The new decision is expected to be published within six months.
In Germany approximately 3,000 and 4,000 people with epilepsy have been treated with Fycompa since its launch in September 2012. Eisai temporarily suspended Fycompa from distribution in Germany following the previous negative G-BA ruling in March 2013 and established a patient access program for continued supply of Fycompa free of charge to German pharmacies through individual import to ensure that people with epilepsy continue to receive treatment with Fycompa, while the G-BA considers the resubmission.
In Germany, approximately one in every 200 people has epilepsy, which equates to an estimated 400,000 people in the country who live with the condition. The successful treatment of partial-onset seizures remains a challenge as over 30% of patients do not achieve adequate seizure control despite appropriate therapy with existing AEDs, and there continues to be a pressing need for innovative new treatments.
Fycompa was approved in over 35 countries in Europe, North America and Asia as an adjunctive treatment for partial-onset seizures (including secondarily generalized seizures) in patients with epilepsy aged 12 years and older.
Eisai believes that through this reassessment of additional benefit, Fycompa will be recognized appropriately for its benefits as well as being an innovative new treatment, and that sales of the drug will be resumed in Germany, ensuring delivery to patients with partial-onset seizures.