CDA | Evidence Driven
CDA | Evidence Driven

durvalumab

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Generic Name:
durvalumab
Project Status:
Complete
Therapeutic Area:
Biliary tract cancer
Manufacturer:
AstraZeneca Canada Inc.
Brand Name:
Imfinzi
Project Line:
Reimbursement Review
Project Number:
PC0296-000
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with gemcitabine-based chemotherapy is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (BTC)
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Gastrointestinal
Indications:
In combination with gemcitabine-based chemotherapy is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (BTC)
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 openJune 14, 2022
Call for patient/clinician input closedAugust 08, 2022
Submission receivedJuly 14, 2022
Review initiatedJuly 29, 2022
Draft CADTH review report(s) provided to sponsor for commentOctober 21, 2022
Deadline for sponsors commentsNovember 01, 2022
CADTH review report(s) and responses to comments provided to sponsorNovember 29, 2022
Expert committee meeting (initial)December 07, 2022
Draft recommendation issued to sponsorDecember 20, 2022
Draft recommendation posted for stakeholder feedbackJanuary 05, 2023
End of feedback periodJanuary 19, 2023
Final recommendation issued to sponsor and drug plansFebruary 03, 2023
Final recommendation postedFebruary 22, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 17, 2023
CADTH review report(s) postedApril 27, 2023

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : May 1, 2023