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

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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.

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Author information

Authors and Affiliations

  1. PAREXEL, 3 Federal Street, Waltham, Billerica, MA, 01821, USA

    Barry Farrimond MSc & Mark Mathieu MA

  2. Network for Excellence in Health Innovation, Cambridge, MA, USA

    Jonathan J. Fleming MPA

  3. Q-State Biosciences, Cambridge, MA, USA

    Jonathan J. Fleming MPA

Authors
  1. Barry Farrimond MSc
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  2. Jonathan J. Fleming MPA
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  3. Mark Mathieu MA
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Corresponding author

Correspondence to Mark Mathieu MA.

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Farrimond, B., Fleming, J.J. & Mathieu, M. Accelerated Pathways Work—Now What? A Survey of Payers in the United States. Ther Innov Regul Sci 51, 224–231 (2017). https://doi.org/10.1177/2168479016668221

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  • DOI: https://doi.org/10.1177/2168479016668221

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