Kerman University of Medical Sciences International Journal of Health Policy and Management 2322-5939 12 Issue 1 2023 12 01 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 1 9 4398 10.34172/ijhpm.2023.6858 EN Sarin Kc Health Intervention and Technology Assessment Program (HITAP), Ministry of Health, Nonthaburi, Thailand Lydia Wenxin Lin Saw Swee Hock School of Public Health, National University of Singapore (NUS), Singapore, Singapore Diana Beatriz Samson Bayani Saw Swee Hock School of Public Health, National University of Singapore (NUS), Singapore, Singapore Yaroslava Zemlyanska Saw Swee Hock School of Public Health, National University of Singapore (NUS), Singapore, Singapore Amanda Adler The Oxford Centre for Diabetes, Endocrinology, and Metabolism, University of Oxford, Oxford, UK Jeonghoon Ahn Ewha Womans University, Seoul, South Korea Kelvin Chan Sunnybrook Odette Cancer Centre, Toronto, ON, Canada Sunnybrook Research Institute, Toronto, ON, Canada Canadian Centre for Applied Research in Cancer Control, Toronto, ON, Canada Dechen Choiphel Essential Medicine and Technology Division, Department of Medical Services, Ministry of Health, Thimphu, Bhutan Anne Julienne Genuino-Marfori Health Technology Assessment Unit, Department of Health, Quezon City, Philippines Brendon Kearney Faculty of Medicine, University of Adelaide, Adelaide, SA, Australia Health Policy Advisory Committee on Technology, Brisbane, QLD, Australia Yuehua Liu China Health Technology Assessment Centre, National Health Development Research Centre, Ministry of Health, Beijing, China Ryota Nakamura Hitotsubashi Institute for Advanced Study, Hitotsubashi University, Tokyo, Japan Fiona Pearce Agency for Care Effectiveness, Ministry of Health, Singapore, Singapore Shankar Prinja Department of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education and Research, Chandigarh, India Raoh-Fang Pwu Taiwan National Hepatitis C Program Office, Ministry of Health and Welfare, Taipei, Taiwan Arsul Akmal Shafie Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia Binyan Sui China Health Technology Assessment Centre, National Health Development Research Centre, Ministry of Health, Beijing, China Auliya Suwantika Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, Indonesia 0000-0001-8671-2065 Sean Tunis Center for Medical Technology Policy (CMTP), Baltimore, MD, USA Hui-Min Wu Taiwan National Hepatitis C Program Office, Ministry of Health and Welfare, Taipei, Taiwan John Zalcberg Cancer Research Program, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia Department of Medical Oncology, Alfred Hospital, Melbourne, VIC, Australia Kun Zhao China Health Technology Assessment Centre, National Health Development Research Centre, Ministry of Health, Beijing, China Wanrudee Isaranuwatchai Health Intervention and Technology Assessment Program (HITAP), Ministry of Health, Nonthaburi, Thailand Centre for Excellence in Economic Analysis Research, St. Michael’s Hospital, Toronto, ON, Canada Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada Yot Teerawattananon Health Intervention and Technology Assessment Program (HITAP), Ministry of Health, Nonthaburi, Thailand Saw Swee Hock School of Public Health, National University of Singapore (NUS), Singapore, Singapore Hwee-Lin Wee Saw Swee Hock School of Public Health, National University of Singapore (NUS), Singapore, Singapore Department of Pharmacy, Faculty of Science, National University of Singapore (NUS), Singapore, Singapore Journal Article 2021 10 13 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.

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