guselkumab

Details

Files
Generic 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:
  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 openApril 01, 2022
Call for patient/clinician input closedMay 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 receivedMay 02, 2022
Submission acceptedMay 16, 2022
Review initiatedMay 17, 2022
Draft CADTH review report(s) provided to sponsor for commentAugust 09, 2022
Deadline for sponsors commentsAugust 18, 2022
CADTH review report(s) and responses to comments provided to sponsorSeptember 16, 2022
Expert committee meeting (initial)September 28, 2022
Draft recommendation issued to sponsorOctober 13, 2022
Draft recommendation posted for stakeholder feedbackOctober 20, 2022
End of feedback periodNovember 03, 2022
Final recommendation issued to sponsor and drug plansNovember 17, 2022
Final recommendation postedDecember 05, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)December 01, 2022
CADTH review report(s) postedFebruary 27, 2023