Generic Name: guselkumab
Brand Name: Tremfya
Manufacturer: Janssen Inc.
Therapeutic Area: Psoriasis, moderate to severe plaque
Indications: Psoriasis, moderate to severe plaque
Submission Type: Initial
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 |
|
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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 |