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Back to School

Modifying access for accelerated approvals: a BioCentury Back to School podcast

Regulators, payers need more tools to ensure the right patients get the right drugs

Regulators and payers need more tools to ensure that the right patients get the right drugs.

September 2, 2021 1:24 PM UTC

The principle of accelerated approval hinges on the third part of the expedited pathway, where regulators, payers, companies and patients act on the evidence that’s generated in confirmatory trials. On the fourth and final Back to School podcast, BioCentury’s editors discuss the need to give regulators and payers more options to dial in appropriate access based on postmarket evidence.

Thursday’s podcast has been preceded by discussions on the first two sections of the accelerated approval pathway: the complexities of creating approvable data packages, and generating the evidence to support an expedited entry to the market. 

Payers and regulators are hampered by a lack of mechanisms, which limits their ability to guide the right patients to the right drugs.

“The stretch vision — what we believe accelerated approval needs to stretch to — would give both regulators and payers more tools, more options than just the binary ones,” says BioCentury Editor in Chief Simone Fishburn.

Washington Editor Steve Usdin explains why it’s difficult for regulators to pull drugs off the market once a therapy has accelerated approval, even in the face of a sponsor’s failure to provide supporting evidence.

Giving regulators tools to enable them to act upon evidence about how particular drugs are likely to work for individuals, rather than forcing them to choose between keeping a drug on the market or taking it off for an entire population or subpopulation, would benefit patients and payers.

“The idea would be that it could be dialed up or dial down, based on data that are pertinent to the actual conditions of actual patients,” Usdin says.

Looking to Europe, Fishburn breaks down how the U.K.’s newly independent MHRA has built upon the existing pathways used by EMA by integrating market access, clinical trial and real-world evidence organizations directly into the process.

On Friday, BioCentury will publish an overarching Back to School essay that details the stretch vision for accelerated approval.  

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