NICE – final guidance on rivaroxaban in DVT

Br J Cardiol 2012;19:107–10 Leave a comment
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The National Institute for Health and Clinical Excellence (NICE) has issued its final appraisal determination (FAD) on the use of rivaroxaban, as an alternative to warfarin, for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT. 

Estimates suggest there will be more than 46,000 cases of acute DVT in England and Wales during 2012, which will rise to nearly 50,000 cases by 2016, due in part to the ageing population.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “For many people, using warfarin is difficult because of the need for regular monitoring with blood tests, dosing adjustments, and the need to be careful about their diet because of warfarin’s interaction with certain foods. Because rivaroxaban does not require frequent blood tests to monitor treatment it represents a potential benefit for many people who have had a DVT, particularly those who have risk factors for recurrence of venous thromboembolism (VTE) and who therefore need longer term treatment. We are pleased, therefore, to be able to recommend rivaroxaban as a cost-effective option for treating DVT and preventing recurrent VTE in adults”.

The EINSTEIN-DVT trial was the key trial supporting the clinical effectiveness of rivaroxaban in this indication. NICE considered the trial to reflect UK clinical practice.

Full guidance is available at

…and AF

NICE has also issued an FAD for rivaroaxaban in atrial fibrillation (AF) recommending it for NHS use in preventing stroke and systemic embolism in adult patients with non-valvular AF.

The guidance advises that the drug should be considered as a therapeutic option in non-valvular AF patients with one or more stroke risk factors. The published NICE final guidance will require NHS commissioners in England and Wales to list rivaroxaban on hospital formularies within 90 days, making it available for clinicians to prescribe for appropriate patients.

Read the guidance in full at