Entresto (sacubitril/valsartan) is a combination of the neprilysin inhibitor sacubitril and the angiotensin receptor blocker valsartan. Neprilysin inhibitors amplify the protective neurohormonal systems of the heart by blocking the breakdown of natriuretic peptides.
Describing sacubitril/valsartan as a 'small step change' in the management of heart failure, NICE concluded that the treatment can be offered as an alternative to ACE inhibitors or angiotensin II receptor blockers in patients who remain symptomatic despite taking a stable dose of these medications.
To qualify for NHS treatment, patients must have a reduced left ventricular ejection fraction of 35% or less and New York Heart Association (NYHA) class II to IV symptoms.
"This recommendation will help ease the symptoms of very ill people, improve their quality of life and help them to take part in normal daily activities. It should also reduce their need for hospital treatment," said Professor Carole Longson, director of the NICE Health Technology Evaluation Centre.
Treatment with sacubitril/valsartan should be started by a heart failure specialist with access to a multidisciplinary heart failure team. Dose titration and monitoring should be performed by the most appropriate member of the team.
Because sacubitril/valsartan has been awarded Early Access to Medicines Scheme status, CCGs are obliged to make it available to suitable patients within 30 days of NICE's decision, rather than within the usual 90 days.
In the pivotal PARADIGM-HF trial, sacubitril/valsartan was superior to enalapril in preventing cardiovascular death or hospitalisation for heart failure. The endpoint occurred in 21.8% of patients treated with the combination and 26.5% of those who received enalapril (hazard ratio in the combination group 0.80, 95% CI 0.73–0.87; p<0.001).