Iron (III) Isomaltoside 1000


Generic Name:
Iron (III) Isomaltoside 1000
Project Status:
Therapeutic Area:
iron deficiency anemia
Pharmacosmos A/S
Call for patient/clinician input open:
Brand Name:
Project Line:
Reimbursement Review
Project Number:
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
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:
Fee Schedule:
Schedule A
iron deficiency anemia
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 posted May 29, 2019
Patient group input closed July 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 groups July 30, 2019
Patient group comments on input summary closed August 06, 2019

- 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

- Reconsideration requested

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

- 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