Once-daily oral anticoagulant receives positive Common Drug Review recommendation for stroke prevention in atrial …

Posted: Published on April 24th, 2012

This post was added by Dr Simmons

Bayer Inc. welcomes support for public reimbursement of new treatment

TORONTO, April 23, 2012 /PRNewswire/ - Hundreds of thousands of Canadians living with atrial fibrillation (AF) are now one step closer to getting public reimbursement for a newstroke prevention therapy - news that was welcomed today by Bayer Inc.

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 the Bayer Inc. 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, Bayer Inc. "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."

AF, the most common form of cardiac arrhythmia in clinical practice, affects approximately 350,000 Canadians and is an established risk factor for stroke and premature death. It is estimated that after age 60, one-third of all strokes are caused by AF. (1)

About Atrial Fibrillation (AF)

In patients with atrial fibrillation (AF), an irregular heartbeat makes them vulnerable to the formation of a blood clot in the atria, which can travel to the brain, potentially resulting in a stroke. Strokes cause damage to the brain, and can lead to physical and behavioural impairment, significant disability, or even death. About a third of people with AF have no symptoms whatsoever. The danger of AF being undetected is that it puts people at risk of serious complications, including stroke.

About Xarelto

Xarelto (rivaroxaban tablet) is a fixed-dose oral anticoagulant that has a rapid onset of action with a predictable dose response, does not require routine coagulation monitoring and dose adjustments, and has limited potential for food* and drug interactions.(2)

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