Priority Review Voucher: Policy Barriers and Opportunities to Increase Access to Voucher-Winning Medicines

Abstract

Background: Access to medicines is a vital component of upholding the right to health. However, there is a gap in access to medicines, especially in resource poor settings, that leads to poor health outcomes. The priority review voucher (PRV) is a ‘pull’ incentivizing mechanism designed to encourage new drug development for otherwise neglected diseases. This mechanism also reduces the cost of the end-product via incentives provided after the product has been developed. This study aims to understand policy and implementation barriers related to access to the PRV-winning drug bedaquiline. Bedaquiline is the first drug approved for multi-drug resistant tuberculosis (MDR-TB) in over 40 years. Based on an understanding of access barriers to this new drug, the study also aims to suggest policy recommendations to improve access for PRV winning drugs for tropical diseases. Methods: The study used semi-structured qualitative interviews with multiple stakeholders at the global level and at the country level in South Africa. These were combined with data from research literature and advocacy materials and analyzed using thematic analysis, organized using Kingdon’s three streams model. The model includes three streams: the problem stream, politics stream, and policy stream. The model also identifies policy entrepreneurs and policy windows. The data were further analyzed using Lewin’s forcefield analysis (FFA) identifying supporting and opposing forces related to increasing access to bedaquiline.Results: Overcoming policy and implementation access barriers related to bedaquiline is the responsibility of multiple stakeholders. The main barriers to access for bedaquiline currently include (i) barriers to registration of the drug at the country level, (ii) lack of research data (especially phase III trial data), (iii) weak health systems, and (iv) the lack of a sustainable pricing model. The manufacturer has a significant role to play, and this role is common among other PRV winners for tropical diseases as well. Conclusion: PRV as an incentivizing mechanism to develop drugs for otherwise neglected diseases should strongly consider including an access plan requirement as part of the application process. The plan should be made available to the public for evaluation.