CDA | Evidence Driven
CDA | Evidence Driven

durvalumab and tremelimumab

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Generic Name:
durvalumab and tremelimumab
Project Status:
Complete
Therapeutic Area:
unresectable hepatocellular carcinoma
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Imfinzi and Imjudo
Project Line:
Reimbursement Review
Project Number:
PC0308-000
Call for patient/clinician input closed:
Tumour Type:
Endocrine
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Application held awaiting decision by Health Canada
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Imjudo (tremelimumab for injection) in combination with durvalumab is indicated for the first-line treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) who require systemic therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Imjudo (tremelimumab for injection) in combination with durvalumab is indicated for the first-line treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) who require systemic therapy.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 open17-Nov-22
Call for patient/clinician input closed13-Jan-23
Clarification:

- Patient input submission received from the Colorectal Cancer Resource & Action Network (CCRAN

Submission received15-Dec-22
Submission accepted06-Jan-23
Review initiated09-Jan-23
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

Draft CADTH review report(s) provided to sponsor for comment21-Jun-23
Deadline for sponsors comments30-Jun-23
CADTH review report(s) and responses to comments provided to sponsor27-Jul-23
Expert committee meeting (initial)09-Aug-23
Draft recommendation issued to sponsor22-Sep-23
Draft recommendation posted for stakeholder feedback05-Oct-23
End of feedback period20-Oct-23
Final recommendation issued to sponsor and drug plans03-Nov-23
Final recommendation posted22-Nov-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)20-Nov-23
CADTH review report(s) posted25-Jan-24

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : January 25, 2024