Last Updated : January 3, 2019
Details
FilesGeneric 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:
- 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 |
Files
Last Updated : January 3, 2019