Eisai 'dismayed' by G-BA decision on Fycompa

Japanese drug major Eisai (TYO: 4523) has expressed “utmost disappointment” that the German Federal Joint Committee (G-BA) has decided that the additional benefit for its new generation anti-epileptic drug (AED) Fycompa (perampanel) has not been proven, when compared to conventional AEDs as defined by the G-BA.

The GBA decision comes after two previous negative reviews by the German Institute for Quality and Efficiency in Healthcare, IQWiG, (The Pharma Letter August 17). At that time, the company said it is expected that the G-BA will publish its decision after due and balanced consideration of all relevant aspects of the IQWiG report, written statements and oral hearing.

The decision, based on methodological rather than clinical considerations, ignores the demands of the German Epilepsy Association (DE) and other epilepsy patient advocacy groups to recognise the additional benefit seen in practical applications as well as in studies. The decision also ignores the recommendations of the German Society of Epileptology (DGfE) to assess the additional benefit of new AEDs, says Eisai.