ozanimod

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Generic Name:
ozanimod
Project Status:
Complete
Therapeutic Area:
Multiple Sclerosis, relapsing - remitting
Manufacturer:
Celgene Inc.
Brand Name:
Zeposia
Project Line:
Reimbursement Review
Project Number:
SR0652-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to decrease the frequency of clinical exacerbations.
Recommendation Type:
Do not reimburse
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 input openJuly 27, 2020
Call for patient input closedSeptember 16, 2020
Clarification:

- Patient input submission received from MS Society of Canada

Submission receivedAugust 25, 2020
Submission acceptedSeptember 09, 2020
Review initiatedSeptember 14, 2020
Draft CADTH review report(s) provided to sponsor for commentDecember 01, 2020
Deadline for sponsors commentsDecember 10, 2020
CADTH responses on draft review report(s) provided to sponsorJanuary 08, 2021
Expert committee meeting (initial)January 20, 2021
Draft recommendation issued to sponsorFebruary 03, 2021
End of embargo periodMarch 18, 2021
Clarification:

- Request for extension to feedback period received from the sponsor

- Feedback extension request granted

- Reconsideration requested

Expert committee meetingJune 16, 2021
Final recommendation issued to sponsor and drug plansJune 23, 2021
Final recommendation postedJune 29, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)July 08, 2021
CADTH review report(s) postedAugust 20, 2021