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NICE asks for more information on new treatment for people with common heart condition

17th August 2011
In preliminary recommendations published today (Wednesday 17 August) NICE is asking Boehringer Ingelheim for more information on its product dabigatran (Pradaxa), for the prevention of stroke and systemic embolism in people with atrial fibrillation.
 
Atrial fibrillation (AF) occurs when the electrical impulses controlling the heart rhythm become disorganised, so that the heart beats irregularly and, occasionally, too fast and so cannot efficiently pump blood around the body. People with AF are at higher risk of developing blood clots and subsequent stroke - however, the risk of stroke can be substantially reduced by appropriate use of antithrombotic therapy (eg warfarin).
 
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[1]. Dabigatran also has a UK marketing authorisation for people with AF aged 65 years or over who have diabetes, coronary heart disease or hypertension.
 
Commenting on NICE's draft recommendation, Dr Gillian Leng, NICE Deputy Chief Executive and Chief Operating Officer for NHS Evidence, said: "The Committee heard that warfarin, the most commonly used antithrombotic, is associated with a number of inconveniences for the patient that make compliance difficult. These include regular monitoring and dose adjustments which cause disruption and changes to routine. Since it does not require frequent blood tests to determine the effectiveness of treatment, dabigatran may have potential benefits for people with atrial fibrillation. The Committee also accepted evidence that showed dabigatran 150 mg twice daily was more clinically effective than warfarin in reducing the risk of stroke/systemic embolism, ischaemic stroke and vascular mortality and that this represented an important development for patients with atrial fibrillation.
 
Dr Leng continued: "However, the independent Appraisal Committee has requested additional information from the manufacturer in a number of areas. In particular it is seeking clarification on the cost effectiveness of the licensed regimen, in which people aged under 80 years begin treatment with dabigatran 150 mg twice daily, and at age 80 years switch to dabigatran 110 mg twice daily. It has requested cost effectiveness analysis of this sequential regimen compared with warfarin using more robust data to estimate effectiveness, and a more plausible set of assumptions about the drug's use in clinical practice. These include using lower costs for anticoagulation monitoring than that suggested in the manufacturer's submission and modelling a patient population more representative of the AF patient population in the UK than was used in the manufacturer's original analysis."
 
NICE has not yet issued final guidance to the NHS; these decisions may change after consultation.
 
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.
 
Final guidance is likely to be published in December 2011.

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