Last Updated : May 1, 2024
Details
FilesGeneric Name:
nivolumab and relatlimab
Project Status:
Complete
Therapeutic Area:
unresectable or metastatic melanoma
Manufacturer:
Bristol Myers Squibb
Call for patient/clinician input open:
Brand Name:
Opdualag
Project Line:
Reimbursement Review
Project Number:
PC0329-000
Call for patient/clinician input closed:
Tumour Type:
Skin & Melanoma
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Opdualag (nivolumab and relatlimab) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma who have not received prior systemic therapy for unresectable or metastatic melanoma.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Opdualag (nivolumab and relatlimab) is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma who have not received prior systemic therapy for unresectable or metastatic melanoma
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | May 30, 2023 |
|---|---|
| Call for patient/clinician input closed | July 21, 2023 |
| Clarification: - Patient input submission received from Melanoma Canada and Save Your Skin Foundation | |
| Submission received | July 10, 2023 |
| Submission accepted | July 24, 2023 |
| Review initiated | July 25, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | October 19, 2023 |
| Deadline for sponsors comments | October 30, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | November 24, 2023 |
| Expert committee meeting (initial) | December 06, 2023 |
| Draft recommendation issued to sponsor | December 18, 2023 |
| Draft recommendation posted for stakeholder feedback | January 04, 2024 |
| End of feedback period | January 18, 2024 |
| Final recommendation issued to sponsor and drug plans | February 02, 2024 |
| Final recommendation posted | February 21, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 16, 2024 |
| CADTH review report(s) posted | May 01, 2024 |
Files
Last Updated : May 1, 2024