Last Updated : May 2, 2022
Details
FilesGeneric Name:
isatuximab
Project Status:
Complete
Therapeutic Area:
Multiple myeloma
Manufacturer:
Sanofi Genzyme, a division of sanofi-aventis Canada Inc.
Brand Name:
Sarclisa
Project Line:
Reimbursement Review
Project Number:
PC0256-000
Tumour Type:
Myeloma
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with carfilzomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Myeloma
Indications:
In combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of 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.
Key Milestones2 | |
---|---|
Call for patient/clinician input open | 16-Jun-21 |
Call for patient/clinician input closed | 09-Aug-21 |
Clarification: - Patient input submission received from Myeloma Canada | |
Submission received | 15-Jul-21 |
Submission accepted | 29-Jul-21 |
Review initiated | 30-Jul-21 |
Draft CADTH review report(s) provided to sponsor for comment | 20-Oct-21 |
Deadline for sponsors comments | 29-Oct-21 |
CADTH review report(s) and responses to comments provided to sponsor | 19-Nov-21 |
Expert committee meeting (initial) | 01-Dec-21 |
Draft recommendation issued to sponsor | 15-Dec-21 |
Draft recommendation posted for stakeholder feedback | 23-Dec-21 |
End of feedback period | 14-Jan-22 |
Final recommendation issued to sponsor and drug plans | 28-Jan-22 |
Final recommendation posted | 15-Feb-22 |
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 11-Feb-22 |
CADTH review report(s) posted | 08-Apr-22 |
Files
Last Updated : May 2, 2022