INTRODUCTION:National Health Technology Assessments (HTAs) for medical devices are crucial to regulate the quality and costs of healthcare systems. However, there is diversity in several aspects among European countries. Consequently, controversial results might arise, generating contrary reimbursement decisions. The European Network for Health Technology Assessment (EUnetHTA) is an interface platform for the harmonization of HTA information across Europe. The European Commission expects national uptake of a European HTA. Thus, European HTAs might overcome the diversity of national HTA requirements.METHODS:We aimed to compare German and European HTAs for medical devices regarding processes, methods, timelines, and involvement of medical device companies. Therefore we analyzed guidelines, requirements, and output of EUnetHTA and compared those aspects with the German G-BA (Federal Joint Committee, Gemeinsamer Bundesausschuss) standard and IQWiG (Institute for Quality and Efficiency in Health Care, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) methods.RESULTS:We found differences between the European and German HTAs for medical devices regarding timelines, involvement of medical device companies, body of evidence, use of surrogate endpoints, and methodology. European HTAs for medical devices reflect the clinical reality by integrating the existing evidence (including real world data) and by using comprehensive statistical methods for medical devices. In contrast, German HTAs for medical device-based technologies are long lasting and are often restricted to a small body of evidence.CONCLUSIONS:As a conclusion, similar to pharmaceuticals, the European HTA framework might also become a worldwide platform for HTAs of medical device-based technologies with the potential to harmonize reimbursement decisions and patients health care across countries on the basis of clinical reality.
Handling of Medical Devices: Reforms and Regulations
