REGULATORY
    Japan to Launch CEA “Technical Discussions” under MHLW Research Group
    By Kohei Hori May 14, 2026
    Japan’s “technical discussions” on the review of its cost-effectiveness assessment (CEA) system will be conducted under an existing health ministry-funded research group, with the first meeting set for this month and discussions expected to be…

    LATEST

    Mounjaro Hit with 25% Price Cut under Japan’s “SPA-SSS” Re-Pricing
    May 14, 2026
    Japan will slash the NHI prices of Eli Lilly’s diabetes therapy Mounjaro (tirzepatide) by 25% and Alnylam Japan’s transthyretin amyloid cardiomyopathy therapy Amvuttra (vutrisiran) by some 15% under the quarterly re-pricing scheme, both effective August…
    Japan OKs Listing of Ambelvist, Dojolvi, Sohonos, and Finally Inrebic
    May 14, 2026
    A total of four new medicines will join Japan’s NHI reimbursement price list on May 20, including Recordati Rare Diseases Japan’s myelofibrosis therapy Inrebic (fedratinib), which took 11 months to reach listing after regulatory approval.The…
    Chuikyo Clears NHI Listing for Amchepry, Akuugo, and Zolgensma Intrathecal
    May 14, 2026
    Japan’s Central Social Insurance Medical Council (Chuikyo) on May 13 approved the NHI listing of three regenerative medicine products, including Sumitomo Pharma’s iPSC-derived Parkinson’s disease therapy Amchepry (raguneprocel), all carrying hefty price tags.The three products…

    Chuikyo Debate on FY2026 Drug Pricing Reform

    Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead

    Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

    COMMENTARY

    Shift Underway in Pharma Workforce as Sales Roles Shrink, Manufacturing Rises
    By Hayate Horiguchi

    Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…

    COLUMN

    The Patient North Star: How Gilead Japan Redefined Innovation
    By Philip Carrigan

    In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…

    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,…

    Chuikyo Debate on Off-Year Drug Price Revisions

    MHLW Unveils New List Prices for FY2025 Revision; Stelara, Januvia Hit by PMP Return
    By Ken Yoshino

    The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…

    Discussions on Next 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…

    Chuikyo on 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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