G-BA backs Celgene's Imnovid

Germany's Federal Joint Committee (G-BA) said Orphan drug Imnovid pomalidomide from Celgene Corp. (NASDAQ:CELG) has "significant" additional benefit to treat multiple myeloma (MM). Under drug pricing law AMNOG, the additional benefit of Orphan products is considered to have been demonstrated by marketing authorization, and Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) does not conduct a formal benefit assessment of Orphan products until they breach a EUR 50 million annual sales threshold. G-BA still determines the extent of the additional benefit. Celgene will now negotiate a price for Imnovid with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband).

Imnovid is approved in the EU to treat patients with relapsed or refractory MM in combination with dexamethasone in adults who have received at least two prior therapies, and whose disease progressed on their last therapy. The thalidomide analog has accelerated approval in the U.S. as Pomalyst. ...