BEYFORTUS (nirsvimab) - Respiratory Syncytial Virus (RSV)

Opinions on drugs - Posted on Nov 20 2024

Reason for request

Indication extension

Summary of opinion

Favourable opinion for reimbursement in the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:

Neonates and infants during their first RSV season;
Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

BEYFORTUS should be used in accordance with official recommendations.

Clinical Benefit

Moderate

The Committee deems that the clinical benefit of BEYFORTUS (nirsevimab) is moderate in the MA indication in the prevention of severe RSV lower respiratory tract disease requiring hospitalisation in neonates and infants at high risk of RSV infection and eligible for palivizumab, during their first and second RSV season:

Infants born at a gestational age of 35 weeks or under and under 6 months of age entering their first RSV season;
Infants under 2 years of age having required treatment for bronchopulmonary dysplasia in the past 6 months;
Infants under 2 years of age with congenital heart disease with a haemodynamic impact.

Clinical Added Value

minor

The Committee deems that BEYFORTUS (nirsevimab) provides a minor clinical added value (CAV IV) in the prevention of RSV lower respiratory tract disease in neonates and infants with or without risk factors and ineligible for palivizumab, during their first RSV season.