THURSDAY, June 30 (HealthDay News) -- The cost of Provenge, an
expensive and newly approved therapeutic prostate cancer vaccine,
will be covered by Medicare for men with metastatic prostate
cancer, the agency announced late Thursday.
The vaccine, made by the Dendreon Corp., costs $93,000 per
patient and extends survival by about four months on average,
according to results from clinical trials. A panel of experts
convened by Medicare gave the nod for coverage last November, but
the agency has only now announced it would cover the treatment.
"We are optimistic that innovative strategies may improve the experience of care for our beneficiaries who have cancer," Dr. Donald M. Berwick, administrator of the Centers for Medicare & Medicaid Services (CMS), said in an agency news release. "CMS is dedicated to assuring that these patients can seek the treatments they need in accordance with their wishes."
Research does suggest that the vaccine can extend the lives of
men with cancer that has spread beyond the prostate. One study,
published in July 2010 in the
New England Journal of Medicine, found that the vaccine extended the lives of men with metastatic tumors resistant to standard hormonal treatment, compared with no treatment. And the therapy involved less toxicity than chemotherapy.
Provenge is a therapeutic (not preventive) vaccine made from the
patient's own white blood cells. Once removed from the patient, the
cells are treated with the drug and placed back into the patient.
These treated cells then trigger an immune response that in turn
kills cancer cells, leaving normal cells unharmed. The vaccine is
given intravenously in a three-dose schedule delivered in two-week
"The strategy of trying to harness the immune system to fight cancer has been something that people have tried to attain for many years; this is one such strategy," study lead researcher Dr. Philip Kantoff, a professor of medicine at Harvard Medical School and a medical oncologist at the Dana-Farber Cancer Institute in Boston, told HealthDay last November.
Another expert said the therapy, while far from a cure, "looks
promising." Speaking at the time of the drug's approval by the CMS
panel, Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital in
New York City, said that "in this unfortunate category of
[hormone-resistant] patient, we have very little to offer. Adding
months to a man's life is better than doing nothing, especially if
the treatment involves minimal morbidity, as this vaccine
The U.S. Food and Drug Administration approved Provenge in April
2010 for the treatment of prostate cancer that has spread to other
parts of the body and is resistant to standard hormone
In his team's study, Kantoff's group randomly assigned 512 men
to receive Provenge or a placebo. All of the patients had advanced
prostate cancer that had proven resistant to standard hormonal
On average, men receiving Provenge lived 4.1 months longer than
men receiving a placebo, the researchers found. Average survival
was 25.8 months for men in the Provenge group, compared with 21.7
months for men in the placebo group, meaning that Provenge extended
survival by 22 to 25 percent, Kantoff said.
He contends that if the vaccine were used by men with less
severe disease, survival might be extended even longer.
"Theoretically, if you take people with less disease and you stimulate the immune system, you could have a more profound effect, but we don't really know that yet," he said.
Compared with other treatments, such as chemotherapy, radiation
and hormone therapy, Provenge has been touted as having fewer and
less severe side effects. In this trial, the most common side
effects were chills, fever and headache, the researchers noted.
Commenting on the high cost of Provenge, Kantoff said that "this
is a treatment given over a four-week period, as opposed to other
treatments that are given over many months, where the costs can be
high as well, if not comparable to or more expensive [than
For more information on prostate cancer, visit the
American Cancer Society.
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