In Response to the Fiscal 2026 (FY2026) Reform of the NHI Drug Price System and Cost-Effectiveness Evaluation System
December 26, 2025
Japan Pharmaceutical Manufacturers Association
Asuka Miyahashira Chairman
The Central Social Insurance Medical Council (hereinafter referred to as "Chuikyo") has recently compiled a "Framework for the Reform of the NHI Drug Price System in Fiscal 2026" and "Framework for the Reform of the Cost-Effectiveness Evaluation System in Fiscal 2026". This framework is the result of the wide-ranging efforts of all parties concerned.
The Pharmaceutical Manufacturers Association of Japan (PMAJ) has expressed its opinions at the discussions on the NHI drug pricing system and cost-effectiveness evaluation system, mainly at the Chuikyo, from the viewpoint of contributing to the realization of a healthy society with longevity and economic growth of Japan through the research and development of innovative new drugs and their stable supply.
We appreciate the fact that the proposal clearly states that (1) verification of the cost-effectiveness evaluation system will be implemented and (2) the application of market expansion reimbursement (including special exceptions) to similar drugs (co-payments) will be abolished. With regard to the cost-effectiveness evaluation system, we will continue to participate vigorously in the discussions, aiming for a desirable system based on the results of the verification, after presenting issues that should be reviewed.
On the other hand, we have postponed action on the following industry proposals, and we will continue to propose them in the future.
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Method of Calculating NHI Drug Prices for Innovative New Drugs
A system in which innovativeness is appropriately evaluated by, for example, broadly selecting similar drugs in a manner that covers the current cost accounting method.
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Innovative New Drug Price Maintenance System
While the average deviation rate is shrinking, the method of deciding which products to maintain NHI prices based on the deviation rate should be changed and NHI prices should be maintained in a simple manner.
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Special Market Expansion Reassessment (Special Price Adjustment for Sustainability)
Re-calculations that are not rational should be abolished.
In the current economic climate, it has been argued that official prices should also follow economic and price trends, and while the increase in the main body of medical fees should be evaluated from the perspective of the sustainability of healthcare, the fact that this idea was not reflected in NHI prices, which are part of medical fees, has a negative impact on the continuous creation of innovation. The fact that this concept was not reflected in NHI drug prices, which are part of reimbursement, has a negative impact on the continued creation of innovation.
Furthermore, with regard to the U.S. MFN (Most Favored Nation) system, as stated in the framework, we expect that measures will be taken from time to time and in a flexible manner, taking into account the international situation.
Finally, as the average deviation rate shrinks, in order to achieve compatibility with fiscal sustainability without undermining innovation, it is no longer feasible to continue operating the NHI drug price system itself, which has been based on the NHI price revision based on prevailing market prices, and it is time for a fundamental review of the system. It is time for a fundamental review. We believe that discussions should be initiated as soon as possible.
The End
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Japan Pharmaceutical Manufacturers Association, Public Relations Department
- Phone
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