NICE fast-tracks appraisal of drug to prevent blood clots after hip and knee surgery
The National Institute for Health and Care Excellence (NICE) has today (25 November) published final draft guidance recommending the use of apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) as an option for the prevention of venous thromboembolism in adults who have undergone planned total hip replacement or total knee replacement surgery.
Venous thromboembolism (VTE) is a term used to describe deep vein thrombosis (DVT) and pulmonary embolism (PE). When a blood clot forms in one of the deep veins in the leg, thigh, pelvis or arm it is known as a DVT. 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 (anticoagulant prophylaxis). During 2010 nearly 120,000 hip and knee replacements were carried out in England and Wales1. These procedures have a high risk of VTE and therefore require effective anticoagulation to protect patients from potentially fatal clots.
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Longson, NICE Health Technology Evaluation Centre Director, said: "We are pleased to have been able to produce final draft guidance on the use of apixaban just six months after it received its license for the prevention of VTE in patients who have undergone planned hip and knee surgery. People having this type of surgery are at risk of venous thromboembolism because of the nature of the trauma caused during surgery and because they need to remain inactive for a period of time after their operation. The NICE clinical guideline ‘Venous thromboembolism: reducing the risk' recommends that people having elective hip replacement or elective knee replacement surgery should be offered low molecular weight heparin, dabigatran etexilate, rivaroxaban or fondaparinux to prevent VTE. Although apixaban had only been directly compared with one of the options recommended by the clinical guideline - enoxaparin, a low molecular weight heparin - the committee was satisfied that apixaban is a clinically and cost effective option for preventing blood clots, alongside other effective treatments already recommended by NICE2."
1National Joint Registry Stats Online. Available at www.njrcentre.org.uk
2 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 draft guidance on apixaban is available at http://guidance.nice.org.uk/TA/Wave21/17
2. A deep vein thrombosis (DVT) occurs when a blood clot forms in a vein. The DVT usually forms in a deep leg vein, and can cause immobility (lack of movement). Deep leg veins are the larger 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. Without anticoagulant prophylaxis the prevalence of DVT ranges from 41 to 85% after elective knee surgery and from 42 to 57% after elective hip surgery. 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 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
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
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This page was last updated: 24 November 2011