Last Updated : February 22, 2023
Details
FilesGeneric 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
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:
- 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.
| Call for patient/clinician input open | November 29, 2021 |
|---|---|
| Call for patient/clinician input closed | January 28, 2022 |
| Clarification: - Patient input submission received from Crohnâs and Colitis Canada and Gastrointestinal Society | |
| Submission received | January 05, 2022 |
| Submission accepted | January 19, 2022 |
| Review initiated | January 20, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | April 05, 2022 |
| Deadline for sponsors comments | April 14, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | May 12, 2022 |
| Expert committee meeting (initial) | May 25, 2022 |
| Draft recommendation issued to sponsor | June 06, 2022 |
| Draft recommendation posted for stakeholder feedback | June 16, 2022 |
| End of feedback period | June 30, 2022 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | September 28, 2022 |
| Draft recommendation issued to sponsor | October 13, 2022 |
| Draft recommendation posted for stakeholder feedback | October 20, 2022 |
| End of feedback period | November 03, 2022 |
| Final recommendation issued to sponsor and drug plans | November 17, 2022 |
| Final recommendation posted | December 05, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | December 01, 2022 |
| CADTH review report(s) posted | February 21, 2023 |
Files
Last Updated : February 22, 2023