Rivaroxaban (Xarelto®) for the prevention of atherothrombotic events

Assessment Status Assessment Process Complete
Drug Rivaroxaban
Brand Xarelto®
Indication For the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.
Assessment Process
Rapid review commissioned 26/09/2018
Rapid review completed 11/10/2018
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of Rivaroxaban compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 17/10/2018
Pre-submission consultation with Applicant 05/11/2018
Full submission received from Applicant 14/01/2019
Preliminary review sent to Applicant 18/01/2019
Follow-up to preliminary review sent to Applicant 01/02/2019
NCPE assessment re-commenced 28/02/2019
Factual accuracy sent to Applicant 07/05/2019
NCPE assessment re-commenced 17/05/2019
NCPE assessment completed 18/06/2019
NCPE assessment outcome The NCPE recommends that rivaroxaban + aspirin not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.

Technical Summary

This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has approved reimbursement following confidential price negotiations October 2022.