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sucroferric oxyhydroxide

Last Updated: December 14, 2018
Result type: Reports
Project Number: SR0571-000
Product Line: Common Drug Review

Generic Name: sucroferric oxyhydroxide

Brand Name: Velphoro

Manufacturer: Vifor Fresenius Medical Care Renal Pharma

Indications: Hyperphosphatemia, end-stage renal disease

Manufacturer Requested Reimbursement Criteria1: The control of serum phosphorus levels in adult patients with end-stage renal disease (ESRD) on dialysis.

Submission Type: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

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 10, 2018
Patient group input closedJune 29, 2018
Clarification:

- Patient input submission received from the Canadian Organization for Rare Disorders

Patient input summary sent for review to patient input groupsJuly 16, 2018
Patient group comments on input summary closedJuly 23, 2018
Clarification:

- Patient input summary feedback received

Submission receivedJune 12, 2018
Submission accepted for reviewJune 26, 2018
Review initiatedJuly 09, 2018
Draft CDR review report(s) sent to applicantSeptember 21, 2018
Comments from applicant on draft CDR review report(s) receivedOctober 02, 2018
Redaction requests from applicant on draft CDR review report(s) receivedOctober 10, 2018
Clarification:

- No redactions requested by theapplicant

CDR review team's comments on draft CDR review report(s) sent to applicantNovember 09, 2018
Canadian Drug Expert Committee (CDEC) meetingNovember 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansDecember 04, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedDecember 18, 2018
CDEC Final Recommendation issued to applicant and drug plansJanuary 02, 2019
CDEC Final Recommendation posted-
Final CDR review report(s) and patient input posted-

Tags

kidney