Eisai temporarily suspend Fycompa in Germany, following negative G-BA decision

Japanese drug major Eisai (TYO: 4523) said today (June 25) that, “with regret,” it will suspend temporarily commercial distribution of its epilepsy drug Fycompa in Germany, saying it is unable to accept the assessment, under the current AMNOG (Act on the Reform of the Market for Medicinal) process (The Pharma Letter March 8), of no additional benefit to inappropriate comparators for this product.

Eisai hopes that this situation will be temporary and will submit Fycompa for reassessment at the earliest opportunity. Commercial availability of Fycompa will continue until the end of the year. Thereafter, a continued access program will be put in place. Eisai will announce the details of the continued access program shortly.

The German Society for Epileptology (DGfE) and German Society for Neurology (DGN), representing epileptologists and neurologists in Germany, agree that German Federal Joint Committee’s (G-BA), the decision-making body of the self-governing medical system in that country, understanding that new anti-epileptic drugs should be compared to single substances is not applicable to the situation of refractory epilepsy, for which an additional benefit should be assessed by considering efficacy in patients drug-resistant to standard therapies. The organizations also confirm that new epilepsy treatment options are needed to help patients improve seizure control and tolerability.