Eisai has issued a damning statement criticising Germany’s healthcare watchdog IQWIG for not backing epilepsy drug Fycompa.
Japan-based Eisia said it was “outraged” with IQWIG’s view that Fycompa (perampanel) offered no additional benefit for epilepsy and should not be reimbursed in Germany at the price set by Eisai.
The decision comes more than a year after IQWIG’s initial decision to turn down Fycompa based on current evidence, a verdict that also led to angry outbursts from Eisai.
In that time Eisai has suspended sales of the drug and subsequently set up an access programme to ensure some patients in Germany were able to receive Fycompa – a medicine that was approved in the EU in 2012.
Eisai announced in May this year that it had resubmitted the drug to IQWIG and the German Federal Joint Committee (G-BA), along with new data from an observational study demonstrating the benefits of Fycompa in people with epilepsy.
However, this new data has failed to convince IQWIG which has problems with the comparator product used by Eisai in its studies.
IQWIG’s decision was criticised by other bodies, including The Kork Epilepsy Centre.
The clinic’s Prof Bernhard Steinhoff said: “The report by IQWiG has neglected to take into account the German people with epilepsy who already experience an additional benefit with Fycompa.
“Considerable real world experience data is available in Germany, and I have personally witnessed and published about the additional benefit this treatment can bring to people with refractory epilepsy.”
IQWIG’s recommendation will now be considered by the G-BA, which is expected to published a decision on Fycompa’s use in Germany in November.
Eisai is hopeful that the G-BA will differ in its decision to IQWIG, with the company stating it 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.”