CMS: Medicare will cover immunotherapy for advanced PCa

The Centers for Medicare and Medicaid Services issued a final National Coverage Decision for sipuleucel-T (Provenge), requiring Medicare contractors to cover the use of the therapy for treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.

The decision was made effective June 30, 2011.

"We are optimistic that innovative strategies may improve the experience of care for our beneficiaries who have cancer," said CMS Administrator Donald M. Berwick, MD. "CMS is dedicated to assuring that these patients can seek the treatments they need in accordance with their wishes."

CMS internally initiated the national coverage determination process for sipuleucel-T for multiple reasons, including variations in local coverage, questions about the appropriate benefit category for the agent, and inquiries from Congress. The coverage decision includes coverage of sipuleucel-T for the uses approved by the FDA: for treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.

Dendreon, the maker of sipuleucel-T, said the agent was also issued a product-specific Q-code effective July 1, 2011, which allows for electronic submission of claims and is expected to accelerate time to payment for physicians.

Separately, Dendreon announced that the FDA approved its Los Angeles immunotherapy manufacturing facility on June 29. The facility includes 36 workstations, and Dendreon said it will bring these on in a staged approach. The company now has a total of 84 workstations to manufacture sipuleucel-T.