[A19-37] Dapagliflozin (type 1 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

Last updated 01.08.2019

Project no.:
A19-37

Commission:
Commission awarded on 18.04.2019 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Digestion, metabolism and hormones

Indication:

Adults with type 1 diabetes and body mass index ≥ 27 kg/m2, when insuline alone provides no adequate glycaemic control despite optimum insulin therapy

Result of dossier assessment:

The non-quantifiable advantage in the change of the HbA1c value (surrogate for microvascuolar late complications) is outweighed by disadvantages in the side effects; added benefit not proven.

Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

Federal Joint Committee (G-BA)

2019-10-17 A G-BA decision was published.

G-BA documents on this decision

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