Icatibant Medicine 08 December 2020 Extended indication Acute aanvallen van erfelijk angio-oedeem (HAE) bij volwassenen en kinderen vanaf 2 jaar met C1-esteraseremmerdeficiëntie. Therapeutic value Possible equal value Total cost Registration phase Registered Product Active substance Icatibant Domain Chronic immune diseases Reason of inclusion Generic G Main indication Other chronic immune diseases Extended indication Acute aanvallen van erfelijk angio-oedeem (HAE) bij volwassenen en kinderen vanaf 2 jaar met C1-esteraseremmerdeficiëntie. Current proprietary name Firazyr (Shire) Already available biosimilars / generics Proprietary name Icatibant Accord Manufacturer Accord Healthcare Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date August 2020 Expected Registration July 2021 Orphan drug Unknown Registration phase Registered Reimbursement Medicine sluice Additional remarks Geen SPC van kracht. Positieve opinie mei 2021. Therapeutic value Current treatment options Therapeutic value Possible equal value 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