[ A24-91] Insulin icodec (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V

Last updated 02.12.2024

Project no.:
A24-91

Commission:
Commission awarded on 30.08.2024 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Digestion, metabolism and hormones

Indication:

Adult patients with type 2 diabetes mellitus

Result of dossier assessment:
  • Insulin-naive adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved sufficient glycaemic control with their present 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 present 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 present 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 present 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/A24-91

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