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In 2011, to respond to public concerns about soaring national health expenditure, the Japanese ministry of Health, Labour and Welfare (MHLW) officially announced serious consideration being given to the use of cost-effectiveness methods for reimbursement and pricing decisions for new medical technologies. As a result, the pilot introduction of the new Health Technology Assessment (HTA) began in April 2016 through March 2018, and potential full-scale implementation was initially suggested to begin in April 2018. This timetable was, however, postponed by one year as of December 2017, due to the new pricing method proposed to the Central Social Insurance Medical Council (CMC) of the MHLW being seriously criticized by both academia and industry. As of March 2018, the CMC planned to revise and finalize this project by March 2019. To fully understand those policy changes, one must look into the Japanese HTA background and identify the questions raised on this issue in the past.
Since 1961, Japan has developed nation-wide universal health coverage and sophisticated HTA systems, which implicitly consider cost and benefit of health technologies to determine official pricing. Once the price is determined by the government, it is automatically approved to be listed on the National Formulary (NF) for reimbursement, unless the pharmaceutical company disagrees to this official price. Then, this official price is revised downwards biennially. The discount rate in re-pricing is determined at the political level by the MHLW…


The reform of pricing rules by the Japanese ministry of Health, Labour and Welfare is in progress since April 2016, as of June 2018. The primary objective is to integrate cost-effectiveness evaluation to the current pricing system, which adds a « premium » on the baseline product price. The government plans to employ an algorithmic method, transparent but mechanical, to adjust the premium price by plugging the estimated cost-effectiveness ratio into an equation (developed by the government) for price adjustment. Whilst a political consensus can easily be reached on this issue, we argue that this approach is neither scientific nor flexible enough for these ongoing discussions. We also argue that those disputed issues in Japan, which deal with wise spending of healthcare resources and the use of pharmacoeconomics, could be employed as an interesting – yet methodologically troubled – case study of High Technology Assessment (HTA) by any public agency elsewhere in the world.

Isao Kamae
M.D., Dr. PH
Project Professor, Health Policy and Technology Assessment ; Graduate School of Public Policy, The University of Tokyo ; Research Director, Canon Institute for Global Studies, Japan.
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