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sucroferric oxyhydroxide

Last Updated: January 4, 2019
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: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: January 2, 2019

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 posted May 10, 2018
Patient group input closed June 29, 2018
Clarification:

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

Patient input summary sent for review to patient input groups July 16, 2018
Patient group comments on input summary closed July 23, 2018
Clarification:

- Patient input summary feedback received

Submission received June 12, 2018
Submission accepted for review June 26, 2018
Review initiated July 09, 2018
Draft CDR review report(s) sent to applicant September 21, 2018
Comments from applicant on draft CDR review report(s) received October 02, 2018
Redaction requests from applicant on draft CDR review report(s) received October 10, 2018
Clarification:

- No redactions requested by theapplicant

CDR review team's comments on draft CDR review report(s) sent to applicant November 09, 2018
Canadian Drug Expert Committee (CDEC) meeting November 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans December 04, 2018
Embargo period ended and validation of redacted CDR review report(s) received December 18, 2018
CDEC Final Recommendation issued to applicant and drug plans January 02, 2019
CDEC Final Recommendation posted January 04, 2019
Final CDR review report(s) and patient input posted February 01, 2019