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.

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Glossary entries