The German Institute for Quality and Efficiency in Health Care (IQWiG) examined a new Federal Joint Committee’s (G-BA) dossier with indirect comparisons between Briviact (brivaracetam) and Vimpat (lacosamide) and concluded that the data provided was unsuitable to assess an added benefit in the treatment of epileptic seizures.
Briviact is an anti-seizure therapy that was approved by the FDA in January as an add-on therapy for adult and teens age 16 and older who have epileptic seizures. The drug is believed to work in a unique way in the brain to control seizures, but how it works is unknown.
The IQWiG decided that neither advantages or disadvantages of the Briviact were demonstrated in the outcome categories of mortality and health-related quality of life over Vimpat.
According to the press release, the available data on the morbidity outcomes of in the categories of seizure frequency, 50 percent responder rate, and freedom of seizure raised doubts regarding the equal effectiveness of Briviact when compared to Vimpat.
For seizure frequency, one Vimpat study failed to show a clear advantage or disadvantage of the comparative drug and another study shows a statistical advantage of Vimpat. However, Briviact showed significant favorable effects in the side effect category specifically for serious adverse events like dizziness or eye disorders.
Overall, the institute determined that the indirect comparison did not show any advantage of Briviact over Vimpat.
In May, IQWiG analyzed a dossier assessment and pointed out that not all Briviact studies presented by the manufacturer were relevant for the benefit assessment.
Despite the IQWiG conclusion that the submitted indirect comparison was methodologically better, the institute determined that the studies were insufficiently similar for informative indirect comparisons, not all relevant outcomes had been presented, and the comparator therapies had not been recognizably customized for each patient as demanded by the G-BA.
The most recent submission of the indirect comparison addressed the three points of criticism but treatment in the control arms had not been customized for each patient and did not correspond to the appropriate comparator therapy.
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