Novartis' new heart failure medicine now available in the UK

Sacubitril/valsartan (Entresto^TM) is now available for UK adults with symptomatic chronic heart failure with reduced ejection fraction.

• Largest heart failure study showed Entresto (sacubitril/valsartan) saves lives and reduces hospitalisation for people with heart failure when compared to enalapril, an ACE-inhibitor, and current gold standard, commonly used to treat the condition^1,2
• New treatments that can reduce hospitalisations and the number of people dying from heart failure are needed as the outlook for patients remains poor³
• Heart failure costs the NHS £2.3 billion, and the figure is rising due to the UK's ageing population^4,5

Entresto^TM (sacubitril/valsartan), a twice-a-day tablet for adult patients with symptomatic heart failure with reduced ejection fraction, is now available in the UK. Heart failure occurs when the heart muscle cannot pump a normal amount of oxygen-rich blood around the body, resulting in a substantial impact on patients' daily lives. The new treatment has been shown to save the lives of patients with heart failure when compared to the gold standard treatment, enalapril^2,6.

"The availability of this new treatment in heart failure could change how heart failure patients are treated," said Professor Iain Squire, Professor of Cardiovascular Medicine, University of Leicester and Honorary Consultant Physician, University Hospitals of Leicester NHS Trust and Chair of British Society for Heart Failure. "For many patients with heart failure, outcomes remain poor and there is clear room for therapies that improve on what we have available at the moment. Doctors can now offer suitable patients an option that has been shown in a large clinical trial to cut the risk of death and reduce the number of hospitalisations."

Sacubitril/valsartan works in a unique way by reducing the strain on the failing heart. In the largest heart failure clinical trial conducted to date, it reduced the risk of death from cardiovascular causes, such as sudden death and worsening heart failure, compared to enalapril, an ACE inhibitor. ACE inhibitors are the most commonly used treatment for heart failure⁷.

Overall, sacubitril/valsartan reduced the risk of death from heart-related causes or of first hospitalisation for heart failure by 20% when compared to enalapril (absolute risk reduction: 4.7%)². Patients on the trial were asked to report on how well they felt and the doctors caring for them how severe the patient's heart failure was: patients taking sacubitril/valsartan reported feeling better and having less severe symptoms in the sacubitril/valsartan group compared to patients taking enalapril2.The clinical trial stopped early as it showed a clear benefit of sacubitril/valsartan over enalapril.

"Patients with heart failure had a poor prognosis for many years, with survival rates being worse than certain types of cancer, such as breast and prostate," said Dimitrios Georgiopoulos MD, Chief Scientific Officer, Novartis Pharmaceuticals UK Ltd. "Our clinical trial showed that treatment with sacubitril/valsartan reduces the risk of death and hospitalisation for patients and the availability of this new treatment will give doctors a new option to manage many of their heart failure patients."

On average, a general practitioner looks after 30 patients with heart failure and will diagnose ten new heart failure patients annually. However, despite being such a common condition, most people fail to recognise the symptoms. Common symptoms include difficulty breathing, swollen limbs due to build-up of fluid, severe fatigue and weight gain due to fluid build-up⁸.

Heart failure is a highly debilitating, life-threatening condition, which affects around 550,000 people in the UK9. Heart failure is a considerable burden to the UK healthcare system. It costs the NHS about £2.3bn a year, accounts for 1 million inpatient bed days and 5% of all emergency and medical admissions to UK hospitals; hospital admissions are projected to rise by 50% over the next 25 years, largely as a result of an ageing population8. Hospitalisation is costly and heart failure patients are frequently readmitted; 70% of treatment costs for heart failure are due to hospitalisations¹⁰.

Novartis is working with NICE and the Scottish Medicines Consortium (SMC) to ensure as many eligible patients as possible will be able to benefit from sacubitril/valsartan once it has been appraised.

About sacubitril/valsartan

Sacubitril/valsartan is a twice-a-day tablet. In its pivotal study, PARADIGM-HF which compared sacubitril/valsartan to enalapril, the risk of dying from a heart-related cause or being hospitalised for the first time in the trial because of heart failure was reduced by a fifth in patients taking sacubitril/valsartan. Patients on sacubitril/valsartan reported feeling better than patients receiving treatment with enalapril.

Fewer patients on sacubitril/valsartan discontinued study medication for any adverse event compared to those on enalapril. The sacubitril/valsartan group had more hypotension and non-serious angioedema but less renal impairment, hyperkalemia and cough than the enalapril group².

British Heart Foundation reaction to availability of sacubitril valsartan

Professor Peter Weissberg, Medical Director at the British Heart Foundation (BHF), said:

"The BHF welcomes NICE's proposed approval of the sacubitril valsartan (Entresto) treatment for a subgroup of heart failure patients. For a number of years, treatment of heart failure has changed little and relied on drugs that have been available for decades. Sacubitril valsartan introduces an entirely new class of drug with an unique mechanism of action therefore widening the therapeutic options available for patients with heart failure.

"As with any new drug, it will take time and further research to establish the true benefits of sacubitril valsartan and to learn which patients can and can't tolerate its potential side effects. It is therefore appropriate that NICE should recommend that it is prescribed and monitored by specialists working as part of a heart failure team.

"While promising, it's important to stress that this treatment is not a cure for heart failure, which affects over half a million people in the UK. We're continuing to fund research looking for treatments that could regenerate and repair the failing heart. A treatment like this would be game-changer for treating, and possibly curing, heart failure."