The Centers for Medicare and Medicaid Services (CMS) has released a proposed decision memo that suggests it will cover the cost of sipuleucel-T (Provenge), the immunotherapy vaccine approved in April 2010 for men with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer, for on-label use. CMS contractors will have discretion as to whether they will cover it for off-label use.
To date, no studies have been published that support off-label use of sipuleucel-T, but CMS decided to leave the coverage question open so that patients in clinical trials investigating off-label indications might have access to the drug. The agency noted that it does not expect clinicians to prescribe sipuleucel-T for indications unsupported by evidence, but if this occurs regularly, CMS said it would reconsider the ruling.
When sipuleucel-T was first approved, CMS took the unusual step having the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) review the clinical trial data before agreeing to cover the drug's estimated $93,000 cost. The committee completed its review in November 2010, and panel members rated the drug an average of 3.6 for effectiveness despite concerns about flaws in the trials' protocols and analyses.
CMS also asked the Blue Cross & Blue Shield Technology Evaluation Center to conduct an independent investigation of the evidence for its effectiveness. The center concluded it had "moderate" efficacy.
In an initial 30-day public comment period, 620 (94.4%) of the 657 comments received supported covering sipuleucel-T for prostate cancer. CMS also reviewed national guidelines and met with officials from Dendreon to discuss the trials.
In issuing its proposed coverage decision, CMS noted underrepresentation of non-white men in the trials and "encourage[d] researchers to take appropriate steps to assure that clinical trials enroll subject populations that reflect the distribution of patients affected by the disease." Black men are more than twice as likely to die from prostate cancer as white men.
CMS has initiated another call for public comments on its proposed determination. After reviewing comments, the agency expects to issue its final ruling by June 30, 2011.