Tixagevimab / cilgavimab Medicine 07 June 2022 Extended indication Extension of indication to include treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID-19, who do not require supplemental oxygen. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Tixagevimab / cilgavimab Domain Infectious diseases Reason of inclusion Indication extension IND Main indication COVID-19 Extended indication Extension of indication to include treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID-19, who do not require supplemental oxygen. Current proprietary name Already available biosimilars / generics Proprietary name Evusheld Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown Route of administration Intramuscular Therapeutical formulation Injection Budgetting framework Unknown Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date May 2022 Expected Registration March 2023 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 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 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