IQWiG again turns down Eisai’s epilepsy drug Fycompa

The German Institute for Quality and Efficiency in Healthcare (IQWiG) has said that epilepsy drug Fycompa (perampanel) from Japanese drug major Eisai (TYO: 4523) provides "no additional benefit" over appropriate comparators to treat partial onset seizures, with or without secondarily generalized seizures, in patients with epilepsy aged 12 years and older.

In a press release headlined that Eisai is “outraged” at the failure of the IQWiG to recognize the additional benefits of its epilepsy treatment, it stated that Eisai, together with leading doctors and patient groups, are disappointed that the report issued by the Institute has determined no additional benefit for new generation epilepsy treatment Fycompa, when compared to conventional antiepileptic drugs as defined by the Federal Joint Committee (G-BA), which makes the final decision on whether drugs can be reimbursed in Germany.

The company said it is expected that the G-BA will publish its 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 generalized seizures, in patients with epilepsy aged 12 years and older.