idecabtagene vicleucel


( Last Updated : December 17, 2020)
Generic Name:
idecabtagene vicleucel
Project Status:
Active
Therapeutic Area:
Multiple myeloma
Manufacturer:
Celgene Inc., a Bristol Myers Squibb company
Brand Name:
Abecma
Project Line:
Reimbursement Review
Project Number:
PG0240-000
Tumour Type:
Myeloma
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who are refractory to their last treatment.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
For the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who are refractory to their last treatment.
  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 18, 2020
Call for patient/clinician input closedJanuary 15, 2021
Clarification:

- Patient input submission received from Myeloma Canada

Submission receivedDecember 16, 2020
Submission acceptedJanuary 07, 2021
Review initiatedJanuary 08, 2021
Draft CADTH review report(s) provided to sponsor for commentMarch 26, 2021
Deadline for sponsors commentsApril 07, 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 04, 2021
Draft recommendation posted for stakeholder feedbackJune 17, 2021
End of feedback periodJuly 02, 2021
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingOctober 13, 2021