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NICE approves dabigatran as first warfarin alternative in 50 years



An alternative anticoagulant to warfarin has been approved by NICE for the prevention of stroke, despite major concerns over the cost implications for the NHS.

Dabigatran is the first treatment in 50 years to be approved for the prevention of stroke in patients with atrial fibrillation, but its use on the NHS had been delayed after managers lodged an appeal with NICE saying it would have ‘one of the largest impacts on the NHS to date’.

A statement from NICE said the appeal had been dismissed ‘on all points’ and their appraisal was now approved.

Their guidance states that dabigatran should be used within its licensed indication, that is, for people with non-valvular atrial fibrillation and another risk factor, including being over 75 years old, suffering a previous stroke or transient ischaemic attack, or being aged 65 years or older with one of the following: diabetes mellitus, coronary artery disease or hypertension.

NICE says that treatment with dabigatran should be made after an ‘informed discussion between the clinician and the person’ about the risks and benefits of dabigatran etexilate compared with warfarin.

Professor Carole Longson, director of the NICE Health Technology Evaluation Centre, said:‘Atrial fibrillation can be a distressing condition and people with it have an increased risk of suffering a stroke. Many people with the condition find it difficult to comply with the most commonly used antithrombotic, warfarin, because, among other things, it requires regular INR monitoring and dose adjustments which can cause disruption and inconvenience.

‘Because dabigatran does not require frequent blood tests to monitor treatment it represents a useful alternative option for people with atrial fibrillation.’