Ferumoxytol

Active substance
Ferumoxytol
Domain
Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Other non-oncological hematological medications
Extended indication
Iron-deficiency anemia

1. Product

Proprietary name
Feraheme
Manufacturer
AMAG
Mechanism of action
Other
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Intermural (MSZ)
Additional comments
Iron oxide nanoparticle that targets phagocytic cells.

2. Registration

Registration route
Centralised (EMA)
Submission date
2019
Expected Registration
2020
Orphan drug
No
Registration phase
Clinical trials
Additional comments
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.

3. Therapeutic value

Current treatment options
Ferrioxidesaccharaat
Therapeutic value
No judgement
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.

4. Expected patient volume per year

Patient volume

< 1,149

Market share is generally not included unless otherwise stated.

References
GIP databank
Additional comments
Aantal patiënten dat parenterale ijzerpreparaten heeft gekregen in 2016 betreft 1.149.

5. Expected cost per patient per year

Cost
2,500
References
Dahl et al. Clinicoecon Outcomes Res. 2017; 9: 557–567.
Additional comments
De kosten voor een kuur Feraheme in de VS bedragen $2.489.

6. Potential total cost per year

Total cost

2,872,500

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

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

9. Other information

There is currently no futher information available.