Medicare Committee Supports Provenge Coverage

December 15th, 2010 | Sources: LA Times, Medscape

Subjects:

Last month, a Medicare advisory committee provided metza metz support for sipuleucel-T, Dendreon’s prostate cancer vaccine that is  better known as Provenge. The lukewarm recommendation by the Medicare Evidence Development & Coverage Advisory Committee means that that Medicare will probably end-up paying for the treatment, but only for FDA-approved uses.

Provenge is the first cancer-fighting vaccine to be approved by the FDA. The regulatory agency green-lighted the vaccine after a key Phase III trial showed the jab increased life-expectancy in patients with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer by a median of 4.1 months and increased 3-year survival by 38%.

Those improvements come at the exceptionally steep price of $93,000 per course of therapy. By law, Medicare cannot factor-in treatment costs when deciding whether to cover a particular treatment.

The final ruling by Medicare won’t be made until next spring. It will be crucial for Dendreon, since prostate cancer strikes elderly men almost exclusively, and many of them use Medicare to insure themselves against catastrophic illness.

The committee’s decision comes at a time when governments around the world are struggling to control spiraling health costs.

In reaching its decision, the committee voted on 5 separate issues concerning the vaccine. On a 5-point scale (with 5 being high), the committee came out with an overall score of 3.6 when asked to rate their confidence in the evidence showing the vaccine improved survival.

Most casual readers would view this as lukewarm support, but Daniel Petrylak, a Provenge investigator and the co-director of the Prostate Cancer Program at Columbia concluded otherwise. “It’s clear that they believe from their voting that there is a survival benefit,” Petrylak told MedScape.

The committee was unequivocallly against the idea that Provenge should be used for non-FDA-approved (that is, off-label) indications. The committee’s average vote regarding the use of Provenge in 3 such categories ranged between 1.1 and 1.4. One of these groups was patients in whom the disease had not metastasized. That’ll cap things, at least a little.


 

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