Rivaroxaban Gets NICE Nod in UK for AF

April 03, 2012

April 2, 2012 (London, United Kingdom) The UK National Institute for Clinical Excellence (NICE) has recommended rivaroxaban (Xarelto, Bayer) as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation [1].

In a final draft guidance issued on March 30, 2012, NICE advises that for patients who are currently taking warfarin for this indication, the potential risks and benefits of switching to rivaroxaban should be considered in light of their INR level.

However, the drug will not be reimbursed within the National Health Service (NHS) until the final guidance is published. This is expected within the next couple of months.

Dr Carole Longson (NICE Health Technology Evaluation Centre director) is quoted in a NICE press release [2] as saying: "Older people with AF and comorbidities 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."

She added: "We are pleased to say that the additional information and analysis received from the manufacturer following our initial draft guidance has enabled us to recommend rivaroxaban as a cost-effective option for the prevention of stroke and systemic embolism in people with atrial fibrillation.”

The appraisal committee noted the incremental cost-effectiveness ratio (ICER) for rivaroxaban compared with warfarin would lie somewhere between the £2900 per quality-adjusted-life-year (QALY) estimate provided by Bayer and the £29 537 figure from NICE's evidence review group. The committee therefore concluded that the most plausible ICER for the whole population eligible for rivaroxaban was within the range that could be considered a cost-effective use of NHS resources.

NICE notes that the provisional cost to the NHS of rivaroxaban is £2.10 per day and £766.50 annually. It estimates that as many as 700 000 people have AF in England and Wales.

The agency further points out that the Scottish Medicines Consortium published guidance in February 2012 accepting rivaroxaban for use in patients who have poor INR control despite evidence that they are complying with a coumarin anticoagulant (such as warfarin) and in patients who are allergic to or unable to tolerate coumarin anticoagulants. This is similar to the recommendation for dabigatran in Scotland.

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