Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

nivolumab

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Generic 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:
  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 open08-Jun-21
Call for patient/clinician input closed30-Jul-21
Clarification:

- Patient input submission received from My Gut Feeling - Stomach Cancer Foundation of Canada.

Submission received07-Jul-21
Submission accepted21-Jul-21
Review initiated22-Jul-21
Draft Canada's Drug Agency review report(s) provided to sponsor for comment12-Oct-21
Deadline for sponsors comments21-Oct-21
Canada's Drug Agency review report(s) and responses to comments provided to sponsor19-Nov-21
Expert committee meeting (initial)01-Dec-21
Draft recommendation issued to sponsor13-Dec-21
Draft recommendation posted for stakeholder feedback23-Dec-21
End of feedback period14-Jan-22
Final recommendation issued to sponsor and drug plans26-Jan-22
Final recommendation posted11-Feb-22
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)09-Feb-22
Canada's Drug Agency review report(s) posted28-Mar-22

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Last Updated : December 23, 2021