Germany to Review Price of Eisai’s Fycompa

Epilepsy patients in Germany may gain access to Eisai’s drug, Fycompa, again after Germany’s Federal Joint Committee agreed to take another look at the drug’s pricing.

Last year, Eisai announced that they would be withdrawing Fycompa (perampanel) from the German market as opposed to selling the epilepsy drug at the price approved by the Germany’s health technology assessment (HTA) agency, the Federal Joint Committee (G-BA).

Fycompa gained European regulatory approval in 2012 for the treatment of partial-onset seizures in patients aged 12 or over.

Last June the G-BA ruled that Fycompa provided no added benefit over existing epilepsy treatments, meaning that the drug could only be reimbursed if it was priced at the same level as cheaper generic drugs.  In response, Eisai suspended sales of Fycompa to new patients, and set up an access programme to ensure the 4,000 patients already taking it in Germany could continue to do so at no cost to the German national healthcare system.

Eisai was not the only drugmaker which chose to suspend sales of new products in Germany as a result of pricing rulings.  Other drugmakers who also chose to suspend new products included AstraZeneca, which withdrew its diabetes drug Forxiga; and Pfizer which pulled their leukaemia therapy, Bosulif.

The committee has provided Eisai with a chance to resubmit Fycompa for early re-assessment, raising the chance that an agreement on pricing may be reached.  In a statement, Eisai noted that they had three months to resubmit Fycompa, and expected the G-BA to take approximately six months to review it.

Eisai has always maintained that Fycompa is a valuable second-line treatment for partial-onset seizures, which occur in roughly 60% of people with epilepsy.  According to Eisai, about a third of these patients have seizures that are not controlled by current therapies and need additional treatment options.

The G-BA’s decision to re-open the file was welcomed by epilepsy specialist, Prof Bernhard Steinhoff from Epilepsiezentrum Kork, who commented that “epilepsy affects hundreds of thousands of people in Germany and treatment options such as Fycompa are a welcome addition to our treatment armamentarium.”


Industry News