Last Updated : July 10, 2018
Details
FilesGeneric Name:
dupilumab
Project Status:
Complete
Therapeutic Area:
atopic dermatitis
Manufacturer:
Sanofi-Genzyme
Brand Name:
Dupixent
Project Line:
Reimbursement Review
Project Number:
SR0533-000
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
atopic dermatitis
Recommendation Type:
Do not reimburse
Final Recommendation:
Key Milestones2 |
|
|---|---|
| Call for patient input posted | August 15, 2017 |
| Patient group input closed | October 04, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | November 16, 2017 |
| Patient group comments on input summary closed | November 21, 2017 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | October 27, 2017 |
| Submission accepted for review | November 10, 2017 |
| Review initiated | November 13, 2017 |
| Clarification:
- Submission temporarily suspended pending receipt of information - Additional information has been received and the temporary suspension of the review has been lifted |
|
| Draft CDR review report(s) sent to applicant | February 20, 2018 |
| Comments from applicant on draft CDR review report(s) received | March 01, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | March 08, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | March 29, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | April 11, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | April 24, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | May 15, 2018 |
| Clarification:
- Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested |
|
| Applicant's request for reconsideration placed on CDEC agenda | June 20, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | June 27, 2018 |
| CDEC Final Recommendation posted | July 09, 2018 |
| Final CDR review report(s) and patient input posted | July 10, 2018 |
Files
Last Updated : July 10, 2018