brexucabtagene autoleucel


( Last Updated : August 24, 2021)
Generic Name:
brexucabtagene autoleucel
Project Status:
Active
Therapeutic Area:
Mantle cell lymphoma
Manufacturer:
Gilead Sciences Canada Inc.
Brand Name:
Tecartus
Project Line:
Reimbursement Review
Project Number:
PG0219-000
Tumour Type:
Lymphoma
NOC Status at Filing:
Pre NOC

Details


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
Fee Schedule:
Schedule E
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).
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 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 sponsorJune 24, 2021
Clarification:

- pERC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.

Draft recommendation posted for stakeholder feedbackJuly 08, 2021
End of feedback periodJuly 22, 2021
Final recommendation issued to sponsor and drug plansAugust 06, 2021
Final recommendation postedAugust 24, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)August 20, 2021
CADTH review report(s) posted