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NICE backs Bayer's Xarelto for DVT treatment

UK cost-effectiveness body won over by new data from the pharma company

Bayer's oral anticoagulant Xarelto should be available in England and Wales under the NHS to patients with deep vein thrombosis (DVT), according to the UK's drug cost-effectiveness watchdog.

In draft final guidance, the UK's National Institute for Health and Clinical Excellence (NICE) has given the green light for Xarelto (rivaroxaban) to be prescribed as a single-drug therapy for DVT, and also to prevent recurrent DVT and pulmonary embolism (PE) after an acute DVT in adults.

The Factor Xa inhibitor is recommended as a simpler alternative to the current standard therapy, a combination of vitamin K antagonist (VKA) warfarin with a low molecular weight heparin given by subcutaneous injection.

Professor Carole Longson, NICE Health Technology Evaluation Centre director, said: "The independent Appraisal Committee was initially unable to recommend rivaroxaban based on the data presented by the manufacturer because it did not adequately demonstrate the drug's clinical and cost effectiveness in the context of UK clinical practice.

“We are pleased to say that, following the submission of additional information and analysis from the manufacturer during consultation, the committee is able to recommend rivaroxaban as a cost-effective option for treating DVT and preventing recurrent DVT and PE in adults."

NICE's latest endorsement comes after it backed Xarelto for preventing strokes and systemic embolism in people with atrial fibrillation last month. Bayer's drug is also NICE-approved for preventing venous thromboembolism in patients undergoing hip or knee replacement surgery.

Xarelto competes in the marketplace with Boehringer Ingelheim's Pradaxa (dabigatran), which has a different mechanism of action (thrombin inhibition) but covers many of the same indications as Bayer's drug. 

If finalised, the latest guidance could give Bayer a leg-up in the marketplace as Xarelto is "the only non-VKA oral anticoagulant to be recommended by NICE as a cost-effective DVT treatment option", according to the company.

There were over 35,000 symptomatic DVTs treated in UK hospitals in 2010-2011, with a further 35,000 PEs. The total cost to the NHS of managing DVT and PE is estimated to be £640m ($980m), according to a recent House of Commons Health Committee report.

Meanwhile, NICE is also reviewing Xarelto's role in the prevention of adverse outcomes in patients after the acute management of acute coronary syndrome (ACS). In the US, an FDA advisory committee voted against approval of an ACS indication for Xarelto last month

1st June 2012


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