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:
Stage IIB or IIC melanoma, adjuvant
Manufacturer:
Bristol Myers Squibb Canada
Call for patient/clinician input open:
Brand Name:
Opdivo
Project Line:
Reimbursement Review
Project Number:
PC0339-000
Call for patient/clinician input closed:
Tumour Type:
Skin & Melanoma
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Nivolumab, as monotherapy, for the adjuvant treatment of adult patients with Stage IIB or IIC melanoma following complete resection.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Opdivo, as monotherapy, is indicated for the adjuvant treatment of adult patients with Stage IIB or IIC melanoma following complete resection.
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 open25-Sep-23
Call for patient/clinician input closed21-Nov-23
Clarification:

- Patient input submission received from Melanoma Canada, and Save Your Skin Foundation

Submission received06-Nov-23
Submission accepted21-Nov-23
Review initiated22-Nov-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment15-Feb-24
Deadline for sponsors comments27-Feb-24
Canada's Drug Agency review report(s) and responses to comments provided to sponsor28-Mar-24
Expert committee meeting (initial)10-Apr-24
Draft recommendation issued to sponsor22-Apr-24
Draft recommendation posted for stakeholder feedback02-May-24
End of feedback period16-May-24
Final recommendation issued to sponsor and drug plans29-May-24
Final recommendation posted14-Jun-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)12-Jun-24
Canada's Drug Agency review report(s) posted26-Sep-24

Files

Recommendation and Reason View PDF
Clinical and Pharmacoeconomic Combined Report View PDF
Feedback on Draft Recommendation View PDF
Patient and Clinician Group input View PDF
Last Updated : September 26, 2024