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

Data Science Subcommittee

January 2025

Cost-effectiveness assessment requires a complex evaluation using a variety of data sources, and real-world data is one of the most important data sources. NICE in the UK released the NICE real-world evidence framework in June 2022 with the aim of improving the quality of real-world evidence, and introduced various ways of using real-world data in cost-effectiveness evaluation. In Japan, after the full-scale introduction of the cost-effectiveness evaluation system in 2019, evaluation cases are gradually beginning to accumulate. Therefore, we summarized how to utilize real-world data in cost-effectiveness evaluation and points to keep in mind when utilizing real-world data, referring to the NICE real-world evidence framework and actual cases of utilization, and also surveyed the status of real-world data utilization in Japan. We hope that this report will help you to utilize real-world data in cost-effectiveness evaluation.

Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Data Science Subcommittee FY2023 Ongoing Task Force 7

Utilization of Real World Data in Cost-Effectiveness Evaluation

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