idecabtagene vicleucel


( Last Updated : December 20, 2021)
Generic Name:
idecabtagene vicleucel
Project Status:
Complete
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.
Recommendation Type:
Do not reimburse
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 open18-Nov-20
Call for patient/clinician input closed15-Jan-21
Clarification:

- Patient input submission received from Myeloma Canada

Submission received16-Dec-20
Submission accepted07-Jan-21
Review initiated08-Jan-21
Draft CADTH review report(s) provided to sponsor for comment26-Mar-21
Deadline for sponsors comments07-Apr-21
CADTH responses on draft review report(s) provided to sponsor03-May-21
Expert committee meeting (initial)14-May-21
Draft recommendation issued to sponsor04-Jun-21
Draft recommendation posted for stakeholder feedback17-Jun-21
End of feedback period02-Jul-21
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting13-Oct-21
Final recommendation issued to sponsor and drug plans27-Oct-21
Final recommendation posted12-Nov-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)10-Nov-21
CADTH review report(s) posted02-Feb-22