Last Updated : April 20, 2025
Details
FilesGeneric Name:
mirikizumab
Project Status:
Active
Therapeutic Area:
Crohn’s disease
Manufacturer:
Eli Lilly Canada Inc.
Call for patient/clinician input open:
Brand Name:
Omvoh
Project Line:
Reimbursement Review
Project Number:
SR0880-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Eli Lilly Canada Inc. requests that Omvoh (mirikizumab) be funded as per the anticipated Health Canada indication.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Omvoh (mirikizumab) is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, loss of response, or were intolerant to either conventional therapy or a biologic treatment.
- 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.
| Call for patient/clinician input open | January 16, 2025 |
|---|---|
| Call for patient/clinician input closed | March 18, 2025 |
| Submission received | March 04, 2025 |
| Submission accepted | March 19, 2025 |
| Review initiated | March 20, 2025 |
| Draft CADTH review report(s) provided to sponsor for comment | June 05, 2025 |
| Deadline for sponsors comments | June 16, 2025 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | July 11, 2025 |
| Expert committee meeting (initial) | July 23, 2025 |
| Draft recommendation issued to sponsor | August 05, 2025 To August 07, 2025 |
| Draft recommendation posted for stakeholder feedback | August 14, 2025 |
| End of feedback period | August 28, 2025 |
Files
Last Updated : April 20, 2025