Casirivimab / imdevimab Medicine 07 June 2022 Extended indication Extension of indication to include treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40kg and receiving supplemental oxygen, who have a negative SARS-CoV-2 antibody test result. Therapeutic value No estimate possible yet 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 indication to include treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40kg and receiving supplemental oxygen, who have a negative SARS-CoV-2 antibody test result. Current proprietary name Already available biosimilars / generics Proprietary name Ronapreve Manufacturer Roche Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Casirivimab and imdevimab have been designed to attach to the spike protein of SARS-CoV-2 at two different sites. When the active substances are attached to the spike protein, the virus is unable to enter the body’s cells. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date February 2022 Expected Registration May 2023 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Commission Decision received 26 May 2023. Positieve CHMP-opinie april 2023 Therapeutic value Current treatment options 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 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://data.rivm.nl/covid-19/ Additional remarks Vanaf 1 november 2020 tot 1 november 2021 waren er in Nederland 51.889 opnames van COVID patiënten in het ziekenhuis. Dit betreft dus zo’n 50.000 opnames per jaar (<20% betreft IC opnames). Dit is de beste data die voorhanden is maar het aantal ziekenhuisopnames kan komend jaar wel af wijken gezien het verloop van de COVID epidemie (dit is onder andere afhankelijk van het aantal gevaccineerde personen, de verschillende varianten van het virus die in opkomst zijn en hoe snel deze zich verspreiden en de overheidsmaatregelen gedurende het jaar). Van deze patiëntengroep zal slechts een deel in aanmerking komen voor dit geneesmiddel. Expected cost per patient per year Cost € 1,125.00 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; EPAR 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. Het betreft een eenmalige dosis van 600mg. Dus twee doses van 300mg kost €1.125,42. 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