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 |
|
|---|---|
| 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 |