IQWiG backs Novartis' Jakavi for MF

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said Orphan drug Jakavi ruxolitinib from Novartis AG (NYSE:NVS; SIX:NOVN) has "significant" additional benefit over best supportive care (BSC) to treat myelofibrosis (MF). Novartis already markets the oral Janus kinase-1 (JAK-1) and JAK-2 inhibitor in Germany to treat disease-related splenomegaly or symptoms in adults with chronic idiopathic MF, post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis (PET-MF). Comments are due Sept. 5, with a final assessment by Germany's Federal Joint Committee (G-BA) expected in early November.

Last year, Jakavi exceeded the EUR 50 million annual sales threshold for Orphan products. For sales below that threshold, IQWiG does not conduct a formal benefit assessment of Orphan products, although G-BA still determines the extent of the additional benefit. ...