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Dossier assessment

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

Status
Status: Commission completed
Project no.
A25-33
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 586 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-33_V1.1_en
    Download file : Extract of dossier assessment (PDF document, 586 kB, EN, not accessible)

  2. Dossier assessment

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

    published on
    Document type
    PDF document, 853 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-33_V1.1
    Download file : Dossier assessment (PDF document, 853 kB, DE, not accessible)

Dossier assessment

Indication:

Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in children during their first RSV season who are not addressed in the therapeutic advice on RSV antibodies

Result of dossier assessment:

Indication of considerable added benefit

Press releases

RSV prophylaxis with nirsevimab: advantages for healthy children in their first RSV season

Children immunized with the antibody nirsevimab develop RSV lower respiratory tract infection notably less frequently.
Press release

Project details

Project no.
A25-33
Commission
Commission awarded on 18.02.2025 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Airways and respiratory system
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 12.06.2025.

DOI

https://doi.org/10.60584/A25-33_V1.1_en

Connected Projects

  1. 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

  2. Dossier assessment

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

    Project no.
    A24-27
    Last updated

    Status: Commission completed

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