Presentation (CTI)

OBJECTIVES: To promote access to innovative drugs, China added 553 drugs to National Reimbursement Drug List (NRDL) through price negotiations from 2017 to 2024. This rapid access approach introduces uncertainties in effectiveness and financial impact. Globally, Performance-based risk-sharing agreements (PBRSAs) have been used to address such risks. However, China has not officially introduced PBRSAs. This study aims to identify key principles for successful implementation of PBRSAs within the Chinese healthcare context.
METHODS: This mixed design study included a systematic literature review and an online survey. The review summarized real-world experiences for implementing PBRSAs across countries. Based on the literature review, a 23-item online survey was disseminated among stakeholders from pharmaceutical companies, healthcare providers, government agencies and research institutions, adopting numerical rating scales (0-10) to quantify stakeholders' perceptions. Documents and responses were thematically analyzed to identify best practices for implementing PBRSAs in China.
RESULTS: The literature review identified 39 publications, and 37 survey responses were analyzed. Findings from all sources revealed 5 core areas for implementing PBRSAs: (1) Establishing protocols with harmonized standards especially identify meaningful and feasible indicators to evaluate efficacy (7.86/10.00); (2) Developing an efficient data collection infrastructure (7.43/10.00); (3) Creating a multi-stakeholder governance and management environment (7.32/10.00); (4) Controlling administrative costs associated with implementation (6.76/10.00); (5) Addressing ethical and moral considerations (6.00/10.00). Notably, 89.2% (33/37) respondents expressed optimism regarding the future potential of PBRSAs. Given the complexity of implementing PBRSAs, 62.2% (23/37) recommended initiating with Cost-sharing agreements (CSAs) as a practical starting point, with the subsequent introduction of PBRSAs. Additionally, 70.3% (26/37) highlighted the breakthrough in the implementation of PBRSAs lies in improving the multi-payer affordability and piloting it outside the basic health insurance system.
CONCLUSIONS: The PBRSAs has garnered extensive interest and attention in China. Effective implementation of it would require thoughtful planning and coordination during the design and execution phases.