Clesrovimab Medicine 04 June 2024 Extended indication Prevention of respiratory syncytial virus Therapeutic value No estimate possible yet Total cost € 6,707,750.00 Registration phase Clinical trials Product Active substance Clesrovimab Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Viral infections other Extended indication Prevention of respiratory syncytial virus Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MSD Portfolio holder MSD Mechanism of action Immunostimulation Route of administration Intramuscular Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2025 Expected Registration 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Palivizumab (synagis) en recent is ook niservimab geregistreerd. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT04938830 Additional remarks 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 Als enkel premature kinderen of kinderen die een stamceltransplantatie moeten ondergaan in aanmerking zullen komen. Zal het patiënt volume 1.500 tot 2.000 bedragen. In het geval dit geneesmiddel opgenomen wordt in het rijksvaccinatieprogramma komen alle nieuwgeborenen in aanmerking 160.000 tot 170.000 kinderen. Expected cost per patient per year Cost € 3,833.00 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, 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 € 6,707,750.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks