Generic Name: tocilizumab
Brand Name: Actemra
Manufacturer: Hoffmann-La Roche Limited
Therapeutic Area: Giant cell arteritis (GCA)
Indications: Giant cell arteritis (GCA)
Submission Type: Initial
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: March 27, 2018
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule B
Key Milestones2 | |
|---|---|
| Call for patient input posted | August 25, 2017 |
| Patient group input closed | October 17, 2017 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | October 23, 2017 |
| Patient group comments on input summary closed | October 30, 2017 |
| Clarification: - Patient input summary feedback received | |
| Submission received | September 25, 2017 |
| Submission accepted for review | October 10, 2017 |
| Review initiated | October 11, 2017 |
| Draft CDR review report(s) sent to applicant | December 21, 2017 |
| Comments from applicant on draft CDR review report(s) received | January 09, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | January 16, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | February 08, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | February 21, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | March 06, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | March 20, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | March 27, 2018 |
| CDEC Final Recommendation posted | March 29, 2018 |
| Final CDR review report(s) and patient input posted | April 24, 2018 |