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 Possible equal value Total cost Registration phase Registered 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 ATMP No Submission date December 2024 Expected Registration April 2026 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in september 2025, EC registratie in april 2026. Therapeutic value Current treatment options Palivizumab (Synagis) en recent is ook nirsevimab geregistreerd. Therapeutic value Possible equal value 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 voor- of nadelen gevonden ten opzichte van nirsevimab. Duration of treatment Frequency of administration 1 times a day Dosage per administration References NCT04938830; Expertopinie 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 € 3,800.00 - 3,900.00 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. Er zijn vijf injecties per patiënt per jaar nodig. De fabrikant geeft aan de lijstprijs van clesrovimab nog niet bekend is. De dosering is één injectie. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks