Leveraging Real-World Data (RWD) to Inform Drug Reimbursement in Asia-Pacific: Addressing Challenges and Building Solutions
Author(s)
Ayantika Biswas, Ph.D.1, Tuli De, PhD2, Sheng Feng, Ph.D.3, Shirley Xiao, PhD4, Lena Sjögren, PhD5, Jacqueline Vanderpuye-Orgle, MSc, PhD2.
1Parexel International, Bengaluru, India, 2Parexel International, Billerica, MA, USA, 3Parexel International, Singapore, Singapore, 4AstraZeneca, Shanghai, China, 5AstraZeneca, Gothenburg, Sweden.
1Parexel International, Bengaluru, India, 2Parexel International, Billerica, MA, USA, 3Parexel International, Singapore, Singapore, 4AstraZeneca, Shanghai, China, 5AstraZeneca, Gothenburg, Sweden.
OBJECTIVES: Real-world data (RWD) is increasingly used to support health technology assessment (HTA), particularly where local clinical trial data are limited. In the Asia-Pacific (APAC) region, diverse healthcare systems and under-representation in global trials create evidence gaps for HTA and reimbursement decisions. This study aimed to identify key challenges and propose region-specific solutions to enable broader use of RWD in reimbursement.
METHODS: Structured discussions were held with Health Economics and Outcomes Research (HEOR) and RWD experts across APAC to identify shared barriers and mitigation strategies.
RESULTS: Limited access to electronic medical records, especially in public healthcare, remains a key barrier. Experts emphasized collaboration with government agencies to establish secure data-sharing agreements. Transparent engagement pathways among payers, regulators, and data custodians are also needed, e.g., in China, access to National Insurance Data is expected to expand in phases, starting with Beijing (21 million lives) by 2025-2026. In Japan, commercial claims databases such as JMDC and MDV are frequently used to generate RWE, with published examples supporting burden-of-illness and outcomes research. Another pathway to enable medical research and faster market access using RWD is the establishment of free trade pilot zones like Boao Lecheng, Hainan Province, China. One landmark case is COSELA, a pre-chemotherapy drug approved in China via the Hainan RWE pathway in 2023. With additional RWD, including a real-world comparator, it passed national insurance negotiation in 2024—marking the first successful use of RWE in China for both regulatory approval and HTA reimbursement. To address data heterogeneity, experts recommended regional adoption of frameworks like the Distributed Research Network (DRN) and Common Data Model (CDM), which support federated analyses while safeguarding data privacy.
CONCLUSIONS: RWD holds significant promise for reimbursement decision-making in APAC. Building robust, regionally adapted frameworks for data quality, stakeholder collaboration, and analytic capacity will be essential to fully realize its value.
METHODS: Structured discussions were held with Health Economics and Outcomes Research (HEOR) and RWD experts across APAC to identify shared barriers and mitigation strategies.
RESULTS: Limited access to electronic medical records, especially in public healthcare, remains a key barrier. Experts emphasized collaboration with government agencies to establish secure data-sharing agreements. Transparent engagement pathways among payers, regulators, and data custodians are also needed, e.g., in China, access to National Insurance Data is expected to expand in phases, starting with Beijing (21 million lives) by 2025-2026. In Japan, commercial claims databases such as JMDC and MDV are frequently used to generate RWE, with published examples supporting burden-of-illness and outcomes research. Another pathway to enable medical research and faster market access using RWD is the establishment of free trade pilot zones like Boao Lecheng, Hainan Province, China. One landmark case is COSELA, a pre-chemotherapy drug approved in China via the Hainan RWE pathway in 2023. With additional RWD, including a real-world comparator, it passed national insurance negotiation in 2024—marking the first successful use of RWE in China for both regulatory approval and HTA reimbursement. To address data heterogeneity, experts recommended regional adoption of frameworks like the Distributed Research Network (DRN) and Common Data Model (CDM), which support federated analyses while safeguarding data privacy.
CONCLUSIONS: RWD holds significant promise for reimbursement decision-making in APAC. Building robust, regionally adapted frameworks for data quality, stakeholder collaboration, and analytic capacity will be essential to fully realize its value.
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD82
Topic Subcategory
Health & Insurance Records Systems
Disease
No Additional Disease & Conditions/Specialized Treatment Areas