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NICE approves new drug to prevent blood clots after hip and knee surgery
London, UK (January 23, 2012) – The National Institute for Health and Clinical Excellence (NICE), the healthcare guidance body, has today (25 January 2012) published final guidance recommending the use of apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) as an option for the prevention of venous thromboembolism (VTE) in adults who have undergone planned total hip replacement or total knee replacement surgery.
Elective hip and knee replacement surgery has a high risk of VTE and therefore patients require effective anticoagulation to prevent potentially fatal clots. Without anticoagulant prophylaxis, the incidence of deep vein thrombosis (DVT) ranges from 41 to 85% after elective knee surgery to 42 to 57% after elective hip surgery. The blood clot itself is not life threatening,and more often than not does not cause any symptoms. However, if it comes loose it can be carried in the blood to another part of the body where it can cause problems. If the blood clot reaches the lungs (pulmonary embolism) it can be fatal. VTE is preventable with correct use of prevention strategies, including the use of anticoagulant drugs given shortly after surgery.
Apixaban 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. Apixaban should be given shortly after surgery and for a few weeks after this to help prevent VTE.
Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "VTE is often difficult to spot because patients may not always have symptoms to give a warning. Even if a blood clot does not come loose, it can still cause long-term damage to the veins – for example, ‘post-thrombotic syndrome‘ may develop up to two years following DVT, causing chronic swelling and ulceration of the legs. Apixaban has been shown to be a clinically and cost effective option for preventing blood clots following elective hip and knee replacement surgery. We are therefore pleased to be able to recommend its use in the NHS in England and Wales alongside other effective treatments already approved by NICE1."
1 Technology Appraisal No 157, September 2008. Dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults.
Technology Appraisal No 170, April 2009. Rivaroxaban for the prevention of venous thromboembolism after total hip or total knee replacement in adults.
Notes to Editors
1. The final guidance on apixaban is available at www.nice.org.uk/TA245
2. A deep vein thrombosis (DVT) occurs when a blood clot forms in a vein – usually one of the larger deep leg veins that run through the muscles of the calf or thigh. A DVT can form across all, or part, of the width of the vein, which can block blood flow either completely or partially.
3. According to the National Joint Registry, during 2010 nearly 120,000 hip and knee replacements were carried out in England and Wales. The prevalence of DVT with PE is up to 0.9 to 28% in hip replacement and up to 1.5 to 10% in knee replacement.
4. Apixaban costs £17.15, £34.30 and £102.90 for packs of 10, 20 and 60 tablets respectively excluding VAT (NHS list price as reported by the manufacturer). The cost of treatment is estimated to be £41.16 (based on 12 days‘ treatment) for knee replacement surgery and £116.62 for hip replacement surgery (based on 34 days‘ treatment). Costs may vary in different settings because of negotiated procurement discounts.
5. The National Institute for Health and Clinical 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
6. 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.
7. 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
8. 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.