Last Updated : April 18, 2023
Details
FilesGeneric 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
Performance Metric:
Achieved
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:
- 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.
| Call for patient/clinician input open | May 26, 2022 |
|---|---|
| Call for patient/clinician input closed | July 15, 2022 |
| Clarification: - Patient input submission received from Asthma Canada | |
| Submission received | June 28, 2022 |
| Submission accepted | July 13, 2022 |
| Review initiated | July 14, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | October 05, 2022 |
| Deadline for sponsors comments | October 17, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | November 11, 2022 |
| Expert committee meeting (initial) | November 23, 2022 |
| Draft recommendation issued to sponsor | December 07, 2022 |
| Draft recommendation posted for stakeholder feedback | December 15, 2022 |
| End of feedback period | January 06, 2023 |
| Final recommendation issued to sponsor and drug plans | January 20, 2023 |
| Final recommendation posted | February 08, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 06, 2023 |
| CADTH review report(s) posted | April 18, 2023 |
Files
Last Updated : April 18, 2023