CDA | Evidence Driven
CDA | Evidence Driven

rivaroxaban

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Generic Name:
rivaroxaban
Project Status:
Active
Therapeutic Area:
Venous thromboembolic events (VTE)
Manufacturer:
N/A
Call for patient/clinician input open:
Brand Name:
N/A
Project Line:
Reimbursement Review
Project Number:
SX0750-000 - SR0750-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Submission Type:
Non-sponsored Submission
Fee Schedule:
N/A
Indications:
Treatment of venous thromboembolic events (VTE) and prevention of VTE recurrence in term neonates, infants and toddlers, children and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
Key Milestones2
Call for patient/clinician input open14-Jul-22
Call for patient/clinician input closed02-Sep-22
Clarification:

- No patient input submission received

Call for industry input open14-Jul-22
Call for industry input closed02-Sep-22
Review initiated12-Oct-22
Expert committee meeting (initial)24-Aug-23
Draft recommendation posted for stakeholder feedback
End of feedback period

Files

Recommendation and Reason View PDF
FMEC Responses to Questions From the Drug Programs View PDF
Clinical Report View PDF
Stakeholder Input View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : November 2, 2023