Dendreon Readies For Next Provenge Hurdles: Supply And Reimbursement
Having gotten over the hurdle of FDA approval with the market's first therapeutic cancer vaccine, Dendreon now faces the challenge of getting Provenge to the market. Already the company is also signaling that supply is unlikely to match demand in the near term
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Provenge Outcomes Data "Moderately" Strong For Labeled Use; Off-Label Insufficient, AHRQ Tech Assessment Says
Clinical research demonstrating positive health outcomes from Dendreon's prostate cancer vaccine Provenge is "moderately" strong, the Agency for Healthcare Research and Quality concludes in a draft technology assessment prepared for the upcoming meeting of the Medicare Evidence Development and Coverage Advisory Committee.
Supply arrangement won't impact availability of Provenge this year; first shipment from GSK will begin in 2011, according to a regulatory filing.
In its ongoing national coverage analysis of Dendreon's Provenge (sipuleucel-T), the Centers for Medicare and Medicaid Services is taking a close look at Medicare coverage for off-label use of the novel prostate cancer vaccine, according to the company