Last Updated : January 21, 2025
Details
FilesGeneric 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. 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.
- 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.
| Call for patient/clinician input open | April 04, 2024 |
|---|---|
| Call for patient/clinician input closed | June 03, 2024 |
| Submission received | May 10, 2024 |
| Submission accepted | May 30, 2024 |
| Clarification: - Submission was not accepted for review on 27-May-2024 | |
| Review initiated | May 31, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | September 04, 2024 |
| Deadline for sponsors comments | September 13, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | October 10, 2024 |
| Expert committee meeting (initial) | October 23, 2024 |
| Draft recommendation issued to sponsor | November 06, 2024 |
| Draft recommendation posted for stakeholder feedback | November 14, 2024 |
| End of feedback period | November 28, 2024 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | February 26, 2025 |
Files
Last Updated : January 21, 2025