mirikizumab

Details

Files
Generic 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:
  1. 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.
Key Milestones2
Call for patient/clinician input openFebruary 08, 2023
Call for patient/clinician input closedApril 03, 2023
Clarification:

- Patient input submission received from the Gastrointestinal Society

Submission receivedMarch 07, 2023
Submission acceptedMarch 22, 2023
Review initiatedMarch 23, 2023
Draft CADTH review report(s) provided to sponsor for commentJune 08, 2023
Deadline for sponsors commentsJune 19, 2023
CADTH review report(s) and responses to comments provided to sponsorJuly 14, 2023
Expert committee meeting (initial)July 26, 2023
Draft recommendation issued to sponsorAugust 09, 2023
Draft recommendation posted for stakeholder feedbackAugust 17, 2023
End of feedback periodAugust 31, 2023
Clarification:

- Reconsideration: minor revisions requested by sponsor

- Request for reconsideration accepted

Final recommendation issued to sponsor and drug plansNovember 16, 2023
Final recommendation postedDecember 04, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)November 30, 2023
CADTH review report(s) postedFebruary 09, 2024