Eisai has resubmitted Fycompa (perampanel) to the German Federal Joint Committee (G-BA) as it continues its bid to secure favourable pricing terms for the first-in-class epilepsy drug.
The G-BA last year concluded the drug provided no additional benefit over existing treatments for epilepsy and so could only be reimbursed if it was priced at the same level as cheap generic drugs.
This prompted Eisai to suspend distribution of Fycompa in Germany, with the exception of an access programme managed by Clinigen for individual patients, until a favourable resolution can be reached.
In February Eisai was granted permission to make an early resubmission to the G-BA for an assessment of Fycompa’s ‘additional therapeutic benefit’, and now that it has done so a new decision is expected within six months.
Gary Hendler, president and CEO at Eisai EMEA, said: “We firmly believe that innovative treatment options are desperately needed for people with this serious condition and believe that the G-BA will reconsider its original position and not effectively deny very ill patients the clinical benefit that Fycompa offers people with partial epilepsy again.”
Part of the back up for its latest attempt to secure a positive G-BA decision comes from a new observational study of Fycompa. Involving specialised hospitals in Germany and Austria the multicenter survey of clinical experiences with perampanel found that half of patients who received Fycompa reduced the frequency of their seizures by 50 per cent.
Fycompa was approved in Europe in 2012 for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older.
Fycompa is the first and only approved anti-epileptic drug in Europe with a mode of action that selectively targets the AMPA receptors thought to play a central role in seizure generation and spread.
Meanwhile, Eisai’s rolling launch programme for Fycompa in Europe continues. The drug, which first reached the Europe market via its UK launch in 2012, has just made its market debut in the Netherlands following the drug’s reimbursement approval there.