Empagliflozin (trade name: Jardiance) has actually been approved due to the fact that Could 2014 for adults along with type 2 diabetes mellitus in whom diet regimen and workout alone do not give adequate glycaemic control. In 2014, the German Institute for Quality and Efficiency in Healthiness Care (IQWiG) concluded in its dossier assessment that an added incentive of the drug in comparison along with the proper comparator therapies was not proven. Partly, the drug manufacturer had presented no relevant data; partly not just the drugs, however additionally the therapeutic strategies differed; in addition, the indirect comparisons were based on studies unsuitable for the assessment.
The manufacturer now requested a brand-new incentive assessment as a result of “brand-new scientific findings”, and submitted two dossiers: one for empagliflozin alone, and one for empagliflozin in combination along with metformin. IQWiG determined in the 2 early incentive assessments that the dossiers still contained no data and analyses relevant or suitable for the research questions. Hence an added incentive of empagliflozin alone or in combination along with metformin in comparison along with the proper comparator therapies is still not proven. The analyses of the large study EMPA-REG-Outcome additionally submitted were unsuitable for an assessment of the added incentive in Germany.
Same studies, Very same problems
Both the solitary agent and the combination of empagliflozin along with metformin are approved alone or in combination along with various other blood-glucose lowering drugs including insulin. According to the Federal Joint Committee (G-BA), this resulted in 3 and four research questions respectively. The manufacturer again presented no relevant data for 5 of these seven research questions to ensure an added incentive is not proven. One study of direct comparison too as several studies for indirect comparisons, every one of which had currently been cited in the dossier or in the commenting procedure in 2014, were offered for the various other two research questions.
The assessment of the data from the indirect comparison was incomplete along with regard to content, even though it had been known to the manufacturer due to the fact that the initial dossier assessment which patient-relevant outcomes were important. In particular, there was no short article on personal side events for which a disadvantage of empagliflozin versus the comparator therapy was shown. The short article offered on among the indirect comparisons had the Very same deficiency; furthermore, there were contradictions to the clinical study reports. The second indirect comparison was not evaluable due to the fact that the studies compared were not sufficiently comparable and due to the fact that therapeutic strategies rather than drugs were compared along with one yet another again.
Hence there was no hint of an added incentive of empagliflozin in comparison along with the proper comparator therapies for the solitary agent or for the fixed combination.
Study EMPA-REG-Outcome unsuitable for the assessment of the added benefit
Both dossiers additionally contained a description of the EMPA-REG-Outcome study used by the manufacturer to answer a question posed by the manufacturer itself, i.e. whether empagliflozin (alone or along with metformin) along with standard treatment offers an added incentive for patients at higher cardio risk in comparison along with standard treatment alone plus placebo.
The antidiabetic therapy in this study cannot be considered standard treatment, however: The blood-glucose lowering treatment was not escalated appropriately and the top threshold values explained in guidelines were not consistently respected. And also if treatment was escalated, this was mostly done as emergency treatment, however not as Section of a planned treatment expansion.
Effects in favour of empagliflozin mainly in Latin America and Asia
Moreover, marked local differences were notable: Effects in favour of empagliflozin mainly taken place in study centres in Latin America and Asia, whereas in Europe, partly benefits and partly disadvantages of empagliflozin were shown. Finally, the study addressed neither the G-BA’s research questions nor the proper comparator therapies explained there.
Thomas Kaiser, Head of the IQWiG Drug Assessment Department, commented on this attempt by the manufacturer to prove an added incentive for a minimum of certain patients: “This is a wasted opportunity. It ought to be welcomed that studies of this dimension and this duration, which are therefore potentially informative, are conducted. however it was conducted along with obvious deficiencies. Experts had pinned higher hopes on this study, particularly as, in contrast to various other large outcome studies, it appeared to create good outcomes at initial glance. A thorough analysis of the study and the outcomes in European participants did not confirm this impression, however.”
Source:
Institute for Quality and Efficiency in Healthiness Care
