Dossier assessment

Insulin degludec (diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A18-84
Last updated

Report documents

  1. Extract of dossier assessment

    Insulin degludec (diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 980 kB, EN, not accessible
  2. Dossier assessment

    Insulin degludec (diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 2 MB, DE, not accessible

Dossier assessment

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.

Additional information

Federal Joint Committee (G-BA)

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

G-BA documents on this decision

Project details

Project no.
A18-84
Commission
Commission awarded on 29.11.2018 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Digestion, metabolism and hormones
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.

Connected Projects

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    Insulin degludec (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment)

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    A15-10
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Insulin degludec - Benefit assessment according to § 35a Social Code Book V (dossier assessment)

    Project no.
    A14-13
    Last updated

    Status: Commission completed

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