What, Where, and How to Collect Real-World Data and Generate Real-World Evidence to Support Drug Reimbursement Decision-Making in Asia: A reflection into the Past and A Way Forward

Abstract

Background: Globally, there is increasing interest in the use of real-world data (RWD) and real-world evidence (RWE) to inform health technology assessment (HTA) and reimbursement decision-making. Using current practices and case studies shared by eleven health systems in Asia, a non-binding guidance that seeks to align practices for generating and using RWD/RWE for decision-making in Asia was developed by the REAL World Evidence In ASia for HEalth Technology Assessment in Reimbursement (REALISE) Working Group, addressing a current gap and needs among HTA users and generators. Methods: The guidance document was developed over two face-to-face workshops, in addition to an online survey, a face-to-face interview and pragmatic search of literature. The specific focus was on what, where and how to collect RWD/ RWE. Results: All 11 REALISE member jurisdictions participated in the online survey and the first in-person workshop, 10 participated in the second in-person workshop, and 8 participated in the in-depth face-to-face interviews. The guidance document was iteratively reviewed by all working group members and the International Advisory Panel. There was substantial variation in: (a) sources and types of RWD being used in HTA; and (b) the relative importance and prioritization of RWE being used for policymaking. A list of national-level databases and other sources of RWD available in each country was compiled. A list of useful guidance on data collection, quality assurance and study design were also compiled. Conclusion: The REALISE guidance document serves to align the collection of better quality RWD and generation of reliable RWE to ultimately inform HTA in Asia.

Real‐world utilization and healthcare costs for multiple myeloma: A retrospective analysis of patients in Singapore

“…Realworld data (RWD) collected from electronic records, claims databases, and registries is increasingly used for this purpose as it provides more accurate and comprehensive information about costs and outcomes beyond controlled trial settings. RWD can be used to inform several aspects of an economic evaluation in myeloma, including but not limited to costs per cycle of treatment, choice of drugs/regimens used, duration of treatment, and number of treatment lines [6][7][8].…”

Integrated Real-World Data Warehouses Across 7 Evolving Asian Health Care Systems: Scoping Review

“…Each nation’s unique landscape for contemporary integrated RWD warehouses tells a narrative that is partially attributed to their economic, clinical, and research settings. Delving deeper into these patterns aids in formulating robust insights for future endeavors in health care research and policy making, including prioritization of competency building based on a nation’s unique infrastructure, skill sets, and research strengths and weaknesses [ 4 ]. As the health care landscape evolves, there is an undeniable value in understanding and leveraging RWD [ 43 ].…”

“…As the health care landscape evolves, there is an undeniable value in understanding and leveraging RWD [ 43 ]. Recognizing the diverse approaches and challenges across countries can lead to more collaborative and informed strategies [ 4 ]. The goal should be to address the present gaps and pave the way for future synergistic, impactful, and patient-centric research [ 3 ].…”

“…The literature on RWD practices and awareness about corresponding warehouses in certain Asian countries like China, Japan, and South Korea is significant [5,[9][10][11][12][13][14][15][16][17], partly because these countries also have recommendations on the utility of RWE by external regulators [3]. This study seeks to understand the evolving landscape of RWD utilization and its implications across Hong Kong, Indonesia, Malaysia, Pakistan, the Philippines, Singapore, and Vietnam, where RWD practices are emerging or undergoing significant development [4]. Our selection of countries for this scoping review was strategically based on selecting contrasting spectrum of HTA maturity across countries with evolving HTA…”

“…RWE has the potential to inform health technology assessments (HTAs), guide evidence-driven policies, and streamline service delivery [3]. Yet, as crucial as RWE is, the Asian healthcare landscape lacks a cohesive framework to harness its full potential despite its promise in pharmacoeconomics, pharmacovigilance, and pharmacoepidemiology [3,4].…”