Dendreon's $93K cancer vax wins final CMS nod

Medicare officials have made their final determination about Dendreon's pricey cancer vaccine Provenge. They'll pay for it as long as patients meet the requirements on the label. Officials said the evidence on Provenge "improves health outcomes" and as such was "reasonable and necessary."

The drug's label limits it to patients whose prostate cancer has metastasized and can't be controlled by hormone therapy, and who also have minimal symptoms at most. Off-label use wasn't included in the Centers for Medicare and Medicaid Services determination. And the final decision wasn't much of a surprise, either; the agency has been signaling for some time that the vaccine would be covered.

The agency has also been promising that Provenge's $93,000 price tag wasn't an issue in its unusual choice to conduct a nationwide coverage review--or in its decision about reimbursement. Considering cost would have touched off major protests; as it was, even the coverage review brought out accusations of treatment rationing.

And Medicare doesn't have the kind of negotiating power on drug prices that other countries' government programs do. That and the cost-is-not-a-consideration meme are pluses for Dendreon. About three-fourths of potential Provenge patients are Medicare beneficiaries.

- read the Bloomberg story
- get more from the New York Times
- see the Reuters article