CMS Says Provenge is Reasonable and Necessary

The Centers for Medicare & Medicaid Services (CMS) announced March 30 that it would pay for Dendreon’s prostate cancer drug, Provenge, when used to treat Medicare beneficiaries with late-stage prostate cancer. The Food and Drug Administration (FDA) approved Provenge for patients with castration-resistant, metastatic prostate cancer in April 2010. In the absence of a national coverage determination (NCD) for autologous cellular immunotherapy treatment, local Medicare contractors have had discretion to determine coverage for the $93,000 drug.

In a proposed decision memo posted on the Medicare Coverage Database website, however, CMS now says Provenge is reasonable and necessary. “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,” CMS concludes in the decision memo.

During the initial 30-day comment period of the national coverage analysis (NCA), CMS received 657 comments, most of them favorable for coverage.

The proposed decision is open for public comment through April 30, and CMS will make a final determination sometime in June.


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