Last Updated : July 12, 2024
Details
FilesGeneric Name:
nivolumab
Project Status:
Active
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:
- 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 | 25-Sep-23 |
---|---|
Call for patient/clinician input closed | 21-Nov-23 |
Clarification: - Patient input submission received from Melanoma Canada, and Save Your Skin Foundation | |
Submission received | 06-Nov-23 |
Submission accepted | 21-Nov-23 |
Review initiated | 22-Nov-23 |
Draft CADTH review report(s) provided to sponsor for comment | 15-Feb-24 |
Deadline for sponsors comments | 27-Feb-24 |
CADTH review report(s) and responses to comments provided to sponsor | 28-Mar-24 |
Expert committee meeting (initial) | 10-Apr-24 |
Draft recommendation issued to sponsor | 22-Apr-24 |
Draft recommendation posted for stakeholder feedback | 02-May-24 |
End of feedback period | 16-May-24 |
Final recommendation issued to sponsor and drug plans | 29-May-24 |
Final recommendation posted | 14-Jun-24 |
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 12-Jun-24 |
CADTH review report(s) posted | - |
Files
Last Updated : July 12, 2024