Extended indication Respiratory syncytial virus infection prevention in Immunocompromised newborns and infants ≤ 24 months.
Therapeutic value Possible added value
Total cost 67,086,250.00
Registration phase Clinical trials

Product

Active substance Nirsevimab
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Other viral infections
Extended indication Respiratory syncytial virus infection prevention in Immunocompromised newborns and infants ≤ 24 months.
Manufacturer AstraZeneca
Mechanism of action Immunostimulation
Route of administration Intramuscular
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Monoclonal antibody targeting RSV-F with amino acid substitutions that prolong half-life.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options palivizumab (synagis)
Therapeutic value Possible added value
Substantiation Toediening van nirsevimab voorafgaand aan het RSV-seizoen, dat loopt van herfst tot winter, leidde tot 70% minder infecties waarvoor medische hulp nodig was en tot 80% minder ziekenhuisopnamen vergeleken met de controlegroep volgens Griffin MP et al.
Dosage per administration 50 mg- 200 mg
References Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants . Griffin MP et al. 2020.
Additional comments Single fixed IM dose of nirsevimab 50mg if body weight < 5kg or 100mg if body weight ≥ 5kg, and subjects entering their second RSV season will receive a single fixed IM dose of nirsevimab 200mg

Expected patient volume per year

Patient volume

1,500 - 2,000

Market share is generally not included unless otherwise stated.

References RIVM;
Additional comments Premtature kinderen of kinderen die een stamceltransplantatie zullen mogelijk in aanmerking komen.

Expected cost per patient per year

Cost 38,335.00
References medicijnkosten.nl
Additional comments De kosten zullen mogelijk vergelijkbaar zijn met de prijs van palivizumab: Gemiddelde prijs per 1 injectieflacon Synagis, 1ml injectievloeistof 100mg/ml €766,70, 5 injecties per patiënt.

Potential total cost per year

Total cost

67,086,250.00

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

Indication extension No

Other information

There is currently no futher information available.