A new drug that could potentially revolutionise the treatment of a certain form of heart failure has been given a preliminary green light for NHS use in England and Wales.
NICE has issued draft guidelines recommending Novartis’ Entresto (sacubitril/valsartan) for treating chronic heart failure with reduced ejection fraction, a condition where the heart muscle does not contract effectively and less oxygen-rich blood is pumped out to the body.
Specifically, the treatment is being endorsed for patients with New York Heart Association class II to III symptoms who are on a stable dose of ACE inhibitors (or angiotensin II receptors) and who have a left ventricular ejection fraction of 35% or less.
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.
In 2012/13, over 30,000 people in England alone were admitted to hospital with heart failure with reduced left ventricular ejection fraction, and despite available options patients face a poor prognosis. Entresto is “an innovative drug that will offer people with this condition a further important treatment option with the potential to prevent deaths and reduce hospital admissions,” noted Meindert Boysen, programme director, technology appraisals at NICE.
The Committee considered that, given the innovative nature of the drug, the most plausible Incremental Cost Effectiveness Ratios of £29,500 and £30,100 per QALY gained compared with ACE inhibitors and ARBs, respectively, represented a cost effective use of NHS resources.
The consultation on NICE’s draft recommendations closes on January 15.