Turns out analysts were right about Provenge's Medicare review. Just as industry-watchers had predicted, a Centers for Medicare and Medicaid Services panel backed Dendreon's ($DNDN) cancer vaccine for reimbursement--but only for the use specified on its label.
The vaccine has the FDA's blessing for use in advanced prostate-cancer patients whose disease has resisted standard hormone treatment. The panel affirmed that Provenge offers a survival benefit, awarding the treatment a 3.6 rating on a 5-point scale. But as the Wall Street Journal Health Blog points out, the panel gave low ratings to the drug's ability to handle pain and other symptoms.
The upshot is that the CMS committee backed Provenge for on-label use, but not for use in patients whose cancer hasn't progressed. Next, the agency will have to consider the panel's advice--and its own internal review, which found "moderate" evidence for Provenge reimbursement--in making its final determination.
The reimbursement decision is a big deal because most prostate cancer patients are over 65, and hence covered by Medicare, and allowing off-label use could really open up the market for the $93,000-per-patient drug. Will the predictions about restricting off-label reimbursement hold true in the final assessment? We'll have to wait a few months to find out.