Last Updated : February 26, 2025
Details
Generic Name:
guselkumab
Project Status:
Active
Therapeutic Area:
Crohn’s disease
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Tremfya
Project Line:
Reimbursement Review
Project Number:
SR0882-000
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 Crohn’s disease.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
The treatment of adult patients with moderately to severely active Crohn’s disease.
- 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 | December 13, 2024 |
|---|---|
| Call for patient/clinician input closed | February 18, 2025 |
| Submission received | January 31, 2025 |
| Submission accepted | February 14, 2025 |
| Review initiated | February 18, 2025 |
| Draft CADTH review report(s) provided to sponsor for comment | May 06, 2025 |
| Deadline for sponsors comments | May 15, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | June 13, 2025 |
| Expert committee meeting (initial) | June 25, 2025 |
| Draft recommendation issued to sponsor | July 08, 2025 To July 10, 2025 |
| Draft recommendation posted for stakeholder feedback | July 17, 2025 |
| End of feedback period | July 31, 2025 |
Last Updated : February 26, 2025