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Last Updated: December 7, 2018
Result type: Reports
Project Number: SR0569-000
Product Line: Reimbursement Review

Generic Name: rivaroxaban

Brand Name: Xarelto

Manufacturer: Bayer Inc.

Indications: Prevention of stroke and cardiovascular events in coronary and peripheral artery disease.

Manufacturer Requested Reimbursement Criteria1: For use in combination with low-dose ASA, for the prevention of stroke, myocardial infarction and cardiovascular death in patients with concomitant coronary artery disease (CAD) and peripheral artery disease (PAD).

Submission Type: New Indication

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: November 20, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule B

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedApril 25, 2018
Patient group input closedJune 14, 2018

- Patient input submission received from Cardiac Health Foundation

Patient input summary sent for review to patient input groupsJune 20, 2018
Patient group comments on input summary closedJune 27, 2018

- Patient input summary feedback received

Submission receivedMay 24, 2018
Submission accepted for reviewJune 07, 2018
Review initiatedJune 08, 2018
Draft CDR review report(s) sent to applicantAugust 23, 2018
Comments from applicant on draft CDR review report(s) receivedSeptember 04, 2018
Redaction requests from applicant on draft CDR review report(s) receivedSeptember 11, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantOctober 04, 2018
Canadian Drug Expert Committee (CDEC) meetingOctober 17, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansOctober 30, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedNovember 13, 2018
CDEC Final Recommendation issued to applicant and drug plansNovember 20, 2018
CDEC Final Recommendation postedNovember 22, 2018
Final CDR review report(s) and patient input postedJanuary 03, 2019