review of
Provenge was aimed at clearing up bureaucratic confusion among Medicare
carriers across the country, some of whom already pay for Provenge. Medicare on
Wednesday called its online memo a "proposed decision," but it
essentially amounts to agreeing to cover the drug for millions of seniors
enrolled in its program.
The news sent Dendreon shares up 66 cents to $36.20
in after-hours trading. The stock closed the regular session down 34 cents at
$35.54 before the announcement.
Copyright 2011 The Associated Press.
