Regulatory Focus™ > News Articles > UK: New Anti-clotting Drug Cleared for NHS Use

UK: New Anti-clotting Drug Cleared for NHS Use

Posted 26 July 2012 | By Louise Zornoza

According to final guidance issued 25 July by the National Institute of Health and Clinical Excellence (NICE) -- the UK's health technology assessment entity -- Bayer's Xarelto (rivaroxaban) has been cleared for use by the National Health Service (NHS) for treatment of deep vein thrombosis (DVT).  

NICE officials said a key factor in the positive assessment was that the new oral anticoagulant is easier to use than warfarin because it does not require the frequent blood tests during treatment that are needed by warfarin patients.  The drug has also received clearance for NHS use in the prevention of thromboembolism after hip replacment and as an option for prevention of stroke in patients with atrial fibrillation.

DVT is a condition in which a blood clot forms in the deep veins of the legs or pelvis, often limiting blood flow through the vein and cause swelling and pain in the leg. If the clot dislodges and travels to the lungs, it can lead to a potentially fatal pulmonary embolism (PE) when the clot blocks the blood supply to the lungs. Other complications of DVT include post-thrombotic syndrome, a chronic disorder that may include symptoms such as pain, heaviness, swelling, cramps, itching or tingling, increased skin pigmentation and ulceration in the affected limb. It is estimated that there will be over 46,000 cases of acute DVT in England and Wales during 2012, rising to nearly 50,000 by 2016 due in large part to the aging population.

Rivaroxaban is an orally administered drug that helps to prevent blood from clotting by inhibiting a substance called Factor Xa which is necessary in the formation of thrombin and fibrin, the key components in blood clot formation. Duration of treatment with rivaroxaban is based on an assessment of the benefit of anticoagulation compared with the risk of bleeding and usually ranges from 3 to 12 months. Some people with ongoing risk factors for recurrence of blot clots need ongoing treatment.

"For many people, using warfarin is difficult because of the need for regular monitoring with blood tests, dosing adjustments, and the need to be careful about their diet because of warfarin's interaction with certain foods. said Professor Carole Longson, Director of NICE's Health Technology Evaluation Centre Director. "Because rivaroxaban does not require frequent blood tests to monitor treatment it represents a potential benefit for many people who have had a DVT, particularly those who have risk factors for recurrence of venous thromboembolism and who therefore need longer-term treatment."

Read more:

NICE recommends new drug to treat blood clots

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