Nirsevimab

Extended indication	Extention of indication for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Therapeutic value	No estimate possible yet
Total cost	76,660.00
Registration phase	Registered

Product

Active substance	Nirsevimab
Domain	Infectious diseases
Reason of inclusion	Indication extension
Main indication	Viral infections other
Extended indication	Extention of indication for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Proprietary name	Beyfortus
Manufacturer	Sanofi
Portfolio holder	Sanofi
Mechanism of action	Immunostimulation
Route of administration	Intramuscular
Therapeutical formulation	Injection
Budgetting framework	Intermural (MSZ)

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	April 2023
Expected Registration	September 2024
Orphan drug	No
Registration phase	Registered
Additional remarks	Positieve CHMP opinie juni 2024

Therapeutic value

Therapeutic value	No estimate possible yet
Substantiation	Er zijn nog geen resultaten bekend van de studie bij deze immuun gecompromitteerde groep. Nirsevimab was wel effectief in het het eerste jaar. Ook in het tweede jaar kan profylaxe gebruikt worden. Nirsevimab is in deze groep wel veilig (2).
Duration of treatment	one-off
Dosage per administration	50 mg-100 mg
References	NCT04484935 (MUSIC) (1); Domachowske et al. Paediatrics. 2024 (2).
Additional remarks	Single fixed IM dose of nirsevimab 50mg if body weight <5kg or 100mg if body weight ≥5kg

Expected patient volume per year

Patient volume	10 - 30 Market share is generally not included unless otherwise stated.
References	Expertopinie (1)
Additional remarks	Naar schatting zullen er ieder jaar enkele tientallen gecomprimeerde kinderen tot 2 jaar zijn in Nederland die hiervoor mogelijk in aanmerking komen (1).

Patient volume

10 - 30

Market share is generally not included unless otherwise stated.

References

Expertopinie (1)

Additional remarks

Naar schatting zullen er ieder jaar enkele tientallen gecomprimeerde kinderen tot 2 jaar zijn in Nederland die hiervoor mogelijk in aanmerking komen (1).

Expected cost per patient per year

Cost	3,833.00
References	medicijnkosten.nl
Additional remarks	De kosten zullen mogelijk vergelijkbaar zijn met de prijs van palivizumab: Gemiddelde prijs per 1 injectieflacon Synagis, 1ml injectievloeistof 100mg/ml €766,70, vijf injecties per patiënt. De fabrikant geeft aan dat indien nirsevimab opgenomen wordt in het vaccinatieprogramma de kosten vergelijkbaar zijn met vergelijkbare vaccins.

Potential total cost per year

Total cost	76,660.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Total cost

76,660.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.