OBJECTIVES

: To identify the state of the Health Technology Assessment for Procedures (HTAPs) in the health care system in Japan in the past decade.

METHODS

: In Japan, in order to set up a new reimbursement fee for a new procedure not currently included in the insurance list, applications are submitted by clinical societies to the government and an HTAP is undertaken by the Health Technology Assessment Sub-committee. In this research, government decisions for HTAPs in the 8 years from 2012 to 2020 were analyzed. The reimbursement fee is determined, after the evaluation of innovation was reviewed in Central Social Insurance Medical Council for the revision of medical service fees Surgical, Medical, Dental and Pharmaceutical procedures were included in the HTAPs.

RESULTS

: The overall number of HTAPs undertaken in Japan has increased from 793 in 2012 to 971 in 2020. The number of recommended HTAPs has increased from 135 in 2014 to 264 in 2020. For those new HTAPs that were recommended, the number increased from 57 in 2014 to 102 in 2020. For those new HTAPs that didn’t satisfy criteria for the discussion, the number increased from 176 in 2012 to 228 in 2020. The most common reasons for not being recommended was inability to show usefulness with evidence about outcome improvement by medical examination or health technology, and not yet having approval from the Pharmaceuticals and Medical Devices Agency. In the all evaluations, a cost-effectiveness analysis was rarely performed.

CONCLUSIONS

: The number of recommended HTAPs to set up a reimbursement fee for a procedure in Japan has grown steadily. However, the applications that didn’t satisfy criteria for discussion have also increased. Therefore, applicants should consider providing more evidence to demonstrate improved outcomes with the new procedure to enable a successful recommendation by the Health Technology Assessment Sub-committee.