Eisai ‘appalled’ by G-BA decision on Fycompa
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.
Eisai ‘appalled’ by German rejection of Fycompa (Pharma Times)
Eisai fires back at G-BA rebuff of Fycompa (Fierce Pharma)
Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.