CMS launches coverage analysis for new prostate Ca immunotherapy

The Centers for Medicare and Medicaid Services has launched a National Coverage Analysis (NCA) of sipuleucel-T (Provenge), a recently approved cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant prostate cancer. The agent is the first in a new therapeutic class known as autologous cellular immunotherapies.

CMS says it is opening this national coverage analysis to determine whether autologous cellular immunotherapy is reasonable and necessary under certain sections of the Social Security Act.

CMS is seeking public comment on the effects of sipuleucel-T on health outcomes in patients with prostate cancer. This does not reflect a change in Medicare coverage policy, according to Dendreon Corp., the drug’s manufacturer. NCAs do not affect existing coverage decisions, and they do not limit local Medicare contractors from covering sipuleucel-T, the company said. Medicare beneficiaries can still access sipuleucel-T and private payers can also still cover sipuleucel-T.

The initial 30-day public comment period began on June 30, 2010 and ends after 30 calendar days. CMS said it is "particularly interested in clinical studies and other scientific information relevant to the subject under review." Instructions on submitting public comments can be found at www.cms.hhs.gov/InfoExchange/02_publiccomments.asp.