• Real-world data (RWD) and real-world evidence (RWE) is gaining increasing interest all over the world. However, there are issues to consider when generating and using RWD and RWE.
  
  
• This project develop guidance documents which provides a framework to generate and use RWD/RWE to support decision-making in Asia.

The RWD and RWE working group (REALISE working group) endorsed by HTAsiaLink in 2019. REALISE was led by Dr. Wee Hwee Lin in Saw Swee Hock School of Public Health in the National University of Singapore (NUS) and Dr. Yot Teerawattananon in Health Intervention and Technology Assessment Program (HITAP), Thailand. The working group was not only supported by HTAsiaLink members but also international advisory panel.

REALISE working group developed non-binding guidance document to provide a framework to generate and use RWD/RWE in a consistent and efficient manner for decision-making in Asia. The working group examined three crucial themes: (1) When is the use of RWD and RWE appropriate? (2) What, where and how to collect RWD? (3) From RWD to RWE. The guidance document, Use of Real-World Data and Real-World Evidence to Support Drug Reimbursement Decision-Making in Asia, was published on November 2020.

The guidance document was published in the International Journal of Technology Assessment in Health Care.

Collaborating HTAsiaLink members: National University of Singapore, Singapore; Ewha Womans University, South Korea; Essential Medicine and Technology Division, Department of Medical Services, Ministry of Health, Bhutan; Health Intervention and Technology Assessment Program (HITAP), Thailand, Faculty of Medicine, University of Adelaide, Australia; Hitotsubashi Institute for Advanced Study, Hitotsubashi University, Japan; National Institute for Health and Care Excellence (NICE), United Kingdom; Agency for Care Effectiveness, Ministry of Health, Singapore; School of Public Health, Post Graduate Institute of Medical Education and Research, India; National Hepatitis C Program Office, Ministry of Health and Welfare, Taiwan; School of Pharmaceutical Sciences, Universiti Sains Malaysia, Malaysia; China National Health Development Research Centre, Ministry of Health, China;