IQWiG in Dialogue 2015
„How confirmatory is HTA?“
The following question commonly arises in the process of approval decisions on new drugs and subsequent decisions on their (added) benefit determined in benefit assessments: Are the fundamental principles on the basis of which these decisions are made comparable at all?
Specifically planned confirmatory studies are required for the approval of a new drug. In contrast, following the principles of evidence-based medicine, benefit assessments use data already available. The presentations and discussions at this year’s IQWiG in Dialogue address the question as to what extent HTA decisions can be of a confirmatory nature and to what extent such a demand can be meaningful at all.
- Introduction Prof. Dr. Ralf Bender (IQWiG)
- HTA meets EMA – Methodological areas of debate from an industry point of view Dr. Claudia Nicolay (Eli Lilly) & Friedhelm Leverkus (Pfizer)
- The regulatory process between confirmatory studies and benefit-risk assessment Dr. Jan Müller-Berghaus (Paul-Ehrlich-Institut, PEI)
- Decision strategies in approval and benefit assessment from a biometric point of view Prof. Dr. Armin Koch & Yvonne Ziert (Hannover Medical School)
- How reliable are HTA decisions based on single RCTs? Prof. Dr. Gerald Gartlehner (Danube University Krems, Austria)
- Summary PD Dr. Stefan Lange (IQWiG)