Eisai ‘appalled’ by G-BA decision on Fycompa

Rebecca Aris

pharmaphorum

Japanese pharmaceutical company, Eisai has announced that it is ‘appalled’ by the ruling of The German Federal Joint Committee (G-BA) that the benefits of the antiepileptic treatment, Fycompa, are unproven.

In a press release, Eisai announced that it believes that the German reimbursement regulatory body "failed to adequately interpret the proven patient-relevant benefits substantiated in the submitted benefit dossier and to responsibly recognise the innovative nature of the new drug in a clinical setting with a highly unmet medical need".

This followed the G-BA’s announcement that it considers the additional benefit of Fycompa (perampanel) unproven when compared to two other treatments Lamicta (lamotrigine), and Topamax (topiramate).

“I cannot understand the decision by the G-BA, from my personal clinical experience, it is definitely certain that perampanel provides additional benefit for patients with partial onset seizures. I can see this additional benefit in my clinical practice every day. There are still a large number of patients requiring new and innovative treatments like perampanel to help them manage their seizures.”

Professor Bernhard Steinhoff from Epilepsiezentrum Kork, Kehl-Kork, Germany

The decision by the G-BA follows the German Institute for Quality and Efficiency in Health Care (IQWiG) assessment, published late last year, which reported that the benefit of Fycompa is unproven based on methodological grounds.