Angiotensin II Medicine 13 December 2018 Extended indication Giapreza is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Angiotensin II Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other medication for cardiovascular diseases Extended indication Giapreza is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. Current proprietary name Already available biosimilars / generics Proprietary name Giapreza Manufacturer PAION Portfolio holder Mechanism of action Receptor agonist Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Angiotensin-type-1-receptor-agonists Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date July 2018 Expected Registration August 2019 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in juni 2019. Geregistreerd per 23/08/2019. De fabrikant heeft dit geneesmiddel overgenomen en geeft aan dat zij bezig zijn met het aanvragen van een vergoeding in Nederland. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De inschatting is dat dit geneesmiddel niet veel gebruikt gaat worden in Nederland. Duration of treatment Frequency of administration Dosage per administration starten met 20 ng/ kg/min voor 3 uur 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 SPS Additional remarks In de Verenigde Staten zijn 300.000 personen die in aanmerking zouden komen voor het geneesmiddel, teruggerekend naar Nederland zou dat gaan 15.000 patiënten. Echter, gezien de verwachting van de werkgroep dat dit geneesmiddel niet veel gebruikt gaat worden in Nederland zal het aantal patiënten beperkt blijven. Expected cost per patient per year Cost € 1,500.00 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 https://www.z-index.nl/ Additional remarks Een flacon is voldoende voor 1 dosis. 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