Abstract The path to patient access post-market approval is anything but straightforward. While some medications seamlessly find their way to those in need, others encounter significant obstacles. Biopharmaceuticals offer benefits in the treatment of many diseases. However, the adoption of these new biological medicines varies widely across European countries in view of often high costs. Despite the significant growth in approvals and economic expansion observed in the biopharmaceutical market, there are few cross-national comparative studies focused on the utilization of biologics to provide future guidance. Objective The study aimed to better understand the disparities in the early diffusion of new biologics across Europe. The research questions included identifying the extent of data availability and variations in the early diffusion of biopharmaceuticals across European countries, as well as investigating macro-level factors influencing their early diffusion. Methods A cross-sectional study was undertaken to analyze the diffusion patterns of 17 biopharmaceuticals, approved between 2015 and 2019, across European countries between 2015 and 2022. The study addressed data availability, diffusion rates, measured with Defined Daily Doses per 1000 population and relative rankings between countries to assess the early diffusion over the initial four years following market authorization. Additionally, macro-level factors influencing early diffusion were identified by meetings with policy researchers and experts. Results Data availability varied, 12 out of 29 countries provided complete data on inpatient and outpatient care, 10 provided limited data, and 7 provided no data. The introduction patterns varied between medicines, with Tildrakizumab and Follitropin delta being introduced in the least number of countries. Germany, Norway, Denmark, and Sweden demonstrated the highest early diffusion rates, while Estonia, Scotland, Romania, and Lithuania had the lowest. Three major categories of macro-level factors were identified, the country's healthcare system, its health technology assessment of new medicines and early awareness, each with associated feasible analytical comparative metrics to provide future guidance. Conclusions This study revealed significant variability in the early diffusion of biopharmaceuticals and inconsistent data availability between European countries. The study also provided a valuable framework for further research on the key macro-level factors influencing biopharmaceutical introduction, aiming to enhance accessibility and efficiency in Europe's biopharmaceutical healthcare landscape.
| Identifer | oai:union.ndltd.org:UPSALLA1/oai:DiVA.org:uu-533361 |
| Date | January 2024 |
| Creators | Veszelei, Ivar |
| Publisher | Uppsala universitet, Institutionen för farmaci |
| Source Sets | DiVA Archive at Upsalla University |
| Language | English |
| Detected Language | English |
| Type | Student thesis, info:eu-repo/semantics/bachelorThesis, text |
| Format | application/pdf |
| Rights | info:eu-repo/semantics/openAccess |
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