Session (CTI)

Issue: Across APAC, CEA and ICERs are applied variably within HTA systems, ranging from informing reimbursement decisions (e.g., Korea, Australia) to guiding pricing and repricing (e.g., Japan). Fixed ICER thresholds are increasingly challenged by therapeutic complexity and the need to reflect broader societal values. Concerns arise when ICERs are used as pass/fail rules or primarily as cost-containment tool rather than part of holistic value assessment. There is growing recognition that ICER interpretation should be flexible and context-sensitive, considering disease severity, unmet need, rarity, patient-relevant outcomes, innovation type, and system priorities. HTA bodies are adopting threshold ranges, modifiers, and complementary decision criteria. The policy challenge is introducing flexibility transparently and operationalize it through clear governance, explicit criteria and consistent deliberation without undermining consistency, equity, or access to innovative medicines. Overview The moderator will provide a 10–minute overview of HTA systems and ICER use across APAC and summarize global experience. The Japan academic expert will discuss how flexibility can be operationalized within appraisal frameworks in applying cost-effectiveness evidence to repricing decisions, including governance and consistency. The industry speaker will highlight the risks of rigid ICER thresholds as cost-containment tools, including implications for timely access to high-value innovative medicines and recognition for broader clinical, patient, and societal benefits. The Korea academic expert will address methodological approaches for more structured deliberative processes, leading to better decision making, including the use of modifiers and integration with multi-criteria frameworks. The session will conclude with moderated discussion on when ICER flexibility is justified, what evidence should support it and how APAC HTA systems can distinguish value assessment from affordability management, helping HTA systems better balance innovation, timely patient access, and long-term funding sustainability within diverse APAC contexts.