Last Updated : February 27, 2023
Details
FilesGeneric Name:
guselkumab
Project Status:
Complete
Therapeutic Area:
Psoriatic arthritis
Manufacturer:
Janssen Inc.
Brand Name:
Tremfya
Project Line:
Reimbursement Review
Project Number:
SR0733-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Tremfya (guselkumab injection) is indicated for the treatment of adult patients with active psoriatic arthritis. Tremfya can be used alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
Tremfya (guselkumab injection) is indicated for the treatment of adult patients with active psoriatic arthritis. Tremfya can be used alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).
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 | April 01, 2022 |
|---|---|
| Call for patient/clinician input closed | May 30, 2022 |
| Clarification: - Patient input submission received from Arthritis Consumer Experts, Canadian Arthritis Patient Alliance, Arthritis Society & CreakyJoints, Canadian Association of Psoriasis Patients (CAPP) and Canadian Psoriasis Network (CPN) | |
| Submission received | May 02, 2022 |
| Submission accepted | May 16, 2022 |
| Review initiated | May 17, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | August 09, 2022 |
| Deadline for sponsors comments | August 18, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | September 16, 2022 |
| Expert committee meeting (initial) | September 28, 2022 |
| Draft recommendation issued to sponsor | October 13, 2022 |
| Draft recommendation posted for stakeholder feedback | October 20, 2022 |
| End of feedback period | November 03, 2022 |
| Final recommendation issued to sponsor and drug plans | November 17, 2022 |
| Final recommendation posted | December 05, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | December 01, 2022 |
| CADTH review report(s) posted | February 27, 2023 |
Files
Last Updated : February 27, 2023