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Added benefits of canagliflozin-metformin combo drug unproven, German quality group says
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The new fixed combination of canagliflozin with metformin to treat type 2 diabetes offers no added benefit over the appropriate comparator therapy, according to a press release from the German Institute for Quality and Efficiency in Health Care.
A dossier assessment for the drug, approved since April 2014 for use in adult patients unable to achieve adequate glycemic control through diet and exercise alone, did not present data for possible subindications, the group argued.
According to the release, the Federal Joint Committee Appropriate had laid out comparator therapies and possible subindications:
- When used alone, the drug should be compared with a sulfonylurea (glibenclamide or glimepiride) in combination with metformin.
- When used together with a sulfonylurea or insulin, the drug should be compared with human insulin plus metformin.
The manufacturer used data from an approval study submitted for an initial dossier assessment to compare the combo drug with a sulfonylurea in combination with metformin, the release said. Further, it claimed no added benefit for the other appropriate comparator therapy, with no direct or indirect comparisons offered in available studies, based on the release.
The study design compared the effects of two drugs with one another, as well as two different therapeutic strategies; therefore, possible differences in treatment results cannot be clearly attributed to either drugs or strategies, according to the release.
The German Institute for Quality and Efficiency in Health Care already noted in the release it already came to the conclusion in assessing canagliflozin as a monotherapy and in various free combination therapies in June 2014.