idecabtagene vicleucel


( Last Updated : November 12, 2021)
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.
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 Milestones

Call for patient/clinician input open 18-Nov-20
Call for patient/clinician input closed 15-Jan-21
Clarification:

- Patient input submission received from Myeloma Canada

Submission received 16-Dec-20
Submission accepted 07-Jan-21
Review initiated 08-Jan-21
Draft CADTH review report(s) provided to sponsor for comment 26-Mar-21
Deadline for sponsors comments 07-Apr-21
CADTH responses on draft review report(s) provided to sponsor 03-May-21
Expert committee meeting (initial) 14-May-21
Draft recommendation issued to sponsor 04-Jun-21
Draft recommendation posted for stakeholder feedback 17-Jun-21
End of feedback period 02-Jul-21
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting 13-Oct-21
Final recommendation issued to sponsor and drug plans 27-Oct-21
Final recommendation posted 12-Nov-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) 10-Nov-21
CADTH review report(s) posted