ISPOR Asia Consortium Industry Committee organized a forum on “Applications of RWD and RWE in Decision Making in Asia Pacific” at ISPOR 2024 in Atlanta, on May 6, 2024. The objective of this forum was to provide the most recent update on the use of real-world data (RWD) and real-world evidence (RWE) in regulatory, reimbursement, and clinical decision making in Asia Pacific. This session was moderated by the Committee Chair, Dr. Larry Liu, Executive Director of Outcomes Research, Value and Implementation, Merck & Co., Inc, Rahway, NJ, USA and Associate Professor of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA. During this session, Dr. Liu provided a comprehensive update of the use of RWD and RWE for regulatory and clinical decision making in China and Japan with specific case examples. Dr. Jianwei Xuan, Professor & Director of Health Economic Research Institute, Sun Yat-sen University, Guangzhou, China, presented the application of RWE in reimbursement decisions as well as hospital payment reform in China. Dr. Viva Ma, Director of Strategic Access, Becton, Dickinson and Company, Greater Asia, presented RWE application in Medtech - a public health case study. The following is a brief summary of each of the three presentations.
Update on the Use of RWD/E for Regulatory and Clinical Decision Making in China and Japan
Dr. Liu started with an overview of regulatory guideline development on the use of RWE with a special focus on the Lecheng pilot zone in Hainan Province, China. For example, four drugs have been approved by National Medical Product Administration, mostly based on RWE collected in Lecheng pilot zone. In clinical practice, RWD has been used broadly with the help of artificial intelligence, as some barriers are being addressed. Overall, many challenges of using RWD existed, especially RWD quality and access. Dr. Liu summarized the findings of his three recent publications to call policy changes, high-quality data standardization and encourage multiple stakeholder collaborations in China.
RWE Application in Health Technology Assessment and Hospital Payment Reform in China
Dr. Xuan reviewed the HTA adaptation in China’s National Reimbursement Drug Listing (NRDL) process started in 2017. The current NRDL process included two phases of value determination. One is the qualified MCDA value process focusing on the determination if the innovative drug meeting the initial criteria to qualify for the inclusion in the NRDL, and the second component is the health economic evaluation to quantify the clinical and economic benefits to support the final pricing negotiation. Dr. Xuan also reviewed the China DRG and DIP process in hospital payment reform and stated the importance of updating the current hospital management efficiency to keep up with the payment reform.
RWE Application in Medtech - a Public Health Case Study
Dr. Ma started by sharing the value of RWE based on more than a decade’s experience working in HEOR and Market Access in Medtech: it is a demonstration of how medical technologies affect the patients, and interact with the health care system, including human, process and infrastructure factors. It not only provides information on the clinical outcomes, but also on operational and economic outcomes. This is followed by a case study on tuberculosis diagnosis in Indonesia as a demonstration of the use of RWD/E in resource limited settings to inform public health strategy. RWD/E was used in a health economics model evaluating the impact of detecting INH resistance through molecular technology in the first step of testing algorithm. The results estimated benefits on cost saving, clinical and mortality outcomes, community transmission, as well as resistance acquisition.