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    REGULATORY

    COMMENTARY

    Deeper CEA Price Cuts Demand More Than a “Certain Degree of Validity”
    By Ken Yoshino

    Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…

    COLUMN

    Japan’s Healthcare Pulse: An 18-Month Market Snapshot
    By Philip Carrigan

    Analysis of individual placements across 43 companies over the past 18 months paints a vivid picture of Japan’s evolving healthcare industry. This comprehensive snapshot illuminates current market demands, strategic shifts, and the enduring appeal of this pivotal Asian market.Rare Diseases…

    Cost Effectiveness Assessment (2025-)

    Chuikyo Reps Back More Pharma Access to CEA Deliberations, Urge Neutrality
    By Kohei Hori

    Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…

    Off-Year Drug Price Revisions

    Pharma Urges Drug Security, Demands 8.5% Price Hike: LDP Hearing
    By Kohei Hori

    Japan’s pharmaceutical industry asked the ruling Liberal Democratic Party (LDP) on October 29 to boost the country’s drug supply security…

    Drug Approval & Reimbursement in 2026

    Imulrio Finally Set for NHI Listing after 296-Day Wait; Zero Rule Strikes Again
    By Takashi Ebisawa

    Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…

    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…