Last Updated : November 14, 2024
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 | 04-Apr-24 |
|---|---|
| Call for patient/clinician input closed | 03-Jun-24 |
| Submission received | 10-May-24 |
| Submission accepted | 30-May-24 |
| Clarification: - Submission was not accepted for review on 27-May-2024 | |
| Review initiated | 31-May-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 04-Sep-24 |
| Deadline for sponsors comments | 13-Sep-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 10-Oct-24 |
| Expert committee meeting (initial) | 23-Oct-24 |
| Draft recommendation issued to sponsor | 06-Nov-24 |
| Draft recommendation posted for stakeholder feedback | 14-Nov-24 |
| End of feedback period | 28-Nov-24 |
Files
Last Updated : November 14, 2024