Session (CTI)

Purpose: Real-world evidence (RWE) is increasingly discussed in health technology assessment (HTA), economic evaluation, managed access, and reassessment. However, the presence of real-world data (RWD) in an evidence package does not necessarily make the evidence decision ready. This workshop will examine how HTA systems can judge whether RWE is fit for purpose for specific decision problems, including initial reimbursement, managed access, and reassessment. Description: HTA systems are moving beyond whether RWE can be used, towards when, how, and for what purpose it should inform decisions. Guidance from NICE and Canada’s CDA-AMC emphasises data relevance, quality, transparent reporting, appropriate methods, and alignment between evidence and the decision problem. In China, RWE is also developing rapidly through regulatory science initiatives and growing policy interest in pharmacoeconomic and reimbursement decisions. This workshop will focus on decision-ready RWE across jurisdictions. Tina Wang will open with an international HTA systems perspective on how RWE is used to manage uncertainty across initial assessment, managed access, post-launch evidence generation. Huajie Jin will provide a methodological perspective on RWE in economic evaluation, focusing on when RWD can support parameter estimation, model structure, care pathways, resource use, costs, and uncertainty analysis. Recent academic work on schizophrenia economic evaluations will illustrate the gap between available RWD and decision-ready evidence. Jing Wu will discuss China’s evolving policy environment for RWE, pharmacoeconomic evaluation, reimbursement decision-making, and the challenges of using RWE in a rapidly developing HTA system. Participants will review a short hypothetical RWE-informed economic evaluation case and vote on whether different RWE components should be used as core evidence, supportive evidence, scenario analysis, or rejected as insufficiently decision-ready. The workshop will conclude with practical appraisal questions for judging whether RWE is fit for purpose in HTA.