¹Uppsala University, Uppsala, Sweden
²Turku University, Turku, Finland
³WIdO, Berlin, Germany

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Background: Many therapeutic innovations are biopharmaceuticals, also referred to as biologics. Their applications include a diverse set of therapeutic areas incorporating oncology, rheumatology, endocrinology, dermatology, infectious diseases, and immunology. Biopharmaceuticals offer a number of advantages over synthetic drugs. Complexity in their development and production as well as in their handling are reasons stated for their high prices compared to traditional medicines. Hence, health systems in Europe face clinical and economic challenges with introducing them. As drug expenditure is rising rapidly, outpacing other healthcare expenses, biopharmaceuticals account for a significant portion of this increase. In view of this, payers and health technology assessment agencies are compelled to prioritize and make tough decisions regarding which medicines genuinely offer value for patient care and deliver favourable cost effectiveness, and which do not, to more effectively target scare resources. Joint efforts across Europe are therefore essential to ensure their sustainable and equitable use. However, to date few cross-national comparative studies have assessed their introduction. Our study aimed to assess the availability of health authority data and variation in the early diffusion of biopharmaceuticals across Europe. – This presentation is based on a paper by Veszelei et al. [1].

Materials and Methods: A cross-sectional design was used to assess the availability of health authority data across Europe and to assess the utilization of biopharmaceuticals introduced between 2015 and 2019, in both hospital and out-of-hospital care. For our study, we selected 17 biopharmaceuticals across 7 distinct ATC groups (level 4), reflecting a wide range of therapeutic areas. 17 European countries and 2 regions were able to provide data on biologica administered in-hospital, dispensed out-of-hospital and/or provided by wholesalers for the period 2015 to 2022. A scoring system was implemented to provide a rank for the whole study population regarding their overall biopharmaceutical diffusion for these therapies. Each country was assigned a score that ranged from 1 to 19, reflecting its relative accumulated diffusion across each therapeutic area. The country with the highest diffusion in each graph received the lowest score, while the country with the lowest diffusion received the highest. If two or more countries/regions had identical values, they were given equal scores. The overall rank was determined by summing their scores across all seven therapeutic areas, where a lower total score indicated higher biopharmaceutical diffusion.

Results: Germany and Austria exhibited the highest overall diffusion rates and were ranked 1 and 2, respectively. Norway, Sweden, Iceland, and Denmark similarly demonstrated high diffusion rates, with Norway leading this group. Finland, the last remaining Northern country, positioned itself in the middle of the rankings. Belgium closely followed the rank of the first four Nordic countries. A small gap separates Belgium from Italy, which ranks eighth with higher diffusion than the average study population. In contrast, Catalonia was ranked in the middle, while Scotland was ranked 13^th with lower diffusion rates. Croatia was ranked among the five countries with the lowest diffusion. All central and Eastern European countries, with the exception of Slovenia, displayed low diffusion rates and were consequently ranked below the average rank. The lowest rankings were observed in Slovakia, Lithuania, Romania, and Latvia. When differentiating according to therapeutic group, the Southern European countries and regions Italy and Catalonia, along with Scotland and Croatia, showed varied diffusion rates in the respective therapeutic groups. In contrast, three Western European countries, Austria, Belgium, and Germany, displayed high or medium diffusion rates across all therapy groups, apart from the fixed dose combination of insulin glargine and lixisenatide, as well as follitropin delta. Notable is that in these categories, comparable European countries, by their respective ranking, exhibited inconsistent diffusion patterns. In examining the early diffusion of specific therapies, tildrakizumab demonstrated the lowest level of diffusion, with 12 countries or regions showing no uptake. Follitropin delta had nine countries/regions without any diffusion during the studied period. In contrast, secukinumab and erenumab exhibited the highest diffusion rates, with all countries showing an uptake. For the remaining therapies, the diffusion was widespread, with only one or two countries or regions lacking diffusion on average.

Conclusion: This study is, to the best of our knowledge, the first to investigate the market diffusion of a large number of different premium-priced biopharmaceuticals across Europe using health authority data. By incorporating real-world drug utilization data from 17 European countries and two regions, it reveals variability in the early diffusion of biopharmaceuticals across these nations and regions. The differences are likely attributable to several interlinking and interacting reasons. Among the determinants are market size, strength of economy, price regulation mechanisms, differences in early access, clinical traditions, and prevalence rates. Additionally, the study highlighted substantial challenges in acquiring data from health authorities and considerable differences in the data that were provided for monitoring drug utilization across the included countries/regions. The findings highlight the importance of strengthened collaboration between European countries to support the sustainable, cost-effective, and equitable introduction of biopharmaceuticals, particularly in settings with constrained resources. They also underscore the need for more harmonized data collection and reporting to better understand the disparities in biopharmaceutical diffusion across Europe.

References

[1] Veszelei I, Godman B, Aaltonen K, Selke GW, Garuolienė K, Cangini A, Kurdi A, Teixeira Rodrigues A, Pontes C, Torre C, Lunghi C, Burton E, Poplavska E, Jónsdóttir F, Petrova G, Langner I, Iaru I, Odnoletkova I, Slabý J, Gvozdanović K, Saastomoinen L, Laius O, Benkő R, Žiogaité S, McTaggart S, Müller T, de Pando T, Tesař T, Mitkova Z, Wettermark B. Introduction of Biopharmaceuticals in Europe: A Cross-Sectional Study of Early Diffusion Patterns and Data Availability. BioDrugs. 2025;39:735-751. DOI: 10.1007/s40259-025-00732-2
[2] Vallano A, Pontes C. Escalating costs of innovative medicines: perspective and proposals. Front Public Health. 2024;12:1449707. DOI: 10.3389/fpubh.2024.1449707
[3] European Commission. Pharmaceutical strategy for Europe. 2024.
[4] Kristensen FB, Mäkelä M, Neikter SA, Rehnqvist N, Håheim LL, Mørland B, et al. European Network for Health Technology Assessment, EUnetHTA: planning, development, and implementation of a sustainable European network for health technology assessment. Int J Technol Assess Health Care. 2009;25:107-16. DOI: 10.1017/S0266462309990754