G-BA rebuffs Trajenta for second indication

Germany's Federal Joint Committee (G-BA) issued a preliminary benefit assessment rebuffing diabetes drug Trajenta linagliptin from Boehringer Ingelheim GmbH (Ingelheim, Germany) as add-on therapy to insulin with or without metformin to treat Type II diabetes -- an indication approved by the European Commission in October. G-BA said Trajenta as add-on therapy to insulin provides "no additional benefit" over human insulin and metformin, G-BA's requested comparator. G-BA said the company did not submit necessary evidence. Boehringer, which has until March 22 to respond, could not be reached for comment. A final decision from G-BA is expected mid-May.

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) typically conducts a preliminary benefit assessment, but if data are not submitted G-BA automatically deems the drug to have no additional benefit. ...