odevixibat

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Generic Name:
odevixibat
Project Status:
Active
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
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).
  1. 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
Call for patient/clinician input open24-May-23
Call for patient/clinician input closed14-Jul-23
Clarification:

- Patient input submission received from the Canadian Liver Foundation

Submission received23-Jun-23
Submission accepted10-Jul-23
Review initiated11-Jul-23
Draft CADTH review report(s) provided to sponsor for comment29-Sep-23
Deadline for sponsors comments12-Oct-23
CADTH review report(s) and responses to comments provided to sponsor09-Nov-23
Expert committee meeting (initial)22-Nov-23
Draft recommendation issued to sponsor04-Dec-23
Draft recommendation posted for stakeholder feedback14-Dec-23
End of feedback period10-Jan-24
Clarification:

- Reconsideration: minor revisions requested by sponsor

- Request for reconsideration not accepted

Final recommendation issued to sponsor and drug plans13-Feb-24
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)08-Feb-24
CADTH review report(s) posted-