The Centers for Medicare and Medicaid Services has announced that Medicare will cover Provenge® (sipuleucel-T) for the uses approved by the U.S. Food and Drug Administration (FDA): the treatment of metastatic, hormone-refractory prostate cancer that is producing few or no symptoms.
Prostate cancer is a hormonally sensitive disease that can often be controlled for long periods with androgen-deprivation therapy. When prostate cancer stops responding to this treatment, it is referred to as hormone-refractory prostate cancer. Metastatic hormone-refractory prostate cancer is cancer that has stopped responding to standard hormone therapy and has spread to other parts of the body.
Provenge is an immunotherapy that prompts the body’s immune system to respond against the cancer. A Phase III clinical trial that contributed to the FDA’s approval of Provenge was a study known as IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment). Study participants had metastatic, hormone-refractory prostate cancer, and were treated with either Provenge or a placebo. Median overall survival was 25.8 months in the Provenge group compared with 21.7 months in the placebo group, a 4.1-month improvement. Side effects that were more common in the Provenge group included chills, fever, and headache.
Provenge was approved by the FDA in April, 2010 for the treatment of asymptomatic or minimally symptomatic, metastatic, hormone-refractory prostate cancer. The decision about Medicare coverage is effective immediately.
Reference: Centers for Medicare and Medicaid Services. Press release: Medicare expands treatment options for patients with advanced prostate cancer. June 30, 2011.