[A24-32] Tirzepatide (type 2 diabetes mellitus) – Addendum to Project A23-112

Last updated 02.05.2024

Project no.:
A24-32

Commission:
Commission awarded on 26.03.2024 by the Federal Joint Committee (G-BA).

Report type:
Addendum

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Digestion, metabolism and hormones

Indication:

Adults with type 2 diabetes mellitus

Result of dossier assessment:

unchanged after addendum:

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:

If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.

DOI:

https://doi.org/10.60584/A24-32_en