Priorities for the Priority Review Voucher

Area of Science:

• Health Economics
• Pharmaceutical Policy
• Drug Development

Background:

• The U.S. Congress established the Priority Review Voucher (PRV) program in 2007.
• This initiative aims to stimulate the creation of medicines for neglected tropical diseases and rare pediatric conditions.
• Approved drugs for these conditions grant developers a voucher for priority review of a subsequent drug.

Purpose of the Study:

• To evaluate the effectiveness and identify areas for improvement in the Priority Review Voucher program.
• To analyze recent experiences and outcomes associated with the voucher program.
• To inform potential legislative modifications for the program.

Main Methods:

• Review of the U.S. Priority Review Voucher program's legislative history and operational framework.
• Analysis of data on voucher utilization and financial transactions up to 2016.
• Assessment of the program's strengths and weaknesses based on available evidence.

Main Results:

• As of 2016, four vouchers had been utilized.
• The average sale price for these vouchers reached $200 million.
• The program demonstrates both successes and challenges in incentivizing drug development.

Conclusions:

• The Priority Review Voucher program has potential but requires adjustments.
• Legislative changes are necessary to optimize the program's impact on neglected disease drug development.
• Further evaluation is recommended to ensure the program's long-term success and efficiency.