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Eisai lines-up Fycompa access programme for Germany

But sales suspension for epilepsy drug will continue

Eisai epilepsy drug Fycompa (perampanel) 

Two and a half months after suspending sales of Fycompa in Germany, and with no pricing settlement in sight, Eisai has set up an access programme to ensure patients can still receive the drug.

The pharma company halted distribution of its new epilepsy treatment in June after the German Federal Joint Committee (G-BA) declined to recommend the drug for reimbursement and demanded new trial data.

Now Eisai has partnered with Clinigen Global Access Programs (GAP) on a named patient access programme that it said “ensures continued supply of anti-epilepsy treatment at no cost to the German healthcare system”.

Gary Hendler, president and CEO of Eisai EMEA, said: "We deeply regret the need to take the difficult decision to suspend Fycompa from commercial distribution in Germany.

“For this reason, Eisai has partnered with a specialist provider, Clinigen GAP, to put a patient access programme in place, so that patients can continue to receive Fycompa after the temporary suspension has come into effect and German stock of the drug is exhausted at the end of the year."

Fycompa won European approval in July 2012 with a licence as an adjunctive treatment for partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.

It was launched in Germany in September and has since been prescribed to between 3,000 and 4,000 people with epilepsy.

But in March this year the G-BA recommended it shouldn't be reimbursed, following a review by the German Institute for Quality and Efficiency in Health Care (IQWiG) that decided Fycompa's benefits were unproven based on current evidence.

IQWiG said at the time the company failed to provide evidence of Fycompa's effectiveness compared to two IQWiG-specified comparators, to which Eisai countered that its evidence dossier did use “appropriate comparative therapy” and the company professed itself “appalled” by the decision.

In Germany, approximately one out of 200 people has epilepsy equating to an estimated 400,000 people in the country living with the condition and a significant market for Eisai's new drug.

The Fycompa (perampanel) access programme is expected to kick in at the beginning of 2014 and Eisai said it would remain in place until commercial distribution is resumed.

The company added that it plans to re-submit Fycompa for assessment “at the earliest opportunity”.

Article by
Dominic Tyer

12th September 2013

From: Sales, Regulatory



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