CMS sees 'moderate' evidence for Provenge

The Centers for Medicare and Medicaid Services didn't exactly give a glowing review to Dendreon's ($DNDN) new prostate-cancer treatment Provenge. The data on the closely watched cancer vaccine--which finally won FDA approval earlier this year--shows only "moderate" evidence for its use, the center's internal analysis determined.

An advisory panel will convene next week to review that analysis and discuss whether to support Medicare coverage of the pricey treatment, which runs more than $90,000 per patient. That CMS chose to review the new vaccine raised some eyebrows among patient advocates and lawmakers, who cautioned that a denial would constitute "rationing"--a loaded term that adds political weight to the center's decision.

The CMS report stated that, based on data from three clinical trials, Provenge did offer a significant survival benefit. It didn't, however, show a significant difference in progression of the disease compared with placebo. Quality of life wasn't measured. "The strength of the body of evidence for improved outcomes was graded as moderate," CMS says in the assessment.

Analysts seem to think the measured review is a positive sign for reimbursement. Some observers say the review isn't so much about whether Medicare will pay for Provenge--they think it will--but about limiting the vaccine to on-label use in patients with advanced cancers that haven't responded to other treatments. "Historically, moderate means that CMS will reimburse the product for its on-label indication," said Robyn Karnauskas, a Deutsche Bank analyst. We'll see what happens next week.

- read the Reuters news

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