Bosulif bosutinib regulatory update

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) and Pfizer both estimate that Orphan drug Bosulif bosutinib will cost the German statutory health insurance funds (GKV) €25.9-€34.4 million ($34.4-$45.7 million) per year based on an estimated 381-506 patients eligible for treatment. Under drug pricing law AMNOG, the additional benefit of Orphan products is regarded as having been demonstrated by marketing authorization. IQWiG does not assess Orphan products until they have annual sales within the German statutory health insurance system of €50 million or more. However, Germany's Federal Joint Committee (G-BA) still determines the extent of the additional benefit for Orphan products; a final benefit assessment from G-BA is expected in mid-October.

In March, the European Commission granted conditional approval to an MAA for Bosulif to treat adult patients with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). The drug is indicated for patients previously treated with >=1 tyrosine kinase inhibitor (TKI) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. FDA granted full approval to the dual inhibitor of BCR-ABL and Src kinase in September (see BioCentury, Sept. 10, 2012 & April 1, 2013). Bosulif has Orphan Drug status in the U.S. and Europe to treat CML. ...