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.