CDA | Evidence Driven
CDA | Evidence Driven

guselkumab

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Generic Name:
guselkumab
Project Status:
Active
Therapeutic Area:
Ulcerative colitis
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Tremfya
Project Line:
Reimbursement Review
Project Number:
SR0874-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
The treatment of adult patients with moderately to severely active ulcerative colitis.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​The treatment of adult patients with moderately to severely active ulcerative colitis.
  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 open05-Sep-24
Call for patient/clinician input closed28-Oct-24
Submission received21-Oct-24
Submission accepted04-Nov-24
Review initiated05-Nov-24
Draft CADTH review report(s) provided to sponsor for comment04-Feb-25
Deadline for sponsors comments13-Feb-25
CADTH review report(s) and responses to comments provided to sponsor13-Mar-25
Expert committee meeting (initial)26-Mar-25
Draft recommendation issued to sponsorApril 07, 2025
To
April 09, 2025
Draft recommendation posted for stakeholder feedback17-Apr-25
End of feedback period05-May-25

Files

Patient and Clinician Group input View PDF
Last Updated : November 7, 2024