[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

Indication:

Type 2 diabetes mellitus in adults

Result of dossier assessment:

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.

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.

Federal Joint Committee (G-BA)

2019-07-04 A G-BA decision was published.

G-BA documents on this decision

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