Accelerated Pathways Work; Now What?

Posted On June 28th, 2016

Accelerated Pathways Work; Now What?
A survey of payer opinions of products that have gone through US FDA expedited pathways from NEHI and PAREXEL.

NEHI and our member, PAREXEL, teamed up to better understand the impact of medicines that are approved through different accelerated pathways.

In recent years, The U.S. Food and Drug Administration has developed numerous accelerated pathways to speed the development and approval of innovative drugs to address unmet medical needs. By surveying 20 national, regional, public, and private payers, NEHI and PAREXEL investigated the benefits that payers have derived from this new template for drug development, and the challenges that it has created.

We found that while the various accelerated pathway programs have accomplished their main goal, and have been embraced broadly by drug developers, they also have added new risks. The ramifications of our findings affect every stakeholder – from payers to physicians, from developers to patients.  

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