Last Updated : April 30, 2018
Details
FilesGeneric 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
Performance Metric:
Achieved
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
Last Updated : April 30, 2018