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NICE wants more evidence on Bayer's Xarelto

UK cost effectiveness watchdog is assessing the oral anticoagulant's use against a common heart condition

Bayer - Xarelto (rivaroxaban) NICE has called on Bayer to provide more clinical information for Xarelto (rivaroxaban), saying the single trial submitted to support the drug's use against a common heart condition did not reflect its patient population.

NICE is currently assessing the oral anticoagulant as a treatment for prevention of stroke and systemic embolism in people with atrial fibrillation (AF).

The UK cost-effectiveness watchdog said in draft guidance that it was “minded not to recommend” the drug on the basis of the available evidence.

Professor Carole Longson, NICE Health Technology Evaluation Centre director, said: “In particular the Committee was concerned that the people in the warfarin arm of the trial on average did not achieve as good control of their blood clotting as might be expected in clinical practice in the UK.

“It was also concerned that the risk of stroke and systemic embolism for the population in the trial was higher than for the overall population eligible for treatment with rivaroxaban. The Committee felt that both these factors could mean that the relative effectiveness of rivaroxaban compared with warfarin had been overestimated for the UK population.”

The provisional cost of Xarelto to the NHS would be £2.10 per day, or £766.50 annually, but costs could vary in different settings because of negotiated procurement discounts.

Bayer's Factor Xa inhibitor Xarelto and Boehringer Ingelheim's direct thrombin inhibitor Pradaxa (dabigatran) are part of a new generation of oral anticoagulants.

Longson said: “The importance of effective antithrombotic therapy in people with atrial fibrillation who are at risk of developing potentially fatal blood clots cannot be overestimated.

“The most commonly used antithrombotic – warfarin – is associated with a number of problems, such as the need for frequent monitoring of the blood's clotting, which can have an adverse effect on quality of life and make compliance difficult for some people. Rivaroxaban, like dabigatran, which NICE is also assessing, represents a significant potential benefit for people with AF because it doesn't require regular monitoring and dose adjustments.”

NICE acknowledges that both drugs represent advances over the much older antithrombotic therapy warfarin but has yet to issue final guidance on either to the NHS.

The watchdog was also poised not to recommend Pradaxa after draft guidance on Boehringer's drug called for more cost effectiveness and dosing data. Although Boehringer provided this, persuading NICE to back Pradaxa in its final appraisal determination, a decision on this has been held up after an appeal from NHS Salford and the meeting for this won't be convened until February 7, 2012.

Meanwhile, final guidance on Xarelto's use in atrial fibrillation, for which Bayer won European approval last month, is due in May.

9th January 2012

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