Last Updated : December 20, 2021
Details
FilesGeneric 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
Performance Metric:
Achieved
Biosimilar:
No
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:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2 | |
---|---|
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 | 02-Feb-22 |
Files
Last Updated : December 20, 2021