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CMS: Provenge shows evidence of ‘moderate’ benefit

CMS: Provenge shows evidence of ‘moderate’ benefit

Kevin E. Behrns, MD

The prostate cancer drug Provenge (sipuleucel-T) offers a moderate survival benefit to patients, according to an analysis performed by the U.S. Centers for Medicare and Medicaid Services. The analysis was undertaken as part of a CMS review initiated in July to determine whether to cover the cost of the therapy.

The report concluded that results from three randomized Provenge trials are "consistent with longer overall survival in patients meeting the FDA-labeled indication."

In these studies, the drug, which costs $93,000 per patient, has been shown to extend survival in patients with prostate cancer by an average of 4.1 months compared to conventional treatments. However, the CMS analysis said there were issues with the design of the trials that made it difficult to assess how effective Provenge really was.

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