To assess the impact of pharmaceutical policy and market dynamics on market access, GlobalData has conducted a comparative analysis of Q1 data from 2024 and 2025 across the five major EU markets (5EU): France, Germany, Italy, Spain, and the UK.
This analysis focuses on three key indicators: the entry of newly priced innovative medicines, health technology assessment (HTA) outcomes in the 5EU, and average price changes to innovative medicines during these two quarters.
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Innovative product launches in Q1 2024 versus Q1 2025
In Q1 2025, 56 innovative (patent-protected) pharmaceutical products were newly priced across the 5EU markets compared to 50 in Q1 2024, representing a 12% increase. The UK accounted for 17 innovative launches in Q1 2025, doubling its figure (8) from the same quarter in 2024. The UK has traditionally been considered an early launch and commercially attractive market for new products. However, the notably high payback rates under the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) risked deterring developers and making the UK a less attractive market in 2023–2024.
The Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG), later introduced in 2024, tried to address these concerns, with early Q1 2025 data already indicating a positive shift. However, an unexpectedly high payback rate for VPAG members in 2025 may possibly slow down the volume of launches again. Other remaining markets in the 5EU maintained a relatively consistent launch volume.
HTA decisions in the 5EU
HTA decisions made for branded medicines across the 5EU in Q1 2025 were then compared against Q1 2024. These HTA outcomes are grouped as either positive, negative, or neutral. Positive decisions refer to medicines that qualify for full reimbursement or a more favourable pricing procedure, while negative decisions indicate those that are rejected for reimbursement. Neutral outcomes specifically include cases where reimbursement is limited to a restricted part of the population or where the pricing procedure is less favourable.
Across the 5EU, HTA decisions showed a slight 8% decrease in volume in comparison to Q1 2024. In 2025, the total number of positive decisions decreased by 18%, negative decisions decreased by 6%, and neutral decisions increased by 22%.
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By GlobalDataIn Q1 of both years, all HTA decisions delivered in Germany were either positive or neutral. In Germany, most approved treatments are typically reimbursed upon market entry as reflected in these outcomes. However, the HTA evaluation determines the pricing pathway. A positive outcome allows for price negotiations with the Gesetzliche Krankenversicherung (GKV), while a neutral outcome leads to therapeutic reference pricing.
In Spain, 36 decisions were delivered in Q1 2024 and 16 decisions in Q1 2025, all positive outcomes. This indicates the largest year-over-year decline (56%) in positive HTA decisions in 2025.
In Q1 2025, Italy delivered the highest number of HTA decisions out of the 5EU markets, accounting for 27% of all assessments during the quarter. Positive outcomes represented 82% of these decisions, slightly lower than the 95% observed in 2024. In Italy, products are typically excluded from the reimbursement list at launch and then included later as either Class A or Class H products.
France displayed a notable shift compared to Q1 2024. While the overall number of HTA decisions remained stable between Q1 of 2024 and Q1 2025, the number of negative decisions dropped by 55% in 2025. Historically, France has demonstrated a more conservative stance, with a higher proportion of neutral and negative decisions often outweighing the number of positive decisions. In fact, no positive decisions were recorded in Q1 of 2024.
In the UK, the volume and distribution of HTA decisions remained stable, with no major shift. This pattern likely reflects the structure of the HTA process in the UK, where the National Institute of Health and Care Excellence (NICE) conducts a more selective review process compared to the other four 5EU markets. However, it is important to note that in the absence of a NICE recommendation, access to a treatment on the National Health Service (NHS) is generally limited. Therefore, even if they are fewer in number, the impact of a NICE decision remains significant in terms of real-world market access.
Q1 pricing trends across the 5EU
Figure 3 (below) compares the number of innovative medicines that received price changes across the 5EU markets in Q1 of both 2024 and 2025. In Q1 2025, this number rose by 19.8% in comparison to Q1 2024. France and Germany took the lead for the greatest number of price changes, together accounting for 91% of the price changes in Q1 for both years. Both countries tightly link prices to their HTA evaluations and assessments. In Germany, the Q1 average price change trend for innovative medicines was -7% in 2024, while in 2025 it was -10%. In France, on average, prices of these innovative medicines declined by -18% and -10% in Q1 2024 and Q1 2025 respectively. Italy saw its share of number of average price changes of innovative medicines grow from 4.5% in Q1 2024 to 6.8% in Q1 2025. For UK and Spain, while there is a slight fluctuation in the number of price changes, they appear to have remained relatively stable. In the UK, list price fluctuations are less pronounced, largely due to the confidential discounting mechanism in place.
Across the 5EU, Q1 2025 data presents notable shifts in pricing dynamics, HTA outcomes, and innovative drug launches compared to 2024. While markets such as Italy show rising HTA activity with a broad mix of outcomes, others, such as Spain, appear to be normalising after high activity in the previous year. Additionally, despite having setbacks during VPAS, the UK is showing signs of regaining its market attractiveness.
This article is produced as part of GlobalData’s Price Intelligence (POLI) service, the world’s leading resource for global pharmaceutical pricing, HTA and market access intelligence integrated with the broader epidemiology, disease, clinical trials and manufacturing expertise of GlobalData’s Pharmaceutical Intelligence Center. Our unparalleled team of in-house experts monitor P&R policy developments, outcomes and data analytics around the world every day to give our clients the edge by providing critical early warning signals and insights. For a demo or further information, please contact us here.
