Rivaroxaban (Xarelto®) for the prevention of atherothrombotic complications in adult patients with coronary artery disease
The National Health Care Institute carried out an assessment of medicinal product rivaroxaban (Xarelto®). The manufacturer requested to extend the existing List 2 conditions. Rivaroxaban is available in the form of 2.5 mg, 10 mg, 15 mg and 20 mg film-coated tablets. This product is already included in the Medicine Reimbursement System (GVS) for use in the prevention of thrombosis in elective knee and hip surgery and for use in the prevention of cerebrovascular accidents (CVA) and systemic embolisms in adults with non-valvular atrium fibrillation. Rivaroxaban is also included in the GVS for the prevention of atherothrombotic complications in adult patients after an acute coronary syndrome (ACS) and for the indication venous thromboembolism (VTE). List 2 conditions apply for these indications.
Registered indication
The manufacturer requested to extend the existing List 2 conditions for rivaroxaban, administered simultaneously with acetylsalicylic acid (ASA), for the prevention of atherothrombotic complications in adult patients with coronary artery disease (CAD) or symptomatic peripheral arterial disorder (PAD) with a high risk of ischaemic events. The recommended dose amounts to 2.5 mg twice daily.
The National Health Care Institute's advice
Rivaroxaban is already included on List 1A. According to the GVS system, this implies a therapeutic added value and a sufficiently substantiated cost-effectiveness analysis, and the National Health Care Institute advises the Minister to extend rivaroxaban's List 2 conditions and stipulate the following condition. Extending with this specific condition will result in additional costs.
Condition
Only for an insured person aged eighteen or older:
5. who relies on this drug in combination with acetylsalicylic acid for the preventive treatment of atherothrombotic complications in patients with coronary artery disease (CAD) or symptomatic peripheral arterial disorder (PAD) with an increased risk of ischaemic events.