NICE has recommended the use of Pradaxa (dabigatran) as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF) in final guidance.
The treatment is the first new oral-anticoagulant in nearly 60 years to be recommended after NICE concluded it was more effective than warfarin.
Boehringer Ingelheim called the appraisal a “landmark decision”.
The recommendation comes after a failed appeal on the draft guidance by NHS Salford who argued that NICE had failed to act fairly and had exceeded its powers.
It claimed NICE had underestimated the likely use of Pradaxa and that its recommendation would require a design overhaul of anticoagulant services at a PCT level.
But its objections were dismissed on all points by an independent Appeal Panel chaired by NICE’s chair Professor Sir Michael Rawlins.
The guidance recommends Pradaxa as a treatment option in accordance with its licensed indications, and that treatment should start after an informed discussion about its risks and benefits compared with warfarin.
Pradaxa has a UK marketing authorisation for the prevention of stroke and systemic embolism in adults with nonvalvular AF who have previously suffered a stroke, transient ischaemic attack or systemic embolism and other heart related problems. It is also authorised for those aged 65 years old or over with AF who have diabetes, coronary heart disease or hypertension.
It’s estimated that there are around 700,000 people with AF in England and Wales. Boehringer believes that the use of Pradaxa twice daily has the potential to prevent around 530 more strokes per 100,000 compared to warfarin. And, if all eligible patients received Pradaxa twice daily, it could prevent up to 5,000 strokes and save the NHS up to £59 million in the first year of use.
Charles De Wet, Medical Director at Boehringer Ingelheim, said “We are committed to sharing value and our priority and commitment now is to work closely with the Trusts to ensure dabigatran is accessible to all eligible patients on the NHS and appropriately prescribed by clinicians”.