25 Feb Japan’s First Pricing Reform Since 2013, expected in April 2021
Chuikyo, a key reimbursement policy panel of the Japanese Central Social Insurance Medical Council has approved the cost-effectiveness assessment (CEA) scheme introduced in 2019, for use in post-launch price adjustments. Discussions with the manufacturers on the price adjustments are expected to be held in April at the earliest. With multiple products expected to go through such adjustments within this year, policymakers would be able to renegotiate the cost of therapies in Japan.
Overview of the Pricing Adjustment Process
- Company submits draft framework analyses to determine the target patient population, comparators and clinical trials as determined by Chuikyo
Submission & Appraisals
- Company submits their economic analysis based on the agreed framework.
- Results will be appraised by public analysis groups (such as academic institutions), and amendments made as required.
- Results will be appraised further by the CEA agency.
- Once the appraisal results have been finalised, Chuikyo will provide approval on the proposed pricing adjustment plan and a new reimbursed price will be determined.
- New prices will be applied three months following approval.
Japan’s CEA system applies health economics to publicly insured healthcare and is mainly utilised for highly innovative but costly drugs and medical devices. Products used only for state-designated intractable diseases, haemophilia, HIV and products used only by children are excluded from this process. The new CEA system is used to adjust the prices of products that have already been listed rather than to determine whether new products should be listed in the National reimbursement system.
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