Last Updated : April 30, 2024
Details
FilesGeneric Name:
difelikefalin
Project Status:
Complete
Therapeutic Area:
Chronic kidney disease
Manufacturer:
Otsuka Canada Pharmaceutical Inc.
Brand Name:
Korsuva
Project Line:
Reimbursement Review
Project Number:
SR0752-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of moderate to severe pruritus associated with chronic kidney disease in adult patients on hemodialysis.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of moderate to severe pruritus associated with chronic kidney disease in adult patients on hemodialysis.
Recommendation Type:
Do not reimburse
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.
| Call for patient/clinician input open | 03-Aug-22 |
|---|---|
| Call for patient/clinician input closed | 23-Sep-22 |
| Clarification: - Patient input submission received from The Kidney Foundation of Canada | |
| Submission received | 22-Sep-22 |
| Submission accepted | 06-Oct-22 |
| Review initiated | 07-Oct-22 |
| Draft CADTH review report(s) provided to sponsor for comment | 21-Dec-22 |
| Deadline for sponsors comments | 09-Jan-23 |
| CADTH review report(s) and responses to comments provided to sponsor | 09-Feb-23 |
| Expert committee meeting (initial) | 22-Feb-23 |
| Draft recommendation issued to sponsor | 06-Mar-23 |
| Draft recommendation posted for stakeholder feedback | 16-Mar-23 |
| End of feedback period | 31-Mar-23 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | 28-Jun-23 |
| Final recommendation issued to sponsor and drug plans | 13-Jul-23 |
| Final recommendation posted | 31-Jul-23 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 01-Aug-23 |
| CADTH review report(s) posted | 27-Sep-23 |
Files
Last Updated : April 30, 2024