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Related Topics >> Provenge | Medicare

Medicare's Provenge review comes into clearer focus

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With billions in revenue at stake, every new twist and turn in the saga revolving around the rollout of Provenge gets put under the microscope. Any possibility of market restrictions, a fear raised by CMS's decision earlier in the summer to review Provenge's use in the elderly, is enough to panic investors. To some, it looked as if the agency was considering that it might not pay for Provenge at all.

So when Medicare announced earlier this week that it's scheduled a Nov. 17 advisory panel meeting to discuss the "labeled and unlabeled use of autologous cellular immunotherapy treatment on health outcomes of patients with metastatic prostate cancer," investors generally decided that Dendreon had dodged a bullet. TheStreet's influential Adam Feuerstein set the tone with a piece outlining the likelihood that Medicare is preparing to make sure that the patients OK'd for the $93,000 therapy look a lot like the patients picked for the late-stage registration trial. That still leaves Provenge poised to develop into a blockbuster, and Dendreon's shares jumped 6 percent.

Dendreon already has most of the carriers who manage each of Medicare's 15 regions on board to pay for the therapeutic vaccine. And there was never really any serious question that CMS would deny coverage altogether. They have never denied coverage of an approved therapy and only rarely go out of their way to draw a line around a drug's label, specifically excluding non-labeled use.

Just in case Medicare was considering stepping over the line, Sens. John Kerry and Arlen Specter waved them off in a recent letter expressing their concern. Patients and physicians have already made their feelings known to CMS. The events leave Provenge not just on track to blockbuster status, but politically connected as well. It doesn't get much better than that.

- read the report from TheStreet
- and here's the WSJ story
- check out the FiercePharma report

Related Articles:
Dendreon shares routed by Medicare Provenge review news
NEJM lays out questions--and facts--about Provenge
Dendreon: Provenge on course to hit blockbuster goal

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More stories about Provenge   Medicare  


You quote the CMS announcement incorrectly and incompletely, leaving out the most telling part of it: the panel is not meeting to discuss "labelled and unlabelled use ...", as you put it, but to "consider the currently available evidence regarding the impact of labeled and unlabeled use ...". The key is that they will consider the *evidence* for both *labelled* and *unlabelled* use. Saying that after this announcement Dendreon has "dodged the bullet", is like saying that Marie Antoinette had dodged the blade when they began erecting the guillotine.

"A CMS spokesman tells us this is a special case and a panel of experts will be convened to review the science." How is that for focus? Source:

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