nivolumab and ipilimumab

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Generic Name:
nivolumab and ipilimumab
Project Status:
Active
Therapeutic Area:
Unresectable or metastatic MSI-H or dMMR colorectal cancer
Manufacturer:
Bristol Myers Squibb Canada Co.
Call for patient/clinician input open:
Brand Name:
Opdivo and Yervoy
Project Line:
Reimbursement Review
Project Number:
PC0396-000
Call for patient/clinician input closed:
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Opdivo (nivolumab), in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Opdivo (nivolumab), in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
  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 openFebruary 11, 2025
Call for patient/clinician input closedApril 07, 2025
Submission receivedMarch 26, 2025
Submission acceptedApril 09, 2025
Review initiatedApril 10, 2025
Draft CADTH review report(s) provided to sponsor for commentJune 26, 2025
Deadline for sponsors commentsJuly 08, 2025
CDA-AMC review report(s) and responses to comments provided to sponsorJuly 31, 2025
Expert committee meeting (initial)August 13, 2025
Draft recommendation issued to sponsorAugust 25, 2025
To
August 27, 2025
Draft recommendation posted for stakeholder feedbackSeptember 04, 2025
End of feedback periodSeptember 18, 2025