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Ward et al. do not express any explicit disagreement with the general form of statistical modelling, using linear mixed models for appropriately transformed outcomes, where the GM genotype is compared to appropriate comparator and reference varieties.
As per German social code, EBA is based on registration trials and includes evaluation of the patient-relevant effect of the new medicines compared to an appropriate comparator as defined by the Federal Joint Committee (G-BA).
So any information on costs and cost-effectiveness compared with an appropriate comparator will be presented.
Randomisation is essential for a comparison of safety among those receiving a study intervention compared to an appropriate comparator group.
The aim of this study was to compare the cost-effectiveness of cetuximab treatment with the appropriate comparator for the National Health Service (NHS) (i.e. active/best supportive care).
The aim of this study was to compare the cost-effectiveness of cetuximab plus irinotecan with an appropriate comparator from a National Health Service (NHS) perspective.
However, the lack of any approved prophylactic treatment for CM makes it difficult to identify an appropriate comparator.
Also a common comparator was missing in the German submission as well as an appropriate comparator which was not used as licensed (within trials).
Since 2013 the G-BA allows more than one appropriate comparator and it is up to the pharmaceutical company to choose one of these.
One main reason for the rejection of indirect comparisons by IQWiG is the choice of an appropriate comparator which differs from the one determined by G-BA.
The benefit and additional benefit of a new pharmaceutical drug are assessed by comparison with a specific appropriate comparator (§ 2 par. 5 AM-NutzenV).
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