Dendreon’s pricey metastatic prostate cancer drug Provenge has won the approval of a Centers for Medicare and Medicaid Services advisory panel, which says the drug should be covered by Medicare. Cleared for U.S. sales in late April, Provenge essentially acts like a cancer vaccine by mixing a patient’s own white blood cells with vaccine components, which are then injected back into the patient to generate immune cells able to target a protein produced by prostate cancer cells. The FDA initially denied approval for Provenge in 2007, when one of two studies failed to show a benefit, but it approved the drug earlier this year specifically for advanced prostate cancer after a third study showed that it could extend patients’ lives an additional four months. ACSH's Dr. Gilbert Ross noted, “It’s unusual for CMS to question covering a drug so soon after FDA approval. It is unavoidable to conclude that this was due to the $93,000 price tag.”
Medicare will make a final decision on whether to cover the drug by June 30.
Provenge not too costly for Medicare coverage
By ACSH Staff — November 17, 2010
By ACSH Staff