Does CMS’s Coverage Decision for Sipuleucel-T Herald More Restrictive Policy?

July 2012, Vol 3, No 5 - AMCP Annual Meeting


San Francisco, CA—In its national coverage decision (NCD) for sipuleucel-T in the treatment of advanced prostate cancer, the Centers for Medicare & Medicaid Services (CMS) left the coverage decision for any off-label use of medications to the discretion of the local Medicare contractors, citing an absence of data on which to make a coverage decision.

Charles A. Stevens, JD, MBA, Vice President and General Manager of Commercialization Strategy at Parexel Consulting, Waltham, MA, and colleagues suggested at the 2012 Academy of Managed Care Pharmacy annual meeting that this could be an emerging trend for future expensive therapies.

“Budget concerns, the high price of new products, and widespread offlabel use of new therapies have combined to place tremendous pressure on the CMS as it evaluates new drugs and biologics under its NCD process,” observed Mr Stevens and colleagues in a poster presentation.

Their goal was to assess how CMS may exercise various NCD options to control drug coverage in light of the recent coverage concerns for sipuleucel-T, a high-priced vaccine for castration-resistant prostate cancer that is likely to be used off-label, Mr Stevens noted. The 4 factors that lead to an NCD review by CMS are:

  • The price of the drug
  • Lack of the drugmaker’s communication with CMS
  • Data sharing between the US Food and Drug Administration and CMS
  • Private versus payer concerns.

In addition, there are 5 options for CMS related to an NCD:

  • Coverage
  • Coverage with evidence development
  • Coverage for on-label use only, and no off-label coverage
  • More restrictive coverage impacting on on-label use
  • Lack of coverage of the drug.

An analysis of NCDs showed that CMS has historically regulated medical devices using the NCD process more often than for drugs or biologics when there has been a concern over unwarranted product utilization that increases costs over existing products without added benefits, Mr Stevens and colleagues noted. These decisions have led to restricted coverage for such products.

In the case of sipuleucel-T, the CMS review resulted in an NCD that allowed coverage only for the approved-label use of this drug, reserving off-label coverage decisions for local contractors.

Effective for services performed on or after June 30, 2011, CMS proposed that “the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment—sipuleucel-T—improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrateresistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for this on-label indication. Coverage of all offlabel uses…is left to the dis cretion of the local Medicare Administrative Contractors.”

Based on this NCD, it is reasonable to assume that “CMS may continue to make overall coverage decisions regarding on-label indications when adequate data exist to demonstrate value,” noted Mr Stevens. “If the data on treatment value are incomplete, CMS may defer off-label coverage determinations to the local contractors. There is also a strong indication that CMS may strictly limit reimbursement to the labeled indication in the absence of data demonstrating value for other indications.”—CH