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guselkumab

Last Updated: April 5, 2018
Result type: Reports
Project Number: SR0530-000
Product Line: Common Drug Review

Generic Name: guselkumab

Brand Name: Tremfya

Manufacturer: Janssen Inc.

Indications: Psoriasis, moderate to severe plaque

Submission Type: New

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: February 21, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

Key Milestones2

Call for patient input posted July 27, 2017
Patient group input closed September 18, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groups September 22, 2017
Patient group comments on input summary closed September 29, 2017
Clarification:

- Patient input summary feedback received

Submission received August 25, 2017
Submission accepted for review September 11, 2017
Review initiated September 12, 2017
Draft CDR review report(s) sent to applicant November 24, 2017
Comments from applicant on draft CDR review report(s) received December 05, 2017
Redaction requests from applicant on draft CDR review report(s) received December 12, 2017
CDR review team's comments on draft CDR review report(s) sent to applicant January 05, 2018
Canadian Drug Expert Committee (CDEC) meeting January 17, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans January 30, 2018
Embargo period ended and validation of redacted CDR review report(s) received February 13, 2018
CDEC Final Recommendation issued to applicant and drug plans February 21, 2018
CDEC Final Recommendation posted February 23, 2018
Final CDR review report(s) and patient input posted March 14, 2018

Tags

dermatology, psoriasis, guselkumab; tremfya; psoriases