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Dossier assessment

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

Status
Status: Commission completed
Project no.
A24-82
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 380 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-82_en
    Download file : Extract of dossier assessment (PDF document, 380 kB, EN, not accessible)

  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

    published on
    Document type
    PDF document, 635 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-82
    Download file : Dossier assessment (PDF document, 635 kB, DE, not accessible)

Dossier assessment

Indication:

Therapeutic indication: Children ≤ 24 months of age during their 2nd 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

Project details

Project no.
A24-82
Commission
Commission awarded on 15.08.2024 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.

DOI

https://doi.org/10.60584/A24-82_en

Connected Projects

  1. 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

  2. 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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