Around 100,000 people in England and Wales could now benefit from treatment with Novartis’ revolutionary heart drug Entresto, after cost regulators issued a final green light for its use on the National Health Service.
The guidance recommends the £3-per-day treatment for people with 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 - but restricts its use to patients with moderate-to-severe symptoms.
The Institute has stipulated that only in those with New York Heart Association (NYHA) class II to IV symptoms, a left ventricular ejection fraction of 35% or less, and those who are already taking a stable dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor-blockers (ARBs) should get NHS access.
The committee concluded that Entresto (sacubitril valsartan) is an innovative drug - the first of a new class of medicines called angiotensin receptor neprilysin inhibitors - that could prevent deaths and cut back the more than 30,000 related hospital admissions each year in England.
Entresto 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.
“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,” said Professor Carole Longson, director of the NICE Health Technology Evaluation Centre. “The committee heard from clinical experts and patient experts that a new treatment option would provide hope and generate optimism.”
“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,” she said.
However, the Institute’s stance that there wasn’t enough evidence to show the drug’s clinical and cost effectiveness in those with a less severe reduced ejection fraction, in people with very mild symptoms, and for those who haven’t yet taken an ACE inhibitor or ARB, will no doubt disappoint campaigners.
Heart failure affects about 410,000 people in England, of whom nearly three quarters (295,800) have heart failure with a reduced ejection fraction.
“This guidance from NICE gives us the final stamp of approval to offer patients with symptomatic chronic heart failure a much needed additional treatment option,” said Dimitrios Georgiopoulos, chief scientific officer, Novartis Pharmaceuticals UK.
“Sacubitril/valsartan has been recommended by NICE and accepted by SMC within 5 months of EMEA approval. This demonstrates both the treatment innovation of sacubitril/valsartan and Novartis’ commitment to addressing unmet patient needs.”
Also commenting, Life Sciences Minister George Freeman MP said: "Heart failure is a devastating condition affecting hundreds of thousands of people in the UK, so I am delighted that this life-enhancing treatment will now become available to NHS patients. Through the Early Access to Medicines Scheme and the Accelerated Access Review we are determined to speed up access to drugs for NHS patients.”_