dupilumab


( Last Updated : August 10, 2021)
Generic Name:
dupilumab
Project Status:
Complete
Therapeutic Area:
Asthma
Manufacturer:
Sanofi Genzyme, a division of sanofi-aventis Canada Inc.
Brand Name:
Dupixent
Project Line:
Reimbursement Review
Project Number:
SR0667-000
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
Add-on maintenance treatment in patients aged 12 years and older with severe asthma with a type 2/eosinophilic phenotype or oral corticosteroid dependent asthma with the following characteristics: 2 or more clinically significant asthma exacerbations in the last 12 months AND Blood eosinophils 150/mcL; OR FeNO 25 ppb; OR Treatment with maintenance oral corticosteroids; OR Clinically allergen-driven asthma
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Dupixent is indicated as an add-on maintenance treatment in patients aged 12 years and older with severe asthma with a type 2/eosinophilic phenotype or oral corticosteroid-dependent asthma.
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 openOctober 29, 2020
Call for patient/clinician input closedDecember 17, 2020
Clarification:

- Patient input submission received from the Lung Health Foundation / Ontario Lung Association

Submission receivedNovember 26, 2020
Submission acceptedDecember 10, 2020
Review initiatedDecember 11, 2020
Draft CADTH review report(s) provided to sponsor for commentMarch 04, 2021
Deadline for sponsors commentsMarch 15, 2021
CADTH responses on draft review report(s) provided to sponsorApril 09, 2021
Expert committee meeting (initial)April 21, 2021
Draft recommendation issued to sponsorMay 05, 2021
Draft recommendation posted for stakeholder feedbackMay 13, 2021
End of feedback periodMay 28, 2021
Final recommendation issued to sponsor and drug plansJune 08, 2021
Final recommendation postedJune 24, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)June 22, 2021
CADTH review report(s) postedAugust 10, 2021