In a final draft guidance published on 1 November the UK National Institute for Health and Clinical Excellence (NICE) has recommended dabigatran (Pradaxa, Boehringer Ingelheim), in accordance with its licensed indications, for the prevention of stroke and systemic embolism in people with atrial fibrillation.
The draft guidance also recommends that the decision about whether to start treatment with dabigatran should be made after an informed discussion about the risks and benefits of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 international normalised ratioi (INR) control if they are already taking warfarin.
The positive recommendation follows the receipt of further information about the product from the manufacturer that had been requested by NICE in its previous draft guidance.
Dabigatran is an orally administered anticoagulant that inhibits the formation of the thrombin enzyme. It has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients aged 75 years and over with nonvalvular atrial fibrillation who have had a previous stroke, transient ischaemic attack or systemic embolism, and/or left ventricular ejection fraction below 40%, and/or symptomatic heart failure of New York Heart Association (NYHA) Class 2 or above. Dabigatran also has a UK marketing authorisation for people with atrial fibrillation aged 65 years or over who have diabetes, coronary heart disease or hypertension.
Commenting on NICE’s draft recommendation, Carole Longson, NICE Health Technology Evaluation Centre director, 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 significant potential benefit for many people with atrial fibrillation.
Longson continued, “The independent Appraisal Committee accepted evidence 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 110 mg twice daily is as effective as warfarin, however there were a number of uncertainties relating to the drug’s cost-effectiveness in the original evidence submission from the manufacturer which required clarification. We are pleased to say that the additional information and analysis received from the manufacturer has enabled the Committee to recommend dabigatran as a cost-effective use of NHS resources for the prevention of stroke and systemic embolism in people with atrial fibrillation.”
NICE has not yet issued final guidance to the NHS. Registered consultees now have the opportunity to appeal the draft guidance. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.
The final guidance is likely to be published in December 2011. The draft guidance is available at https://guidance.nice.org.uk/TA/Wave21/10