Ferumoxytol Medicine 12 June 2018 Extended indication Indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have chronic kidney disease (CKD). Therapeutic value No estimate possible yet Total cost € 2,602,500.00 Registration phase No registration expected Product Active substance Ferumoxytol Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other non-oncological hematological medications Extended indication Indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have chronic kidney disease (CKD). Current proprietary name Already available biosimilars / generics Proprietary name Feraheme Manufacturer Covis Portfolio holder Mechanism of action Other Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks IJzeroxide nanopartikel dat gericht is tegen phagocyterende cellen. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date May 2022 Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Teruggetrokken op 9 maart 2023 (zie CHMP highlights maart 2023) Therapeutic value Current treatment options Ferrioxidesaccharaat Therapeutic value No estimate possible yet 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 < 1,041 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 2021 betreft 1.041. Expected cost per patient per year Cost € 2,500.00 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 Dahl et al. Clinicoecon Outcomes Res. 2017; 9: 557–567. Additional remarks De kosten voor een kuur Feraheme in de Verenigde Staten bedragen $2.489. Potential total cost per year Total cost € 2,602,500.00 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 3 studie voor "Coronary Artery Disease" References clinicaltrials.gov Additional remarks Other information Additional remarks