Last Updated : August 20, 2021
Details
FilesGeneric 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
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:
- 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 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 | |
| Expert committee meeting | June 16, 2021 |
| Final recommendation issued to sponsor and drug plans | June 23, 2021 |
| Final recommendation posted | June 29, 2021 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | July 08, 2021 |
| CADTH review report(s) posted | August 20, 2021 |
Files
Last Updated : August 20, 2021