Last Updated : September 29, 2021
Details
FilesGeneric 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
NOC Status at Filing:
Pre NOC
Performance Metric:
Not applicable due to external delays - Application held awaiting decision by Health Canada
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:
- 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 open | 30-Sep-20 |
Call for patient/clinician input closed | 19-Nov-20 |
Clarification:
- Patient input submission received from Lung Cancer Canada |
|
Submission received | 29-Oct-20 |
Submission accepted | 12-Nov-20 |
Review initiated | 13-Nov-20 |
Draft Canada's Drug Agency review report(s) provided to sponsor for comment | 25-Feb-21 |
Deadline for sponsors comments | 08-Mar-21 |
Canada's Drug Agency responses on draft review report(s) provided to sponsor | 05-Apr-21 |
Expert committee meeting (initial) | 15-Apr-21 |
Draft recommendation issued to sponsor | 07-Jun-21 |
Draft recommendation posted for stakeholder feedback | 17-Jun-21 |
End of feedback period | 02-Jul-21 |
Final recommendation issued to sponsor and drug plans | 16-Jul-21 |
Final recommendation posted | 04-Aug-21 |
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s) | 30-Jul-21 |
Canada's Drug Agency review report(s) posted | 29-Sep-21 |
Files
Last Updated : September 29, 2021