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.
For more details, go to: http://www.pmlive.com/pharma_news/eisai_outraged_by_iqwigs_failure_to_back_epilepsy_drug_593394