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UK’s NICE says Xarelto can be used in atrial fibrillation

Will compete with Boehringer’s Pradaxa in prevention of stroke

Bayer Xarelto rivaoxaban

Bayer's Xarelto should be available for mainstream use in the UK's NHS for people with atrial fibrillation (AF), according to the country's drug-pricing watchdog.

The UK's National Institute for Health and Clinical Excellence (NICE) has given a final recommendation for the bloodthinner as an option in the prevention of stroke and systemic embolism in people who have an irregular heartbeat.

The approval means the drug will be in direct competition with Boehringer Ingelheim's Pradaxa (dabigatran etexilate), which was recommended in the same indication by NICE in March at a cost of £2.52 a day.

Boehringer later announced that it would cut Pradaxa's price to £2.20, in a move some have suggested anticipated NICE's positive decision for Xarelto.

However, even with this extra discount, the price of Pradaxa is still 10p per day higher than the provisional cost to the NHS of Xarelto (rivaroxaban), after Bayer set a price of £2.10 per day for its drug.

NICE had previously turned down Xarelto for use in people in draft guidance, but turned its decision around after Bayer provided more information about the drug's effectiveness in the context of UK clinical practice to justify its price.

“Rivaroxaban, like dabigatran etexilate [Pradaxa], which NICE recently approved as an option for this indication, can benefit people with AF,” said Professor Carole Longson, NICE health technology evaluation centre director.

“We are therefore pleased to recommend rivaroxaban as another cost-effective option for the prevention of stroke and systemic embolism in people with atrial fibrillation.”

Commenting on the decision Bayer Healthcare's UK medical director Luis-Felipe Graterol said: “Rivaroxaban has the potential to make a positive difference to NHS anticoagulation services by helping simplify clot prevention for AF patients, including those who are not currently achieving an adequate level of stroke protection with warfarin.

“We are committed to ensuring that rivaroxaban is available to eligible AF patients and we look forward to continuing our work with local NHS fundholders to help evolve services with this once-daily therapy.”

Bayer and its partner Johnson & Johnson (J&J) also have hopes for Xarelto in other indications, with the drug already approved by NICE for the prevention of VTE in adults who have elective total hip replacement surgery or total knee replacement surgery.

It is also approved in Europe to treat deep vein thrombosis, and is currently being assessed by the US Food and Drug Administration (FDA) for the same condition as well as one to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome.

Both Xarelto and Pradaxa are part of a new generation of oral anticoagulants looking to replace warfarin. Xarelto is developed as an inhibitor of the Factor Xa enzyme, which is required in the development of the proteins thrombin and fibrin - key factors in the formation of blood clots. Pradaxa works by inhibiting the function of the thrombin protein. 

23rd May 2012

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