Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Chuikyo OKs Pricing Plan for Xocova Listing, 100 Billion Yen Threshold for Possible Re-Pricing
An all-powerful Japanese reimbursement policy panel on February 15 approved the basic pricing and post-listing price adjustment plan for Shionogi’s COVID-19 pill Xocova (ensitrelvir). The re-pricing threshold based on estimated sales data was set at 100 billion yen, a setback…
To read the full story
Related Article
- Xocova to Be Commercially Available from March 31
March 24, 2023
- Xocova Priced at 51,851 Yen per Course with Peak Sales Put at 19.2 Billion Yen
March 9, 2023
- Pharma Trade Groups Stress Concern for Re-Pricing Debate over Xocova: Chuikyo
February 9, 2023
- Chuikyo Talks Over Sales Criteria to Trigger Possible Xocova Re-Pricing; Is 3-Month-Based Estimate an Overestimate?
February 9, 2023
- Chuikyo OKs Use of Multiple Comparators to Price Xocova, Upping of Reduction Cap Mooted for Re-Pricing
February 2, 2023
- Chuikyo Begins Xocova Price Debate under Mega Seller Rule, Weighs Quicker Re-Pricing
January 26, 2023
- Xocova Might Trigger Mega Seller Price Control Rule for First Time
January 24, 2023
REGULATORY
- Panel Clears Zolgensma Intrathecal Form to Expand Use in Older SMA Patients
March 10, 2026
- Japan Approves MSD’s HIV Combo Idvynso
March 9, 2026
- MHLW Updates Elective Care LLP List; Target Products Down Sharply to 776
March 9, 2026
- MHLW Orders Label Revisions for Cancer Drugs, Anticoagulant over Bleeding Risk
March 9, 2026
- Japan Health Minister Lauds Approval of iPSC-Based Therapies
March 9, 2026
International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…