Session (CTI)

PURPOSE: The objective of this session is to explore, with series of new national initiatives, how real-world data (RWD) and real-world evidence (RWE) can better support comprehensive value assessment of innovative drugs for access and reimbursement decisions in the US and China. It offers a multi-stakeholder perspective on policy progress, international experience, and industry implications. DESCRIPTION: In recent years, the US and China have increasingly embraced RWD/RWE in access and reimbursement decisions, such as Medicare Part D and National Reimbursement Drug List (NRDL) negotiations, respectively. However, despite this progress, gaps and barriers remain. The session will begin with an introduction of the context and current status (5 minutes, Xie). The next speaker will then discuss China’s evolving policy environment and key initiatives (e.g., real-world research pilot for comprehensive value assessment), along with the administration’s vision and expected outcomes. Challenges in integrating RWE into value assessment and reimbursement decisions in China will also be addressed (15 minutes, Wu). The session will continue with a comparative analysis of RWE’s role in Medicare Part D vs. China’s NRDL reimbursement pathway. Specifically, the role of RWE in the first round of US Medicare Part D negotiations and recent price reduction in weight management products will be examined, offering insights for China’s evolving system (15 minutes, Shi). The last speaker will then provide a global pharmaceutical industry perspective. The impact of recent RWE-related policy shifts on market access strategy, the operational and technical barriers, and examples of RWE successfully supporting value assessment will be shared (15 minutes, Tang). The session concludes with a 10-minute panel discussion among presenters and the audience, addressing open questions and practical recommendations to strengthen the RWE ecosystem for drug value assessment, especially in evolving markets like China. This session will benefit all HTA professionals, policymakers, pharmaceutical manufacturers, and RWE researchers.