LAUSR

INTRODUCTION: Health Technology Assessment (HTA) processes have become a fundamental part in the lifecycle of new medicines. However, their deep relation with national legislation creates ambiguous and controversial results between the European countries. Can they be standardized across Europe? METHODS: Sources of national differences have been identified in timelines, documents, methods, data interpretation, and conclusions. In order to harmonize and standardize HTA cooperation across Europe the European Network for HTA (EUnetHTA) was established. We analyzed guidelines, requirements, and output of EUnetHTA and noted the differences between those guidelines and 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: The comparison between German and European HTAs highlights that although both procedures follow the rules of Evidence-Based Medicine, differences in Body of Evidence, Comparator, Surrogate Endpoints, Subgroups, and Evidence Synthesis may lead to diverging HTA outcomes. The European HTA framework facilitates the appropriate depiction of clinical reality through comprehensive inclusion of the existing evidence with context specific statistical methods. It might become a worldwide platform for HTA evaluation and discussion. CONCLUSIONS: Only the involvement of both, pharmaceutical companies and HTA bodies within a unified European framework can lead to a mature and transparent procedure with a reliable outcome independent of legal requirements.