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Last Updated: November 27, 2018
Result type: Reports
Project Number: SR0546-000
Product Line: Reimbursement Review

Generic Name: cladribine

Brand Name: Mavenclad

Manufacturer: EMD Serono, a Division of EMD Inc., Canada

Therapeutic Area: Multiple Sclerosis, relapsing-remitting

Indications: Multiple Sclerosis, relapsing

Submission Type: Initial

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: October 24, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

Key Milestones2

Call for patient input postedNovember 03, 2017
Patient group input closedDecember 22, 2017

- Patient input submission received

Patient input summary sent for review to patient input groupsJanuary 09, 2018
Patient group comments on input summary closedJanuary 16, 2018

- Patient input summary feedback received

Submission receivedDecember 01, 2017
Submission accepted for reviewDecember 15, 2017
Review initiatedDecember 18, 2017
Draft CDR review report(s) sent to applicantMarch 28, 2018
Comments from applicant on draft CDR review report(s) receivedApril 09, 2018
Redaction requests from applicant on draft CDR review report(s) receivedApril 16, 2018

- Manufacturer waived the opportunity to request redactions

CDR review team's comments on draft CDR review report(s) sent to applicantMay 04, 2018
Canadian Drug Expert Committee (CDEC) meetingMay 16, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansMay 30, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedJuly 12, 2018

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested

Applicant's request for reconsideration placed on CDEC agendaOctober 17, 2018
CDEC Final Recommendation issued to applicant and drug plansOctober 24, 2018
CDEC Final Recommendation postedOctober 26, 2018
Final CDR review report(s) and patient input postedOctober 31, 2018