Following the receipt of further evidence from Bayer HealthCare, a unit of German drugmaker Bayer (BAY: DE), of the clinical and cost effectiveness of its Xarelto (rivaroxaban), UK drug watchdog the National Institute of Health and Clinical Excellence (NICE) this morning published final draft guidance recommending the drug as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation.
Rivaroxaban has a UK marketing authorization for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation who have one or more risk factors such as congestive heart failure, hypertension, aged 75 years or older, diabetes mellitus, prior stroke or transient ischemic attack. The draft guidance is now with consultees.
Commenting on NICE’s draft recommendation, Carole Longson, NICE Health Technology Evaluation Centre Director, said: “We know that people taking warfarin can find it difficult to maintain their blood clotting at a proper level and are often not within the target therapeutic range. For example, older people with atrial fibrillation and co-morbidities are more likely to have poorly controlled clotting and may be at an increased risk of stroke or bleeding. Rivaroxaban, like dabigatran etexilate, which NICE recently approved as an option for this indication, can benefit people with AF in these circumstances because it doesn’t require such regular monitoring and dose adjustments.”
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