Empagliflozin / Metformin -- Benefit Assessment According to §35a Social Code Book V
Abstract
Background In accordance with §35a Social Code Book (SGB) V, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to assess the benefit of the drug combination empagliflozin/metformin. The assessment was based on a dossier compiled by the pharmaceutical company (hereinafter referred to as “the company”). The dossier was sent to IQWiG on 29 February 2016. Research question The aim of this report was to assess the added benefit of the fixed combination of empagliflozin and metformin (hereinafter referred to as “empagliflozin/metformin”) for the treatment of adults with type2 diabetes mellitus in comparison with the appropriate comparator therapy (ACT) in the following approved subindications: empagliflozin/metformin: in patients inadequately controlled on their maximally tolerated dose of metformin alone; empagliflozin/metformin in combination with other blood-glucose lowering drugs, including insulin: in patients inadequately controlled with metformin in combination with other blood-glucose lowering drugs, including insulin. Following the G-BA’s subdivision of the therapeutic indication, the assessment was conducted for 3 research questions versus the ACT specified by the G-BA.
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