Last Updated : April 13, 2023
Details
FilesGeneric 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:
- 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.
| Request for Advice received | July 15, 2022 |
|---|---|
| Manufacturer informed of request for advice | July 25, 2022 |
| Manufacturer information or comments due | August 09, 2022 |
| Request for Advice initiated | August 10, 2022 |
| Draft CADTH review report(s) sent to sponsor | October 06, 2022 |
| Deadline for sponsors comments | October 18, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | November 11, 2022 |
| Expert committee meeting (initial) | November 23, 2022 |
| Expert committee meeting (initial) | November 23, 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 18, 2023 |
| Final recommendation posted | February 06, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 02, 2023 |
| CADTH review report(s) posted | April 13, 2023 |
Files
Last Updated : April 13, 2023