2021 Volume 70 Issue 1 Pages 22-27
Advancing medical technologies is one of the main reasons to increase medical expenditure. One possible way to consider efficiency is to evaluate cost effectiveness of medical technologies and make decisions upon the results. It is often described as health technology assessment, HTA. In Japan, introduction of HTA system was discussed since 2010. After 10 years of discussion, a new HTA system was established in 2019.
In the new HTA system, the manufacturer must submit the data first. The submitted analysis is reviewed and reanalyzed by academic analysis groups and is finalized by Center for Outcomes Research and Economic Evaluation for Health(C2H) at the National Institute of Public Health. Based on the manufacturer's submission and the C2H public analysis, the Expert Committee on Cost-Effectiveness Evaluation at the Central Social Insurance Medical Council (CSIMC) examines the scientific quality of the analysis and determines the most likely incremental cost effectiveness ratio (ICER) figure or range for the product in the appraisal process.
The target drugs and medical devices are principally selected when they are newly listed at the general assembly of CSIMC based on the predetermined selection criteria. The results of the evaluation will be used for reimbursement price adjustment, not for coverage decision. When ICER exceeds 5 million JPY per QALY, the price will be adjusted. For some diseases, such as rare or pediatric diseases and cancer, 7.5 million JPY per QALY will be used as threshold for price adjustment.
In order to implement full scale cost effectiveness evaluation, a new unit, “Center for Outcomes Research and Economic Evaluation for Health”, was established in 2018 at the National Institute of Public Health.
