Casirivimab/imdevimab Medicine 08 June 2021 Extended indication Treatment and prevention of COVID-19. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Casirivimab/imdevimab Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Viral infections other Extended indication Treatment and prevention of COVID-19. Current proprietary name Already available biosimilars / generics Proprietary name REGEN-COV Manufacturer Regeneron 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 Accelerated assessment Particularity Unknown ATMP Unknown Submission date March 2021 Expected Registration November 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Uit de fase 3 data blijkt dat casirivimab/imdevimab het aantal ziekenhuisopnames met 70% terugdrong in niet opgenomen patiënten met COVID-19. Duration of treatment Frequency of administration 1 times a day Dosage per administration References NCT04425629 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks De verwachting is dat deze combinatie mogelijk een plek zal krijgen als PEP/prep voor hoog risico individuen. Expected cost per patient per year Cost References Additional remarks 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