Last Updated : March 21, 2025
Details
FilesGeneric 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).
- 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 | January 20, 2025 |
|---|---|
| Call for patient/clinician input closed | March 18, 2025 |
| Submission received | February 28, 2025 |
| Submission accepted | March 19, 2025 |
| Clarification: - Submission was not accepted for review on 17 Mar 2025 | |
| Review initiated | March 20, 2025 |
| Draft CADTH review report(s) provided to sponsor for comment | June 05, 2025 |
| Deadline for sponsors comments | June 16, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | July 11, 2025 |
| Expert committee meeting (initial) | July 23, 2025 |
| Draft recommendation issued to sponsor | August 05, 2025 To August 07, 2025 |
| Draft recommendation posted for stakeholder feedback | August 14, 2025 |
| End of feedback period | August 28, 2025 |
Files
Last Updated : March 21, 2025