dupilumab

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Generic Name:
dupilumab
Project Status:
Complete
Therapeutic Area:
atopic dermatitis
Manufacturer:
Sanofi Genzyme, a division of sanofi-aventis Canada Inc.
Brand Name:
Dupixent
Project Line:
Reimbursement Review
Project Number:
SF0754-000
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of patients aged 12 years and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable and/or who are refractory to or ineligible for systemic immunosuppressant therapies (i.e., due to contraindications, intolerance, or need for long-term treatment).
Submission Type:
Request for Advice
Fee Schedule:
N/A
Indications:
Dupixent (dupilumab) is indicated for the treatment of patients aged 12 years 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.
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
Request for Advice receivedJuly 15, 2022
Manufacturer informed of request for adviceJuly 25, 2022
Manufacturer information or comments dueAugust 09, 2022
Request for Advice initiatedAugust 10, 2022
Draft CADTH review report(s) sent to sponsorOctober 06, 2022
Deadline for sponsors commentsOctober 18, 2022
CADTH review report(s) and responses to comments provided to sponsorNovember 11, 2022
Expert committee meeting (initial)November 23, 2022
Expert committee meeting (initial)November 23, 2022
Draft recommendation posted for stakeholder feedbackDecember 15, 2022
End of feedback periodJanuary 06, 2023
Final recommendation issued to sponsor and drug plansJanuary 18, 2023
Final recommendation postedFebruary 06, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 02, 2023
CADTH review report(s) postedApril 13, 2023