Nirsevimab Medicine 08 June 2021 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. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer AstraZeneca Portfolio holder Mechanism of action Immunostimulation Route of administration Intramuscular Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Monoclonal antibody targeting RSV-F with amino acid substitutions that prolong half-life. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options palivizumab (synagis) Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. 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. Duration of treatment Frequency of administration Dosage per administration 50 mg- 200 mg References Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants . Griffin MP et al. 2020. Additional remarks 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. Maximum patient volume for sluice References RIVM; Additional remarks Premtature kinderen of kinderen die een stamceltransplantatie zullen mogelijk in aanmerking komen. Expected cost per patient per year Cost € 38,335.00 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. 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, 5 injecties per patiënt. Potential total cost per year Total cost € 67,086,250.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks