Regulatory Focus™ > News Articles > NICE Gives Thumbs-Up to Bayer's Xarelto

NICE Gives Thumbs-Up to Bayer's Xarelto

Posted 26 June 2013 | By Louise Zornoza

The UK's cost containment agency, 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.

Rivaroxaban is an orally administered anticoagulant. It has a UK marketing authorization for the treatment of DVT and PE, and prevention of recurrent DVT and PE in adults. According to NICE's Health Technology Evaluation Centre Director, Professor Carole Longson, rivaroxaban "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." 

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.

NICE Decision on Xarelto

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