CDA | Evidence Driven
CDA | Evidence Driven

nivolumab

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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 open25-Sep-23
Call for patient/clinician input closed21-Nov-23
Clarification:

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

Submission received06-Nov-23
Submission accepted21-Nov-23
Review initiated22-Nov-23
Draft CADTH review report(s) provided to sponsor for comment15-Feb-24
Deadline for sponsors comments27-Feb-24
CADTH review report(s) and responses to comments provided to sponsor28-Mar-24
Expert committee meeting (initial)10-Apr-24
Draft recommendation issued to sponsor22-Apr-24
Draft recommendation posted for stakeholder feedback02-May-24
End of feedback period16-May-24

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Draft Recommendation View PDF
Last Updated : May 16, 2024