Last Updated : February 1, 2019
Details
FilesGeneric Name:
sucroferric oxyhydroxide
Project Status:
Complete
Therapeutic Area:
Hyperphosphatemia, end-stage renal disease
Manufacturer:
Vifor Fresenius Medical Care Renal Pharma
Call for patient/clinician input open:
Brand Name:
Velphoro
Project Line:
Reimbursement Review
Project Number:
SR0571-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
The control of serum phosphorus levels in adult patients with end-stage renal disease (ESRD) on dialysis.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Hyperphosphatemia, end-stage renal disease
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 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 |
Files
Last Updated : February 1, 2019