tocilizumab


( Last Updated : April 30, 2018)
Generic Name:
tocilizumab
Project Status:
Complete
Therapeutic Area:
Giant cell arteritis (GCA)
Manufacturer:
Hoffmann-La Roche Limited
Call for patient/clinician input open:
Brand Name:
Actemra
Project Line:
Reimbursement Review
Project Number:
SR0534-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC

Details

Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule B
Indications:
Giant cell arteritis (GCA)
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:

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

Files

Recommendation and Reasons

Clinical Report

Pharmacoeconomic Report

Patient Group Input Submissions