Canada’s Drug Agency | Drugs, Health Technologies and Systems.

nivolumab-ipilimumab

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Generic Name:
nivolumab-ipilimumab
Project Status:
Complete
Therapeutic Area:
Malignant Pleural Mesothelioma (MPM)
Manufacturer:
Bristol-Myers Squibb
Brand Name:
Opdivo-Yervoy
Project Line:
Reimbursement Review
Project Number:
PC0229-000
Tumour Type:
Lung
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation/Report:
  1. 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.
Key Milestones2
Call for patient/clinician input openSeptember 30, 2020
Call for patient/clinician input closedNovember 19, 2020
Clarification:

- Patient input submission received from Lung Cancer Canada

Submission receivedOctober 29, 2020
Submission acceptedNovember 12, 2020
Review initiatedNovember 13, 2020
Draft CADTH review report(s) provided to sponsor for commentFebruary 25, 2021
Deadline for sponsors commentsMarch 08, 2021
CADTH responses on draft review report(s) provided to sponsorApril 05, 2021
Expert committee meeting (initial)April 15, 2021
Draft recommendation issued to sponsorJune 07, 2021
Draft recommendation posted for stakeholder feedbackJune 17, 2021
End of feedback periodJuly 02, 2021
Final recommendation issued to sponsor and drug plansJuly 16, 2021
Final recommendation postedAugust 04, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)July 30, 2021
CADTH review report(s) postedSeptember 29, 2021

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Patient Group Input Submission View PDF
Clinician Input View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : January 29, 2025