1. 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.
- Author
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Kc, Sarin, Wenxin Lin, Lydia, Bayani, Diana Beatriz Samson, Zemlyanska, Yaroslava, Adler, Amanda, Jeonghoon Ahn, Chan, Kelvin, Choiphel, Dechen, Genuino-Marfori, Anne Julienne, Kearney, Brendon, Yuehua Liu, Nakamura, Ryota, Pearce, Fiona, Prinja, Shankar, Raoh-Fang Pwu, Shafie, Arsul Akmal, Binyan Sui, Suwantika, Auliya, Tunis, Sean, and Hui-Min Wu
- Subjects
REIMBURSEMENT ,TECHNOLOGY assessment ,DECISION making ,MEDICAL technology ,ADVISORY boards - 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 Data 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 policy-making. 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. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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