difelikefalin


( Last Updated : March 16, 2023)
Generic Name:
difelikefalin
Project Status:
Active
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

Details


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.
  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.

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Key Milestones2
Call for patient/clinician input openAugust 03, 2022
Call for patient/clinician input closedSeptember 23, 2022
Clarification:

- Patient input submission received from The Kidney Foundation of Canada/p>

Submission receivedSeptember 22, 2022
Submission acceptedOctober 06, 2022
Review initiatedOctober 07, 2022
Draft CADTH review report(s) provided to sponsor for commentDecember 21, 2022
Deadline for sponsors commentsJanuary 09, 2023
CADTH review report(s) and responses to comments provided to sponsorFebruary 09, 2023
Expert committee meeting (initial)February 22, 2023
Draft recommendation issued to sponsorMarch 06, 2023
Draft recommendation posted for stakeholder feedbackMarch 16, 2023
End of feedback periodMarch 31, 2023