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
Performance Metric:
Achieved
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 openAugust 10, 2022
Call for patient/clinician input closedSeptember 30, 2022
Clarification:

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

Submission receivedSeptember 15, 2022
Submission acceptedSeptember 29, 2022
Review initiatedOctober 03, 2022
Draft CADTH review report(s) provided to sponsor for commentDecember 19, 2022
Deadline for sponsors commentsJanuary 05, 2023
CADTH review report(s) and responses to comments provided to sponsorJanuary 26, 2023
Expert committee meeting (initial)February 08, 2023
Draft recommendation issued to sponsorFebruary 22, 2023
Draft recommendation posted for stakeholder feedbackMarch 02, 2023
End of feedback periodMarch 16, 2023
Final recommendation issued to sponsor and drug plansMarch 29, 2023
Final recommendation postedApril 17, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)April 13, 2023
CADTH review report(s) postedJune 09, 2023