5EU Q1 2024 versus 2025: Pricing shifts, HTA outcomes, and modern drug developments

To evaluate the affect of pharmaceutical coverage and market dynamics on market entry, GlobalData has carried out a comparative evaluation of Q1 information from 2024 and 2025 throughout the 5 main EU markets (5EU): France, Germany, Italy, Spain, and the UK.

This evaluation focuses on three key indicators: the entry of newly priced modern medicines, well being know-how evaluation (HTA) outcomes within the 5EU, and common worth modifications to modern medicines throughout these two quarters.

Modern product launches in Q1 2024 versus Q1 2025

In Q1 2025, 56 modern (patent-protected) pharmaceutical merchandise have been newly priced throughout the 5EU markets in comparison with 50 in Q1 2024, representing a 12% enhance. The UK accounted for 17 modern launches in Q1 2025, doubling its determine (8) from the identical quarter in 2024. The UK has historically been thought of an early launch and commercially enticing marketplace for new merchandise. Nonetheless, the notably excessive payback charges underneath the Voluntary Scheme for Branded Medicines Pricing and Entry (VPAS) risked deterring builders and making the UK a much less enticing market in 2023–2024.

The Voluntary Scheme for Branded Medicines Pricing, Entry, and Development (VPAG), later launched in 2024, tried to deal with these considerations, with early Q1 2025 information already indicating a optimistic shift. Nonetheless, an unexpectedly excessive payback fee for VPAG members in 2025 could presumably decelerate the amount of launches once more. Different remaining markets within the 5EU maintained a comparatively constant launch quantity.

HTA choices within the 5EU

HTA choices made for branded medicines throughout the 5EU in Q1 2025 have been then in contrast towards Q1 2024. These HTA outcomes are grouped as both optimistic, unfavorable, or impartial. Constructive choices discuss with medicines that qualify for full reimbursement or a extra beneficial pricing process, whereas unfavorable choices point out these which can be rejected for reimbursement. Impartial outcomes particularly embrace circumstances the place reimbursement is restricted to a restricted a part of the inhabitants or the place the pricing process is much less beneficial.

Throughout the 5EU, HTA choices confirmed a slight 8% lower in quantity compared to Q1 2024. In 2025, the overall variety of optimistic choices decreased by 18%, unfavorable choices decreased by 6%, and impartial choices elevated by 22%.

In Q1 of each years, all HTA choices delivered in Germany have been both optimistic or impartial. In Germany, most authorised therapies are usually reimbursed upon market entry as mirrored in these outcomes. Nonetheless, the HTA analysis determines the pricing pathway. A optimistic end result permits for worth negotiations with the Gesetzliche Krankenversicherung (GKV), whereas a impartial end result results in therapeutic reference pricing.

In Spain, 36 choices have been delivered in Q1 2024 and 16 choices in Q1 2025, all optimistic outcomes. This means the biggest year-over-year decline (56%) in optimistic HTA choices in 2025.

In Q1 2025, Italy delivered the best variety of HTA choices out of the 5EU markets, accounting for 27% of all assessments throughout the quarter. Constructive outcomes represented 82% of those choices, barely decrease than the 95% noticed in 2024. In Italy, merchandise are usually excluded from the reimbursement record at launch after which included later as both Class A or Class H merchandise.

France displayed a notable shift in comparison with Q1 2024. Whereas the general variety of HTA choices remained steady between Q1 of 2024 and Q1 2025, the variety of unfavorable choices dropped by 55% in 2025. Traditionally, France has demonstrated a extra conservative stance, with a better proportion of impartial and unfavorable choices typically outweighing the variety of optimistic choices. In actual fact, no optimistic choices have been recorded in Q1 of 2024.

Within the UK, the amount and distribution of HTA choices remained steady, with no main shift. This sample possible displays the construction of the HTA course of within the UK, the place the Nationwide Institute of Well being and Care Excellence (NICE) conducts a extra selective overview course of in comparison with the opposite 4 5EU markets. Nonetheless, it is very important observe that within the absence of a NICE suggestion, entry to a therapy on the Nationwide Well being Service (NHS) is usually restricted. Due to this fact, even when they’re fewer in quantity, the affect of a NICE choice stays important by way of real-world market entry.

Q1 pricing developments throughout the 5EU

Determine 3 (under) compares the variety of modern medicines that obtained worth modifications throughout the 5EU markets in Q1 of each 2024 and 2025. In Q1 2025, this quantity rose by 19.8% compared to Q1 2024. France and Germany took the lead for the best variety of worth modifications, collectively accounting for 91% of the worth modifications in Q1 for each years. Each nations tightly hyperlink costs to their HTA evaluations and assessments. In Germany, the Q1 common worth change development for modern medicines was -7% in 2024, whereas in 2025 it was -10%. In France, on common, costs of those modern medicines declined by -18% and -10% in Q1 2024 and Q1 2025 respectively. Italy noticed its share of variety of common worth modifications of modern medicines develop from 4.5% in Q1 2024 to six.8% in Q1 2025. For UK and Spain, whereas there’s a slight fluctuation within the variety of worth modifications, they seem to have remained comparatively steady. Within the UK, record worth fluctuations are much less pronounced, largely because of the confidential discounting mechanism in place.

Throughout the 5EU, Q1 2025 information presents notable shifts in pricing dynamics, HTA outcomes, and modern drug launches in comparison with 2024. Whereas markets equivalent to Italy present rising HTA exercise with a broad mixture of outcomes, others, equivalent to Spain, look like normalising after excessive exercise within the earlier yr. Moreover, regardless of having setbacks throughout VPAS, the UK is displaying indicators of regaining its market attractiveness.

This text is produced as a part of GlobalData’s Worth Intelligence (POLI) service, the world’s main useful resource for world pharmaceutical pricing, HTA and market entry intelligence built-in with the broader epidemiology, illness, scientific trials and manufacturing experience of GlobalData’s Pharmaceutical Intelligence Middle. Our unparalleled workforce of in-house specialists monitor P&R coverage developments, outcomes and information analytics all over the world daily to provide our purchasers the sting by offering important early warning indicators and insights. For a demo or additional data, please contact us right here.