Last Updated : February 9, 2024
Details
FilesGeneric Name:
mirikizumab
Project Status:
Complete
Therapeutic Area:
Ulcerative colitis
Manufacturer:
Eli Lilly Canada
Call for patient/clinician input open:
Brand Name:
Omvoh
Project Line:
Reimbursement Review
Project Number:
SR0773-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.
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 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 | February 08, 2023 |
|---|---|
| Call for patient/clinician input closed | April 03, 2023 |
| Clarification: - Patient input submission received from the Gastrointestinal Society | |
| Submission received | March 07, 2023 |
| Submission accepted | March 22, 2023 |
| Review initiated | March 23, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | June 08, 2023 |
| Deadline for sponsors comments | June 19, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | July 14, 2023 |
| Expert committee meeting (initial) | July 26, 2023 |
| Draft recommendation issued to sponsor | August 09, 2023 |
| Draft recommendation posted for stakeholder feedback | August 17, 2023 |
| End of feedback period | August 31, 2023 |
| Clarification: - Reconsideration: minor revisions requested by sponsor - Request for reconsideration accepted | |
| Final recommendation issued to sponsor and drug plans | November 16, 2023 |
| Final recommendation posted | December 04, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 30, 2023 |
| CADTH review report(s) posted | February 09, 2024 |
Files
Last Updated : February 9, 2024