From Cost Containment to Modernization: Market Access Updates Across the EU4 and the UK in 2025
Author(s)
Andrea Bernardini, PhD1, Katarzyna Lasota, MSc2, Sanja Stanisic, Pharm D, MSc3.
1Certara Evidence and Access, London, United Kingdom, 2Certara Evidence and Access, Kraków, Poland, 3Certara Evidence and Access, Milan, Italy.
1Certara Evidence and Access, London, United Kingdom, 2Certara Evidence and Access, Kraków, Poland, 3Certara Evidence and Access, Milan, Italy.
OBJECTIVES: In 2025, European countries are implementing a considerable number of policy reforms to manage national healthcare system (NHS) expenditures, optimize access pathways, and update NHS services. This research systematically maps these changes across the EU4 and the UK, assessing their implications for pharmaceutical launch strategies and patient access.
METHODS: A structured review of publicly available national policy updates (issued between 01/01/2025 and 15/06/2025) was conducted across 5 major European markets: the UK, France, Germany, Italy, and Spain. Identified policies were categorized into 5 trends: Pricing & Cost Containment, Access Pathway Updates, Health Technology Assessment (HTA) Processes, Real-World Evidence (RWE), and NHS Service Modernization. Trends are not mutually exclusive to reflect the multidimensional impact of identified policies.
RESULTS: Twenty-three new policies were identified across the UK (n=6), France (n=5), Germany (n=4), Italy (n=4) and Spain (n=4). Pricing & Cost Containment was the most frequent, (47.8%, n=11), followed by NHS Service Modernization (17.4%, n=4), Access Pathway Updates (13.0%, n=3), HTA Processes (13.0%, n=3), and RWE (8.7%, n=2). Germany’s focus is overwhelmingly on pricing, with removal of international reference pricing (IRP) and new rebates policy. Similarly, also the UK and France primarily focus on pricing and cost-containment with half of their policy updates centered on this. In addition, the UK policies are geared towards Access Pathway updates and the RWE use. Italy shows equal distribution across all five trends. Spain is streamlining national HTA process and improving NHS coordination and response capacity.
CONCLUSIONS: First half of 2025 reflects evolving policy landscape characterized by continued focus on pricing reforms, and a shift towards improved HTA processes and access pathways, and the RWE integration. Manufacturers should adopt adaptive launch strategies prioritizing earlier evidence generation planning to support robust value demonstration, and alignment with national access priorities.
METHODS: A structured review of publicly available national policy updates (issued between 01/01/2025 and 15/06/2025) was conducted across 5 major European markets: the UK, France, Germany, Italy, and Spain. Identified policies were categorized into 5 trends: Pricing & Cost Containment, Access Pathway Updates, Health Technology Assessment (HTA) Processes, Real-World Evidence (RWE), and NHS Service Modernization. Trends are not mutually exclusive to reflect the multidimensional impact of identified policies.
RESULTS: Twenty-three new policies were identified across the UK (n=6), France (n=5), Germany (n=4), Italy (n=4) and Spain (n=4). Pricing & Cost Containment was the most frequent, (47.8%, n=11), followed by NHS Service Modernization (17.4%, n=4), Access Pathway Updates (13.0%, n=3), HTA Processes (13.0%, n=3), and RWE (8.7%, n=2). Germany’s focus is overwhelmingly on pricing, with removal of international reference pricing (IRP) and new rebates policy. Similarly, also the UK and France primarily focus on pricing and cost-containment with half of their policy updates centered on this. In addition, the UK policies are geared towards Access Pathway updates and the RWE use. Italy shows equal distribution across all five trends. Spain is streamlining national HTA process and improving NHS coordination and response capacity.
CONCLUSIONS: First half of 2025 reflects evolving policy landscape characterized by continued focus on pricing reforms, and a shift towards improved HTA processes and access pathways, and the RWE integration. Manufacturers should adopt adaptive launch strategies prioritizing earlier evidence generation planning to support robust value demonstration, and alignment with national access priorities.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR101
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Public Spending & National Health Expenditures, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas