Nirsevimab (2) – Beyfortus®

Secondary prophylaxis of RSV infections, children during their 2nd RSV season, ≥ 24 months of life

Characteristics

Start date 15.08.2024 – Marketing authorisation: 01.08.2024
Resolution 20.02.2025
INN Nirsevimab
Brand name Beyfortus®
Pharm. company Sanofi-Aventis Deutschland GmbH
G-BA Procedure ID D-1105
ATC code J06BD08 IMMUNOGLOBULINS (J06B)
ICD-10 codes (AIS) Z29.1Encounter for administration of immunoglobulin
Alpha-ID codes (AIS) I32424Preventive immunotherapy
Therapeutic area Infectious diseases RSV infections
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in children up to 24 months of age with indication for secondary prophylaxis during their second RSV season
Subpopulation Indication Comparator
a) Children during their 2nd RSV season aged up to 24 months with indication for secondary prophylaxis of lower respiratory tract infections caused by RSV in whom palivizumab is indicated Palivizumab
b) Children during their 2nd RSV season aged up to 24 months with indication for secondary prophylaxis of lower respiratory tract infections caused by RSV in whom palivizumab is not indicated Observational waiting

Studies and Results

No. of studies
(best subpopulation) 		1 (MUSIC) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: H2H vs. ACT)
Reason for dividing into subpopulations (G-BA) Patient eligibility

  • Clinical trials
    • For the benefit assessment, the pharmaceutical manufacturer has submitted results from the MEDLEY trial. This trial is a completed double-blind RCT comparing nirsevimab with palivizumab in children during their first and second RSV seasons.
    • For the benefit assessment, the pharmaceutical manufacturer cites the single-arm MUSIC trial.

a) Children up to 24 months of age during their second RSV season who have an indication for secondary prophylaxis against lower respiratory tract infections caused by RSV, for whom palivizumab is indicated

  • An additional benefit is not proven.
  • For the assessment of the additional benefit of nirsevimab compared with the appropriate comparator therapy in children during their second RSV season, aged up to 24 months, with an indication for secondary prophylaxis against lower respiratory tract infections caused by RSV, for whom palivizumab is indicated, are therefore not available.
  • morbidity
    • Patient-relevant secondary endpoints were assessed in the morbidity category.
  • Side effects
    • The primary endpoint of the study was the assessment of safety and tolerability based on endpoints in the side effects category.

b) Children up to 24 months of age during their second RSV season for whom there is an indication for secondary prophylaxis against lower respiratory tract infections caused by RSV, but for whom palivizumab is not indicated

  • The additional benefit is not proven.
  • For the assessment of the additional benefit of nirsevimab compared with the appropriate comparator therapy in children during their second RSV season, aged up to 24 months, with an indication for secondary prophylaxis against lower respiratory tract infections caused by RSV, for whom palivizumab is not indicated, there are therefore no suitable data available.

Courtesy translation only, please refer to the German original.

Associated procedures



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