18 October 2019 - NICE has published the final appraisal determination for Xarelto (rivaroxaban).
The approval is for the indication of preventing atherothrombotic events in adult patients with coronary artery disease or symptomatic peripheral artery disease who are at high risk of ischaemic events, and is approved to be administered at a dose of 2.5 mg twice daily 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 death, stroke or myocardial infarction by 24%.