Last Updated : April 23, 2024
Details
Generic 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
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.
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | September 25, 2023 |
|---|---|
| Call for patient/clinician input closed | November 21, 2023 |
| Clarification: - Patient input submission received from Melanoma Canada, and Save Your Skin Foundation | |
| Submission received | November 06, 2023 |
| Submission accepted | November 21, 2023 |
| Review initiated | November 22, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | February 15, 2024 |
| Deadline for sponsors comments | February 27, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | March 28, 2024 |
| Expert committee meeting (initial) | April 10, 2024 |
| Draft recommendation issued to sponsor | April 22, 2024 |
| Draft recommendation posted for stakeholder feedback | May 02, 2024 |
| End of feedback period | May 16, 2024 |
Last Updated : April 23, 2024