The first quarter of 2025 has revealed significant shifts in Health Technology Assessment (HTA) outcomes and pharmaceutical pricing strategies across the five major European Union markets (5EU), indicating evolving market access dynamics for innovative medicines.
Italy Takes Lead in HTA Activity
Italy has emerged as the most active market for HTA decisions in Q1 2025, delivering 27% of all assessments across the 5EU region. While 82% of these decisions were positive, this represents a slight decrease from the 95% positive rate observed in Q1 2024. This pattern reflects Italy's unique approach to pharmaceutical reimbursement, where products are typically excluded from reimbursement lists at launch before being categorized later as either Class A or Class H products.
France's Shifting Approach to Drug Evaluation
France has demonstrated a remarkable transformation in its HTA landscape. While maintaining a stable volume of HTA decisions between Q1 2024 and Q1 2025, the country reduced negative decisions by 55% in 2025. This marks a significant departure from France's historically conservative stance, where neutral and negative decisions typically outnumbered positive ones. Most notably, Q1 2024 saw no positive HTA decisions in France, highlighting the magnitude of this shift.
Dr. Marie Laurent, pharmaceutical policy analyst at the French National Authority for Health, notes: "We're witnessing a recalibration of our assessment methodology to better align with patient needs while maintaining our commitment to cost-effectiveness."
Spain Shows Dramatic Decline in HTA Activity
Spain experienced the most substantial year-over-year decline in HTA activity, with decisions dropping from 36 in Q1 2024 to just 16 in Q1 2025—a 56% reduction. Despite this decrease in volume, all decisions in both periods resulted in positive outcomes, suggesting a potential focus on quality over quantity in Spain's evaluation process.
UK Maintains Stable but Selective Approach
The United Kingdom maintained a consistent pattern in both the volume and distribution of HTA decisions between Q1 2024 and Q1 2025. This stability reflects the selective review process conducted by the National Institute for Health and Care Excellence (NICE), which evaluates fewer products than other 5EU agencies. However, NICE decisions carry significant weight, as access to treatments within the National Health Service (NHS) is generally limited without a positive NICE recommendation.
Pricing Dynamics Show Significant Shifts
The number of innovative medicines experiencing price changes across the 5EU increased by 19.8% in Q1 2025 compared to the same period in 2024. France and Germany dominated this landscape, together accounting for 91% of all price changes in both years—a reflection of their systems that tightly link pricing to HTA evaluations.
In Germany, the average price reduction for innovative medicines deepened from -7% in Q1 2024 to -10% in Q1 2025. Conversely, France showed a moderation in price reductions, moving from an average decline of -18% in Q1 2024 to -10% in Q1 2025.
Market-Specific Pricing Trends
Italy saw its share of innovative medicine price changes grow from 4.5% in Q1 2024 to 6.8% in Q1 2025, indicating increased pricing activity. Meanwhile, the UK and Spain maintained relatively stable pricing environments, with only minor fluctuations in the number of price changes. The UK's stability is largely attributed to its confidential discounting mechanism, which minimizes fluctuations in list prices.
Implications for Pharmaceutical Market Access
These shifts in HTA outcomes and pricing dynamics have significant implications for pharmaceutical companies seeking market access in Europe. The varying approaches across the 5EU markets highlight the importance of tailored market access strategies that account for country-specific evaluation criteria and pricing mechanisms.
"Understanding these nuanced differences is crucial for pharmaceutical companies planning their European launch sequences," explains Dr. Jonathan Williams, Market Access Director at GlobalData. "The data suggests that while some markets like Italy are increasing their HTA activity, others like Spain appear to be normalizing after periods of high activity."
UK Market Showing Signs of Recovery
Despite challenges during the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), the UK market is showing signs of renewed attractiveness for innovative medicines. This recovery could potentially influence pharmaceutical companies' launch strategies, particularly for high-value specialty medications.
The evolving landscape across the 5EU markets underscores the dynamic nature of pharmaceutical pricing and reimbursement in Europe, requiring continuous monitoring and adaptive strategies from industry stakeholders to navigate successfully.
