Xarelto rivaroxaban regulatory update

The U.K.'s NICE said it needs additional information before it can recommend the use of Xarelto rivaroxaban from Bayer to prevent stroke and systemic embolism in patients with atrial fibrillation (AF). NICE said the population included in the Phase III ROCKET-AF trial of Xarelto was not reflective of all AF patients in the U.K. because the trial's mean time in therapeutic range for warfarin was at the lower end of the level that would be expected in U.K. clinical practice. The committee said this could have underestimated warfarin's efficacy and biased the data in favor of Xarelto.

NICE asked for a revised cost-effectiveness analysis to account for the low proportion of time in therapeutic range for warfarin. NICE also said the model should use an annual international normalized ratio (INR) monitoring cost for warfarin of £242 ($374) per person, instead of Bayer's original figure of £535 ($826) per person. Comments on the preliminary appraisal are due Jan. 30, with a second appraisal committee meeting scheduled for Feb. 15. ...