nivolumab

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.
  1. 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.
Key Milestones2
Call for patient/clinician input openSeptember 25, 2023
Call for patient/clinician input closedNovember 21, 2023
Clarification:

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

Submission receivedNovember 06, 2023
Submission acceptedNovember 21, 2023
Review initiatedNovember 22, 2023
Draft CADTH review report(s) provided to sponsor for commentFebruary 15, 2024
Deadline for sponsors commentsFebruary 27, 2024
CADTH review report(s) and responses to comments provided to sponsorMarch 28, 2024
Expert committee meeting (initial)April 10, 2024
Draft recommendation issued to sponsorApril 22, 2024
To
April 24, 2024
Draft recommendation posted for stakeholder feedbackMay 02, 2024
End of feedback periodMay 16, 2024