Dendreon's prostate cancer vaccine will be fully covered for Medicare patients, under a proposed payment plan from the Centers for Medicare and Medicaid Services. And not only will the $93,000 treatment, dubbed Provenge, get coverage for its FDA-approved use in men with advanced, metastatic prostate cancer, Reuters reports. The agency also held out hope that off-label uses might win coverage, despite its current determination that evidence for use in other patient groups is "virtually nil."
The decision comes after some months of consternation. When CMS announced that it would actually review payment for Provenge--rather than its usual tactic of automatically extending coverage to new, FDA-approved drugs--controversy ensued. Some politicians suggested that the CMS review amounted to "rationing" of healthcare; others wrote letters to the agency, warning that the review had better be about off-label use, not the FDA-approved one. Patient advocacy groups loudly criticized the very idea of a review. And Dendreon ($DNDN) investors cried foul, knowing that Medicare would be the primary payor for Provenge--so losing it would be an enormous blow to the company.
CMS held an advisory committee hearing in November, where experts who'd analyzed the data determined that there was enough evidence backing the FDA-approved use--but not enough for patients who didn't have advanced cancer that had metastasized. The payment proposal echoes that determination: CMS says the "evidence is adequate" that Provenge actually helps patients who meet the approval criteria, but that evidence for off-label use just isn't there.
Still, as the Wall Street Journal points out, the CMS announcement included a tantalizing line: "[C]overage of off-label use would be determined by Medicare's local contractors." An analyst told Reuters that this loophole leaves the door open to future off-label use. "They are suggesting that if new evidence comes for off-label use," Needham & Co's Mark Monane said, "they may be able to pay for Provenge without going through an NCD (National Coverage Decision) again." The final CMS decision is expected June 30.