[A21-167] Dapagliflozin (type 2 diabetes mellitus in children and adolescents) - Benefit assessment according to §35a Social Code Book V
Last updated 15.03.2022
Project no.:
A21-167
Commission:
Commission awarded on 13.12.2021 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Digestion, metabolism and hormones
Children and adolescents aged 10 to 17 years with insufficiently controlled type 2 diabetes mellitus (T2DM), adjunct to diet and exercise, either as monotherapy when metformin is considered inappropriate due to intolerance or in addition to other blood-glucose lowering drugs
- Insulin-naive children aged 10 to 17 years with type 2 diabetes mellitus who have not achieved sufficient glycaemic control with their ongoing drug treatment consisting of at least one blood-glucose lowering drug in addition to diet and exercise: added benefit not proven
- Insulin-experienced children aged 10 to 17 years with type 2 diabetes mellitus who have not achieved sufficient glycaemic control with their ongoing insulin regimen in addition to diet and exercise: 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 |
|---|---|---|
| A21-109 | Dapagliflozin (kidney disease) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A20-113 | Dapagliflozin (heart failure) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A19-53 | Dapagliflozin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A19-37 | Dapagliflozin (type 1 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A17-65 | Dapagliflozin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V (new scientific findings) | Commission completed |
| A12-18 | Dapagliflozin - Benefit assessment according to § 35a Social Code Book V (dossier assessment) | Commission completed |
| A23-11 | Dapagliflozin (heart failure with preserved ejection fraction) – Benefit assessment according to §35a Social Code Book V | Commission completed |