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Dossier assessment

Nirsevimab (prevention of RSV disease) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A24-27
Last updated

Report documents

  1. Extract of dossier assessment

    Nirsevimab (prevention of RSV disease) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 545 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-27_en
    Download file : Extract of dossier assessment (PDF document, 545 kB, EN, not accessible)

  2. Dossier assessment

    Nirsevimab (prevention of RSV disease) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 854 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-27_V1.1
    Download file : Dossier assessment (PDF document, 854 kB, DE, not accessible)

Dossier assessment

Indication:

Children during their 1st RSV season with indication for secondary prophylaxis of lower respiratory tract infections caused by respiratory syncytial virus.

Result of dossier assessment:
  • Children in whom palivizumab is indicated: added benefit not proven
  • Children in whom palivizumab is not indicated: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2024-08-15 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A24-27
Commission
Commission awarded on 04.03.2024 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Immune system and infections
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 2024-07-18.

DOI

https://doi.org/10.60584/A24-27_en

Connected Projects

  1. Addendum

    Nirsevimab (secondary prophylaxis of RSV lower respiratory tract disease) - Addendum to Project A24-27

    Project no.
    A24-75
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Nirsevimab (secondary prophylaxis of RSV lower respiratory tract disease, 2nd. RSV season) – Benefit assessment according to §35a Social Code Book (SGB) V

    Project no.
    A24-82
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Nirsevimab (prevention of RSV lower respiratory tract disease) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-33
    Last updated

    Status: Commission completed

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