Presentation (CTI)

OBJECTIVES: The United States Most Favored Nation (MFN) policy links US drug prices to reference markets, including Germany, and may affect global launch strategies. This study assessed whether MFN was associated with higher non-entry of medicines in Germany and changes in launch timing.
METHODS: We conducted a retrospective cohort analysis of all human medicines receiving EMA marketing authorization between November 2024 and April 2026. Three MFN cutoffs were tested to capture key policy milestones: July 2025 (formal announcement), November 2025 (policy signal), and January 2026 (implementation). Biosimilars (n=44) and generics (n=10) were excluded. EMA authorization dates were used as the approval date, and German Lauertaxe entries as the marker of market entry. To address recency bias, we confirmed that all post-MFN products had follow-up longer than the pre-MFN mean time to listing (132 days).
RESULTS: The cohort included 52 non-biosimilar, non-generic medicines. Using the July 2025 cutoff, non-entry rose from 22.2% pre-MFN (8/36) to 43.8% post-MFN (7/16), with similar findings across the alternative cutoffs. Recency checks suggested this was not explained by limited follow-up. Among products that did launch, mean time from EMA authorization to Lauertaxe listing fell from 132.1 days pre-MFN (n=28; range, 25-456) to 58.4 days post-MFN (n=9; range, 27-134), a 55.8% reduction. This likely reflects survivorship bias, with only the most commercially viable products proceeding to launch in Germany under greater reference pricing pressure.
CONCLUSIONS: These early findings suggest that MFN may be associated with higher non-entry of medicines in Germany. Faster listing among launchers is more likely to reflect selective launch decisions than true acceleration of market entry. Together, these results suggest a split manufacturer response, with potential implications for patient access and global pricing. Larger studies with longer follow-up are needed to confirm these patterns.