Dossier assessment
Tirzepatide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V
Report documents
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Extract of dossier assessment
Tirzepatide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V
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Dossier assessment
Tirzepatide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V
Dossier assessment
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
Additional information
Federal Joint Committee (G-BA)
2024-05-02 A G-BA decision was published.
Project details
- Project no.
- A23-112
- Commission
- Commission awarded on 15.12.2023 by the Federal Joint Committee (GBA).
- Report type
- Dossier assessment
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Digestion, metabolism and hormones
- Note
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After completion of the assessment by IQWiG the Federal Joint Committee (GBA) 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 GBA website.
- DOI
https://doi.org/10.60584/A23-112_en
Connected Projects
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Addendum
Tirzepatide (type 2 diabetes mellitus) – Addendum to Project A23-112
Status: Commission completed
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Dossier assessment
Tirzepatide (type 2 diabetes mellitus in children and adolescents) – Benefit assessment according to §35a Social Code Book V
Status: Commission completed