In Response to the Fiscal 2026 Reform of the NHI Drug Price System and Cost-Effectiveness Evaluation System
December 26, 2025
Japan Pharmaceutical Manufacturers Association
Asuka Miyabashira, Chairman of the Board of Directors
Recently, the Central Social Insurance Medical Council (hereinafter referred to as "Chuikyo") compiled the "Framework for the FY2026 NHI Drug Price Reform" and the "Framework for the FY2026 Cost-Effectiveness Evaluation System Reform". This framework is the result of the wide-ranging efforts of all parties concerned.
The JPMA has expressed its opinions at the discussions on the NHI drug pricing system and the 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 in 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 will continue to make proposals regarding the following industry proposals, which have been postponed and will continue to be addressed.
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NHI drug price calculation method 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 determining drug price maintenance items based on the deviation rate should be changed and drug prices should be simply maintained.
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Special re-pricing for market expansion (special price adjustment for sustainability)
Re-calculation that is not rational should be abolished.
In the current economic situation, it has been argued that official prices should also follow economic and price trends, and that increases in the main body of medical fees should be evaluated from the perspective of sustainability of medical care. However, 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.