guselkumab

Details

Files
Generic Name:
guselkumab
Project Status:
Complete
Therapeutic Area:
Psoriasis, moderate to severe plaque
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Tremfya
Project Line:
Reimbursement Review
Project Number:
SR0530-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
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 postedJuly 27, 2017
Patient group input closedSeptember 18, 2017

Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsSeptember 22, 2017
Patient group comments on input summary closedSeptember 29, 2017

Clarification:

- Patient input summary feedback received

Submission receivedAugust 25, 2017
Submission accepted for reviewSeptember 11, 2017
Review initiatedSeptember 12, 2017
Draft CDR review report(s) sent to applicantNovember 24, 2017
Comments from applicant on draft CDR review report(s) receivedDecember 05, 2017
Redaction requests from applicant on draft CDR review report(s) receivedDecember 12, 2017
CDR review team's comments on draft CDR review report(s) sent to applicantJanuary 05, 2018
Canadian Drug Expert Committee (CDEC) meetingJanuary 17, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJanuary 30, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedFebruary 13, 2018
CDEC Final Recommendation issued to applicant and drug plansFebruary 21, 2018
CDEC Final Recommendation postedFebruary 23, 2018
Final CDR review report(s) and patient input postedMarch 14, 2018