Medicare Will Cover Provenge Treatment for Prostate Cancer
The Centers for Medicare and Medicaid Services (CMS) announced it will cover the cost of sipuleucel-T (Provenge), an autologous cellular immunotherapy for prostate cancer, for Medicare beneficiaries. In a National Coverage Determination (NCD) memo released June 30, CMS stated that there is sufficient evidence that the therapy is effective for its FDA-approved use: the treatment of men with metastatic prostate cancer who have few or no symptoms of the disease.
Sipuleucel-T was approved by the FDA in April 2010 based on the results of a phase III clinical trial called IMPACT. The trial showed that the treatment, which uses a modified form of a patient’s own white blood cells, improved the median overall survival of men with metastatic, hormone-refractory prostate cancer by 4.1 months compared with the median survival of men who received a placebo treatment. Sipuleucel-T also showed little evidence of serious side effects.
CMS initiated a National Coverage Analysis last year, agency officials explained, because of questions about whether all of Medicare’s regional carriers would cover the therapy. In the absence of an NCD, local Medicare contractors had discretion to decide whether to cover the therapy. Treatment with sipuleucel-T consists of three vaccinations over a 4- to 6-week period at a total cost of $93,000.
In November 2010, a Medicare advisory panel offered support for sipuleucel-T coverage. Three other treatments are approved for metastatic, hormone-refractory prostate cancer: the chemotherapy drug docetaxel, which has significant toxic effects that deter many men from taking it; cabazitaxel (Jevtana), which was approved by the FDA last year for men with advanced disease who do not respond to docetaxel; and abiraterone (Zytiga), which was approved earlier this year for the same indication.