G-BA to assess DPP-4 inhibitors launched before AMNOG

Germany's Federal Joint Committee (G-BA) plans to assess the benefit of Type II diabetes drugs in the dipeptidyl peptidase-4 (DPP-4) inhibitor (gliptin) class that were launched before the country's stricter pricing process took effect in January 2011. Earlier this year, G-BA issued a negative assessment of Trajenta linagliptin from Boehringer Ingelheim GmbH (Ingelheim, Germany), the only DPP-4 inhibitor launched since the changes. Boehringer subsequently broke off pricing talks for the product and called for a reassessment of its benefit. Prior to the AMNOG drug pricing law, companies were able to determine their own price; now, a price must be negotiated with the Statutory Health Insurance Funds Association (GKV-Spitzenverband) on the basis of a comparative benefit analysis by G-BA.

This will be G-BA's first assessment of any drugs launched before AMNOG. G-BA said the move is aimed at ensuring equal competition between the pre- and post-AMNOG products. AMNOG says that assessments of drugs launched before the law should be prioritized when competing drugs launched after the law have been assessed. ...