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CDA | Evidence Driven

ferric carboxymaltose

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Generic Name:
ferric carboxymaltose
Project Status:
Active
Therapeutic Area:
Iron deficiency anemia
Manufacturer:
CSL Vifor
Call for patient/clinician input open:
Brand Name:
Ferinject
Project Line:
Reimbursement Review
Project Number:
SR0842-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Ferric carboxymaltose (FCM) for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older when oral iron preparations are not tolerated or are ineffective.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Ferinject (ferric carboxymaltose) is indicated: for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older when oral iron preparations are not tolerated or are ineffective. for the treatment of iron deficiency (ID) in adult patients with heart failure and New York Heart Association (NYHA) class II/III to improve exercise capacity. The diagnosis of iron deficiency must be based on laboratory tests.
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input openMarch 14, 2024
Call for patient/clinician input closedMay 14, 2024
Submission receivedMay 10, 2024
Submission acceptedMay 30, 2024
Clarification:

- Submission was not accepted for review on 27 May 2024

Review initiatedMay 31, 2024
Draft CADTH review report(s) provided to sponsor for commentAugust 15, 2024
Deadline for sponsors commentsAugust 26, 2024
CADTH review report(s) and responses to comments provided to sponsorOctober 10, 2024
Expert committee meeting (initial)October 23, 2024
Draft recommendation issued to sponsorNovember 04, 2024
To
November 06, 2024
Draft recommendation posted for stakeholder feedbackNovember 14, 2024
End of feedback periodNovember 28, 2024

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Patient and Clinican Group Input View PDF
Last Updated : May 30, 2024