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

Biosimilar:

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:

July 13, 2023

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
Milestones title	Date
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

Last Updated : September 27, 2023