European Priority Review Vouchers for Neglected Disease Product Development

Background: Neglected diseases are a significant global health challenge. Encouraging the development of therapeutics and vaccines for these diseases would address an important unmet medical need. We propose a priority review voucher program for the European Union (EU). The developer of a drug or vaccine for a neglected disease would receive a voucher for accelerated assessment of a different product at the European Medicines Agency (EMA). Methods: We calculated the value of the proposed voucher program through a five-step approach: (1) estimating the time saved in the EMA accelerated regulatory review; (2) gauging time reductions in accelerated pricing and reimbursement decisions by EU member states; (3) selecting ten high-revenue products launched between 2015 and 2020 representing typical voucher users; (4) analyzing IQVIA MIDAS sales data for the selected products; and (5) calculating the net present value of the voucher based on the ten products. Findings: The accelerated EMA review would reduce regulatory time by an average of 182 days. Additionally, products could save more than a year in many member states through an expedited 120-day pricing and reimbursement review. For instance, in France, this would save an average of 322 days on top of the 182-day regulatory review reduction. The estimated net present value of regulatory acceleration by two quarters would be €100 million. In addition, if France, Italy, and Spain reviewed pricing and reimbursement in only 120 days, then the value would double. Interpretation: An EU voucher estimated at more than €100 million, coupled with a $100 million US counterpart, offers a meaningful incentive for novel product development. However, the voucher program should be part of a comprehensive strategy for tackling neglected diseases, rather than a standalone solution. Funding: The study was supported by Deutsche Stiftung Weltbevölkerung (DSW) and Duke University. DSW received funding from the Bill & Melinda Gates Foundation. Declaration of Interest: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.