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ocrelizumab

Last Updated: February 7, 2018
Result type: Reports
Project Number: SR0519-000
Product Line: Common Drug Review

Generic Name: ocrelizumab

Brand Name: Ocrevus

Manufacturer: Hoffman-La Roche Limited

Indications: multiple sclerosis, relapsing

Submission Type: New

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: November 21, 2017

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

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

Tags

multiple sclerosis, multiple sclerosis, relapsing-remitting, Multiple Sclerosis; Multiple sclerosis treatment