Eisai has expressed its outrage at the German reimbursement regulatory body's ruling that the benefits of the Japan-headquartered firm's first-in-class antiepileptic Fycompa are unproven.

The German Federal Joint Committee (G-BA) has announced that it considers the additional benefit of Fycompa (perampanel) unproven when compared to two other treatments - GlaxoSmithKline's Lamicta (lamotrigine), which was the principal comparator, and Johnson & Johnson's Topamax (topiramate). The decision follows the German Institute for Quality and Efficiency in Health Care (IQWiG) assessment, published at the end of last year, which reported that the benefit of Fycompa is unproven based on methodological grounds.

Fycompa is indicated as an adjunctive treatment of partial-onset seizures in patients with epilepsy aged 12 and older. Eisai notes that it is the first in an entirely new class of innovative treatment for uncontrolled partial epilepsy with a novel mechanism of action.

The company said it is "appalled by the G-BA's ruling" and believes that the latter "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".

Eisai goes on to say that it "diligently developed the benefit dossier following scientific advice from the G-BA" and provided further evidence  preceding the latter's oral hearing on January 29 this year. The firm maintains that the information sent "contains a methodologically robust comparative analysis" against Lamictal and on the advice of the G-BA, Eisai also performed an indirect analysis using published clinical data for the GSK drug.

Nick Burgin, European director of market access at Eisai, said the G-BA decision "failed to take into account the patient need for new innovative treatments. Further they did not acknowledge the patient-value of perampanel that was demonstrated in the comprehensive analyses submitted".

He added that "this is a clear example where this process of evaluation does not reflect the additional patient benefit seen in clinical experience in an area of high unmet need". Eisai also quoted Bernhard Steinhoff from the Epilepsiezentrum Kork in Germany, who said "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".

In Germany, 400,000 people are living with epilepsy but over 30% of patients do not achieve seizure freedom despite appropriate therapy with anti-epileptic drugs. Eisai notes that the clinical experience with perampanel shows that it reduces the frequency of both complex partial and secondarily generalised in these difficult to treat patients.

Fycompa, which was first launched in Germany and the UK in September 2012, "has been well received by both patients and doctors", the company concludes. It is the only licensed AED to selectively target AMPA receptors which play a critical role in causing seizures as it blocks the effects of glutamate, which can trigger and maintain seizures.