Casirivimab / imdevimab Medicine 04 June 2024 Extended indication Extension of the indication to include the treatment of pediatric patients from 2 to less than 12 years of age, weighing at least 10 kg, who do not require supplemental oxygen and who are at increased risk of progression to severe COVID-19 for Ronapreve. Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Registered Product Active substance Casirivimab / imdevimab Domain Infectious diseases Reason of inclusion Indication extension IND Main indication COVID-19 Extended indication Extension of the indication to include the treatment of pediatric patients from 2 to less than 12 years of age, weighing at least 10 kg, who do not require supplemental oxygen and who are at increased risk of progression to severe COVID-19 for Ronapreve. Current proprietary name Already available biosimilars / generics Proprietary name Ronapreve Manufacturer Roche Portfolio holder Mechanism of action Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date March 2024 Expected Registration March 2025 Orphan drug No Registration phase Registered Reimbursement Excluded from the basic package Medicine sluice Rejected Additional remarks Therapeutic value Current treatment options Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Casirivimab/imdevimab, regdanvimab en tixagevimab/cilgavimab worden bij COVID-19 ontraden, omdat de omikronvariant van het virus minder gevoelig is voor deze monoklonale antilichamen (3). De huidige varianten van SARS-CoV-2 zijn niet gevoelig voor casirivimab/imdevimab. Casirivimab/imdevimab heeft geen therapeutische waarde meer voor behandeling of preventie van COVID-19 (4). Duration of treatment Frequency of administration Dosage per administration 600mg/ 600mg casirivimab / imdevimab References NCT04425629 (1); NCT04452318 (2); Casirivimab/imdevimab. FK. 2024 (3); Expertopinie (4). Additional remarks Expected patient volume per year Patient volume < 0 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie (1). Additional remarks Geen patiënten omdat de huidige SARS-CoV-2 varianten resistent zijn tegen casirivimab/imdevimab (1). Expected cost per patient per year Cost References Medicijnkosten.nl Additional remarks Prijs inclusief BTW: Ronapreve 300mg/2,5ml (120mg/ml) €562,71 per stuk. Ronapreve 1.332mg/11,1ml (120mg/ml) €2.250,85 per stuk. 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