dupilumab

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Generic Name:
dupilumab
Project Status:
Complete
Therapeutic Area:
Asthma
Manufacturer:
Sanofi-aventis Canada Inc.
Call for patient/clinician input open:
Brand Name:
Dupixent
Project Line:
Reimbursement Review
Project Number:
SR0745-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As an add-on maintenance treatment in patients aged 6 to 12 years with severe asthma with a type 2 or eosinophilic phenotype characterized by: Symptoms that are not controlled despite optimal treatment, defined by the daily use of a medium or high dose ICS + 1 controller medication or high-dose ICS alone. EOS 150 or FeNO 20 or allergy driven asthma. Uncontrolled asthma having at least one severe exacerbation, defined by having experienced one or more hospitalization/emergency care visit OR treatment with a systemic corticosteroid (SCS, oral, or parenteral) in the past 12 months. A baseline assessment of asthma symptom control using a validated asthma control questionnaire must be completed prior to initiation of dupilumab treatment.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​As an add-on maintenance treatment in patients aged 6 years and older with severe asthma with a type 2/eosinophilic phenotype or oral corticosteroid-dependent asthma.
Date NOC Issued:
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input openMay 26, 2022
Call for patient/clinician input closedJuly 15, 2022
Clarification:

- Patient input submission received from Asthma Canada

Submission receivedJune 28, 2022
Submission acceptedJuly 13, 2022
Review initiatedJuly 14, 2022
Draft CADTH review report(s) provided to sponsor for commentOctober 05, 2022
Deadline for sponsors commentsOctober 17, 2022
CADTH review report(s) and responses to comments provided to sponsorNovember 11, 2022
Expert committee meeting (initial)November 23, 2022
Draft recommendation issued to sponsorDecember 07, 2022
Draft recommendation posted for stakeholder feedbackDecember 15, 2022
End of feedback periodJanuary 06, 2023
Final recommendation issued to sponsor and drug plansJanuary 20, 2023
Final recommendation postedFebruary 08, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 06, 2023
CADTH review report(s) postedApril 18, 2023