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

Document Type : Original Article

Authors

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.

Keywords


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  • Receive Date: 13 October 2021
  • Revise Date: 24 December 2022
  • Accept Date: 28 January 2023
  • First Publish Date: 29 January 2023