Drug Evaluation Committee Utilization of real-world data in cost-effectiveness assessment -lessons learned from the NICE real-world evidence framework and the status of utilization of real-world data in Japan
January 2025
Cost-effectiveness evaluations require the integrated use of various data sources, and real-world data is one of the key sources.In June 2022, the UK’s NICE published the NICE Real-World Evidence Framework with the aim of improving the quality of real-world evidence; the framework outlines methods for utilizing various types of real-world data in cost-effectiveness evaluations. In Japan, following the full-scale introduction of the cost-effectiveness evaluation system in 2019, a body of evaluation cases has gradually begun to accumulate.Therefore, drawing on the NICE Real-World Evidence Framework and actual case studies, we have summarized methods for utilizing real-world data in cost-effectiveness evaluations and key considerations for its use, and further investigated the current status of real-world data utilization in Japan. We hope this will serve as a helpful resource for utilizing real-world data in cost-effectiveness evaluations.
Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee
Data Science Subcommittee FY2023 Continuing Task Force 7