risankizumab

Details

Generic Name:
risankizumab
Project Status:
Active
Therapeutic Area:
Ulcerative colitis
Manufacturer:
AbbVie Corporation
Call for patient/clinician input open:
Brand Name:
Skyrizi
Project Line:
Reimbursement Review
Project Number:
SR0890-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with moderately to severely active UC who have had an inadequate response, loss of response, or were intolerant to conventional therapy or advanced therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For 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 conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.
  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 open14-Feb-25
Call for patient/clinician input closed11-Apr-25
Submission received31-Mar-25
Submission accepted14-Apr-25
Review initiated15-Apr-25
Draft CADTH review report(s) provided to sponsor for comment02-Jul-25
Deadline for sponsors comments11-Jul-25
CDA-AMC review report(s) and responses to comments provided to sponsor15-Aug-25
Expert committee meeting (initial)27-Aug-25
Draft recommendation issued to sponsorSeptember 09, 2025
To
September 11, 2025
Draft recommendation posted for stakeholder feedback19-Sep-25
End of feedback period06-Oct-25