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.
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
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Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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