Novartis has launched its eagerly-awaited and potentially revolutionary heart pill Entresto in the UK, giving patients with a certain form of heart failure a much needed new treatment approach that offers a significant mortality benefit over standard therapy.

Entresto (sacubitril/valsartan) was approved in Europe last November to treat patients with heart failure and reduced ejection fraction, a condition where the heart muscle does not contract effectively and less oxygen-rich blood is pumped out to the body. Despite available therapies, patients with the condition face a poor prognosis, highlighting the need for new options.

The drug 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 fanfare surrounding Entresto stems from the fact that it 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.

The drug, already given to some patients through the UK’s Early Access to Medicines Scheme, has already won early backing from the National Institute for Health and Care Excellence. In preliminary guidelines, the cost watchdog is recommending its use 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.

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.

Heart failure is a highly debilitating, life-threatening condition, which affects around 550,000 people in the UK, and there is “a real need for new and effective treatments that can reduce the number of hospitalisations and mortality in patients,” said Dimitrios Georgiopoulos, chief scientific officer of Novartis Pharmaceuticals UK Ltd. 

“Despite use of current treatments and availability of clinical guidelines, 40% of patients die within a year of first hospital admission for heart failure and survival rates are worse than certain types of cancer, such as breast and prostate,” he noted, adding: “In an area of high unmet need, sacubitril/valsartan gives doctors a new option that can potentially improve the outcomes of many of their heart failure patients.”