PhRMA Proposes New Compendia To Guide Off-Label Rx Coverage
CMS should expand its list of drug compendia that can support coverage of off-label drug use, the Pharmaceutical Research & Manufacturers of America said in comments on a proposal to cover four cancer drugs used in clinical trials
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It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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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.
