nivolumab

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Generic Name:
nivolumab
Project Status:
Complete
Therapeutic Area:
Urothelial carcinoma
Manufacturer:
Bristol Myers Squibb Canada
Brand Name:
Opdivo
Project Line:
Reimbursement Review
Project Number:
PC0272-000
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Opdivo is indicated as a monotherapy for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. A positive association was observed between tumor PD-L1 expression and the magnitude of the treatment benefit. An improvement in overall survival has not yet been established.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Genitourinary
Indications:
Opdivo is indicated as a monotherapy for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. A positive association was observed between tumor PD-L1 expression and the magnitude of the treatment benefit. An improvement in overall survival has not yet been established.
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 openJanuary 25, 2022
Call for patient/clinician input closedMarch 18, 2022
Clarification:

- Patient input submission received from Bladder Cancer Canada

Submission receivedFebruary 22, 2022
Submission acceptedMarch 10, 2022
Review initiatedMarch 11, 2022
Draft CADTH review report(s) provided to sponsor for commentMay 27, 2022
Deadline for sponsors commentsJune 07, 2022
CADTH review report(s) and responses to comments provided to sponsorJuly 28, 2022
Expert committee meeting (initial)August 10, 2022
Draft recommendation issued to sponsorAugust 23, 2022
Draft recommendation posted for stakeholder feedbackSeptember 01, 2022
End of feedback periodSeptember 16, 2022
Final recommendation issued to sponsor and drug plansSeptember 28, 2022
Final recommendation postedOctober 17, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)October 13, 2022
CADTH review report(s) postedDecember 23, 2022