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

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) survey...

Full description

Saved in:
Bibliographic Details
Published in:Therapeutic innovation & regulatory science 2017-03, Vol.51 (2), p.224-231
Main Authors: Farrimond, Barry, Fleming, Jonathan J., Mathieu, Mark
Format: Article
Language:English
Subjects:
Chief executive officers
Decision making
Drug Safety and Pharmacovigilance
Drugs
Funding
Innovations
Patients
Pharmaceutical industry
Pharmacotherapy
Pharmacy
Product Development and Innovation: Original Research
Quality of life
Studies
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:2168-4790
2168-4804
DOI:10.1177/2168479016668221