NICE backs Bayer's Xarelto in new stroke and heart attack prevention use

Bayer’s Xarelto (rivaroxaban) can be funded by the NHS to prevent strokes and heart attacks in high-risk adults with coronary artery disease, NICE has said.

In final draft guidance NICE recommended use of Xarelto at a dose of 2.5mg daily combined with aspirin, as an option for preventing atherothrombotic events in adults with coronary artery disease (CAD), or symptomatic peripheral artery disease (PAD), who are at high risk of ischaemic events.

NICE’s recommendation is based on evidence from the phase 3 COMPASS study, which was stopped early after meeting its primary efficacy endpoint.

The cost-effectiveness body has defined those at high risk of ischaemic events as patients aged 65 or over, with atherosclerosis in at least two vascular territories, or those with risk factors such as smoking, diabetes, kidney dysfunction, heart failure, or history of stroke.

NICE has been assessing Xarelto in an indication granted by the European Commission last year – it is already approved in Europe in a range of uses including prevention of venous thromboembolism after hip or knee replacement, and stroke prevention adults with atrial fibrillation and other risk factors.

NICE’s decision means that Xarelto is available to NHS patients ahead of any rival novel anticoagulant drugs in this indication.

Dr Derek Connolly, who worked on the COMPASS trial, noted that cardiovascular disease remains the biggest cause of years of life lost in the UK.

There have been few recent major new advances in management of CAD and PAD to protect patients against strokes and heart attacks.

Connolly added: “Rivaroxaban vascular dose in combination with aspirin is the first treatment of its kind for this patient population and this recommendation from NICE provides clinicians with an important additional option for treating patients at risk of major adverse cardiac events such as CV death, stroke or MI.”

The large reduction in events such as strokes outweighed an increase in major bleeding events seen in patients treated with Xarelto, he added.

The decision will also be passed on to health officials in Wales, who will likely grant funding on the country's devolved NHS in the coming months.