REGULATORY APPROVAL AND PATIENT ACCESS TIMELINES IN THE US AND EUROPE: A BASELINE ANALYSIS TO INFORM POTENTIAL EFFECTS OF MOST-FAVOURED-NATION PRICING POLICIES
Author(s)
Giulia Fagnocchi1, Stefania Brancone, Jr., MSc2, Letizia Rossi, PharmD, MD3, Virginia Niglio, PharmD, MD4, Mariangela Prada, MSc5, Claudia Bertozzi, MSc5.
1Market Access Specialist, Intexo Società Benefit, Rome, Italy, 2Intexo Società Benefit, Roma, Italy, 3Intexo Società Benefit, Rome, Italy, 4PLG - ProductLife Group, Rome, Italy, 5ProductLife Group, Rome, Italy.
1Market Access Specialist, Intexo Società Benefit, Rome, Italy, 2Intexo Società Benefit, Roma, Italy, 3Intexo Società Benefit, Rome, Italy, 4PLG - ProductLife Group, Rome, Italy, 5ProductLife Group, Rome, Italy.
OBJECTIVES: Timely access to innovative medicines varies across regions due to differences in regulatory and post-approval processes. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both operate expedited review pathways, historical evidence suggests persistent differences in approval sequencing. In parallel, policy discussions around Most-Favoured-Nation (MFN)-type pricing approaches are gaining attention, particularly in high-expenditure therapeutic areas. The GLOBE initiative focuses on such areas, including oncology (39%), immunology (19%), skin substitutes (13%), ophthalmology (12%), endocrinology (9%), and rheumatology (5%), with oncology representing the primary area of interest. Establishing a robust pre-policy baseline of transatlantic regulatory timelines is therefore essential to contextualize how MFN-type policies may influence launch sequencing and patient access across regions.
METHODS: A list of centrally authorized medicines was extracted from the EMA database. The dataset was filtered to include human medicines with a marketing authorization granted between 2022 and 2025, excluding generics and biosimilars. For each product, EMA approval dates were collected and compared with corresponding FDA and EU4 approval timelines.
RESULTS: Within ATC L01 (oncology), 51 drugs were identified: 39/51 (76%) were approved earlier by the FDA, 9/51 (18%) by the EMA, and 3/51 (6%) were not FDA approved. The median approval delay was 277 days (FDA-EMA) and 92 days (EMA-FDA). Further analysis will include additional ATC groups.
CONCLUSIONS: Preliminary results show that most oncology medicines are approved earlier in the US, with approximately three-quarters of products receiving FDA approval before EMA authorization. These findings are consistent with prior evidence of a structural transatlantic timing gap. In the context of MFN-type pricing policies, earlier FDA approval may disproportionately influence price anchoring and reinforce sequencing asymmetries, with potential implications for patient access in later-approving regions. For payers and policymakers, these results highlight the importance of considering regulatory timing alongside pricing rules when assessing MFN-type approaches.
METHODS: A list of centrally authorized medicines was extracted from the EMA database. The dataset was filtered to include human medicines with a marketing authorization granted between 2022 and 2025, excluding generics and biosimilars. For each product, EMA approval dates were collected and compared with corresponding FDA and EU4 approval timelines.
RESULTS: Within ATC L01 (oncology), 51 drugs were identified: 39/51 (76%) were approved earlier by the FDA, 9/51 (18%) by the EMA, and 3/51 (6%) were not FDA approved. The median approval delay was 277 days (FDA-EMA) and 92 days (EMA-FDA). Further analysis will include additional ATC groups.
CONCLUSIONS: Preliminary results show that most oncology medicines are approved earlier in the US, with approximately three-quarters of products receiving FDA approval before EMA authorization. These findings are consistent with prior evidence of a structural transatlantic timing gap. In the context of MFN-type pricing policies, earlier FDA approval may disproportionately influence price anchoring and reinforce sequencing asymmetries, with potential implications for patient access in later-approving regions. For payers and policymakers, these results highlight the importance of considering regulatory timing alongside pricing rules when assessing MFN-type approaches.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR255
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas