Health Technology Assessment (HTA)
Many non-European biotech companies have little experience with Health Technology Assessments (HTA). However, an understanding of HTA is helpful if European markets are to be accessed and reimbursement procedures are to be operated.
Tilo Mandry, Director Business Development International of the IGES Group, gives an overview and explains the main features of HTA procedures in Europe.
What is Health Technology Assessment (HTA)?
Health technology assessment (HTA) is the systematic, evidence-based evaluation of medical procedures and technologies with regard to their effects on health care. The scope of the assessment can go beyond the mere medical benefit and also take into account economic, ethical, social and other effects. The assessment is mainly of therapeutic and diagnostic procedures, but complex health care measures can also be subjected to an HTA assessment.
HTA decisions as a basis for reimbursement
In Europe, HTA reports are regularly used as a decision-making tool for the inclusion or rejection of new procedures, technologies or measures in standard medical care. They thus serve as the basis for reimbursement decisions by public healthcare systems.
The role of Health Technology Assessment in Germany
Systematic benefit assessment with consequences for statutory health insurance is in Germany institutionally anchored at the Federal Joint Committee (Gemeinsamer Bundesausschuss (G-BA)) and the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)). A distinction must be made between evaluations of pharmaceuticals (the so-called AMNOG procedure) and of medical diagnostic and treatment procedures (with and without the involvement of medical devices - see in particular Sections 137c, 137e and 137h SGB V). Although none of these procedures are officially referred to as "HTA", the objective and methodology correspond to the definition.
Harmonization of HTA in the European Union
At the European level, the EU Commission is pursuing the goal of extending its diverse harmonization efforts to the preparation of HTAs. After initially promoting exclusively voluntary cooperation between HTA institutions in the EU member states, the EU Commission is now planning mandatory centralization of benefit assessments at the EU level. The EU Commission emphasizes the separation of clinical benefit assessment on the one hand and the assessment of the social (or socio-legal) ethical, economic and other dimensions on the other. Only the clinical evaluation is to be carried out centrally; in particular, the social and economic evaluation is to be carried out by the respective member states, since the social law is the responsibility of the individual EU states themselves.
IGES Pharma provides comprehensive advice on all aspects of HTA in Europe.
If you would like information on this topic and our work in this area, please do not hesitate to contact me.
Dr Tilo Mandry
Lead International Liaison Manager
Tilo Mandry is responsible for international business development at IGES Group. He supports international companies in accessing European markets. Tilo Mandry has many years of experience in the life science and high-tech industry. His main focus is on digital health, innovative drugs for rare diseases and innovative medical technologies. He is a fully qualified lawyer and holds a doctorate in the field of pharmaceutical law (from the Research Center for Pharmaceutical Law at the University of Marburg), as well as a Master of Laws from Vanderbilt University in the USA with a research focus on phamarcogenomics.
Phone: +49 30 230 80 90