Last Updated : May 19, 2020
Details
FilesGeneric Name:
Iron (III) Isomaltoside 1000
Project Status:
Complete
Therapeutic Area:
iron deficiency anemia
Manufacturer:
Pharmacosmos A/S
Call for patient/clinician input open:
Brand Name:
Monoferric
Project Line:
Reimbursement Review
Project Number:
SR0622-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Reimbursed for the treatment of iron deficiency anemia in adult patients who have intolerance or unresponsiveness to oral iron therapy. The diagnosis must be based on laboratory tests.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
iron deficiency anemia
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 input posted | May 29, 2019 |
| Patient group input closed | July 18, 2019 |
| Clarification:
- Patient input submission received from Crohn's and Colitis Canada and The Kidney Foundation of Canada |
|
| Patient input summary sent for review to patient input groups | July 30, 2019 |
| Patient group comments on input summary closed | August 06, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | June 26, 2019 |
| Submission accepted | July 11, 2019 |
| Review initiated | July 12, 2019 |
| Draft CADTH review report(s) sent to sponsor | October 02, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | October 11, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | November 08, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | November 20, 2019 |
| CDEC recommendation sent to sponsor and drug plans | December 03, 2019 |
| Embargo period ended | December 17, 2019 |
| Clarification:
- Reconsideration requested |
|
| Sponsor's request for reconsideration placed on CDEC agenda | February 19, 2020 |
| Clarification:
- Deferred to March 18, 2020 CDEC meeting |
|
| CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans | March 25, 2020 |
| CDEC Final Recommendation posted | March 27, 2020 |
| Redaction requests from sponsor on draft CADTH review report(s) received | April 08, 2020 |
| Redacted CADTH review report(s) sent to sponsor and drug plans | April 21, 2020 |
| Validation of redacted CADTH review report(s) received | April 28, 2020 |
| Final CADTH review report(s) posted | May 19, 2020 |
Files
Last Updated : May 19, 2020