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NICE backs Xarelto in AF after Bayer provides new analyses

March 30, 2012 12:48 AM UTC

The U.K.'s NICE issued a final appraisal determination recommending the use of Xarelto rivaroxaban from Bayer AG (Xetra:BAYN) to prevent stroke and systemic embolism in patients with atrial fibrillation (AF) with one or more risk factors -- its approved indication. NICE made the recommendation after Bayer submitted a revised cost-effectiveness analysis addressing concerns raised in a January preliminary appraisal.

Bayer's new model used an annualized normalized ratio (INR) monitoring cost for warfarin of L242 ($374) per person, instead of the pharma's original figure of L535 ($826) per person. The model also included a revised event rate in the warfarin arm of the Phase III ROCKET-AF trial to better reflect the higher mean time in therapeutic range for warfarin that would be expected in U.K. clinical practice. NICE was concerned that the original analysis' time in therapeutic range could have underestimated warfarin's efficacy and biased the data in favor of Xarelto. Based on Bayer's revised model, NICE concluded that the incremental cost-effectiveness ratio (ICER) for Xarelto compared with warfarin would be no more than L29,537 ($46,800) per quality-adjusted life year (QALY) (see BioCentury Extra, Jan. 9). ...