Last Updated : September 12, 2024
Details
FilesGeneric Name:
teclistamab
Project Status:
Complete
Therapeutic Area:
Relapsed or refractory multiple myeloma
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Tecvayli
Project Line:
Reimbursement Review
Project Number:
PC0332-000
Call for patient/clinician input closed:
Tumour Type:
Myeloma
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Teclistamab injection is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Teclistamab injection is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
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 | July 20, 2023 |
|---|---|
| Call for patient/clinician input closed | September 11, 2023 |
| Clarification: - Patient input submission received from Myeloma Canada | |
| Submission received | August 31, 2023 |
| Submission accepted | October 04, 2023 |
| Clarification: - Submission was not accepted for review on 15 Sep 23 | |
| Review initiated | October 05, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | December 20, 2023 |
| Deadline for sponsors comments | January 08, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | February 02, 2024 |
| Expert committee meeting (initial) | February 14, 2024 |
| Draft recommendation issued to sponsor | February 28, 2024 |
| Draft recommendation posted for stakeholder feedback | March 07, 2024 |
| End of feedback period | March 22, 2024 |
| Final recommendation issued to sponsor and drug plans | April 08, 2024 |
| Final recommendation posted | April 24, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | April 22, 2024 |
| CADTH review report(s) posted | September 11, 2024 |
Files
Last Updated : September 12, 2024