Last Updated : August 10, 2021
Details
FilesGeneric 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
Performance Metric:
Achieved
Biosimilar:
No
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:
- 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 open | October 29, 2020 |
| Call for patient/clinician input closed | December 17, 2020 |
| Clarification: - Patient input submission received from the Lung Health Foundation / Ontario Lung Association | |
| Submission received | November 26, 2020 |
| Submission accepted | December 10, 2020 |
| Review initiated | December 11, 2020 |
| Draft CADTH review report(s) provided to sponsor for comment | March 04, 2021 |
| Deadline for sponsors comments | March 15, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | April 09, 2021 |
| Expert committee meeting (initial) | April 21, 2021 |
| Draft recommendation issued to sponsor | May 05, 2021 |
| Draft recommendation posted for stakeholder feedback | May 13, 2021 |
| End of feedback period | May 28, 2021 |
| Final recommendation issued to sponsor and drug plans | June 08, 2021 |
| Final recommendation posted | June 24, 2021 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | June 22, 2021 |
| CADTH review report(s) posted | August 10, 2021 |
Files
Last Updated : August 10, 2021