Healthcare guidance body NICE has today (28 November) published guidance recommending ivabradine (Procoralan, Servier Laboratories) as an option for the treatment of people with chronic heart failure (NYHA class II to IVⁱ) with systolic dysfunctionⁱⁱ, who are in sinus rhythmⁱⁱⁱ and whose heart rate is 75 beats per minute or more) and who have a left ventricular ejection fraction of 35% or less^iv.

The guidance also states that ivabradine should be taken in combination with standard therapy, including beta-blockers, angiotensin-converting enzyme (ACE) inhibitors and aldosterone antagonists, or when beta-blockers are contraindicated or not tolerated, and only after a stabilisation period of 4 weeks on optimised standard therapy. Treatment with ivabradine should be initiated by a heart failure specialist with access to a multi-disciplinary heart failure team. Dose titration and monitoring should be carried out by a heart failure specialist or, in primary care, by either a GP with a special interest in heart failure or a heart failure specialist nurse.

Heart failure, which affects about 900,000 people in the UK, 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.

The aim of treatment for heart failure is to improve life expectancy, quality of life and also to avoid hospitalisations. Ivabradine is a heart-rate-lowering druglicensed 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 ACE inhibitors, beta blockers and aldosterone antagonists.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "The prevalence of heart failure is expected to rise in the future as more people live longer generally, people survive longer with coronary artery disease and there are better treatments for heart failure. Heart failure can have a significant detrimental impact on quality of life and a person's ability to perform everyday tasks - an impact that is exacerbated by comorbidities that commonly affect the elderly. The independent committee that advises NICE considered that, on the basis of the available evidence, 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, therefore, that ivabradine could be considered a cost-effective use of NHS resources for treating chronic heart failure after optimal treatment with these drugs has been achieved and when patients are still symptomatic after receiving optimised initial therapies, or when beta-blockers are contraindicated or not tolerated by the patients."

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:

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.

iv. A measurement of the percentage of blood leaving the heart each time it contracts. A normal LV ejection fraction is 55 to 70 percent.

About the guidance

1. The guidance is available (from 28 November) on the NICE website at ta267 Please contact the NICE press office for an embargoed copy of the 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 SHIFT trial results from the population covered by the drug's marketing authorisation (heart rate of 75 beats per minute or more) demonstrated a statistically significant reduction in cardiovascular death of 17% with ivabradine compared with placebo, unlike the main SHIFT population, in which there was a non-significant reduction in cardiovascular death of 9%

7. 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 in the population covered by the marketing authorisation.

8. 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

9. 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

10. 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.

11. 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

12. 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.