THE IMPLICATIONS OF THE MOST-FAVORED-NATION (MFN) POLICY IN THE UNITED STATES (US) ON PHARMACEUTICAL PRODUCTS LAUNCH TIMELINES IN EUROPE
Author(s)
Linda M. Wiinberg, MSc Public Health1, Jake Peter James, MSc Drug Discovery and Pharma Management2, Paula Skowron, MPharm, Msc Computational Biology3, Ajinkya Bendre, MSc4, Peter Wagner, BMS5, Oliver David Staples, PhD1, Anke van Engen, MsC Chem6.
1IQVIA, Basel, Switzerland, 2IQVIA, London, United Kingdom, 3IQVIA, Warszawa, Poland, 4IQVIA, Bengaluru, India, 5IQVIA, Frankfurt, Germany, 6IQVIA, Amsterdam, Netherlands.
1IQVIA, Basel, Switzerland, 2IQVIA, London, United Kingdom, 3IQVIA, Warszawa, Poland, 4IQVIA, Bengaluru, India, 5IQVIA, Frankfurt, Germany, 6IQVIA, Amsterdam, Netherlands.
OBJECTIVES: The Most Favored Nation (MFN) policy aims to rebalance US drug prices to peer nations. Elements of MFN are implemented via international reference pricing (IRP). Including European markets in IRP baskets may create spillover effects and this research aimed to examine if MFN adoption impacted new product launch timelines in Europe.
METHODS: Using the IQVIA Market Access Insights platform, we identified the original approvals of medicinal products by Food and Drug Administration (FDA) and European Medicines Agency (EMA) between May 2016-2026; excluding biosimilars and generics. We estimated the median approval lag between FDA and EMA for pre- and post-MFN periods. We analysed whether the FDA-EMA lag is longer than the historical median lag of 500 days (i.e., since December 2023) and whether differences exist between manufacturers with and without MFN deals. For products of those with deals, we compared the current FDA-EMA lags with the historical lag per manufacturer.
RESULTS: Among 169 original approvals by FDA since December 2023, 69 (41%) are EMA approved, with a median lag of 181 days. 74 (44%) have not yet been submitted to EMA, and many were likely never intended for EMA submission. Historically, on average 39% of FDA approved products do not submit for EMA approval. Of the 74 products not yet submitted, 31 (42%) have exceeded the historical median approval lag of 500 days. Only 1 of these 31 products is developed by a manufacturer with an MFN deal. Among the remaining 43 products within the historical median, 8 have MFN deals and 6 have exceeded the average lag per manufacturer.
CONCLUSIONS: The data indicates early signs of approval delays; however, there is not yet enough data to suggest MFN had a concrete impact on new product launches in Europe. Monitoring trends as more data becomes available is crucial to understand the potential MFN impact.
METHODS: Using the IQVIA Market Access Insights platform, we identified the original approvals of medicinal products by Food and Drug Administration (FDA) and European Medicines Agency (EMA) between May 2016-2026; excluding biosimilars and generics. We estimated the median approval lag between FDA and EMA for pre- and post-MFN periods. We analysed whether the FDA-EMA lag is longer than the historical median lag of 500 days (i.e., since December 2023) and whether differences exist between manufacturers with and without MFN deals. For products of those with deals, we compared the current FDA-EMA lags with the historical lag per manufacturer.
RESULTS: Among 169 original approvals by FDA since December 2023, 69 (41%) are EMA approved, with a median lag of 181 days. 74 (44%) have not yet been submitted to EMA, and many were likely never intended for EMA submission. Historically, on average 39% of FDA approved products do not submit for EMA approval. Of the 74 products not yet submitted, 31 (42%) have exceeded the historical median approval lag of 500 days. Only 1 of these 31 products is developed by a manufacturer with an MFN deal. Among the remaining 43 products within the historical median, 8 have MFN deals and 6 have exceeded the average lag per manufacturer.
CONCLUSIONS: The data indicates early signs of approval delays; however, there is not yet enough data to suggest MFN had a concrete impact on new product launches in Europe. Monitoring trends as more data becomes available is crucial to understand the potential MFN impact.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR207
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling
Disease
No Additional Disease & Conditions/Specialized Treatment Areas