The White Paper is focused on providing a brief description of the health technology assessment (HTA) framework for medical technologies in individual European countries and showcasing trends in Med Tech HTA in individual EU countries. The level of activity was determined by reviewing the number of non-pharmaceutical assessments performed (or published) over a 10-year period (2015–2024). In total, HTAs were collected from four EU countries - England, Germany, Italy, and Spain. The largest number of reports was published in Spain (397 reports, 35.4%) and England (391 reports, 34.8%).
Building on this dataset, the White Paper highlights how the structure, methods, and decision-making roles of national HTA agencies differ across countries, and how these differences influence the evaluation of medical technologies. It also identifies clear trends across Europe, including growing attention to digital health, more frequent assessments of minimally invasive and high-risk technologies, and increasing expectations for robust clinical and economic evidence. These insights help illustrate how HTA activity is evolving and what this means for market access strategies within the EU.
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