Exploring the Application of Cost-Effectiveness Evaluation in the Japanese National Health Insurance System.

OBJECTIVES: Advances in health care due to the development and introduction of new drugs and medical devices have brought considerable benefits to people and patients in terms of upgraded quality of life and extended years of survival. However, some are concerned that the very advancement of health care would increase further the inflation of national healthcare costs. In response to these concerns, Japan's Central Social Insurance Medical Council ("Chuikyo") began in 2012 to examine how cost-effectiveness evaluation might be applied to the national health insurance system, and has been working toward establishing a system for its usage.

METHODS: Cost-effectiveness evaluation was adopted on a trial basis in fiscal year (FY) 2016, targeting seven drugs and six medical devices. Analyses and re-analyses were performed by manufacturers and a public expert organization, respectively. Based on these analyses, a cost-effectiveness evaluation expert organization conducted an overall assessment ("appraisal"). Results of the evaluation were used to adjust the prices of the target items.

RESULTS: Following the trial adoption of cost-effectiveness evaluation, price adjustments were performed for three items in April 2018. Meanwhile, a decision was also made to examine seven items for which technical requirements were identified due to differences in the understanding of analysis methods between involved parties.

CONCLUSIONS: The Chuikyo will examine how to meet the newly identified technical requirements and discuss specific details with regard to establishing a system that incorporates cost-effectiveness evaluation. The Chuikyo plans to reach a conclusion by the end of FY 2018.