Brivaracetam (1) – Briviact®

• Clinical trials
  • The follow-up assessment by the IQWiG (Addendum A16-38) included studies EP0008 and SP755 (in each case, the study arms receiving 400 mg of lacosamide daily) and the brivaracetam study N01254 were included in the indirect comparison.
  • All three studies were placebo-controlled, randomised, double-blind trials.

a) Adjunctive treatment of focal seizures with or without secondary generalisation in adults and adolescents aged 16 years and over with epilepsy

• An additional benefit of brivaracetam is not proven.
• The pharmaceutical manufacturer has not submitted any directly comparative study for the assessment of the additional benefit of brivaracetam compared with the G-BA’s appropriate comparator therapy (individualised adjunctive antiepileptic therapy), as the G-BA’s appropriate comparator therapy was not implemented in any of the studies.
• Taking all the aspects cited into account, the G-BA concludes that the evidence submitted, in particular the indirect comparison, is not suitable for assessing any additional benefit.

Courtesy translation only, please refer to the German original.