A new combination treatment for heart failure has been recommended for NHS use by the National Institute for Health and Care Excellence (NICE).
NICE’s decision on sacubitril valsartan (Entresto), manufactured by Novartis, comes nearly six months after the European Commission granted the drug a marketing authorisation in November 2015. The UK had already endorsed the drug under its early access to medicines scheme in September 2015, which aims to give patients with serious conditions access to drugs that do not yet have marketing authorisation.
Entresto, which has been heralded as an innovative treatment for heart failure and was launched in the UK in January 2016, contains two drugs: sacubitril, a neprilysin inhibitor, which blocks the breakdown of natriuretic peptides produced in the body, thereby reducing strain on the heart; and valsartan, an angiotensin-II-receptor antagonist. It is usually taken twice a day.
NICE has recommended the oral treatment as an option for symptomatic chronic heart failure with reduced ejection fraction for patients with moderate or very severe symptoms (defined by New York Heart Association class II to IV symptoms), plus a left ventricular ejection fraction of 35% or less, and who are already taking a stable dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor-blockers (ARB).
NICE says the treatment offers the potential to prevent deaths and reduce more than 30,000 hospital admissions for heart failure each year in England.
“ACE inhibitors have been the initial gold standard treatment for chronic heart failure for almost 25 years. However, for some people their symptoms persist despite them being on the maximum dose,” says Carole Longson, director of NICE’s health technology evaluation centre.
“The [NICE] committee heard from clinical experts and patient experts that a new treatment option would provide hope and generate optimism,” she adds.
In the guidance, published on 27 April 2016, NICE says its committee recognises the “innovative nature” of the product in that the inhibition of neprilysin is a novel development in the pharmaceutical management of heart failure. It concludes that Entresto offers a “small step-change in the management of this condition”.
NICE did not think there was enough evidence to back the drug in patients who do not have severely reduced ejection fractions, those with very mild symptoms, and for people who have not already had an ACE inhibitor or ARB.
NICE advises that treatment with Entresto should be started by a heart failure specialist with access to a multidisciplinary heart failure team.
Peter Weissberg, medical director at the British Heart Foundation, says: “There is currently no cure for heart failure and we welcome the news that this drug will now be available to some patients to help control and manage their condition.
“In the UK, over half a million people are living with this crippling illness which can cause chronic breathlessness and fatigue, leaving patients with a long and difficult fight for life,” he adds.
Alison Warren, lead cardiovascular pharmacist at Brighton and Sussex University Hospitals NHS Trust, says: “[Entresto] is an exciting new development in heart failure treatment and introduction into practice by the specialist heart failure team offers opportunities for pharmacists to be involved in medicines optimisation for this group of patients.”
Clinical commissioning groups (CCGS) now have an obligation to ensure that the product is made available to appropriate patients within 30 days and no later than 27 May 2016.