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
Performance Metric:
Achieved
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.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
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.
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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 sponsor06-Nov-24
Draft recommendation posted for stakeholder feedback14-Nov-24
End of feedback period28-Nov-24
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting26-Feb-25
Draft recommendation issued to sponsor11-Mar-25
Draft recommendation posted for stakeholder feedback20-Mar-25
End of feedback period03-Apr-25
Final recommendation issued to sponsor and drug plans-
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)-
CADTH review report(s) posted-