Provenge, a new therapy for incurable stage prostate cancer with a $93,000 price tag, will be covered by Medicare, officials confirmed yesterday. The medication has been shown to give men whose cancer has not responded to radiation or hormone therapy and has spread through the body an extra four months of life.
A Medicare spokesman described Provenge as a "reasonable and necessary" medication.
Off-label use of Provenge will not be covered, Medicare stressed.
Provenge triggers the individual's immune system against prostate cancer. Treatment involves collecting the patient's white blood cells and exposing them to proteins that make them attack the cancer cells. After treating the patient's cells, they are placed back into his body in order to stimulate his immune system. This is done repeatedly over several weeks for a total of three months.
CMS Administrator Donald M. Berwick, M.D., said:
"We are optimistic that innovative strategies may improve the experience of care for our beneficiaries who have cancer. CMS is dedicated to assuring that these patients can seek the treatments they need in accordance with their wishes."
Prostate cancer is the most common male cancer in the USA, after skin cancer. It develops in the prostate and can spread to other parts of the body - it is potentially life-threatening.
According to Medicare, approximately 192,280 patients were diagnosed with prostate cancer in the USA in 2009; in that same year 27,360 males died of the disease. The majority of prostate cancers are diagnosed in men after the age of 65 years (average age 72).
In an online communiqué, CMS (Centers for Medicare & Medicaid Services) wrote:
"Today's coverage decision includes coverage of Provenge for the uses approved by the FDA: for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer."
Patrick Conway, MD, MSc, CMS Chief Medical Officer and Director of the Agency's Office of Clinical Standards & Quality, said:
"CMS is covering Provenge nationally only for those indications supported by evidence and consistent with the FDA label. Similar to other treatment decisions, individual patients should discuss the risks and benefits with their physician to make an individual decision."
"Questions and Answers - Provenge"
When deciding whether it will pay for new treatment, Medicare is not allowed to consider the price. However, the $93,000 price tag had been controversial with many experts and lawmakers wondering what the government's role should be in covering their costs - given the large number of baby boomers, Medicare costs are rising.
Dendreon Corporation, the makers of Provenge explain that its medication's median survival time is double that of chemotherapy, with much fewer and less severe side effects. The company says it spent over $1 billion on R&D before the drug was ready to go on the market.
US authorities have approved the opening of a second Dendreon manufacturing plant in Los Angeles, California. By the end of August the company expects to have three plants, its original one in New Jersey, the new one in Los Angeles, plus another new one in Atlanta, Georgia.
Written by Christian Nordqvist