After months of anticipation, the Centers for Medicare & Medicaid Services has decided that the Provenge prostate cancer vaccine is eligible for reimbursement. The unsurprising decision comes just four months after a CMS advisory panel voted that Dendreon’s Provenge vaccine for advanced prostate cancer shows “clinically significant” improvement in survival (look here)
The panel was convened, however, after the agency last year unexpectedly initiated a so-called National Coverage Determination in response to questions raised by Medicare contractors amid concerns over off-label use. Such a review was unusual, given that Medicare generally pays automatically for FDA-approved oncology meds (read here).
For that reason, the CMS review set off a firestorm of protest that the agency was using Provenge as a litmus test for health care rationing. Among those registering concern was the American Society of Clinical Oncology and several US senators (see this and this). All totaled, CMS received 657 comments and the overwhelming majority - 620, or 94.4 percent - supported coverage.
At issue has been whether coverage for the $93,000 treatment, which is sold by Dendreon and is the first such therapeutic cancer vaccine, is deemed reasonable and necessary. The drug was approved last year based on a study showing a four-month survival benefit and most patients who qualify for Provenge treatment also qualify for Medicare.
In the memo released today, CMS officials stated that "we do not believe there is any persuasive evidence for the off label use of (Provenge) at this time," because it appears "virtually nil’’ that Provenge was effective for men who had other stages of the disease and so off-label should not be reimbursed. But the agency is going to leave more specific coverage decisions to each of the Medicare contractors, because Dendreon has indicated off-label use is unlikely and the underlying product technology is new and Medicare contractors need flexibility to determine coverage (you can read the complete CMS memo here).
UPDATE: RW Baird analyst Chris Raymond writes this in an investor note: "No off-label endorsement, but no binding restriction either. Delving into the detail of the proposed National Coverage Determination, CMS leaves the door open for regional MACs to determine noncoverage. We view the lack of an outright off-label restriction as positive."