ferric carboxymaltose

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Generic Name:
ferric carboxymaltose
Project Status:
Active
Therapeutic Area:
Iron deficiency in adult patients with heart failure
Manufacturer:
CSL Vifor
Call for patient/clinician input open:
Brand Name:
Ferinject
Project Line:
Reimbursement Review
Project Number:
SR0852-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Ferric carboxymaltose is indicated 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.
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 open04-Apr-24
Call for patient/clinician input closed03-Jun-24
Submission received10-May-24
Submission accepted30-May-24
Clarification:

- Submission was not accepted for review on 27-May-2024

Review initiated31-May-24
Draft CADTH review report(s) provided to sponsor for comment04-Sep-24
Deadline for sponsors comments13-Sep-24
CADTH review report(s) and responses to comments provided to sponsor10-Oct-24
Expert committee meeting (initial)23-Oct-24
Draft recommendation issued to sponsorNovember 04, 2024
To
November 06, 2024
Draft recommendation posted for stakeholder feedback14-Nov-24
End of feedback period28-Nov-24