Ferumoxytol Medicine 12 June 2018 Extended indication Iron-deficiency anemia Therapeutic value No judgement Total cost € 229,800.00 Registration phase Clinical trials Product Active substance Ferumoxytol Domain Cardiovascular diseases Reason of inclusion Main indication Other non-oncological hematological medications Extended indication Iron-deficiency anemia Current proprietary name Already available biosimilars / generics Proprietary name Feraheme Manufacturer AMAG Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Iron oxide nanoparticle that targets phagocytic cells. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine ATMP Unknown Submission date 2018 Expected Registration 2019 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks FIRM trial: reduction in hypophosphatemia. Ferumoxytol eerder op de markt gebracht door Takeda onder de merknaam Rienso en op hun verzoek weer van de markt gehaald. Therapeutic value Current treatment options Ferrioxidesaccharaat Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 2 week / weeks Frequency of administration 1 times a week Dosage per administration 510 mg References J Blood Med. 2017; 8: 155–163. Farmacotherapeutisch kompas. Additional remarks Expected patient volume per year Patient volume < 1,149 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank Additional remarks Aantal patiënten dat parenterale ijzerpreparaten heeft gekregen in 2016 betreft 1.149. Expected cost per patient per year Cost € 150.00 - 250.00 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 GIP databank Additional remarks Vergoeding per gebruiker voor parenterale ijzerpreparaten in 2016 betreft 206,60 euro. Potential total cost per year Total cost € 229,800.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Fase III studie voor "Coronary Artery Disease" References clinicaltrials.gov Additional remarks Other information Additional remarks