Clesrovimab Medicine 04 June 2024 Extended indication Enflonsia is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season. Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Clesrovimab Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Viral infections other Extended indication Enflonsia is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season. Current proprietary name Already available biosimilars / generics Proprietary name Enflonsia Manufacturer MSD Portfolio holder MSD Mechanism of action Immunostimulation Route of administration Intramuscular Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date December 2024 Expected Registration November 2025 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in september 2025. Therapeutic value Current treatment options Palivizumab (Synagis) en recent is ook nirsevimab geregistreerd. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Palivizumab is inferieur aan nirsevimab en clesrovimab. Er zijn op dit moment geen duidelijke voordelen of nadelen gevonden ten opzichte van nirsevimab (2). Duration of treatment Frequency of administration Dosage per administration References NCT04938830 (1); Expertopinie (2). Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References RIVM (1); Expertopinie (2). Additional remarks In het geval dit geneesmiddel opgenomen wordt in het Rijksvaccinatieprogramma komen alle nieuwgeborenen in aanmerking: 160.000 tot 170.000 kinderen (1). Dit is echter afhankelijk van de therapeutische waarde ten opzichte van nirsevimab en de prijs (2). 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. Potential total cost per year Total cost 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