Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

isatuximab

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Generic 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:
  1. 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 open16-Jun-21
Call for patient/clinician input closed09-Aug-21
Clarification:

- Patient input submission received from Myeloma Canada

Submission received15-Jul-21
Submission accepted29-Jul-21
Review initiated30-Jul-21
Draft Canada's Drug Agency review report(s) provided to sponsor for comment20-Oct-21
Deadline for sponsors comments29-Oct-21
Canada's Drug Agency review report(s) and responses to comments provided to sponsor19-Nov-21
Expert committee meeting (initial)01-Dec-21
Draft recommendation issued to sponsor15-Dec-21
Draft recommendation posted for stakeholder feedback23-Dec-21
End of feedback period14-Jan-22
Final recommendation issued to sponsor and drug plans28-Jan-22
Final recommendation posted15-Feb-22
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)11-Feb-22
Canada's Drug Agency review report(s) posted08-Apr-22

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Patient Group Input Submissions View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : May 2, 2022