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

Sarin Kc, Lydia Wenxin Lin, Diana Beatriz Samson Bayani, Yaroslava Zemlyanska, Amanda Adler, Jeonghoon Ahn, Kelvin Chan, Dechen Choiphel, Anne Julienne Genuino-Marfori, Brendon Kearney, Yuehua Liu, Ryota Nakamura, Fiona Pearce, Shankar Prinja, Raoh Fang Pwu, Arsul Akmal Shafie, Binyan Sui, Auliya Suwantika, Sean Tunis, Hui Min WuJohn Zalcberg, Kun Zhao, Wanrudee Isaranuwatchai, Yot Teerawattananon, Hwee Lin Wee

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

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.

Original languageEnglish
Article number6858
JournalInternational Journal of Health Policy and Management
Volume12
Issue number1
DOIs
StatePublished - 2023

Bibliographical note

Publisher Copyright:
© 2023 The Author(s); Published by Kerman University of Medical Sciences.

Keywords

  • Asia
  • Cost-Effectiveness Analysis
  • Health Technology Assessment
  • Real-World Data
  • Real-World Evidence
  • Reimbursement

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