CMS proposes Medicare coverage for Provenge

The Centers for Medicare and Medicaid Services (CMS) proposed yesterday that there is sufficient and adequate evidence 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.  In essence, CMS is proposing that it will cover Provenge for “on-label” use.

CMS is requesting public comments on this proposed determination. After considering such public comments, the agency will make a final determination and issue a final decision memorandum. The current, proposed decision memorandum, a 22-page document reviewing the evidence CMS considered,  is available on the CMS web site.

CMS’s stand regarding “off-label” use — meaning use not covered by the FDA approved label, is interesting.  Many advanced patients are in the off-label area, for example, being more than minimally symptomatic, or being castrate resistant but not metastatic, or being metastatic but not yet castrate resistant.  While CMS does not propose covering off-label use, as CMS explains on page 14 of the document, it could have proposed national non-coverage of off-label use. CMS’s finding that there was essentially no evidence regarding off-label use could have supported that stand.  Instead it proposes to leave off-label use decisions up to their local administrative contractors.  It gives four reasons for doing so; fundamentally, it wanted to provide flexibility as evidence accumulates to the local units without having to reconsider a National Coverage Determination.  From a patient’s standpoint, I find that encouraging.

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