G-BA issues final assessments for Fycompa, Jakavi

Germany's Federal Joint Committee (G-BA) issued final benefit assessments for epilepsy drug Fycompa perampanel from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) and Orphan drug Jakavi ruxolitinib from Novartis AG (NYSE:NVS; SIX:NOVN). G-BA said Fycompa has no additional benefit over comparators to treat partial onset seizures, with or without secondarily generalized seizures, in patients with epilepsy aged 12 years and older. The recommendation is in line with a December preliminary benefit assessment from the Institute for Quality and Efficiency in Health Care (IQWiG). Fycompa is an AMPA-type glutamate receptor antagonist. Drugs that do not have an additional benefit are added to the reference pricing system, which gives a similar base price to all comparable drugs. If there is no reference price, Eisai will negotiate with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband) a price no higher than that of the comparator (see BioCentury Extra, Dec. 17, 2012).

G-BA said Jakavi has a "marginal" additional benefit for its approved indications of chronic myelofibrosis, post-polycythemia vera or essential thrombocythemia myelofibrosis. Novartis will now negotiate a price for the oral Janus kinase-1 (JAK-1) and JAK-2 inhibitor with GKV-Spitzenverband. ...