NICE recommends new treatment option for potentially fatal blood clotting disease
The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending rivaroxaban (Xarelto, Bayer Healthcare) as an option for treating pulmonary embolism (PE) and preventing recurrent deep vein thrombosis (DVT) and PE after acute PE in adults.
DVT occurs when a blood clot (thrombus) forms in the deep veins of the leg or pelvis. Blood flow through the affected vein can be limited by the clot, and it can cause swelling and pain in the leg. If the thrombus dislodges and travels to the lungs, this can lead to a potentially fatal pulmonary embolism (PE) when the clot blocks the blood supply to the lungs. Even if blood clots are not fatal, they can still result in long-term illness, including venous ulceration and development of a post-thrombotic limb (chronic pain, swelling and skin changes in the affected limb) and have a significant impact on quality of life.
Risk factors for DVT and PE include age over 60 years, recent surgery/serious injury, obesity, prolonged travel, acute medical illness, immobility and pregnancy. It is estimated that there will be over 50,000 cases of acute DVT in England and Wales each year by 2016, due largely to the aging population.
People with suspected PE are generally treated immediately with drugs that help to prevent the blood from clotting (anticoagulants), most commonly with injections of low molecular weight heparin (LMWH), and when the diagnosis has been confirmed, an oral anticoagulant such as warfarin. The length of treatment is based on individual risk of the DVT or PE recurring, as well as their risk of bleeding. The usual length of treatment in UK practice is 6 months or more. However, people who are at high risk of recurrence may be given indefinite treatment with anticoagulants to prevent further episodes.
Rivaroxaban is an orally administered anticoagulant. It has a UK marketing authorisation for the treatment of DVT and PE, and prevention of recurrent DVT and PE in adults.
Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "The Committee heard from the patient expert that the sometimes frequent monitoring and dose adjustment needed with warfarin, which require visits to hospital or GP appointments, can be costly and inconvenient, and means some people might have to take time off work. Also, because warfarin interacts with many other drugs, it may be unsuitable for people being treated for other conditions. In addition, the Committee heard that warfarin has various food interactions which often require people to adjust and monitor their diet and lifestyle. Rivaroxaban therefore represents a significant potential benefit for people with PE and DVT because it avoids the need to begin treatment with heparin and the subsequent transition to warfarin."
The guidance on rivaroxaban for pulmonary embolism is available on the NICE website (from 26 June). Please contact the press office for an embargoed copy of the guidance.
Notes to Editors
About the draft guidance
1. The draft guidance can be found from Friday 19 April on the NICE website
1. The closing date for appeal is 3 May 2013.
2. In all scenarios assessed for the 3-, 6- and 12-month treatment durations, rivaroxaban either remained dominant or the ICER compared with LMWH and a vitamin K antagonist could be considered a cost-effective use of NHS resources. The Committee concluded that rivaroxaban was cost effective for treating pulmonary embolism for 3, 6 or 12 months.
3. For lifelong treatment, the Committee concluded that the most plausible ICER for lifelong treatment was between £17,900 and £22,900 per QALY gained. The Committee concluded that rivaroxaban is a cost-effective treatment option for the lifelong treatment of pulmonary embolism and prevention of recurrent thromboembolism for people in whom long-term treatment is indicated.
4. Rivaroxaban costs £2.10 per 15 mg or 20 mg tablet ('British National Formulary' edition 65). The cost of treatment is estimated to be £235.86, £427.61 and £811.13 for 3, 6 and 12 months of treatment respectively. Costs may vary in different settings because of negotiated procurement discounts.
1. Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism(NICE technology appraisal 261) recommends rivaroxaban as an option for treating deep vein thrombosis and preventing recurrent deep vein thrombosis and pulmonary embolism after a diagnosis of acute deep vein thrombosis in adults.
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