Cost regulators for the National Health Service in England and Wales have reiterated their support for the use of Novartis’ revolutionary heart drug Entresto to treat patients with a certain type of heart failure.
In final draft guidance, the National Institute for Health and Care Excellence has recommended the drug as an option for treating symptomatic chronic heart failure with reduced ejection fraction in adult patients with New York Heart Association class II to IV symptoms, but restricting its use to those with a left ventricular ejection fraction of 35% or less.
The Institute stressed that Entresto (sacubitril/valsartan) is an “innovative and cost-effective treatment”, but its guidance is in marked contrast to guidelines in Scotland, where the drug has been accepted for use by the NHS as per its full licensed indication, with no restrictions, again highlighting the postcode lottery of case facing patients in Great Britain.
Entresto, which is already available through the UK’s Early Access to Medicines Scheme - offers a novel dual mechanism of action thought to reduce the strain on the failing heart: valsartan suppresses the harmful effects of angiotensin II on the cardiovascular system, while sacubitril blocks the enzyme neprilysin to enhance the protective neurohormonal systems of the heart.
The drug is the first treatment shown to offer a significant mortality benefit over an ACE-inhibitor; with data from the 8,442 patient PARADIGM-HF demonstrating that it cut cardiovascular deaths by 20% versus enalapril, as well as heart failure hospitalisations and all-cause mortality by 21% and 16%, respectively.
“With ACE inhibitors being the gold standard treatment for almost 25 years, there is a high unmet need for new effective treatments that improve the quality of life, morbidity and mortality for seriously ill patients. This is a very positive development and we are delighted that NICE has taken on board the level of need and valued the patient input and evidence,” said Nick Hartshorne-Evans, chief executive and Founder of Pumping Marvellous Foundation.
However, he went on to say that “even though this guidance means that now some people with chronic heart failure with reduced ejection fraction will have access to sacubitril/valsartan, we are disappointed that with the restrictions in place not all patients covered by the marketing authorisation will receive this vital treatment option.”
Heart failure affects around 550,000 people in the UK and is a leading cause of hospital admission in patients _65 years, accounting for one million inpatient bed days and £2.3 billion of the NHS budget (2015-16), a figure set to rise with the ageing population.