The German Federal Joint Committee (G-BA), the decision-making body of the self-governing medical system in Germany, today announced that it considers the additional benefit of Fycompa(R) (perampanel) unproven when compared to two other treatments as defined by the G-BA. 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. Perampanel is the first in an entirely new class of innovative treatment for uncontrolled partial epilepsy with a novel mechanism of action that is different from all other anti-epileptic drugs (AEDs).
Eisai is appalled by the G-BA's ruling. 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. The company believes that the G-BA 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 diligently developed the benefit dossier following scientific advice from the G-BA. In addition, Eisai provided further evidence in a written statement preceding the G-BA Oral Hearing on 29 January 2013, and re-iterated the additional benefit perampanel provides to patients, especially to patients who require new options to help manage their seizures. Eisai maintains that the submitted benefit dossier contains a methodologically robust comparative analysis against the appropriate comparative therapy, lamotrigine, as defined by the G-BA. On the advice of the G-BA, Eisai also performed an indirect analysis using published clinical data for lamotrigine. Eisai strongly believes that it has provided compelling evidence to demonstrate the additional benefit of perampanel.
"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," said Professor Bernhard Steinhoff from Epilepsiezentrum Kork, Kehl-Kork, Germany
Nick Burgin, European Director of Market Access, Eisai added; "We believe 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. 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."
In Germany, approximately one out of 200 people has epilepsy equating to an estimated 400,000 people in the country living with the condition.Epilepsy is one of the most common neurological conditions in the world The successful treatment of partial-onset seizures remains a challenge as over 30% of patients do not achieve seizure freedom despite appropriate therapy with anti-epileptic drugs.
Many of these patients have exhausted other treatment options. The clinical experience with perampanel shows that it reduces the frequency of both complex partial and secondarily generalised in these difficult to treat patients.
Perampanel was first launched in Europe in Germany and the UK in September 2012. It has been well received by both patients and doctors. It is the first and only licensed AED to selectively target AMPA receptors which play a critical role in causing seizures. It blocks the effects of glutamate, which can trigger and maintain seizures.
Perampanel was approved by the European Commission on 23 July 2012. The FDA approved perampanel for use in the US on 22 October 2012. In Europe, it is currently available in the UK, Denmark, Germany, Austria, Sweden, Norway and Switzerland.
The development of perampanel underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families. Eisai is proud to currently market more epilepsy products in Europe than any other company.