nivolumab-ipilimumab

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Generic Name:

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:

N/A delay outside our control - Application held awaiting decision by Health Canada

Biosimilar:

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:

August 4, 2021

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 CADTH review report(s) provided to sponsor for comment	25-Feb-21
Deadline for sponsors comments	08-Mar-21
CADTH 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 CADTH review report(s)	30-Jul-21
CADTH review report(s) posted	29-Sep-21