Stroke prevention warfarin alternative gains final NICE approval

GPs can now offer AF patients an alternative to warfarin for stroke prevention after NICE gave its final approval.

NICE's verdict on the oral anticoagulant dabigatran etexilate (Pradaxa) opens the door for AF patients to access the first alternative to warfarin treatment for nearly 60 years.

The drug avoids the need for regular INR monitoring and dose adjustments required on warfarin therapy.

Dabigatran will cost the NHS around £2.52 per day per patient - more than twice the combined cost of warfarin and INR monitoring at £1.18 per day.

Nevertheless, Professor Carole Longson, director of the NICE Health Technology Evaluation Centre Director, said the drug was a 'cost-effective option' for the prevention of stroke and systemic embolism in AF patients.

'Because dabigatran does not require frequent blood tests to monitor treatment it represents a useful alternative option for people with AF,' she said.

'The independent appraisal committee accepted evidence from clinical trials that showed dabigatran 150 mg twice daily is more clinically effective than warfarin in reducing the risk of stroke or systemic embolism, and that dabigatran 110mg twice daily is as effective as warfarin.'

Peter Rowe, England's national Quality, Improvement, Productivity and Prevention (QIPP) lead for medicines, said the approval was a 'positive step forward' for AF patients whose stroke risk was not being appropriately managed. 'Until now, for these patients, treatment has often been hard to control, time consuming for both them and clinicians and expensive for the NHS,' he said.

About 750,000 people in the UK have AF, which increases the risk of developing blood clots and subsequent stroke.

NICE's guidance recommends that the decision to start treatment with dabigatran should be made after an informed discussion about the risks and benefits of dabigatran compared with warfarin, and in light of a person's current level of INR control if they are already taking warfarin.

Patients can access dabigatran if they have nonvalvular AF and meet one of several criteria. These include either a history of stroke, TIA or embolism; older than 75 years; or older than 65 years and have diabetes, coronary artery disease or high BP.

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