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NICE set to hand Bayer wider recommendation for Xarelto

Backs drug’s use to treat pulmonary embolism and prevent DVT

NICE recommends extending blood clot indication of Bayer's Xarelto

Bayer's oral anticoagulant Xarelto could soon be available to more patients in England and Wales after the National Institute for Health and Care Excellence (NICE) released draft guidance recommending it in a new blood clot indication.

NICE, which assesses new medicines for cost-effectiveness, said that Xarelto (rivaroxaban) was an efficient use of NHS resources to treat pulmonary embolism (PE) and to prevent recurrent deep vein thrombosis (DVT) and PE after acute PE in adults.

If finalised, this would add to Xarelto's existing NICE recommendation to treat patients with DVT and prevent recurrent DVT and pulmonary embolism in adults diagnosed with acute DVT.

PE occurs when a clot in an artery blocks the blood supply to the lungs, while DVT occurs when a blood clot forms in the deep veins of the leg or pelvis. DVT can lead to PE if the clot is dislodged and travels to the lungs.

According to NICE, an aging population means there will be over 50,000 cases of acute DVT in England and Wales each year by 2016, providing a large market for Bayer, which is touting Xarelto as a safer, easier-to-use successor to warfarin - the current standard therapy.

The need for new bloodthinner treatments was backed by Professor Carole Longson, NICE Health Technology Evaluation Centre director, who noted that the requirement for regualar monitoring and dose adjustment for patients on warfarin meant regular visits to hospitals or GP surgeries.

“Also, because warfarin has many drug interactions, it may be unsuitable for people with co-morbidities,” she said. “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 for initiation with heparin and the subsequent transition to warfarin,” she added.

The draft guidance could also give Bayer an edge over rivals Boehringer Ingelheim and Bristol-Myers Squibb/Pfizer, whose own respective next generation anticoagulants Pradaxa (dabigatran etexilate) and Eliquis (apixaban) are yet to be assessed by NICE in the indication.

Xarelto, Pradaxa and Eliquis are recommended by NICE as a cost-effective treatment for the prevention of stroke and systemic embolism in some people with non-valvular atrial fibrillation (AF).

23rd April 2013

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