dupilumab


( Last Updated : July 10, 2018)
Generic 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

Details


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