Rivaroxaban

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Generic Name:
Rivaroxaban
Project Status:
Complete
Therapeutic Area:
Prevention of stroke and cardiovascular events in coronary and peripheral artery disease.
Manufacturer:
Bayer Inc.
Call for patient/clinician input open:
Brand Name:
Xarelto
Project Line:
Reimbursement Review
Project Number:
SR0569-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
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:
Initial
Fee Schedule:
Schedule B
Indications:
Prevention of stroke and cardiovascular events in coronary and peripheral artery disease.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input posted April 25, 2018
Patient group input closed June 14, 2018
Clarification:

- Patient input submission received from Cardiac Health Foundation

Patient input summary sent for review to patient input groups June 20, 2018
Patient group comments on input summary closed June 27, 2018
Clarification:

- Patient input summary feedback received

Submission received May 24, 2018
Submission accepted for review June 07, 2018
Review initiated June 08, 2018
Draft CDR review report(s) sent to applicant August 23, 2018
Comments from applicant on draft CDR review report(s) received September 04, 2018
Redaction requests from applicant on draft CDR review report(s) received September 11, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant October 04, 2018
Canadian Drug Expert Committee (CDEC) meeting October 17, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans October 30, 2018
Embargo period ended and validation of redacted CDR review report(s) received November 13, 2018
CDEC Final Recommendation issued to applicant and drug plans November 20, 2018
CDEC Final Recommendation posted November 22, 2018
Final CDR review report(s) and patient input posted January 03, 2019