Last Updated : December 23, 2021
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
Performance Metric:
Achieved
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:
- 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 | 08-Jun-21 |
Call for patient/clinician input closed | 30-Jul-21 |
Clarification: - Patient input submission received from My Gut Feeling - Stomach Cancer Foundation of Canada. | |
Submission received | 07-Jul-21 |
Submission accepted | 21-Jul-21 |
Review initiated | 22-Jul-21 |
Draft CADTH review report(s) provided to sponsor for comment | 12-Oct-21 |
Deadline for sponsors comments | 21-Oct-21 |
CADTH review report(s) and responses to comments provided to sponsor | 19-Nov-21 |
Expert committee meeting (initial) | 01-Dec-21 |
Draft recommendation issued to sponsor | 13-Dec-21 |
Draft recommendation posted for stakeholder feedback | 23-Dec-21 |
End of feedback period | 14-Jan-22 |
Final recommendation issued to sponsor and drug plans | 26-Jan-22 |
Final recommendation posted | 11-Feb-22 |
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 09-Feb-22 |
CADTH review report(s) posted | 28-Mar-22 |
Files
Last Updated : December 23, 2021