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Accelerated Approval Price Caps: Policy Has High Profile Support – But Can It Be Done?

 
• By Michael McCaughan

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.

Price cap
Questions remain about how to impose a price cap on products cleared using accelerated approval. • Source: Shutterstock

Count the current US Food and Drug Administration leadership team among those who think it would be a good idea to use federal reimbursement policy as a way to incentivize sponsors to complete clinical outcomes studies of drugs approved via the accelerated approval pathway.

The idea was discussed during a panel of current and former FDA commissioners at the annual University of California San Francisco-Stanford Centers for Excellence in Regulatory Science and Innovation Summit...

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