Addendum

Tirzepatide (type 2 diabetes mellitus) – Addendum to Project A23-112

Status
Status: Commission completed
Project no.
A24-32
Last updated

Report documents

  1. Addendum

    Tirzepatide (type 2 diabetes mellitus) – Addendum to Project A23-112

    published on
    Document type
    PDF document, 664 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-32_en

Dossier assessment

Indication:

Adults with type 2 diabetes mellitus

Result of dossier assessment:

unchanged after addendum:

  • Insulin-naive adults without manifest cardiovascular disease who have not achieved sufficient glycaemic control with their ongoing drug treatment consisting of one blood-glucose lowering drug in addition to diet and exercise: added benefit not proven
  • Insulin-naive adults with manifest cardiovascular disease who have not achieved sufficient glycaemic control with their ongoing drug treatment consisting of one blood-glucose lowering drug in addition to diet and exercise: added benefit not proven
  • Insulin-naive adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved sufficient glycaemic control with their ongoing drug treatment consisting of 2 blood-glucose lowering drugs in addition to diet and exercise and for whom insulin therapy is not 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 ongoing drug treatment consisting of 2 blood-glucose lowering drugs in addition to diet and exercise and for whom insulin therapy is not indicated: added benefit not proven
  • Insulin-naive adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved sufficient glycaemic control with their ongoing 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 ongoing 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 ongoing 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 ongoing insulin regimen in addition to diet and exercise: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2024-05-02 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A24-32
Commission
Commission awarded on 26.03.2024 by the Federal Joint Committee (GBA).
Report type
Addendum
Status
Commission completed
Department/Division
Drug Assessment
Topic
Digestion, metabolism and hormones
Note

If the need for additional work on a project commissioned by the GBA arises during consultations, IQWiG submits an addendum. The subsequent decides on the extent of the added benefit concludes the early benefit assessment.

DOI

https://doi.org/10.60584/A24-32_en

Connected Projects

  1. Dossier assessment

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

    Project no.
    A23-112
    Last updated

    Status: Commission completed

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