How Far Has Real-World Evidence Gone in Asia? Mapping Uptake, Influence, and Gaps in Regulatory, HTA, and Pricing Decisions Across Japan, Korea, China, and Taiwan
Author(s)
Omar Akhtar, MSc1, Hannah Jin, BSc2.
1Poa Alpina Research, Burlington, ON, Canada, 2Tigerise, Tokyo, Japan.
1Poa Alpina Research, Burlington, ON, Canada, 2Tigerise, Tokyo, Japan.
OBJECTIVES: RWE is increasingly emphasized in regulatory and HTA frameworks globally. In Asia, regulators, HTA bodies, and payers are adopting RWE at varying paces and in diverse ways. However, systematic cross-country analysis of how far RWE has penetrated regulatory, HTA, and pricing decision-making in Asia remains limited.Objectives: To systematically map and compare the role of RWE in regulatory approvals, HTAs, and pricing/reimbursement decisions across Japan, Korea, China, and Taiwan, identifying both cross-country patterns and existing evidence-policy gaps.
METHODS: A cross-country database was developed through a structured review of publicly available regulatory dossiers, HTA reports, and pricing/reimbursement decisions between 2015 and 2024. Cases were coded according to: 1. RWE presence2. RWE type (Effectiveness, External Control, Adherence, Safety, PROs)3. RWE impact (0 = not mentioned, 1=mentioned, 2=supportive, 3=influential, 4=pivotal).The database also mapped major RWE-related policies and guidance released during this period. Descriptive analyses and cross-country comparisons were performed to assess alignment or gaps between RWE policy development and actual RWE utilization.
RESULTS: Preliminary findings show heterogeneous patterns. Japan and China have formalized regulatory frameworks for RWE, yet its role in HTA and pricing remains limited. China demonstrates early signs of RWE being used in NRDL inclusion decisions, particularly through cases supported by the Boao Lecheng pilot. Korea and Taiwan show more reactive dynamics, with RWE incorporated into HTA processes even before formal policies were established, although its influence on pricing decisions remains minimal. Across all countries, RWE plays a supportive role, rarely acting as pivotal evidence, except in selected cases involving rare diseases or digital health.
CONCLUSIONS: RWE penetration in Asia varies: Japan and China have formal regulatory pathways but cautious HTA and pricing uptake; Korea and Taiwan show ad hoc HTA use but limited pricing impact. Only China, via Boao Lecheng, shows early RWE-driven reimbursement. Compared to Western systems, Asia's evolution remains fragmented and regulator-led.
METHODS: A cross-country database was developed through a structured review of publicly available regulatory dossiers, HTA reports, and pricing/reimbursement decisions between 2015 and 2024. Cases were coded according to: 1. RWE presence2. RWE type (Effectiveness, External Control, Adherence, Safety, PROs)3. RWE impact (0 = not mentioned, 1=mentioned, 2=supportive, 3=influential, 4=pivotal).The database also mapped major RWE-related policies and guidance released during this period. Descriptive analyses and cross-country comparisons were performed to assess alignment or gaps between RWE policy development and actual RWE utilization.
RESULTS: Preliminary findings show heterogeneous patterns. Japan and China have formalized regulatory frameworks for RWE, yet its role in HTA and pricing remains limited. China demonstrates early signs of RWE being used in NRDL inclusion decisions, particularly through cases supported by the Boao Lecheng pilot. Korea and Taiwan show more reactive dynamics, with RWE incorporated into HTA processes even before formal policies were established, although its influence on pricing decisions remains minimal. Across all countries, RWE plays a supportive role, rarely acting as pivotal evidence, except in selected cases involving rare diseases or digital health.
CONCLUSIONS: RWE penetration in Asia varies: Japan and China have formal regulatory pathways but cautious HTA and pricing uptake; Korea and Taiwan show ad hoc HTA use but limited pricing impact. Only China, via Boao Lecheng, shows early RWE-driven reimbursement. Compared to Western systems, Asia's evolution remains fragmented and regulator-led.
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD273
Topic Subcategory
Health & Insurance Records Systems
Disease
No Additional Disease & Conditions/Specialized Treatment Areas