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Session 8: Translate RWD into Decision-Ready for HTA and Market Access
Session Chair(s)
Xiang Zhang, PhD
Head of Medical Affairs and HTA Statistics/Co-lead FORExcellence, CSL Behring, United States
RWD/RWE is increasingly used to support HTA, reimbursement, and market access decisions, but its impact depends on whether the evidence is credible, relevant to local decision questions, and actionable across the access lifecycle. This session will examine practical strategies for translating RWD into decision-ready RWE, including fit-for-purpose data selection, transparent causal and statistical methods, use in comparative effectiveness and economic evaluation under uncertainty, and alignment with payer and HTA evidence needs. Through examples from HTA submissions and market access contexts, speakers will discuss where RWE can reduce uncertainty, where it may be discounted, and how sponsors can plan lifecycle evidence to improve decision usefulness. Attendees will leave with a cross-functional framework for designing RWE that connects methodology, HTA decision-making, and access strategy.
Learning Objective : At the conclusion of this session, participants should be able to: - Identify criteria that make RWE fit for purpose for HTA and access decisions
- Compare common uses of RWE across appraisal, re-appraisal, and lifecycle planning
- Apply a credibility–relevance–actionability framework to plan payer-relevant RWE
Speaker(s)
Speaker
Mingyang Shan, PhD
Senior Director, Eli Lilly and Company, United States
Speaker
Renske MT Ten Ham, PharmD, PhD, MSc
Assistant Professor, UMC Utrecht, Netherlands
China’s RWE Pilots Experience: Driving Regulatory Decisions with Real-World Data (117764)
Wei Hong Yuan
, Hainan Boao Lecheng Real-World Data Research Institute, China
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