Drug manufacturer chose a gliptin as comparator therapy
In its dossier, the manufacturer compared linagliptin with a different drug from the gliptin class (sitagliptin) in all three treatment situations and thereby deviated from the specifications of the G-BA. However, in IQWiG's opinion, the manufacturer insufficiently justified this deviation. For the dossier assessment IQWiG therefore uses the appropriate comparator therapy specified by the G-BA.
In the dossier, the manufacturer makes no statements on the extent and probability of an added benefit of linagliptin versus the appropriate comparator therapy specified by the G-BA. Studies that would have been relevant for this purpose were explicitly excluded from the assessment. The manufacturer's dossier therefore provides no proof of an added benefit of linagliptin versus the G-BA's appropriate comparator therapy. This applies to all three treatment situations mentioned above, that is, monotherapy, dual and triple combination therapy.
In the dossier the manufacturer did not determine an added benefit of linagliptin versus the comparator therapy they had chosen themselves (sitagliptin).
G-BA decides on the extent of added benefit
The procedure for inferring the overall conclusion on the extent of added benefit is a proposal from IQWiG. The G-BA, which has opened a formal commenting procedure, will decide on the extent of added benefit.
|Contact: Anna-Sabine Ernst|
Institute for Quality and Efficiency in Health Care