UK’s NICE recommends second new anticoagulant for atrial fibrillation


Following its recent recommendation for dabigatran (Pradaxa, Boehringer Ingelheim), the UK’s National Institute for Health and Clinical Excellence (NICE) now recommends rivaroxaban (Xarelto, Bayer) as an option for preventing stroke and systemtic embolism in patients with non-valvular atrial fibrillation.

In final draft guidance, after receiving requested further evidence about rivaroxaban’s clinical and cost effectiveness from its manufacturer Bayer, NICE states that the Factor Xa inhibitor can be used in patients with non-valvular atrial fibrillation who have one or more risk factors for stroke (such as congestive heart failure). Similar to its recommendations for dabigatran, NICE advises that the decision to start treatment with rivaroxaban should be made after an informed discussion between the treating physician and the patient about the risks and benefits of the drug compared with warfarin. NICE also states that patients who are already receiving warfarin should review, with their treating clinician, the potential risks and benefits of switching from warfarin to rivaroxaban in the light of their INR level.

Professor Carole Longson, NICE Health Technology Evaluation Centre director, said: “We are pleased to say that the additional information and analysis received from the manufacturer following our initial draft has enabled us to recommend rivaroxaban as a cost-effective option for the prevention of stroke and systemic embolism in people with atrial fibrillation.”

Earlier this year, the Scottish Medicines Consortium published guidance that stated that rivaroxaban can be used in patients who have poor INR control despite being concordant with their warfarin regimen and in patients who are not able to tolerate warfarin.

Keith Fox, professor of Cardiology, Centre for Cardiovascular Science, University of Edinburgh, Scotland, and co-chair of ROCKET-AF (the key study for rivaroxaban), said: “There are many patients with atrial fibrillation and who have a risk of stroke who currently are not treated with warfarin or any other anti-coagulant. Rivaroxaban now presents a new oral once a day treatment option with reduced risks of intracerebral bleeding compared to warfarin”.