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

Viral infections other

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 moeten ondergaan 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.