In final draft guidance published today (23 January) NICE has recommended Apixaban (Eliquis, Bristol-Myers Squibb and Pfizer), in accordance with its licensed indications, for the prevention of stroke and systemic embolism in some people with non-valvular atrial fibrillation. The draft guidance also recommends that the decision about whether to start treatment with apixiban should be made after an informed discussion about the risks and benefits of apixaban compared with warfarin, dabigatran etexilate and rivaroxaban, and in light of a person's current level of international normalised ratioi (INR) control if they are already taking warfarin.
Atrial fibrillation (AF) is the most common cardiac arrhythmia (irregular heart beat). It 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, however the risk of stroke can be substantially reduced by appropriate use of antithrombotic therapy such as warfarin.
Apixaban, which only received its license for this indication in November 2012, is an orally administered anticoagulant 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. Apixaban has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients with with non-valvular atrial fibrillation and one or more risk factors such as prior stroke or transient ischaemic attack, age 75 years or older, hypertension, diabetes mellitus, or symptomatic heart failure (New York Heart Association [NYHA] class 2 or higher)ii.
Commenting on NICE's draft recommendation, Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "Atrial fibrillation can be a distressing condition and people with it have an increased risk of suffering a stroke. Many people with the condition find it difficult to comply with the most commonly used antithrombotic, warfarin, because, among other things, its use requires regular monitoring of the blood's clotting properties and dose adjustments which can cause disruption and inconvenience. It also has multiple interactions with food, alcohol and drugs that can cause further inconvenience. The Appraisal Committee heard from patient experts that warfarin can have a greater impact on a person's quality of life than atrial fibrillation itself. Apixaban, like rivaroxaban and dabigatran etexilate, which NICE recently approved as options for this indication, has potential benefits for people with AF in these circumstances because it doesn't require such regular monitoring and dose adjustments.
Professor Longson continued: "From the evidence submitted, the Committee concluded that apixaban was more clinically effective than warfarin for the primary efficacy outcome of reducing stroke and systemic embolism. The Committee also noted that treatment with apixaban resulted in fewer bleeding events than warfarin, including a reduced rate of intracranial bleeding. The Committee recognised that intracranial bleeding has a high mortality rate and a large impact on a person's quality of life, and is the most feared bleeding outcome for people taking any type of anticoagulant."
NICE has not yet issued final guidance to the NHS. Registered consultees now have the opportunity to appeal the draft guidance. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.
Final guidance is likely to be published in February 2013.
Notes to Editors
i. A measure of how long it takes the blood to clot
ii. New York Heart Association (NYHA) classification of heart failure symptoms:
Class I - No limitations
Class II - Slight limitation of physical activity (symptomatically "mild" heart failure)
Class III - Marked limitation of physical activity (symptomatically "moderate" heart failure)
Class IV - Symptoms of heart failure are present even at rest (symptomatically "severe" heart failure)
About the draft guidance
1. The draft guidance is available (from 23 January) on the NICE website at TA275 .
2. The cost per day for both doses (2.5 mg and 5 mg twice daily) of apixaban (excluding VAT) is £2.20, and the annual cost is £803. Costs may vary in different settings because of negotiated procurement discounts.
3. The Committee concluded that apixaban had been shown to be cost-effective compared with warfarin, the most plausible ICER being less than £20,000 per QALY gained.
About atrial fibrillation and stroke
4. Atrial fibrillation (AF) is the most common heart rhythm disturbance and its main characteristic is an erratic and rapid heartbeat.
5. AF leads to deterioration in the mechanical function of the atria (the upper chambers of the heart which receive blood returning to it from other areas of the body) and prevents complete expulsion of blood, which can then become stagnant and form blood clots.
6. These clots can then travel throughout the body and cause systemic embolism if they become stuck in an artery and block blood flow. If a blood clot travels to the brain, it can cause stroke.
7. More than 20% of the 130,000 strokes that occur annually in England and Wales are attributed to atrial fibrillation. Approximately a third of people who have a stroke are likely to die within the first 10 days, about a third are likely to make a recovery within 1 month and about a third are likely to be left with disabilities needing rehabilitation.
8. 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.
9. 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
- social care - the Health and Social Care Act (2012) sets out a new responsibility for NICE to develop guidance and quality standards for social care. To reflect this new role, from 1 April 2013 NICE will be called the National Institute for Health and Care Excellence (NICE) and it will become a Non-Departmental Public Body.
10. NICE produces standards for patient care:
- quality standards - these describe high-priority areas for quality improvement in a defined care or service area
- 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
- CCG Outcomes Indicator Set (formerly known as COF) - NICE develops the potential clinical health improvement indicators to ensure quality of care for patients and communities served by the clinical commissioning groups (CCGs).
11. NICE provides advice and support on putting NICE guidance and standards into practice through itsimplementation 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.