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Japan Initiates Major Medicine Repricing Strategies for National Insurance Amid Demographic Shifts

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In a bid to ensure the financial viability of Japan’s national insurance system amid a burgeoning public health sector burden exacerbated by an aging population, the Japanese government has initiated a significant reform in medicine repricing for national health insurance (NHI)-listed drugs. This reform, slated for implementation in fiscal years 2024 and 2025, introduces new medicine repricing schemes and imposes stricter rules for regular price reductions, marking a pivotal shift from Japan’s traditionally generous funding towards innovative drugs.

The outlines of this reform, approved by Japan’s Central Social Insurance Medical Council (Chuikyo) at the end of 2023, are anticipated to be disclosed before April 2024, setting the stage for a transformative period in Japan’s healthcare sector. Historically, Japan has been a forerunner in subsidizing innovative drugs, but the escalating financial strain due to demographic shifts has compelled the Ministry of Health, Labour and Welfare (MHLW) to recalibrate its approach. The MHLW’s reform objectives are twofold: to expedite drug approvals in Japan and to fortify the drug supply chain’s stability.

To this end, the introduction of market expansion schemes and cost-effectiveness assessment (CEA) repricing, predominantly enacted between 2018 and 2020, aims to alleviate the pricing pressures on generic drugs. These measures have positioned Japan at the forefront of price reductions when compared to leading European countries, with the average price cut for branded drugs in Japan escalating from 7.48% in April 2014 to 11.11% in April 2022.

Japan’s Medicine Repricing Reform Tackles ‘Drug Lag’ and Boosts Incentives for Innovative Drug Development

This aggressive medicine repricing strategy, while intended to curb healthcare expenditures, has inadvertently stifled the growth of Japan’s pharmaceutical market in value terms, deterring foreign companies from launching their products in the Japanese market prematurely. The resultant ‘drug lag’ phenomenon has become more pronounced in Japan than in the US and EU, signifying a critical area of concern for health policy and market access.

A notable aspect of the reform is the enhancement of price premiums for innovative drugs, a move designed to invigorate drug development activities within Japan. The reform aims to broaden the eligibility criteria for sakigake designation—Japan’s fast-track regulatory approval pathway—by relaxing the stringent application timelines and introducing a new ‘pioneer premium’.

This premium, albeit lower than the sakigake premium, seeks to incentivize drugs that are either part of multinational clinical trials including Japan, or have prioritized Japan in their clinical trial and filing timelines.

Medicine Repricing

Balancing Economic Sustainability with Pharmaceutical Innovation

The systematic overhaul of Japan’s drug pricing system, particularly the recalibration of price premiums and the introduction of rigorous medicine repricing mechanisms, reflects a strategic effort to balance financial sustainability with the imperative to foster innovation within the pharmaceutical sector. By adjusting the financial incentives and regulatory pathways for innovative drugs, Japan aims to not only mitigate the economic pressures on its healthcare system but also to catalyze the development and accessibility of novel therapies.

This reform underscores a nuanced understanding of the challenges at the intersection of healthcare financing and pharmaceutical innovation. As Japan navigates these reforms, the global healthcare community watches closely, recognizing the potential implications for medicine repricing policies, market access strategies, and the broader quest for sustainable healthcare innovation.

The endeavor to refine the nexus between healthcare economics and therapeutic advancement in Japan serves as a compelling case study in balancing cost containment with the imperative to drive pharmaceutical innovation.


Resource: Pharmaceutical Technology, February 16, 2024

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