Yoko Ishiguro, Sr. Reimbursement Analyst of Health Care Economics & Government Affairs, Medtronic North Asia (Korea and Japan), yoko.ishiguro@medtronic.com
Japan’s reimbursement scheme has a routine revision system. It takes place every two years in April and the next revision will be made on April 1, 2022. Japan’s health technology assessment (HTA) program known as cost-effectiveness evaluation (CEE) is to undertake the revision, which would be the first revision after fierce debate since its implementation in 2019; 2020 was too early for the revision.
On January 19th, Japan's Central Social Insurance Medical Council (CSIMC, locally known as Chuikyo) was held, and proposals from the Ministry of Health, Labour and Welfare of (MHLW) for procedure fees, drug prices, medical technology prices and CEE were reported to Chuikyo members [1]. As Chuikyo members accepted these proposals, the CEE scheme and operation are expected to be changed for products which will be selected for CEE after April this year. Generally, the scheme change is limited to operational changes for smoother deliberations. Compared to its expected amendment in the long-term such as expanding objectives from price adjustment to reimbursement determination, it seems better to explicitly say what it is. Although 28 products had been selected for CEE and there were a lot of operational issues, a resolution was achieved. At the same time, reassessment guidelines were also accepted.
Main CEE schemes change from April 2022
（1） Base schedule
Changes in the timing scheme of each expert panel are shown below. It is expected to shorten the process without changing manufacturer report and academic report submission deadline.
- 1st expert panel: after preliminary consultation to agree analytical framework (no change)
- 2nd expert panel: in the conventional scheme, the second one was held after manufacturer report submission, but it was changed to the middle of academia review as it is better to clarify the time for manufacturer report to be issued or revised for price adjustment.
- 3rd expert panel: the objective is appraisal and there is no change in timing (after academic analysis).
（2） Physician inclusion
Physicians was allowed to attend the preliminary consultation only from 2nd expert panel: preliminary consultation is serial discussion between manufacturer and C2H (HTA agency in charge) to finalize analytical framework. From this April, physicians are allowed to attend the first meeting as well.
（3） Rule for small subgroups
With a reasonable rationale, small subgroups can be excluded.
Reference
[1] https://www.mhlw.go.jp/stf/shingi2/0000212500_00134.html