Last Updated : November 21, 2024
Details
FilesGeneric Name:
ciltacabtagene autoleucel
Project Status:
Active
Therapeutic Area:
Relapsed or refractory multiple myeloma
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Carvykti
Project Line:
Reimbursement Review
Project Number:
PG0361-000
Call for patient/clinician input closed:
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 1 to 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
• For the treatment of adult patients with multiple myeloma, who have received 1 to 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide.• For the treatment of adult patients with multiple myeloma, who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and who are refractory to their last treatment.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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.
| Call for patient/clinician input open | March 06, 2024 |
|---|---|
| Call for patient/clinician input closed | April 30, 2024 |
| Clarification: - Patient input submission received from Myeloma Canada | |
| Submission received | April 18, 2024 |
| Submission accepted | May 03, 2024 |
| Review initiated | May 06, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | July 24, 2024 |
| Deadline for sponsors comments | August 02, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | August 29, 2024 |
| Expert committee meeting (initial) | September 11, 2024 |
| Draft recommendation issued to sponsor | September 24, 2024 |
| Draft recommendation posted for stakeholder feedback | October 03, 2024 |
| End of feedback period | October 18, 2024 |
| Final recommendation issued to sponsor and drug plans | November 01, 2024 |
| Final recommendation posted | November 20, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 18, 2024 |
| CADTH review report(s) posted | - |
Files
Last Updated : November 21, 2024