brexucabtagene autoleucel


( Last Updated : May 4, 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

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).
  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 open November 20, 2020
Call for patient/clinician input closed January 22, 2021
Clarification:

- Patient input submission received from Lymphoma Canada

Submission received December 18, 2020
Submission accepted January 11, 2021
Review initiated January 12, 2021
Draft CADTH review report(s) provided to sponsor for comment March 30, 2021
Deadline for sponsors comments April 09, 2021
CADTH responses on draft review report(s) provided to sponsor May 03, 2021
Expert committee meeting (initial) May 14, 2021
Draft recommendation issued to sponsor June 24, 2021
Clarification:

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

Draft recommendation posted for stakeholder feedback July 08, 2021
End of feedback period July 22, 2021