Bayer's Xarelto reimbursement backed in Canada; EMA concludes Yvidually arbitration

The Canadian Agency for Drugs and Technologies in Health (CADTH) through the Common Drug Review (CDR), has positively recommended to Canada's provincial and other publicly funded drug plans that they reimburse German drug major Bayer’s (BAY: DE) once-daily oral anticoagulant Xarelto (rivaroxaban tablet), for the prevention of stroke and systemic embolism in patients with non-valvular AF, in whom warfarin is indicated, and who meet all of the following criteria: are unable to achieve adequate anticoagulation with warfarin and have a CHADS2 score of ≥ 2.

This recommendation is based on a review of cost-effectiveness and clinical evidence supported by ROCKET AF, a randomized, double-blind global Phase III study that compared once-daily Xarelto with warfarin in more than 14,000 patients, including 750 from Canada. Xarelto is indicated for the prevention of stroke and systemic embolism in patients with AF, in whom anticoagulation is appropriate.

"This positive recommendation is great news for patients with AF," said Doug Grant, head, corporate affairs, at Bayer Inc, adding: "As a company with a significant and long-standing focus on anticoagulation, we are pleased to see CADTH's recommendation that provinces reimburse a once-daily treatment that does not require routine blood tests or dose adjustments for AF patients at risk of stroke."