difelikefalin

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Generic 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:
  1. 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/clinician input open03-Aug-22
Call for patient/clinician input closed23-Sep-22
Clarification:

- Patient input submission received from The Kidney Foundation of Canada

Submission received22-Sep-22
Submission accepted06-Oct-22
Review initiated07-Oct-22
Draft CADTH review report(s) provided to sponsor for comment21-Dec-22
Deadline for sponsors comments09-Jan-23
CADTH review report(s) and responses to comments provided to sponsor09-Feb-23
Expert committee meeting (initial)22-Feb-23
Draft recommendation issued to sponsor06-Mar-23
Draft recommendation posted for stakeholder feedback16-Mar-23
End of feedback period31-Mar-23
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting28-Jun-23
Final recommendation issued to sponsor and drug plans13-Jul-23
Final recommendation posted31-Jul-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)01-Aug-23
CADTH review report(s) posted27-Sep-23