Investigation of the Process for Generating Evidence for Innovations in Medical Technology

Sammanfattning: Health technology assessment (HTA) is a process that evaluates the value and effects of health technology during its life cycle and provides scientific information to decision makers. However, the chasm between healthcare and innovation has been highlighted in several research areas. HTA as a bridge connecting the research and decision-making demands, achieving more transparent processes and high quality of evidence to enable more effective and safer MedTech innovations to reach and benefit healthcare and patients. This thesis aims to examine the current status of HTA across different countries compared to Sweden to identify the major hurdles and enablers in this process and any opportunities for learning across systems. Germany, the United Kingdom, and Finland are three countries being compared to Sweden in the thesis. A literature review combined with interviews were the main methodologies used for this project. Peer-reviewed literature, government documents, and official websites gave an overview of the HTA systems in selected countries and laid a solid foundation for the more in-depth interviews. Eight interviews (nine interviewees) with HTA agencies and companies were performed via Zoom, along with an email communication(one interviewee) with Fimea. The interviews were used as a support tool to gain a better understanding of the whole HTA system. Some personal opinions were also helpful to gain a view of the system from an alternative, more practical perspective. The results show the different HTA processes and the evidence generation paths in four countries. Views from MedTech companies are also given. The HTA in Sweden has two main pathways: SBU and TLV. These two agencies have particular traits that work differently with distinct purposes. In terms of the evidence generation and assessment methods, they also share different points of view. It is difficult to simply compare these systems in parallel due to the system's complexity and different healthcare conditions in every country. But all countries, including Sweden, should realize the challenges ofthe existing HTA systems, and try to reduce the evidence generation gap between expectation and reality. This would create more opportunities for small MedTech companies to be involved in the process, and actively participate in international HTA cooperation.