Last Updated : January 3, 2023
Details
FilesGeneric 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:
- 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 open | January 25, 2022 |
| Call for patient/clinician input closed | March 18, 2022 |
| Clarification: - Patient input submission received from Bladder Cancer Canada | |
| Submission received | February 22, 2022 |
| Submission accepted | March 10, 2022 |
| Review initiated | March 11, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | May 27, 2022 |
| Deadline for sponsors comments | June 07, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | July 28, 2022 |
| Expert committee meeting (initial) | August 10, 2022 |
| Draft recommendation issued to sponsor | August 23, 2022 |
| Draft recommendation posted for stakeholder feedback | September 01, 2022 |
| End of feedback period | September 16, 2022 |
| Final recommendation issued to sponsor and drug plans | September 28, 2022 |
| Final recommendation posted | October 17, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | October 13, 2022 |
| CADTH review report(s) posted | December 23, 2022 |
Files
Last Updated : January 3, 2023