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brexucabtagene autoleucel

Last Updated: December 22, 2020
Result type: Reports
Project Number: PG0219-000
Product Line: Reimbursement Review

Generic Name: brexucabtagene autoleucel

Brand Name: TBC

Manufacturer: Gilead Sciences Canada Inc.

Therapeutic Area: Mantle cell lymphoma

Indications: For the treatment of adult patients with relapsed or refractory (r/r) mantle cell lymphoma (MCL) who have received treatment with a Bruton’s tyrosine kinase inhibitor (BTKi).

Manufacturer Requested Reimbursement Criteria1: For the treatment of adult patients with relapsed or refractory (r/r) mantle cell lymphoma (MCL) who have received treatment with a Bruton’s tyrosine kinase inhibitor (BTKi).

Submission Type: Initial

Tumour Type: Lymphoma

NOC Status at Filing: Pre NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule1: Schedule E

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input openNovember 20, 2020
Call for patient/clinician input closedJanuary 22, 2021
Clarification:

- Patient input submission received from Lymphoma Canada

Submission receivedDecember 18, 2020
Submission acceptedJanuary 11, 2021
Review initiatedJanuary 12, 2021
Draft CADTH review report(s) provided to sponsor for commentMarch 30, 2021
Deadline for sponsors commentsApril 09, 2021
CADTH responses on draft review report(s) provided to sponsorMay 03, 2021
Expert committee meeting (initial)May 14, 2021
Draft recommendation issued to sponsorMay 27, 2021
To
May 31, 2021
Draft recommendation posted for stakeholder feedback-