NICE Publish Guidance for Sacubitril valsartan
NICE gives green light to new heart failure drug set to benefit 100,000 people with common heart condition
In guidance published today NICE has recommended new heart failure drug sacubitril valsartan (Entresto, Novartis), the first drug of its kind, as an option for some people with heart failure.
The guidance for sacubitril valsartan recommends the £3 per day treatment for this life-threatening condition in over 100,000 people with moderate to very severe symptoms whose heart is only able to pump a reduced amount of oxygenated blood around the body (known as a reduced ejection fraction), and whose heart failure is not controlled by the commonly used drugs, ACE inhibitors or ARBs.
The committee concluded that sacubitril valsartan is an innovative drug that offers the potential to prevent deaths and reduce the more than 30,000 hospital admissions for this condition each year in England.
Sacubitril valsartan is the first of a new kind of drug called angiotensin receptor neprilysin inhibitors. These work by widening the blood vessels, increasing blood flow while reducing blood pressure and taking the strain off the heart.
The drug is also the first non-cancer drug to be fast-tracked through the Medicines and Healthcare Products Regulatory Agency’s Early Access to Medicines Scheme. The scheme aims to give patients with life threatening or seriously debilitating conditions access to medicines before they are licensed where there is a clear unmet medical need.
Professor Carole Longson MBE, Director of the NICE Health Technology Evaluation Centre, said: “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. The committee heard from clinical experts and patient experts that a new treatment option would provide hope and generate optimism.
“We are pleased to be able to recommend this innovative new treatment for those people with a severely reduced ejection fraction and whose symptoms mean they are almost constantly bedbound.
“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.
“There was not enough evidence to show the clinical and cost effectiveness of sacubitril valsartan in people who do not have such a severely reduced ejection fraction, or in people who have very mild symptoms, and for people who have not already had an ACE inhibitor or ARB, so the committee weren’t able to recommend the drug for these people.”
Heart failure affects about 410,000 people in England, of whom nearly three quarters (295,800) have heart failure with a reduced ejection fraction. Common symptoms of heart failure include breathlessness, tiredness and fluid retention. The most common cause of heart failure in the UK is heart disease, with many patients having had a heart attack in the past.
Heart failure causes significant ill-health and death. In 2012/13 over 30,000 people were admitted to hospital in England with heart failure with reduced left ventricular ejection fraction. Around 30-40% of patients diagnosed with heart failure die within a year but after that the mortality rate falls to less than 10% per year.