Eisai, together with leading doctors and patient groups, are disappointed that the report issued by the Institute for Quality and Efficiency in Health Care (IQWiG) has determined no additional benefit for new generation epilepsy treatment Fycompa (perampanel), when compared to conventional antiepileptic drugs (AEDs) as defined by the Federal Joint Committee (G-BA).[1]
It is expected that the G-BA will publish their decision after due and balancedconsideration of all relevant aspects of the IQWiG report, written statements and oral hearing, in November 2014. Eisai is confident that the G-BA will take a more flexible, patient-oriented approach to their decision making process which considers both the evidence of perampanel's clinical benefit and the needs of people with poorly controlled epilepsy. Perampanel was approved by the European Commission in 2012 and is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.[2]
"The report by IQWiG has neglected to take into account the German people with epilepsy who already experience an additional benefit with Fycompa. Considerable real world experience data is available in Germany, and I have personally witnessed and published about the additional benefit this treatment can bring to people with refractory epilepsy," commented Professor Bernhard Steinhoff from Epilepsiezentrum Kork, Kehl-Kork, Germany.
The IQWiG assessment concludes that Eisai deviated from the appropriate comparative therapy as defined by the G-BA. The assessment does not include a statement with regard to perampanel's proven clinical efficacy and safety, as demonstrated by the studies submitted to the G-BA and used for the EU approval of perampanel in September 2012.[2]
The efficacy and safety of adjunctive perampanel in the treatment of partial onset seizures in real world clinical practice is investigated in a multi-centre, six-month observational study from nine epilepsy centres in Germany and Austria.[3] Half of the 281 people with highly refractory epilepsy who took part in the study experienced at least a 50% reduction in seizure frequency and up to 15% became seizure free with adjunctive perampanel.[3] Fycompa is approved in more than 35 countries worldwide.
"IQWiG has yet again failed to acknowledge the benefit of Fycompa based purely on methodological, rather than clinical considerations. Patients are our first concern and we feel that this new report has again ignored the over 4,000 people with epilepsy in Germany who have already benefitted from Fycompa. We remain confident that the G-BA will take a broader perspective which recognises that additional adjunctive treatment options for people with epilepsy are always needed," commented Gary Hendler, President & CEO, Eisai EMEA.
"It is becoming more and more recognised that treatments in epilepsy have to be individually tailored. Even though we do not understand how to predict who will benefit from a given medication, access to the full complement of new medicines that may help is of crucial importance for the future. This is particularly relevant given the relatively high percentage of people that remain refractory to treatment. It is worrying that IQWiG do not recognise this aspect, which is particularly relevant for etiologically complex CNS diseases, in particular epilepsy," added Professor Heinz Beck, President of the German Society of Epileptology (DGfE).
Epilepsy is one of the most common neurological conditions in the world[4] and over half a million people in Germany live with the condition.[5] The successful treatment of partial onset seizures remains a challenge; up to a third of people with epilepsy do not achieve seizure freedom despite appropriate therapy with AEDs.[6]
Perampanel is the first and only licensed AED to selectively target AMPA receptors which play a critical role in causing seizures.[7]Eisai is committed to the therapeutic area of epilepsy and to addressing the unmet medical needs of people with epilepsy and their families, an integral part of our human health care (hhc) mission. Eisai is proud to currently market more epilepsy products in EMEA than any other company.
Notes to Editors
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Eisai Outraged at IQWiG Failure to Recognise Additional Benefit of Innovative Partial Epilepsy Treatment Fycompa ...