Sotrovimab Medicine 08 June 2021 Extended indication Treat confirmed COVID-19 in adults and adolescents (aged 12 years and above and weighing at least 40kg) who do not require supplemental oxygen therapy and who are at risk of progressing to severe COVID-19. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Sotrovimab Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Viral infections other Extended indication Treat confirmed COVID-19 in adults and adolescents (aged 12 years and above and weighing at least 40kg) who do not require supplemental oxygen therapy and who are at risk of progressing to severe COVID-19. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer GSK Portfolio holder Mechanism of action Virus inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Sotrovimab (also known as VIR-7831 and GSK4182136) is a monoclonal antibody with activity against SARS-CoV-2, the virus that causes COVID-19. A monoclonal antibody is a type of protein that attaches to a specific structure (called an antigen). Sotrovimab is designed to attach to the spike protein of SARS-CoV-2, limiting the ability of the virus to enter the body’s cells. Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity Unknown ATMP Unknown Submission date May 2021 Expected Registration January 2022 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Remdesivir Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Uit de resultaten van de interim-analyse bleek dat sotrovimab het risico op hospitalisatie voor meer dan 24 uur of overlijden met 85% verminderde ten opzichte van placebo: hospitalisatie voor meer dan 24 uur of overlijden kwam voor in 1% (3 out of 291) van de patiënten die sotrovimab ontvingen en 7% (21 van de 292) patiënten die placebo kregen. De potentie is er om het in te zetten als preventief middel bij patiënten die een suboptimale of afwezige respons hebben op vaccinatie ( ie ouderen/ immuun-gecompromitteerden). Duration of treatment Frequency of administration Dosage per administration References NCT04545060 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Zie actuele informatie hierover bij het RIVM: https://www.rivm.nl/coronavirus-covid-19/actueel Additional remarks 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