Generic Name: ozanimod
Brand Name: Zeposia
Manufacturer: Celgene Inc.
Therapeutic Area: Multiple Sclerosis, relapsing - remitting
Indications: For the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to decrease the frequency of clinical exacerbations.
Manufacturer Requested Reimbursement Criteria1: For the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS).
Submission Type: Initial
NOC Status at Filing: Pre NOC
Project Status: Active
Companion Diagnostics: No
Fee Schedule: Schedule A
- 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 | |
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Call for patient input open | July 27, 2020 |
Call for patient input closed | September 16, 2020 |
Clarification: - Patient input submission received from MS Society of Canada | |
Submission received | August 25, 2020 |
Submission accepted | September 09, 2020 |
Review initiated | September 14, 2020 |
Draft CADTH review report(s) provided to sponsor for comment | December 01, 2020 |
Deadline for sponsors comments | December 10, 2020 |
CADTH responses on draft review report(s) provided to sponsor | January 08, 2021 |
Expert committee meeting (initial) | January 20, 2021 |
Draft recommendation issued to sponsor | February 03, 2021 |
End of embargo period | March 18, 2021 |
Clarification: - Request for extension to feedback period received from the sponsor - Feedback extension request granted - Reconsideration requested - Target EXPERT COMMITTEE reconsideration meeting date to be determined |