On 28 November, the UK National Institute for Health and Clinical Excellence (NICE) published guidance recommending the heart-rate-lowering drug ivabradine (Procoralan, Servier Laboratories) as an option for the treatment of people with chronic heart failure (NYHA class II to IV) with systolic dysfunction, who are in sinus rhythm and whose heart rate is 75 beats per minute or more and who have a left ventricular ejection fraction of 35% or less.
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 four weeks on optimised standard therapy.
The guidance recommends that 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.
The independent Appraisal Committee considered the benefits ivabradine provided to patients compared with current standard therapy including ACE inhibitors, beta blockers and aldosterone antagonists.
According to NICE, the aim of treatment for heart failure is to improve life expectancy, quality of life and also to avoid hospitalisations. 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.
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 arterial 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.”