German Federal Joint Committee decides additional benefit of Fycompa (Eisai) unproven as a treatment for Epilepsy
The German Federal Joint Committee (G-BA), the decision-making body of the self-governing medical system in Germany, has announced that it considers the additional benefit of Fycompa (perampanel) unproven when compared to two other treatments. Perampanel is indicated as an adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.
This decision follows the German Institute for Quality and Efficiency in Health Care (IQWiG) assessment, published 17 December 2012 which reported that the benefit of perampanel is unproven based on methodological grounds. Perampanel was approved by the European Commission on 23 July 2012. The FDA approved perampanel for use in the US on 22 October 2012.
Eisai were "appalled" at the German ruling that the additional benefit of Fycompa is unproven compared to current treatments, Lamictal and Topamax.
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