Presentation (CTI)

OBJECTIVES: This study aimed to identify implementation gaps, enablers and best practices for the use of real-world evidence (RWE) to support patient access, reimbursement, and post-evaluation reassessment through benchmarking across selected APAC and advanced international markets.
METHODS: A targeted literature review was conducted to assess RWE use across reimbursement and post-evaluation contexts in selected markets (South Korea, Taiwan, Europe, Canada, and Australia). Identified approaches were synthesised using a structured benchmarking framework covering governance, stakeholder engagement, data access and operational feasibility, data infrastructure/governance, methodological standards, contracting arrangements, evidence review, reassessment processes, and transparency. In parallel, interviews were conducted with payer, regulatory, academic, and industry stakeholders in South Korea and Taiwan to capture contextual perspectives, validate findings, and derive key insights.
RESULTS: Findings identified several enablers for effective RWE use. First, clear governance and early, structured multi-stakeholder engagement facilitate alignment on evidence requirements and reduce uncertainty, with more formalised processes in the UK and Canada compared to evolving Asian markets. Second, interoperable health data systems, supported by standardised data quality, linkage and privacy frameworks, enable credible and decision-relevant RWE generation. Third, well-defined and fit-for-purpose methodological guidance, including pre-specified study protocols, transparent reporting standards, and appropriate endpoints, supports reproducible and decision-grade RWE-generation, with several European markets demonstrating more explicit and publicly available guidance. Lastly, structured evidence review and reassessment processes, including predefined timelines and decision criteria, improve predictability and consistency, though implementation remains heterogeneous. Key improvement areas across APAC include greater clarity on RWE expectations in addressing uncertainty, data access pathways, endpoint feasibility, stakeholder roles, and transparent use of RWE in reassessment.
CONCLUSIONS: Effective RWE use in reimbursement and post-evaluation requires coordinated development across governance, data infrastructure, methodological standards, and transparent decision processes. Strengthening these elements and fostering cross-stakeholder collaboration through collaborative policy dialogue is critical to advance consistent and decision-grade RWE use across APAC health systems.