[A18-84] Insulin degludec (diabetes mellitus) - Benefit assessment according to §35a Social Code Book V
Last updated 01.03.2019
Project no.:
A18-84
Commission:
Commission awarded on 29.11.2018 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Digestion, metabolism and hormones
Type 2 diabetes mellitus in adults
If treatment with at least 2 blood-glucose lowering drugs (except insulin) is insufficient and if the treatment goal is near-normal blood glucose levels: indication of lesser benefit versus appropriate comparator therapy. Other goals or patients pretreated with insulin: added benefit not proven. No suitable analyses of the DEVOTE study.
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 |
|---|---|---|
| A15-10 | Insulin degludec (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment) | Commission completed |
| A14-13 | Insulin degludec - Benefit assessment according to § 35a Social Code Book V (dossier assessment) | Commission completed |
Federal Joint Committee (G-BA)
2019-07-04 A G-BA decision was published.