Abstract

Objectives: Biopharmaceuticals add value in the treatment of many diseases but different health systems in Europe face clinical and economic challenges with introducing them. 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. This study aimed to assess the availability of health authority data and variation in the early diffusion of biophar-maceuticals across Europe. Methods: A cross-sectional study was undertaken to analyze the diffusion of 17 biopharmaceu-ticals, approved between 2015 and 2019, among European countries between 2015 and 2022. The study assessed data availability, diffusion rates measured as accumulated Defined Daily Doses per 1,000 inhabitants, as well as relative rankings between countries during the first four years following market authorization. Results: Twenty countries and two regions out of 31 European countries provided data on bio-pharmaceutical utilization for out-of-hospital care, 15 provided wholesaler data, and 14 provided hospital data. Certain countries and regions contributed data in multiple categories, while 6 did not provide any data. Diffusion rates were assessed for 17 countries and two regions, which showed appreciable variation, with secukinumab and erenumab being introduced in most and fol-litropin delta and tildrakizumab in the least number of countries. Germany, Austria, and Norway demonstrated the highest early diffusion rates, while Lithuania, Romania and Latvia had the low-est. Conclusion: This study revealed a substantial variation between European countries and regions in the early diffusion of biopharmaceuticals and the availability of data to monitor their use. The reasons behind these patterns require further investigation to support European countries in op-timizing the use of biopharmaceuticals to reach an equitable and cost-effective use of medicines across Europe.