IS THE U.S. MOST FAVORED NATION (MFN) INITIATIVE EXPECTED TO AFFECT DRUG LAUNCHES IN KOREA...

OBJECTIVES: Prescription drug prices in the United States (US) are substantially higher than in peer countries. In May 2025, the US administration announced a “Most Favored Nation” (MFN) pricing initiative to benchmark US prices to the lowest prices observed in economically comparable countries, effectively extending international reference pricing (IRP) principles. Although MFN is US-focused, it may generate global spillover effects, particularly in countries positioned at the lower end of international price corridors. In December 2025, the US Centers for Medicare & Medicaid Services (CMS) released proposed MFN models (GLOBE and GUARD), referencing prices from 19 OECD countries, including Korea. This study assessed whether Korea’s pricing position may increase the risk of launch sequencing delays for innovative medicines.
METHODS: New drugs from multinational manufacturers receiving first-time reimbursement approval in Korea in 2025 were identified. Products with prior reimbursed indications were excluded. Korean list prices were ranked against those in the 19 MFN reference countries under the GLOBE and GUARD frameworks, with adjustment for GDP per capita (PPP), as suggested by GLOBE and GUARD, to reflect economic comparability.
RESULTS: Fifteen drugs met inclusion criteria. Korea had the lowest list price in 6 of 15 products and ranked among the three lowest-priced countries in 12 of 15 cases. The mean Korean price rank was 2.6 (range: 1-8, where 1 indicates the lowest price). After GDP-PPP adjustment, Korean prices were, on average, 64% lower than US prices.
CONCLUSIONS: Korea consistently occupies a low position within MFN reference price distributions, increasing exposure to upward pricing pressure or delayed market entry driven by US benchmarking. An expanded scope of flexible list pricing eligibility in Korea may support earlier market entry and reduce the risk of launch de-prioritization driven by global MFN considerations.