Brivaracetam (trade name: Briviact) has been approved since January 2016 as add-on therapy for adolescents from the age of 16 years and adults with epileptic seizures. The German Institute for Quality and Efficiency in Health Care (IQWiG) now examined in an early benefit assessment whether this drug offers an added benefit for patients in comparison with the appropriate comparator therapy.

The drug manufacturer presented no data from a study of direct comparison, and the indirect comparisons conducted in its dossier were unsuitable for the derivation of an added benefit for several reasons. IQWiG therefore sees no hint of an added benefit of brivaracetam in comparison with the appropriate comparator therapy.

The appropriate comparator therapy specified by the Federal Joint Committee (G-BA) was an individual antiepileptic add-on therapy, which can consist of one of ten drugs named by the G-BA depending on subindication, resistances or intolerances.

In its dossier, the manufacturer limited itself to the two antiepileptic drugs lacosamide and eslicarbazepine without showing that these constituted the add-on therapy customized for the individual patient in each case.

Irrespective of the question whether or not lacosamide and eslicarbazepine were the therapy customized for the individual patient in the studies presented by the manufacturer, IQWiG investigated the data presented in the dossier for their suitability for a benefit assessment. It concluded that the indirect comparisons conducted by the company on the basis of 15 studies on the three drugs were not evaluable.

In some cases, the studies themselves were irrelevant for the comparisons, for example because brivaracetam was not titrated for the individual patient as recommended in the Summary of Product Characteristics, or because the studies were too short. In some cases, the studies compared were not sufficiently similar. Moreover, the comparisons were incomplete because the manufacturer did not present analyses on patient-relevant outcomes.

Since no suitable data were available, an added benefit of brivaracetam is not proven.

The dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.

An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the Website gesundheitsinformation.de, published by IQWiG, provides easily understandable German-language information.More English-language information will be available soon (Sections 2.1 to 2.6 of the dossier assessment as well as subsequently published health information on informedhealth.org).

If you would like to be informed when these documents are available, please send an e-mail to info@iqwig.de.