Accelerated Approval Price Caps: Policy Has High Profile Support – But Can It Be Done?
US Medicare Payment Advisory Commission likely to recommend that drugs granted Accelerated Approval be subject to some form of price cap when confirmatory clinical data is lacking. The idea has a lot of supporters, but even they seem a bit unclear about how it could actually work.
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Private Payers Have ‘Significant’ Role In Ensuring Confirmatory Trials Get Done, FDA’s Califf Says
In an unusual appearance at AHIP annual conference on Medicare and Medicaid, the US FDA commissioner discusses accelerated approvals and argues that payers should be more than ‘passive recipients’ of research. Insurers should help develop the confirmatory data for drugs, Califf says.
Medicare Part D Redesign Could Expand Rebate-Driven Formulary Exclusions In Program
Increased application of utilization management controls expected as plans face higher costs under the redesign. However, the formulary advantages available to drugs in the protected classes may lead developers to sharpen their focus on those categories.
MedPAC’s Message To Congress: Drug Pricing Still Needs Attention
The US Medicare Payment Advisory Commission is continuing its work on proposals to overhaul federal payment for physician administered drugs. That is an ominous message for the biopharma industry as it reels from passage of dramatic pricing legislation earlier this year.