Importance of approval status for the benefit assessment

The therapeutic indication a drug is approved for does not always correspond to the approval studies actually conducted. This can pose a problem - particularly for the early benefit assessment according to AMNOG - for IQWiG and the G-BA as well as for the drug manufacturers.

There are two main reasons when the approval population deviates from the study population: On the one hand, the approval studies themselves may have provided indications that a positive benefit-risk relation exists only for a subgroup of the patients examined. It is then only necessary to analyse subgroups of the approval studies - also in order not to provide a false negative assessment of the new drug. On the other hand, general reservations of the regulatory authority concerning certain therapeutic indications can lead to the regulation that a new drug is not to be widely used, but only in selected areas, e.g. as second- or third-line therapy. However, adequate subgroup analyses might not be possible in these cases because the drug was not tested as second- or third-line therapy in studies. This is a dilemma both for the manufacturer and the institutions conducting the assessment.

Presentations and discussions during this year's "IQWiG in dialogue" will explore the reasons for these discrepancies and ways of avoiding them or dealing with them appropriately.

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Glossary entries