CDA | Evidence Driven
CDA | Evidence Driven

dupilumab

Details

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Generic Name:
dupilumab
Project Status:
Complete
Therapeutic Area:
Atopic dermatitis, pediatrics
Manufacturer:
Sanofi-aventis Canada Inc.
Call for patient/clinician input open:
Brand Name:
Dupixent
Project Line:
Reimbursement Review
Project Number:
SR0774-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Treatment of patients aged 6 months to 12 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable, as per the Health Canada indication. * Note that the 12+ population has been reviewed and recommended by CADTH.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Indicated for the treatment of patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupilumab can be used with or without topical corticosteroids.
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 open28-Feb-23
Call for patient/clinician input closed24-Apr-23
Clarification:

- Patient input submission received from the Canadian Skin Patient Alliance (CSPA) & Eczéma Québec and Eczema Society of Canada

Submission received29-Mar-23
Submission accepted13-Apr-23
Review initiated14-Apr-23
Draft CADTH review report(s) provided to sponsor for comment06-Jul-23
Deadline for sponsors comments17-Jul-23
CADTH review report(s) and responses to comments provided to sponsor11-Aug-23
Expert committee meeting (initial)23-Aug-23
Draft recommendation issued to sponsor06-Sep-23
Draft recommendation posted for stakeholder feedback14-Sep-23
End of feedback period28-Sep-23
Final recommendation issued to sponsor and drug plans13-Oct-23
Final recommendation posted31-Oct-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)27-Oct-23
CADTH review report(s) posted12-Dec-23

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : December 13, 2023