Eisai Outraged at IQWiG Failure to Recognise Additional Benefit of Innovative Partial Epilepsy Treatment Fycompa® (Perampanel)

HATFIELD, England, August 15, 2014 /PRNewswire/ --

Institute for Quality and Efficiency in Health Care (IQWiG) report ignores thousands of people with epilepsy in Germany who have already benefited from the first-in-class antiepileptic drug 

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 balanced consideration 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 

About Fycompa^® (perampanel) 

Perampanel 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]

Perampanel is a highly selective, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist that has demonstrated seizure reduction in Phase II and III studies. AMPA receptors, widely present in almost all excitatory neurons, transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain and are believed to play a role in central nervous system diseases characterised by excess neuroexcitatory signalling including epilepsy.^[2]

Further information for healthcare professionals can be found at http://www.fycompa.eu  

About Perampanel in Germany 

The first multicentre, real world experiences with perampanel in a larger series of consecutive patients with difficult-to-treat epilepsy from nine specialised hospitals in Germany (seven centers) and Austria (two centers) have been published in Epilepsy Research.^[3] Patients (54% female, mean age 39 years) were followed up for treatment outcome for a minimum of six months. In half of the 281 patients included, who received perampanel mostly as add-on to a baseline therapy consisting of two or three AEDs (65%), seizure frequency was reduced by at least 50%. Seizure freedom was achieved in 15% of patients. Adverse events were reported by 52% of patients, with somnolence (24.6%) and dizziness (19.6%) being most frequently reported. The retention rate after six months was 60%. The mean perampanel dosage was 7.7 mg. In some patients, a marked response could be observed at relatively low dosages.

About Perampanel in PGTC

Eisai has a continued commitment to Fycompa and the undertaking of new research. This has been shown by results announced last month for a Phase III study for perampanel in the adjunctive treatment of primary generalised tonic-clonic seizures (PGTC) which demonstrate that the AED significantly reduced PGTC seizure frequency and improved responder rates (≥50% reduction in seizure frequency per 28 days in the maintenance period, relative to baseline), the study's two primary outcome measures, when compared to placebo.^[8] Eisai will submit an application to the European Commission in 2014 for an indication expansion for perampanel to include the adjunctive treatment of PGTC seizures in people with epilepsy.  

About Epilepsy  

Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe, and an estimated 50 million people worldwide.^[9],[10] Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity which cause seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.

About Eisai EMEA in Epilepsy  

Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. The development of AEDs is a major strategic area for Eisai in Europe, the Middle East, Africa, Russia and Oceania (EMEA).

In the EMEA region, Eisai currently has four marketed treatments including:

• Fycompa^® (perampanel) for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older
• Inovelon^® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients ≥4 years. (Rufinamide was originally developed by Novartis)
• Zebinix^® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
• Zonegran^® (zonisamide) as monotherapy in adults and adjunctive therapy in adults, adolescents and children aged six years and above with partial onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator Dainippon Sumitomo Pharma)

About Eisai  

Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and we define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc).

Eisai concentrates its R&D activities in three key areas:

• Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight management
• Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc.
• Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, the Middle East, the Netherlands, Norway, Portugal, Russia, Slovakia, Spain, Switzerland, Sweden, and the United Kingdom.

For further information please visit our web site: http://www.eisai.co.uk

References 

1. IQWiG Assessment dossier. Available at: https://www.iqwig.de/download/A14-16_Perampanel_Nutzenbewertung-35a-SGB-V.pdf (accessed August 2014)

2. SPC Fycompa (updated November 2013). Available at: http://www.medicines.org.uk/emc/medicine/26951/ (accessed July 2014) 

3. Steinhoff BJ et al. A multicentre survey of clinical experiences with perampanel in real life in Germany and Austria. Epilepsy Res 2014:108(5):986-988 

4. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at: http://www.ilae-epilepsy.org/Visitors/Documents/EUROReport160510.pdf (accessed July 2014)  

5. Pfäfflin, M. Epidemiologie der Epilepsien. Available at: http://www.izepilepsie.de/home/showdoc.id.387.aid.4163.html (accessed July 2014) 

6. Schmidt D. Drug treatment of epilepsy: options and limitations. Epilepsy & Behavior 2009:15:56-65 

7. Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Currents 2011:11:56-63 

8. Data on file, Eisai Co. Ltd. 

9. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (accessed July 2014) 

10. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007:48(12):2224-2233.

Date of preparation: August 2014 

Job code: Perampanel-UK2170