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

nivolumab and relatlimab

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Generic Name:
nivolumab and relatlimab
Project Status:
Complete
Therapeutic Area:
unresectable or metastatic melanoma
Manufacturer:
Bristol Myers Squibb
Call for patient/clinician input open:
Brand Name:
Opdualag
Project Line:
Reimbursement Review
Project Number:
PC0329-000
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:
Opdualag (nivolumab and relatlimab) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma who have not received prior systemic therapy for unresectable or metastatic melanoma.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Opdualag (nivolumab and relatlimab) is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma who have not received prior systemic therapy for unresectable or metastatic melanoma
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 open30-May-23
Call for patient/clinician input closed21-Jul-23
Clarification:

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

Submission received10-Jul-23
Submission accepted24-Jul-23
Review initiated25-Jul-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment19-Oct-23
Deadline for sponsors comments30-Oct-23
Canada's Drug Agency review report(s) and responses to comments provided to sponsor24-Nov-23
Expert committee meeting (initial)06-Dec-23
Draft recommendation issued to sponsor18-Dec-23
Draft recommendation posted for stakeholder feedback04-Jan-24
End of feedback period18-Jan-24
Final recommendation issued to sponsor and drug plans02-Feb-24
Final recommendation posted21-Feb-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)16-Feb-24
Canada's Drug Agency review report(s) posted01-May-24

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : May 7, 2024