Last Updated : June 15, 2020
Details
FilesGeneric Name:
dupilumab
Project Status:
Complete
Therapeutic Area:
atopic dermatitis
Manufacturer:
Sanofi Genzyme, a division of sanofi-aventis Canada Inc.
Call for patient/clinician input open:
Brand Name:
Dupixent
Project Line:
Reimbursement Review
Project Number:
SR0636-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
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:
Initial
Fee Schedule:
Schedule B
Indications:
atopic dermatitis
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 input posted | September 23, 2019 |
| Patient group input closed | November 12, 2019 |
| Clarification:
- Patient input submission received from Eczema Society of Canada -Canadian Skin Patient Alliance |
|
| Patient input summary sent for review to patient input groups | November 27, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Patient group comments on input summary closed | December 09, 2019 |
| Submission received | October 22, 2019 |
| Submission accepted | November 05, 2019 |
| Review initiated | November 06, 2019 |
| Draft CADTH review report(s) sent to sponsor | February 03, 2020 |
| Comments from sponsor on draft CADTH review report(s) received | February 12, 2020 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | March 06, 2020 |
| Canadian Drug Expert Committee (CDEC) meeting | March 18, 2020 |
| CDEC recommendation sent to sponsor and drug plans | March 31, 2020 |
| Embargo period ended | April 15, 2020 |
| CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans | April 22, 2020 |
| CDEC Final Recommendation posted | April 24, 2020 |
| Redaction requests from sponsor on draft CADTH review report(s) received | May 06, 2020 |
| Redacted CADTH review report(s) sent to sponsor and drug plans | May 19, 2020 |
| Validation of redacted CADTH review report(s) received | May 26, 2020 |
| Final CADTH review report(s) posted | June 11, 2020 |
Files
Last Updated : June 15, 2020