ozanimod


( Last Updated : June 8, 2022)
Generic Name:
ozanimod
Project Status:
Active
Therapeutic Area:
Ulcerative colitis
Manufacturer:
Celgene Inc., a Bristol Myers Squibb Company
Call for patient/clinician input open:
Brand Name:
Zeposia
Project Line:
Reimbursement Review
Project Number:
SR0714-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC

Details


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.
  1. 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.

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Key Milestones2

Call for patient/clinician input open 29-Nov-21
Call for patient/clinician input closed 28-Jan-22
Clarification:

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

Submission received 05-Jan-22
Submission accepted 19-Jan-22
Review initiated 20-Jan-22
Draft CADTH review report(s) provided to sponsor for comment 05-Apr-22
Deadline for sponsors comments 14-Apr-22
CADTH review report(s) and responses to comments provided to sponsor 12-May-22
Expert committee meeting (initial) 25-May-22
Draft recommendation issued to sponsor 06-Jun-22
Draft recommendation posted for stakeholder feedback 16-Jun-22
End of feedback period 30-Jun-22