ozanimod

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Generic Name:
ozanimod
Project Status:
Complete
Therapeutic Area:
Ulcerative colitis
Manufacturer:
Celgene Inc., a Bristol Myers Squibb Company
Brand Name:
Zeposia
Project Line:
Reimbursement Review
Project Number:
SR0714-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
The treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response, or were intolerant to either conventional therapy or a biologic agent.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
​The treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response, or were intolerant to either conventional therapy or a biologic agent.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 openNovember 29, 2021
Call for patient/clinician input closedJanuary 28, 2022
Clarification:

- Patient input submission received from Crohn’s and Colitis Canada and Gastrointestinal Society

Submission receivedJanuary 05, 2022
Submission acceptedJanuary 19, 2022
Review initiatedJanuary 20, 2022
Draft CADTH review report(s) provided to sponsor for commentApril 05, 2022
Deadline for sponsors commentsApril 14, 2022
CADTH review report(s) and responses to comments provided to sponsorMay 12, 2022
Expert committee meeting (initial)May 25, 2022
Draft recommendation issued to sponsorJune 06, 2022
Draft recommendation posted for stakeholder feedbackJune 16, 2022
End of feedback periodJune 30, 2022
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingSeptember 28, 2022
Draft recommendation issued to sponsorOctober 13, 2022
Draft recommendation posted for stakeholder feedbackOctober 20, 2022
End of feedback periodNovember 03, 2022
Final recommendation issued to sponsor and drug plansNovember 17, 2022
Final recommendation postedDecember 05, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)December 01, 2022
CADTH review report(s) postedFebruary 21, 2023