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

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.

Ends.

Notes to Editors

About the guidance

1. The draft guidance is available (from Wednesday 17 August) on the NICE website at http://guidance.nice.org.uk/TA/Wave21/10.

2. Dabigatran is available as 110 mg and 150 mg capsules and comes in packs of 10, 30, 60 and 180 capsules. The manufacturer has stated that the cost to the NHS of a pack of 60 tablets will be £75.60 (excluding VAT) for both 110mg and 150mg doses. The cost per day per patient based on the recommended dosage will be £2.52 (excluding VAT). Costs may vary in different settings because of negotiated procurement discounts.

About NICE

3. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

4. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

5. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

6. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.



[1] New York Heart Association (NYHA) classification of heart failure symptoms

Class I-No limitations

Class II-Slight limitation of physical activity (symptomatically “mild” heart failure)

Class III-Marked limitation of physical activity (symptomatically “moderate” heart failure)

Class IV- Symptoms of heart failure are present even at rest (symptomatically “severe” heart failure)

This page was last updated: 16 August 2011

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.