CMS Issues Proposed Decision Memo on Medicare Coverage of Sipuleucel-T
The Centers for Medicare and Medicaid Services (CMS) has issued a Proposed Decision Memo on sipuleucel-T (Provenge) for the treatment of advanced prostate cancer. According to the memo, “Provenge improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for that indication.”
The memo is one of the final steps in a National Coverage Analysis (NCA) initiated by CMS last year for the treatment. NCAs are performed to determine whether Medicare will routinely cover a treatment for all beneficiaries, or whether the decision will be left to individual regional Medicare carriers. In November 2010, the agency’s Medicare Evidence Development & Coverage Advisory Committee offered moderately strong support for coverage of sipuleucel-T.
The FDA approved sipuleucel-T, an immunotherapy, in April 2010, based on the results of a clinical trial that showed a median improvement in overall survival of 4 months in patients who received the treatment compared with men who received a placebo.
CMS is accepting public comments on the proposed decision memo for 90 days.