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NICE draft guidance recommends new treatment for people with chronic heart failure

In draft guidance published today (7 August), healthcare guidance body NICE has recommended ivabradine (Procoralan, Servier Laboratories) as an option for the treatment of people with chronic heart failure (NYHA class II to IViwith systolic dysfunctionii, in people in sinus rhythmiii and whose heart rate is 75 beats per minute or more) in combination with standard therapy, including beta-blocker therapy, or when beta-blocker therapy is contraindicated or not tolerated.

The draft guidance also recommends that therapies that are used routinely for managing heart failure (ACE inhibitors, beta-blockers and aldosterone antagonists) should be optimised before treatment with ivabradine is initiated by a heart failure specialist with access to a multi-disciplinary heart failure team, and after a stabilisation period on these therapies of 4 weeks.

Heart failure is a complex clinical syndrome of symptoms - such as breathlessness and fatigue - and signs - such as fluid retention - that suggest the efficiency of the heart is impaired. The most common cause of heart failure in the UK is coronary artery disease, with many patients having suffered a myocardial infarction (heart attack) in the past. It affects about 900,000 people in the UK, and that number is increasing as a result of improved prognosis of coronary artery disease, ageing of the population and better treatments.

The aim of treatment for heart failure is to improve life expectancy, quality of life of patients and also to avoid hospitalisations. Current strategies include pharmacological management, implantation of devices, surgery and management of any co-morbid conditions. The NICE clinical guideline for chronic heart failure (CG108) recommends that all patients be considered for first-line treatment with beta-blockers and an angiotensin-converting enzyme (ACE) inhibitor unless contraindicated or not tolerated.

Ivabradine is licensed for the treatment of NYHA II to IV class chronic heart failure in patients with systolic dysfunction and in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. The independent Appraisal Committee considered the benefits ivabradine provided to patients compared with current standard therapy including beta blockers.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “Although the prognosis for people with heart failure has been improving over recent years, largely as a result of better treatments, heart failure can have a significant detrimental impact on quality of life, particularly in terms of affecting a person's ability to perform everyday tasks. Because heart failure is predominantly a disease of the elderly, comorbidities increase the impact of the disease and usually require lifestyle changes. In clinical trials ivabradine has been shown to have a beneficial effect in reducing mortality and improving quality of life in people with some types of chronic heart failure.

“The Committee was mindful that there is robust evidence for the effectiveness of ACE inhibitors, beta-blockers and aldosterone antagonists that are used routinely in managing heart failure. They concluded that ivabradine should be initiated only after optimal treatment with these drugs has been achieved when patients are still symptomatic after receiving optimised initial therapies, or when beta-blockers are contraindicated as specified in the marketing authorisation or not tolerated by the patients.”

The draft guidance has been issued for consultation; it has not been issued to the NHS. Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.

Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.

Ends

Notes to Editors

References and explanation of terms

i. New York Heart Association (NYHA) Functional Classification classifies the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity:

NYHA Class Symptoms
I No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc
II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).
Comfortable only at rest
IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

ii. Impairment in the filling of the ventricles after they contract to pump blood around the body. For example, some patients have heart failure due to left ventricular systolic dysfunction (LVSD) which is associated with a reduced left ventricular ejection fraction.

iii. In a normal heart rhythm (60 - 80 bpm in adults), the sinus node generates an electrical impulse which travels through the right and left atrial muscles. This is called normal sinus rhythm.

About the guidance

1. The draft guidance is available (from 7 August) on the NICE website. Please contact the NICE press office for an embargoed copy of the draft guidance.

2. Estimates suggest that as many as 900,000 people have chronic heart failure in the UK. Almost as many again have damaged hearts but, as yet, no symptoms of heart failure.

3. Both the incidence and prevalence of heart failure increase steeply with age, with the average age at first diagnosis being 76 years. The prevalence of heart failure is expected to rise in future as a result of an ageing population, improved survival of people with ischaemic heart disease and more effective treatments for heart failure.

4. Heart failure has a poor prognosis and has a mortality rate similar to that of some cancers: 30-40% of patients diagnosed with heart failure die within a year - but thereafter the mortality is less than 10% per year.

5. Heart failure accounts for a total of 1 million inpatient bed days - 2% of all NHS inpatient bed-days - and 5% of all emergency medical admissions to hospital. Hospital admissions because of heart failure are projected to rise by 50% over the next 25 years - largely as a result of the ageing population.

6. The Committee concluded that the manufacturer's ICER estimate of approximately £8500 per QALY gained was plausible and was likely to represent the expected cost-effectiveness of adding ivabradine to standard care for the treatment of chronic heart failure.

7. Ivabradine is available in 5 mg and 7.5 mg tablets at a net price of £40.17 per 56-tablet pack each (excluding VAT; ‘British national formulary' [BNF] edition 63). The manufacturer's submission quoted an average monthly cost of £42.10 (excluding VAT) based on the proportion of patients using 2.5 mg (7%) and 5 mg/7.5 mg (93%) in the SHIFT study. Costs may vary in different settings because of negotiated procurement discounts.

About NICE

8. 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

9. 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.

10. 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

11. 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.

This page was last updated: 06 August 2012

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Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

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