brodalumab

Details

Files
Generic Name:
brodalumab
Project Status:
Complete
Therapeutic Area:
Psoriasis, moderate to severe plaque
Manufacturer:
Valeant Canada LP
Call for patient/clinician input open:
Brand Name:
Siliq
Project Line:
Reimbursement Review
Project Number:
SR0547-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Psoriasis, moderate to severe plaque
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:

Key Milestones2

Call for patient input postedNovember 08, 2017
Patient group input closedJanuary 04, 2018

Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJanuary 11, 2018
Patient group comments on input summary closedJanuary 18, 2018

Clarification:

- Patient input summary feedback received

Submission receivedDecember 14, 2017
Submission accepted for reviewJanuary 05, 2018
Review initiatedJanuary 08, 2018
Draft CDR review report(s) sent to applicantMarch 22, 2018
Comments from applicant on draft CDR review report(s) receivedApril 03, 2018
Redaction requests from applicant on draft CDR review report(s) receivedApril 10, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantMay 04, 2018
Canadian Drug Expert Committee (CDEC) meetingMay 16, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansMay 30, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedJune 13, 2018
CDEC Final Recommendation issued to applicant and drug plansJune 20, 2018
CDEC Final Recommendation postedJune 22, 2018
Final CDR review report(s) and patient input postedJuly 16, 2018