Xarelto given thumbs up after extra data

Bayer HealthCare’s Xarelto (rivaroxaban) has been recommended in final draft guidance as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF).

NICE revised its original decision not to recommend the convenient pill after Bayer supplied requested additional evidence on the clinical and cost effectiveness of the medication.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said she was “pleased” additional information had been supplied enabling NICE to recommend the treatment.

It is estimated there are currently up to 700,000 people with AF in England and Wales. People with the condition are at a higher risk of developing blood clots and subsequent stroke.

However, the risk of stroke can be reduced by the appropriate use of antithrombotic therapy. Xarelto is the first in a class of drugs known as Factor Xa inhibitors, which act at a critical point in the blood-clotting process to prevent clots forming.

It 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 and has been demonstrated in a clinical study to be non-inferior to warfarin, the current standard of care.

Professor John Camm, Professor of Clinical Cardiology at St George’s University of London, welcomed its recommendation. He said: “This news could be particularly important for patients who require long-term or lifelong anticoagulation (for non-valvular AF) who may be seeking a simplified regimen.”

Final guidance is now expected as early as next month.

NICE recently published final guidance recommending the use of Pradaxa (dabigatran) – which recently had its UK price reduced by Boehringer Ingelheim – for the same indication.