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

brexucabtagene autoleucel

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Generic Name:
brexucabtagene autoleucel
Project Status:
Complete
Therapeutic Area:
Acute lymphoblastic leukemia
Manufacturer:
Gilead Sciences Canada, Inc.
Brand Name:
Tecartus
Project Line:
Reimbursement Review
Project Number:
PG0304-000
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
The indication filed for review with Health Canada is: for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
​The indication filed for review with Health Canada is: “for treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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 open10-Aug-22
Call for patient/clinician input closed30-Sep-22
Clarification:

- Patient input submission received from The Leukemia & Lymphoma Society of Canada.

Submission received15-Sep-22
Submission accepted29-Sep-22
Review initiated03-Oct-22
Draft CADTH review report(s) provided to sponsor for comment19-Dec-22
Deadline for sponsors comments05-Jan-23
CADTH review report(s) and responses to comments provided to sponsor26-Jan-23
Expert committee meeting (initial)08-Feb-23
Draft recommendation issued to sponsor22-Feb-23
Draft recommendation posted for stakeholder feedback02-Mar-23
End of feedback period16-Mar-23
Final recommendation issued to sponsor and drug plans29-Mar-23
Final recommendation posted17-Apr-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)13-Apr-23
CADTH review report(s) posted09-Jun-23

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic and Ethics combined Report View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : January 27, 2025