Extended indication Indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance t
Therapeutic value No estimate possible yet
Total cost 2,602,500.00
Registration phase Registration application pending

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).
Proprietary name Feraheme
Manufacturer Covis
Mechanism of action Other
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments IJzeroxide nanopartikel dat gericht is tegen phagocyterende cellen.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date May 2022
Expected Registration June 2023
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Ferrioxidesaccharaat
Therapeutic value No estimate possible yet
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.

Expected patient volume per year

Patient volume

< 1,041

Market share is generally not included unless otherwise stated.

References GIP databank
Additional comments Aantal patiënten dat parenterale ijzerpreparaten heeft gekregen in 2021 betreft 1.041.

Expected cost per patient per year

Cost 2,500.00
References Dahl et al. Clinicoecon Outcomes Res. 2017; 9: 557–567.
Additional comments De kosten voor een kuur Feraheme in de Verenigde Staten bedragen $2.489.

Potential total cost per year

Total cost

2,602,500.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Fase 3 studie voor "Coronary Artery Disease"
References clinicaltrials.gov

Other information

There is currently no futher information available.