odevixibat

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Generic Name:
odevixibat
Project Status:
Active
Therapeutic Area:
Alagille syndrome
Manufacturer:
Medison Pharma Canada Inc.
Call for patient/clinician input open:
Brand Name:
Bylvay
Project Line:
Reimbursement Review
Project Number:
SR0884-000
Call for patient/clinician input closed:
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Odevixibat is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Odevixibat is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).
  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 openJanuary 20, 2025
Call for patient/clinician input closedMarch 18, 2025
Submission receivedFebruary 28, 2025
Submission acceptedMarch 19, 2025
Clarification:

- Submission was not accepted for review on 17 Mar 2025

Review initiatedMarch 20, 2025
Draft CADTH review report(s) provided to sponsor for commentJune 05, 2025
Deadline for sponsors commentsJune 16, 2025
CADTH review report(s) and responses to comments provided to sponsorJuly 11, 2025
Expert committee meeting (initial)July 23, 2025
Draft recommendation issued to sponsorAugust 05, 2025
To
August 07, 2025
Draft recommendation posted for stakeholder feedbackAugust 14, 2025
End of feedback periodAugust 28, 2025