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tocilizumab

Last Updated: April 30, 2018
Result type: Reports
Project Number: SR0534-000
Product Line: Common Drug Review

Generic Name: tocilizumab

Brand Name: Actemra

Manufacturer: Hoffmann-La Roche Limited

Indications: Giant cell arteritis (GCA)

Submission Type: New Indication

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 postedAugust 25, 2017
Patient group input closedOctober 17, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsOctober 23, 2017
Patient group comments on input summary closedOctober 30, 2017
Clarification:

- Patient input summary feedback received

Submission receivedSeptember 25, 2017
Submission accepted for reviewOctober 10, 2017
Review initiatedOctober 11, 2017
Draft CDR review report(s) sent to applicantDecember 21, 2017
Comments from applicant on draft CDR review report(s) receivedJanuary 09, 2018
Redaction requests from applicant on draft CDR review report(s) receivedJanuary 16, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantFebruary 08, 2018
Canadian Drug Expert Committee (CDEC) meetingFebruary 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansMarch 06, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedMarch 20, 2018
CDEC Final Recommendation issued to applicant and drug plansMarch 27, 2018
CDEC Final Recommendation postedMarch 29, 2018
Final CDR review report(s) and patient input postedApril 24, 2018

Tags

nervous system, giant cell arteritis, cardiovascular, giant cell arteritis