Nirsevimab Medicine 06 June 2023 Extended indication Extention of indication for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Therapeutic value No estimate possible yet Total cost € 76,660.00 Registration phase Registered Product Active substance Nirsevimab Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Viral infections other Extended indication Extention of indication for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Current proprietary name Already available biosimilars / generics Proprietary name Beyfortus Manufacturer Sanofi Portfolio holder Sanofi 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 Normal trajectory Particularity Unknown ATMP No Submission date April 2023 Expected Registration September 2024 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie juni 2024 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten bekend van de studie bij deze immuun gecompromitteerde groep. Nirsevimab was wel effectief in het het eerste jaar. Ook in het tweede jaar kan profylaxe gebruikt worden. Nirsevimab is in deze groep wel veilig (2). Duration of treatment Frequency of administration Dosage per administration 50 mg-100 mg References NCT04484935 (MUSIC) (1); Domachowske et al. Paediatrics. 2024 (2). Additional remarks Single fixed IM dose of nirsevimab 50mg if body weight <5kg or 100mg if body weight ≥5kg Expected patient volume per year Patient volume 10 - 30 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie (1) Additional remarks Naar schatting zullen er ieder jaar enkele tientallen gecomprimeerde kinderen tot 2 jaar zijn in Nederland die hiervoor mogelijk in aanmerking komen (1). 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 € 76,660.00 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