Once again, no proof of added benefit found for Boehringer/Lilly's Trajenta by Germany's IQWiG

Once again, the German Institute for Quality and Efficiency in Health Care (IQWiG) has found no added benefit for German independent drugmaker Boehringer Ingelheim and US partner Eli Lilly’s (NYSE: LLY) Trajenta (linagliptin; The Pharma Letter January 10), which has been approved since August 2011 to improve blood glucose control in adults with type 2 diabetes.

The assessment of the new dossier according to the German Act on the Reform of the Market for Medicinal Products (AMNOG) again showed that no added benefit of the drug over the appropriate comparator therapy (ACT) can be determined, because the pharmaceutical company has not submitted any relevant studies. This is the conclusion of the report by the IQWiG, published earlier this month

In its first early benefit assessment dated January 2012, the IQWiG was unable to determine any added benefit because the pharmaceutical company (Boehringer Ingelheim) had chosen sitagliptin as comparator therapy in its first dossier instead of the ACT (a sulfonylurea) specified by the Federal Joint Committee (G-BA). A decision based on the IQWiG report was made by the G-BA on 29th March 2012.