Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the entry of 11 new drugs into the National Health Insurance (NHI) reimbursement system effective May 21, 2025. The newly listed drugs include BeiGene’s cancer immunotherapy Tevimbra (tislelizumab), Servier’s Tibsovo (ivosidenib) for acute myeloid leukemia, and nine others. At the same time, it imposed major price decreases (up to 20%) for nine commercially successful therapies via the Market Expansion Repricing program. The MHLW announced price reductions of major therapies such as Bayer/Regeneron’s Eylea (aflibercept) and Roche/Chugai’s Vabysmo (faricimab) as well as seven others, effective August 1, 2025. These price adjustments demonstrate Japan’s attempts to control costs despite efforts to encourage innovation.
On June 18, the MHLW stated that it will remove 16 drug products from the NHI price list under a brand-new procedure for delisting. Two of the 16 products to be delisted are a result of a change in MAH. The other 14 products to be delisted will be exchanged for equivalent formulations with different trade names. Delisting is expected to occur on April 1, 2026. Manufacturers of these 16 drugs had applied for delisting in late 2024 and early 2025.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.