Dossier assessment

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

Status
Status: Commission completed
Project no.
A18-16
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 121 kB, EN, not accessible
  2. Dossier assessment

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

    published on
    Document type
    PDF document, 823 kB, DE, not accessible

Dossier assessment

Indication:

Adults with type 2 diabetes mellitus when metformin combined with another oral glucose-lowering medicinal product or with basal insulin does not provide adequate glycaemic control

Result of dossier assessment:

Depending on therapeutic indication and treatment goal: hint of lesser benefit than under the comparator therapy or added benefit not proven

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.
A18-16
Commission
Commission awarded on 28.02.2018 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

  1. Dossier assessment

    Insulin glargine/lixisenatide (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A20-38
    Last updated

    Status: Commission completed

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