UK – NICE ‘ok’ for Bayer’s Xarelto

The National Institute for Health and Care Excellence (NICE) has published the final appraisal determination (FAD) for Xarelto (rivaroxaban).

The approval is for the indication of preventing atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) who are at high risk of ischaemic events, and is approved to be administered at a dose of 2.5 mg twice daily (BID) combined with aspirin (75-100 mg) once daily.

The approval is based on evidence from the COMPASS study, the largest Phase III study involving the drug, which showed that the combination statistically significantly reduced the risk of the composite of cardiovascular (CV) death, stroke or myocardial infarction (MI) by 24%.

The drug in question is an anticoagulant that targets Factor Xa, an enzyme which acts at a key point in the blood clotting process, inhibiting its ability to generate thrombin. Coronary artery disease patients who are at high risk of ischaemic events are defined by NICE as those aged 65 or over, patients with atherosclerosis in at least two vascular territories, or those presenting risk factors such as smoking, diabetes, kidney dysfunction, heart failure or a history of stroke…