New decision-making processes for the pricing of health technologies in Japan: The FY 2016/2017 pilot phase for the introduction of economic evaluations.

Economic evaluation is used for decision-making processes in healthcare technologies in many developed countries. In Japan, no health economic data have been requested for drugs, medical devices, and interventions till date. However, economic evaluation is gradually gaining importance, and a trial implementation of the cost-effectiveness evaluation of drugs and medical devices has begun. Discussions on economic evaluation began in May 2012 within a newly established sub-committee of the Chuikyo, referred to as the "Special Committee on Cost Effectiveness." After four years of discussions, this committee determined that during the trial implementation, the results of the cost-effectiveness evaluation would be used for the re-pricing of drugs and medical devices at the end of fiscal year (FY) 2017. Chuikyo selected 13 products (7 drugs and 6 medical devices) as targets for this evaluation. These products will be evaluated until the end of FY 2017 based on the following process: manufacturers will submit the data of economic evaluation; the National Institute of Public Health will coordinate the review process; academic groups will perform the actual review of the submitted data, and the expert committee will appraise these data. This represents the first step to introducing cost-effectiveness analysis in the Japanese healthcare system. We believe that these efforts will contribute to the efficiency and sustainability of the Japanese healthcare system.