IQWiG again rebuffs Eisai's Fycompa

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said epilepsy drug Fycompa perampanel from Eisai Co. Ltd. (Tokyo:4523) provides "no additional benefit" over appropriate comparators to treat partial onset seizures, with or without secondarily generalized seizures, in patients with epilepsy aged 12 years and older. IQWiG said in a reassessment that Eisai failed to provide "relevant data" for a comparison between Fycompa and comparators, which Germany's Federal Joint Committee (G-BA) defines as any of several conventional antiepileptic drugs.

Eisai submitted data from three placebo-controlled trials comparing Fycompa as adjunct therapy to existing therapy comprising one to three concomitant antiepileptic drugs vs. existing therapy alone. According to IQWiG, the existing therapy was already "individually aligned" to a large extent, and therefore could not be improved by an additional therapy. IQWiG said the additional benefit of Fycompa seen in the trials therefore should be compared with placebo, which is not an appropriate comparator. In a statement, Eisai said it was "outraged" by IQWiG's decision, which the company said was based purely on "methodological, rather than clinical considerations." ...