Last Updated : April 14, 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 | 20-Jan-25 |
|---|---|
| Call for patient/clinician input closed | 18-Mar-25 |
| Submission received | 28-Feb-25 |
| Submission accepted | 19-Mar-25 |
| Clarification: - Submission was not accepted for review on 17 Mar 2025 | |
| Review initiated | 20-Mar-25 |
| Draft CADTH review report(s) provided to sponsor for comment | 05-Jun-25 |
| Deadline for sponsors comments | 16-Jun-25 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | 11-Jul-25 |
| Expert committee meeting (initial) | 23-Jul-25 |
| Draft recommendation issued to sponsor | August 05, 2025 To August 07, 2025 |
| Draft recommendation posted for stakeholder feedback | 14-Aug-25 |
| End of feedback period | 28-Aug-25 |
Files
Last Updated : April 14, 2025