In a decision memo released March 30, the Centers for Medicare and Medicaid Services (CMS) proposed that “the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment sipuleucel-T [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 under 1862(a)(1)(A) of the Social Security Act.” The memo calls for public comments on the proposed determination, after which a final decision on the drug will be made.

Sipuleucel-T was approved by the FDA in April 2010, after controversial delays and resulting protests by patients, advocates, and other supporters of approval. Adding to the controversy is the drug’s $93,000 cost for a complete course of therapy, which leads to a median 4.1-month survival benefit. The unusual decision by CMS to formally study the drug prior to granting coverage stirred further debate. ■