[A23-112] Tirzepatide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V
Last updated 02.05.2024
Project no.:
A23-112
Commission:
Commission awarded on 15.12.2023 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 2 diabetes mellitus
Result of dossier assessment:
- Insulin-naive adults without manifest cardiovascular disease who have not achieved sufficient glycaemic control with their ongoing drug treatment consisting of one blood-glucose lowering drug in addition to diet and exercise: added benefit not proven
- Insulin-naive adults with manifest cardiovascular disease who have not achieved sufficient glycaemic control with their ongoing drug treatment consisting of one 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 in addition to diet and exercise: 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.
DOI:
https://doi.org/10.60584/A23-112_en
| Project no. | Title | Status |
|---|---|---|
| A24-32 | Tirzepatide (type 2 diabetes mellitus) – Addendum to Project A23-112 | Commission completed |
Federal Joint Committee (G-BA)
2024-05-02 A G-BA decision was published.