Last Updated : January 29, 2025
Details
FilesGeneric Name:
nivolumab
Project Status:
Complete
Therapeutic Area:
Esophageal or gastroesophageal junction cancer
Manufacturer:
Bristol-Myers Squibb
Brand Name:
Opdivo
Project Line:
Reimbursement Review
Project Number:
PC0253-000
Tumour Type:
Head and Neck
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Opdivo (nivolumab) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer in patients who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT).
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Head and Neck
Indications:
Opdivo (nivolumab) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer in patients who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation/Report:
- 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 | June 08, 2021 |
|---|---|
| Call for patient/clinician input closed | July 30, 2021 |
| Clarification: - Patient input submission received from My Gut Feeling - Stomach Cancer Foundation of Canada. | |
| Submission received | July 07, 2021 |
| Submission accepted | July 21, 2021 |
| Review initiated | July 22, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | October 12, 2021 |
| Deadline for sponsors comments | October 21, 2021 |
| CADTH review report(s) and responses to comments provided to sponsor | November 19, 2021 |
| Expert committee meeting (initial) | December 01, 2021 |
| Draft recommendation issued to sponsor | December 13, 2021 |
| Draft recommendation posted for stakeholder feedback | December 23, 2021 |
| End of feedback period | January 14, 2022 |
| Final recommendation issued to sponsor and drug plans | January 26, 2022 |
| Final recommendation posted | February 11, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 09, 2022 |
| CADTH review report(s) posted | March 28, 2022 |
Files
Last Updated : January 29, 2025