ocrelizumab


( Last Updated : March 1, 2018)
Generic Name:
ocrelizumab
Project Status:
Complete
Therapeutic Area:
multiple sclerosis, relapsing
Manufacturer:
Hoffman-La Roche Limited
Call for patient/clinician input open:
Brand Name:
Ocrevus
Project Line:
Reimbursement Review
Project Number:
SR0519-000
Call for patient/clinician input closed:

Details

Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
multiple sclerosis, relapsing
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:

Key Milestones2

Call for patient input posted3April 18, 2017
Patient group input closed3June 07, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJune 15, 2017
Patient group comments on input summary closedJune 22, 2017
Clarification:

- Patient input submission received

Submission receivedMay 16, 2017
Submission accepted for reviewMay 31, 2017
Review initiatedJune 01, 2017
Draft CDR review report(s) sent to applicantAugust 21, 2017
Comments from applicant on draft CDR review report(s) receivedAugust 30, 2017
Redaction requests from applicant on draft CDR review report(s) receivedSeptember 07, 2017
CDR review team's comments on draft CDR review report(s) sent to applicantOctober 05, 2017
Canadian Drug Expert Committee (CDEC) meetingOctober 18, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansOctober 31, 2017
Embargo4 period ended and validation of redacted CDR review report(s) receivedNovember 14, 2017
CDEC Final Recommendation issued to applicant and drug plansNovember 21, 2017
CDEC Final Recommendation posted5November 23, 2017
Final CDR review report(s) and patient input posted5December 15, 2017

Files

Recommendations and Reasons

Pharmacoeconomic Report

Clinical Report

Patient Group Input Submissions