Apixaban gets NICE’s blessing in U.K.

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The U.K.’s National Institute of Health and Clinical Excellence (NICE) has recommended apixaban in its final draft guidance for the prevention of stroke and systemic embolism in some people with nonvalvular atrial fibrillation (AF).

The draft guidance also recommends that the decision about whether to start treatment with apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) should be made after an informed discussion about the risks and benefits of apixaban compared with warfarin, dabigatran etexilate (Pradaxa, Boehringer Ingelheim) and rivaroxaban (Xarelto, Janssen Pharmaceuticals/Bayer HealthCare), and in light of a person's current level of international normalized ratio (INR) control if they are already taking warfarin.

Apixaban is an orally administered factor Xa inhibitor. It has U.K. marketing authorization for the prevention of stroke and systemic embolism in patients with nonvalvular AF and one or more risk factors such as prior stroke or transient ischemic attack, age 75 years or older, hypertension, diabetes mellitus or symptomatic heart failure.

Apixaban, like rivaroxaban and dabigatran, has potential benefits for people with AF in these circumstances, because it doesn't require warfarin’s regular monitoring and dose adjustments, according to the agency.

Carole Longson, director of the NICE Centre for Health Technology Evaluation, said the committee reviewed evidence and concluded that apixaban was more clinically effective than warfarin for the primary efficacy outcome of reducing stroke and systemic embolism. They also noted that treatment with apixaban resulted in fewer bleeding events than warfarin, including a reduced rate of intracranial bleeding. “The committee recognized that intracranial bleeding has a high mortality rate and a large impact on a person's quality of life, and is the most feared bleeding outcome for people taking any type of anticoagulant," she said in a release.

Until NICE issues final guidance, National Health Service bodies should make decisions locally on the funding of specific treatments. Final guidance is likely to be published in February 2013.