Last Updated : May 10, 2024
Details
FilesGeneric Name:
odevixibat
Project Status:
Complete
Therapeutic Area:
Progressive familial intrahepatic cholestasis (PFIC)
Manufacturer:
Medison Pharma Canada Inc.
Call for patient/clinician input open:
Brand Name:
Bylvay
Project Line:
Reimbursement Review
Project Number:
SR0788-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of pruritus in patients aged 6 months or older with progressive familial intrahepatic cholestasis (PFIC).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
The treatment of pruritus in patients aged 6 months or older with progressive familial intrahepatic cholestasis (PFIC).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 | 24-May-23 |
|---|---|
| Call for patient/clinician input closed | 14-Jul-23 |
| Clarification: - Patient input submission received from the Canadian Liver Foundation | |
| Submission received | 23-Jun-23 |
| Submission accepted | 10-Jul-23 |
| Review initiated | 11-Jul-23 |
| Draft CADTH review report(s) provided to sponsor for comment | 29-Sep-23 |
| Deadline for sponsors comments | 12-Oct-23 |
| CADTH review report(s) and responses to comments provided to sponsor | 09-Nov-23 |
| Expert committee meeting (initial) | 22-Nov-23 |
| Draft recommendation issued to sponsor | 04-Dec-23 |
| Draft recommendation posted for stakeholder feedback | 14-Dec-23 |
| End of feedback period | 10-Jan-24 |
| Clarification: - Reconsideration: minor revisions requested by sponsor - Request for reconsideration not accepted | |
| Final recommendation issued to sponsor and drug plans | 13-Feb-24 |
| Final recommendation posted | 01-Mar-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 08-Feb-24 |
| CADTH review report(s) posted | 10-May-24 |
Files
Last Updated : May 10, 2024