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Dossier assessment

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

Status
Status: Commission completed
Project no.
A24-91
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 516 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-91_en
    Download file : Extract of dossier assessment (PDF document, 516 kB, EN, not accessible)

  2. Dossier assessment

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

    published on
    Document type
    PDF document, 1 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-91
    Download file : Dossier assessment (PDF document, 1 MB, DE, not accessible)

Dossier assessment

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

Project details

Project no.
A24-91
Commission
Commission awarded on 30.08.2024 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 (GBA) 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 GBA website.

DOI

https://doi.org/10.60584/A24-91_en

Connected Projects

  1. Dossier assessment

    Insulin icodec (type 1 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A24-90
    Last updated

    Status: Commission completed

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