Sarin Kc
1 
, Lydia Wenxin Lin
2, Diana Beatriz Samson Bayani
2, Yaroslava Zemlyanska
2 , Amanda Adler
3, Jeonghoon Ahn
4, Kelvin Chan
5,6,7, Dechen Choiphel
8, Anne Julienne Genuino-Marfori
9, Brendon Kearney
10,11, Yuehua Liu
12, Ryota Nakamura
13, Fiona Pearce
14, Shankar Prinja
15, Raoh-Fang Pwu
16, Arsul Akmal Shafie
17 , Binyan Sui
12, Auliya Suwantika
18 , Sean Tunis
19, Hui-Min Wu
16, John Zalcberg
20,21, Kun Zhao
12, Wanrudee Isaranuwatchai
1,22,23 , Yot Teerawattananon
1,2 , Hwee-Lin Wee
2,24* 1 Health Intervention and Technology Assessment Program (HITAP), Ministry of Health, Nonthaburi, Thailand
2 Saw Swee Hock School of Public Health, National University of Singapore (NUS), Singapore, Singapore
3 The Oxford Centre for Diabetes, Endocrinology, and Metabolism, University of Oxford, Oxford, UK
4 Ewha Womans University, Seoul, South Korea
5 Sunnybrook Odette Cancer Centre, Toronto, ON, Canada
6 Sunnybrook Research Institute, Toronto, ON, Canada
7 Canadian Centre for Applied Research in Cancer Control, Toronto, ON, Canada
8 Essential Medicine and Technology Division, Department of Medical Services, Ministry of Health, Thimphu, Bhutan
9 Health Technology Assessment Unit, Department of Health, Quezon City, Philippines
10 Faculty of Medicine, University of Adelaide, Adelaide, SA, Australia
11 Health Policy Advisory Committee on Technology, Brisbane, QLD, Australia
12 China Health Technology Assessment Centre, National Health Development Research Centre, Ministry of Health, Beijing, China
13 Hitotsubashi Institute for Advanced Study, Hitotsubashi University, Tokyo, Japan
14 Agency for Care Effectiveness, Ministry of Health, Singapore, Singapore
15 Department of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education and Research, Chandigarh, India
16 Taiwan National Hepatitis C Program Office, Ministry of Health and Welfare, Taipei, Taiwan
17 Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia
18 Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, Indonesia
19 Center for Medical Technology Policy (CMTP), Baltimore, MD, USA
20 Cancer Research Program, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia
21 Department of Medical Oncology, Alfred Hospital, Melbourne, VIC, Australia
22 Centre for Excellence in Economic Analysis Research, St. Michael’s Hospital, Toronto, ON, Canada
23 Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada
24 Department of Pharmacy, Faculty of Science, National University of Singapore (NUS), Singapore, Singapore
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.