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:
Resectable Non-Small Cell Lung Cancer
Manufacturer:
Bristol-Myers Squibb
Brand Name:
Opdivo
Project Line:
Reimbursement Review
Project Number:
PC0303-000
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Neoadjuvant treatment of adult patients with resectable NSCLC (tumours 4cm or node positive) when used in combination with platinum-doublet chemotherapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Neoadjuvant treatment of adult patients with resectable NSCLC (tumours ≥4cm or node positive) when used in combination with platinum-doublet chemotherapy.
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 openAugust 15, 2022
Call for patient/clinician input closedOctober 07, 2022
Clarification:

- Patient input submission received from Canadian Cancer Society, Lung Cancer Canada

Submission receivedSeptember 13, 2022
Submission acceptedSeptember 27, 2022
Review initiatedSeptember 28, 2022
Draft Canada's Drug Agency review report(s) provided to sponsor for commentDecember 15, 2022
Deadline for sponsors commentsJanuary 03, 2023
Canada's Drug Agency review report(s) and responses to comments provided to sponsorJanuary 26, 2023
Expert committee meeting (initial)February 08, 2023
Draft recommendation issued to sponsorFebruary 22, 2023
Draft recommendation posted for stakeholder feedbackMarch 02, 2023
End of feedback periodMarch 16, 2023
Final recommendation issued to sponsor and drug plansMarch 30, 2023
Final recommendation postedApril 18, 2023
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)April 14, 2023
Canada's Drug Agency review report(s) postedJuly 11, 2023

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : July 11, 2023