REGULATORY
    Chuikyo OKs Tougher CEA Price Cuts for Drugs Tagged “Cost Increase”
    By Kohei Hori November 12, 2026
    A Japanese health ministry proposal to impose steeper price cuts on certain medicines deemed to carry poor cost-effectiveness profiles cleared a key reimbursement panel on November 11, setting the stage for the new rules to…

    LATEST

    Chuikyo Weighs “Agile Response” to MFN as Providers Question Drug Lag, Loss Impact
    November 12, 2026
    A Japanese drug pricing panel on November 11 discussed ways to respond to the US most-favored-nation (MFN) policy, with healthcare providers questioning its actual impact on drug lag and drug loss in Japan even as…
    Japan to List Eylea Biosimilars from SamChunDang, Celltrion on Nov. 13
    November 12, 2026
    South Korea’s SamChunDang Pharm (SCD) is set to enter Japan’s biosimilar market on November 13 with the listing of its follow-on version of Eylea (aflibercept). Daiichi Sankyo Espha will handle domestic sales, marking its own…
    MSD Set to Match Beyfortus Price for RSV Antibody Enflonsia if Added to NIP
    November 12, 2026
    MSD plans to offer its RSV preventive antibody Enflonsia (clesrovimab) at the same price as Sanofi’s Beyfortus (nirsevimab) if the products are added to Japan’s national immunization program (NIP), potentially in April 2027.In a statement…

    COMMENTARY

    Japan Drug Wholesalers Caught in Multiple Dilemmas as Price Gap Narrows
    By Tatsuya Otsuka

    On paper, things should be looking up for Japan’s pharmaceutical wholesalers. Industry expectations are mounting that the average gap between NHI and market prices will narrow further in FY2026 from the previous year’s record low of 4.8%.A shrinking gap should…

    Drug Approval & Reimbursement in 2026

    Keytruda SC Tops New NHI Listing Round with 75 Billion Yen Sales Outlook
    By Hayate Horiguchi

    Japan is set to add 16 new drugs to its NHI reimbursement price list on November 13, including a subcutaneous…

    Cost Effectiveness Assessment (2025-)

    Kisunla Price Cut Set at 3.93% under Japan’s CEA Scheme

    Japan will trim the NHI price of Eli Lilly Japan’s Alzheimer’s treatment Kisunla (donanemab) by 3.93% under the cost-effectiveness assessment…

    COLUMN

    New York Note - 2: The Tariff Roller Coaster
    By Shunsuke Tani

    Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…

    Off-Year Drug Price Revisions

    MOF Presses for Full FY2027 Drug Price Revision Without Price Gap Thresholds
    By Kohei Hori

    As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…

    FY2026 Drug Pricing Reform

    Romiplate to See Steepest Cut in April Market Expansion Re-Pricing

    Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…

    Drug Approval & Reimbursement in 2025

    Chuikyo OKs Listing of Novartis’ Pluvicto, Peak Sales Outlook at 42.1 Billion Yen

    Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

    PMD Act Amendment

    Japan Cabinet Approves Bill to Amend PMD Act

    The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…

    Drug Approval & Reimbursement in 2024

    Japan Approves Zepbound, Qalsody, and Lots More Drugs

    Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…

    FY2024 Reimbursement Reform

    Chuikyo OKs Outline of FY2024 Drug Pricing Reform; No Unprofitability Re-Pricing for 7%-Plus Price Gap

    Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…

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