Dossier assessment

Sacubitril/valsartan (heart failure, children and adolescents) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A23-56
Last updated

Report documents

  1. Extract of dossier assessment

    Sacubitril/valsartan (heart failure, children and adolescents) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 304 kB, EN, PDF
  2. Dossier assessment

    Sacubitril/valsartan (heart failure, children and adolescents) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 888 kB, DE, PDF
    DOI-Link
    https://doi.org/10.60584/A23-56_V1.1

Dossier assessment

Indication:

Children and adolescents aged 1 year or older with symptomatic chronic heart failure with left ventricular systolic dysfunction

Result of dossier assessment:

Added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2023-12-07 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A23-56
Commission
Commission awarded on 14.06.2023 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Heart and circulation
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.

The current version 1.1 of the dossier assessment replaces version 1.0 published on 2023-09-15.

DOI
https://doi.org/10.60584/A23-56_V1.1

Connected Projects

  1. Dossier assessment

    Sacubitril/valsartan - Benefit assessment according to §35a Social Code Book V

    Project no.
    A15-60
    Last updated

    Status: Commission completed

  2. Addendum

    Sacubitril/valsartan (heart failure, children and adolescents) – Addendum to Commission A23-56

    Project no.
    A23-103
    Last updated

    Status: Commission completed

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