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.
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.