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ocrelizumab

Last Updated: May 9, 2018
Result type: Reports
Project Number: SR0542-000
Product Line: Common Drug Review

Generic Name: ocrelizumab

Brand Name: Ocrevus

Manufacturer: Hoffman-La Roche Limited

Indications: Primary progressive multiple sclerosis

Submission Type: New Indication

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: April 26, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule B

Key Milestones2

Call for patient input postedSeptember 27, 2017
Patient group input closedNovember 16, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsNovember 22, 2017
Patient group comments on input summary closedNovember 29, 2017
Clarification:

- Patient input summary feedback received

Submission receivedOctober 26, 2017
Submission accepted for reviewNovember 09, 2017
Review initiatedNovember 10, 2017
Draft CDR review report(s) sent to applicantFebruary 05, 2018
Comments from applicant on draft CDR review report(s) receivedFebruary 14, 2018
Redaction requests from applicant on draft CDR review report(s) receivedFebruary 22, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantMarch 09, 2018
Canadian Drug Expert Committee (CDEC) meetingMarch 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansApril 05, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedApril 19, 2018
CDEC Final Recommendation issued to applicant and drug plansApril 26, 2018
CDEC Final Recommendation postedApril 30, 2018
Final CDR review report(s) and patient input postedMay 08, 2018

Tags

multiple sclerosis, multiple sclerosis, chronic progressive, multiple sclerosis, relapsing-remitting, Ocrevus; ocrelizumab; PPMS; primary progressive multiple sclerosis