Session (CTI)

ISSUE: Addressing the escalating costs of pharmaceuticals is critical to ensuring the sustainability of healthcare financing systems worldwide. The vast and growing pool of real-world data offers a valuable opportunity to generate real-world evidence (RWE), complementing the limitations of randomized controlled trials and informing evidence-based decision-making. In China and the U.S.—the world’s two largest pharmaceutical markets—national payers have engaged in drug price negotiations with manufacturers, with preliminary steps toward incorporating RWE. However, the effective integration of RWE into price negotiations and broader drug policy decisions remains an area requiring deeper exploration. This session will examine the application of RWE in drug price negotiations in both China and the U.S., addressing key questions such as: What types of RWE should be submitted? How can RWE be evaluated? And how can it be leveraged to support pricing and reimbursement decisions? OVERVIEW: The session will commence with an overview of RWE's growing importance in comprehensive drug value assessment presented by Dr. Wen Chen (10 minutes). Dr. Jifang Zhou will then provide an overview of China's evolving RWE ecosystem, including current data infrastructure and analytical capabilities. This will be followed by Dr. Luying Zhang's presentation of case studies demonstrating RWE's actual application in China's national reimbursement drug list and price negotiations. Dr. Lizheng Shi will offer the U.S. perspective, focusing on Medicare's experience with RWE in coverage and price determinations. The session will culminate in a panel discussion synthesizing cross-country experiences to identify: (1) the most impactful RWE categories for pricing decisions; (2) robust methodologies for RWE generation and validation; and (3) practical strategies for integrating RWE into policy-making processes. These insights will provide actionable guidance for healthcare systems seeking to balance drug affordability with sustainable innovation.