IQWiG: No additional benefit for linagliptin
04.12.2012 11:31
"The company did not present any relevant studies to assess the added benefit of linagliptin in mono-, dual- and triple-therapy compared to the G-BA's ACT. Overall, there is no evidence of an added benefit of linagliptin." It is therefore clear to IQWiG that there are no groups of patients treated with Trajanta (active ingredient linagliptin) for whom a therapeutically significant additional benefit can be derived.
The main reason for this assessment is once again a lack of studies according to IQWiG. There was no study available for mono- and triple therapy with linagliptin for a direct comparison with the appropriate comparator therapy. And for dual therapy only one (comparison of linagliptin plus metformin vs. glimepiride plus metformin, study 1218.20). The institute complains that this study did not only compare linagliptin versus glimepiride, as would have been necessary for the additional benefit assessment; Instead, two different therapy strategies were compared (therapy strategy without a specific blood sugar target value vs. blood sugar target value-controlled therapy strategy), each of which used different active ingredients (linagliptin or glimepiride). It is therefore not certain that the effects observed in the study can be attributed to the active ingredients used, as these could also be caused solely by the different therapeutic strategies.
The situation is completely different for the companies involved. “We see a clear additional benefit for linagliptin in the care of patients with type 2 diabetes and do not agree with the IQWiG assessment,” explains Dr. Engelbert Günster, country manager for Germany at Boehringer Ingelheim. In the further process, the companies cooperating in the marketing of “Trajenta” (Boehringer and Lilly) would “take advantage of the opportunities provided to explain this again in detail to the Federal Joint Committee (G-BA)”. Because the final decision is made by the G-BA - as was the case the first time, when Boehringer and Lilly failed because they had not recognized the appropriate comparative therapy that had already been specified at the time.
According to legal requirements, the corresponding resolution must be passed in the next three months. Until then, the innovative drug will (as before) not be available to German patients (see MA&HP October 2011). The next steps:
- Publication of the benefit assessment and start of the written comment process: 01.03.2013
- Deadline for submitting a written statement: 22.03.2013
- Resolution: Mid-May 2013