Last Updated : April 14, 2025
Details
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.
- 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.
| Call for patient/clinician input open | 11-Feb-25 |
|---|---|
| Call for patient/clinician input closed | 07-Apr-25 |
| Submission received | 26-Mar-25 |
| Submission accepted | 09-Apr-25 |
| Review initiated | 10-Apr-25 |
| Draft CADTH review report(s) provided to sponsor for comment | 26-Jun-25 |
| Deadline for sponsors comments | 08-Jul-25 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | 31-Jul-25 |
| Expert committee meeting (initial) | 13-Aug-25 |
| Draft recommendation issued to sponsor | August 25, 2025 To August 27, 2025 |
| Draft recommendation posted for stakeholder feedback | 04-Sep-25 |
| End of feedback period | 18-Sep-25 |
Last Updated : April 14, 2025