Following the receipt of further evidence from Bayer HealthCare of the clinical and cost effectiveness of its drug rivaroxaban (Xarelto), NICE has published final draft guidance recommending rivaroxaban as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation.

Atrial fibrillation (AF) occurs when the electrical impulses controlling the heart rhythm become disorganised, so that the heart beats irregularly and, occasionally, too fast and so cannot efficiently pump blood around the body. People with AF are at higher risk of developing blood clots and subsequent stroke (with an approximately five-fold greater risk than that of people without AF) because the erratic heart rhythm of AF causes turbulent blood flow within the heart chambers. However, the risk of stroke can be substantially reduced by appropriate use of antithrombotic therapy, such as warfarin.

Rivaroxaban is an orally administered drug that helps to prevent blood from clotting. It does this by stopping a substance called Factor Xa from working. Factor Xa is necessary in the formation of thrombin and fibrin, the key components in blood clot formation. Rivaroxaban has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation who have one or more risk factors such as congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, prior stroke or transient ischaemic attack.

The draft guidance states that the decision about whether to start treatment with rivaroxaban should be made after an informed discussion between the clinician and the person about the risks and benefits of rivaroxaban compared with warfarin. It also recommends that for people who are taking warfarin, the potential risks and benefits of switching to rivaroxaban should be considered in light of their level of international normalised ratio (INR)ⁱ control.

Commenting on NICE's draft recommendation, Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “We know that people taking warfarin can find it difficult to maintain their blood clotting at a proper level and are often not within the target therapeutic range. For example, older people with atrial fibrillation and comorbidities are more likely to have poorly controlled clotting and may be at an increased risk of stroke or bleeding. Rivaroxaban, like dabigatran etexilate, which NICE recently approved as an option for this indication, can benefit people with AF in these circumstances because it doesn't require such regular monitoring and dose adjustments.

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

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.

Ends

Notes to Editors

References and explanation of terms

i. A standardised laboratory measure of blood coagulation used to monitor the adequacy of anticoagulation in patients who are having treatment with a vitamin K antagonist (eg warfarin)

About the draft guidance

1. The draft guidance is available (from 30 March) on the NICE website at TA256. Please contact the NICE press office for an embargoed copy of the draft guidance.

2. Estimates suggest that as many as 700,000 people have AF in England and Wales.

3. The Appraisal Committee noted the ICER of £2,900 from the manufacturer (which including disutility associated with warfarin and warfarin monitoring costs of £580) and £29,500 from the ERG (which excluded disutility associated with warfarin and reduced warfarin monitoring costs of £242) presented by the manufacturer and ERG respectively. The Committee agreed that given that there could be some degree of utility decrement associated with treatment with warfarin and that the estimate of annual anticoagulation monitoring costs of £242 was likely to be conservative, the ICER for rivaroxaban compared with warfarin would be no more than £29,537 per QALY gained and would lie somewhere between £2,900 and £29,537 per QALY gained. The Committee therefore concluded that the most plausible ICER for the whole population eligible for rivaroxaban was within the range which could be considered a cost-effective use of NHS resources.

4. The provisional cost to the NHS of rivaroxaban is £2.10 per day and £766.50 annually. Costs may vary in different settings because of negotiated procurement discounts.

5. On 15 March NICE published its final guidance recommending dabigatran for the same indication.

6. The Scottish Medicines Consortium published guidance in February 2012 accepting rivaroxaban for use in patients who have poor INR control despite evidence that they are complying with a coumarin anticoagulant [such as warfarin] and in patients who are allergic to or unable to tolerate coumarin anticoagulants.

7. NICE is also appraising rivaroxaban for the treatment of deep vein thrombosis (DVT) and preventing recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults (see: TA261) and for the prevention of VTE in people hospitalised for acute medical conditions (see: /guidance/indevelopment/GID-TAWave263).

8. NICE has recommended rivaroxaban for the prevention of venous thromboembolism in adults having elective total hip replacement surgery or elective total knee replacement surgery.(See: TA170)

About NICE

9. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

10. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

11. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

12. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.