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Accelerated Pathways Work-Now What? A Survey of Payers in the United States

Barry Farrimond¹, Jonathan J Fleming^2,3, Mark Mathieu¹

¹1 PAREXEL, Waltham, MA, USA.

Therapeutic Innovation & Regulatory Science

|September 21, 2018

Abstract

Background:

The US FDA has developed numerous accelerated pathways (APs) to facilitate faster development and approval of innovative drugs addressing unmet needs.

Methods:

To gauge how payers in the United States view APs, PAREXEL and the Network for Excellence in Healthcare Innovation (NEHI) surveyed 20 national, regional, public, and private payers whose coverage decisions impact 228 million patients.

Results:

The survey shows that APs have created new challenges and concerns for payers, including greater difficulty valuing drugs that have less clinical information available at launch.

Conclusions:

Our survey indicates that policies must further the goal of getting needed new medicines to patients expeditiously, while managing the risks AP drugs entail for payers and, most importantly, patients. For developers, a trend toward value-based assessments of both AP and non-AP drugs by payers may require ever-earlier and more data-driven decision making about the value of new products in development.

Keywords:

Breakthrough Therapy designation FDA US regulatory policy accelerated approval accelerated pathways payers

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