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Nirsevimab

Beyfortus

Extended indication Extension of indication to include treatment of children up to 24 months of age who remain vulnerabl
Therapeutic value No estimate possible yet
Total cost 76,660.00
Registration phase Registration application pending

Product

Active substance Nirsevimab
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Viral infections other
Extended indication Extension of indication to include treatment of children up to 24 months of age who remain vulnerable to severe Respiratory Syncytial Virus (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 Registration application pending

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.
Duration of treatment one-off
Dosage per administration 50 mg- 100 mg
References NCT04484935
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.

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.

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.