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Iron (III) Isomaltoside 1000

Last Updated: May 19, 2020
Result type: Reports
Project Number: SR0622-000
Product Line: Reimbursement Review

Generic Name: Iron (III) Isomaltoside 1000

Brand Name: Monoferric

Manufacturer: Pharmacosmos A/S

Therapeutic Area: iron deficiency anemia

Indications: iron deficiency anemia

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

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: March 25, 2020

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedMay 29, 2019
Patient group input closedJuly 18, 2019

- 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 groupsJuly 30, 2019
Patient group comments on input summary closedAugust 06, 2019

- Patient input summary feedback received

Submission receivedJune 26, 2019
Submission acceptedJuly 11, 2019
Review initiatedJuly 12, 2019
Draft CADTH review report(s) sent to sponsorOctober 02, 2019
Comments from sponsor on draft CADTH review report(s) receivedOctober 11, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorNovember 08, 2019
Canadian Drug Expert Committee (CDEC) meetingNovember 20, 2019
CDEC recommendation sent to sponsor and drug plansDecember 03, 2019
Embargo period endedDecember 17, 2019

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agendaFebruary 19, 2020

- Deferred to March 18, 2020 CDEC meeting

CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansMarch 25, 2020
CDEC Final Recommendation postedMarch 27, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedApril 08, 2020
Redacted CADTH review report(s) sent to sponsor and drug plansApril 21, 2020
Validation of redacted CADTH review report(s) receivedApril 28, 2020
Final CADTH review report(s) postedMay 19, 2020