ferumoxytol

Details

Generic Name:
ferumoxytol
Project Status:
Withdrawn
Therapeutic Area:
Iron deficiency anemia
Manufacturer:
Covis Pharma Canada Ltd.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0753-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron.
  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 openAugust 03, 2022
Call for patient/clinician input closedSeptember 23, 2022
Clarification:

- Patient input submission received from the Gastrointestinal Society

Submission receivedAugust 31, 2022
Submission acceptedSeptember 15, 2022
Review initiatedSeptember 16, 2022
Draft CADTH review report(s) provided to sponsor for commentNovember 30, 2022
Deadline for sponsors commentsDecember 09, 2022
CADTH review report(s) and responses to comments provided to sponsorJanuary 13, 2023
Expert committee meeting (initial)January 25, 2023
Clarification:

- CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.

- Withdrawn by the sponsor on 20 Mar 2023