[A21-158] Ertugliflozin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V
Last updated 19.05.2022
Project no.:
A21-158
Commission:
Commission awarded on 01.12.2021 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Digestion, metabolism and hormones
Inadequately controlled type 2 diabetes mellitus, as an adjunct to diet and exercise: monotherapy if metformin is unsuitable due to intolerance of contraindications; in addition to other drugs for the treatment of diabetes.
- Insulin-naive adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved sufficient glycaemic control with their ongoing drug treatment consisting of 1 blood-glucose lowering drug in addition to diet: added benefit not proven
- Insulin-naive adults with type 2 diabetes mellitus with manifest cardiovascular disease who have not achieved sufficient glycaemic control with their ongoing drug treatment consisting of 1 blood-glucose lowering drug in addition to diet and exercise: added benefit not proven
- Insulin-naive adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved sufficient glycaemic control with their ongoing drug treatment consisting of 2 blood-glucose lowering drugs in addition to diet and exercise and for whom insulin therapy is not indicated: added benefit not proven
- Insulin-naive adults with type 2 diabetes mellitus with manifest cardiovascular disease who have not achieved sufficient glycaemic control with their ongoing drug treatment consisting of 2 blood-glucose lowering drugs in addition to diet and exercise and for whom insulin therapy is not indicated: added benefit not proven
- Insulin-naive adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved sufficient glycaemic control with their ongoing drug treatment consisting of at least 2 blood-glucose lowering drugs in addition to diet and exercise and for whom insulin therapy is indicated: added benefit not proven
- Insulin-naive adults with type 2 diabetes mellitus with manifest cardiovascular disease who have not achieved sufficient glycaemic control with their ongoing drug treatment consisting of at least 2 blood-glucose lowering drugs in addition to diet and exercise and for whom insulin therapy is indicated: added benefit not proven
- Insulin-experienced adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved sufficient glycaemic control with their ongoing insulin regimen in addition to diet and exercise: added benefit not proven
- Insulin-experienced adults with type 2 diabetes mellitus with manifest cardiovascular disease who have not achieved sufficient glycaemic control with their ongoing insulin regimen: added benefit not proven
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.
| Project no. | Title | Status |
|---|---|---|
| G22-12 | Ertugliflozin (type 2 diabetes mellitus) - Addendum to Commission A21-158 | Commission completed |
Federal Joint Committee (G-BA)
2022-05-19 A G-BA decision was published.