In final guidance, the National Institute for Health and Clinical Excellence (NICE) has recommended the use of Bayer HealthCare's Xarelto (rivaroxaban) as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF).
Xarelto, a once-daily oral anticoagulant, has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients with non-valvular AF who have one or more risk factors such as congestive heart failure, hypertension, age 75 or older, diabetes mellitus, prior stroke or transient ischaemic attack.
NICE's guidance states that the decision about whether to start treatment with Xarelto should be made after an informed discussion between the clinician and the person about the risks and benefits of the drug compared with warfarin. It also recommends that for people who are taking warfarin, the potential risks and benefits of switching to Xarelto should be considered in light of their level of international normalised ratio (INR)i control.
"We know that some people taking warfarin can find it difficult to maintain their blood clotting at a proper level. Rivaroxaban, like dabigatran etexilate [Boehringer Ingelheim's Pradaxa], which NICE recently approved as an option for this indication, can benefit people with AF," said Professor Carole Longson, director of NICE's health technology evaluation centre.
'We are therefore pleased to recommend rivaroxaban as another cost-effective option for the prevention of stroke and systemic embolism in people with atrial fibrillation," she added.
NICE’s recommendation was welcomed by John Camm, professor of clinical cardiology at St George's University of London, who described as "a further advance in antithrombotic care."
Not all AF patients are equal in terms of their stroke risk, he pointed out. "The availability of one tablet once-daily warfarin alternative which demonstrates a comparable efficacy and safety profile while removing the need for routine monitoring requirements is particularly important news for clinicians and their patients, including those patients who are poorly controlled with warfarin despite adherence to it, as well as those who are unable to tolerate it, or are subject to other factors which make warfarin use challenging," said Prof Camm.
AF affects 750,000 people in the UK and increases the risk of stroke by up to five times. An estimated 14% of all strokes are caused by AF and over 12,500 strokes in the UK are directly linked to the condition, says Bayer HealthCare, which adds that it is "delighted" with NICE's decision.
"Rivaroxaban has the potential to make a positive difference to NHS anticoagulation services by helping simplify clot prevention for AF patients, including those who are not currently achieving an adequate level of stroke protection with warfarin," said Luis-Felipe Graterol, medical director at Bayer HealthCare UK.
"We are committed to ensuring that rivaroxaban is available to eligible AF patients and we look forward to continuing our work with local NHS fundholders to help evolve services with this once-daily therapy," he added.