Novartis' new heart failure medicine, Entresto™ (sacubitril/valsartan) accepted for use by the Scottish Medicines Consortium
Mar 07, 2016
SMC recognised sacubitril/valsartan represents a new therapeutic option for adult patients with symptomatic chronic heart failure with reduced ejection fraction1 and may be used instead of the current gold standard treatment for the condition
Heart failure affects over 45,000 people in Scotland, around 11,900 people were admitted to hospital and approximately 23% died within 30 days of being discharged in 20132,3,4
The largest ever heart failure study to date, PARADIGM-HF, was led by co-principal investigator, Professor John McMurray from University of Glasgow. It showed sacubitril/valsartan saved lives and reduced hospitalisation for people with heart failure when compared to the current gold standard, enalapril, an ACE-inhibitor commonly used to treat the condition 5,6
Clinical experts and the patient group consulted by SMC noted that there is an unmet need for more effective treatments in the management of heart failure1
Frimley, UK, March 07 2016 – The Scottish Medicines Consortium (SMC) has accepted Entresto™ (sacubitril/valsartan) for use within NHS Scotland for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction1. The SMC recognised sacubitril/valsartan represents a new therapeutic option for patients with chronic heart failure with reduced ejection fraction. It noted that it may be used instead of angiotensin converting enzyme (ACE) inhibitors1, the current gold standard treatment for the condition.
"Patients with heart failure can have a poor prognosis, with survival rates often being worse than certain types of cancer, such as breast and prostate." said Dr Roy Gardner, Consultant Cardiologist, Scottish National Advanced Heart Failure Service, Golden Jubilee National Hospital. "The acceptance of sacubitril/valsartan will allow many heart failure patients in Scotland to benefit from a reduced risk of death and hospitalisation."
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. In Scotland, heart failure was responsible for 11,900 hospitalisations in 20133. It was estimated that 25% of patients needed emergency re-admissions within 30 days of hospital discharge4 and 23% of patients hospitalised with heat failure died within 30 days of being discharged from hospital4.
"Today's advice represents an important milestone for heart failure patients in Scotland." said Dimitrios Georgiopoulos MD, Chief Scientific Officer, Novartis Pharmaceuticals UK Ltd. "The SMC conducts a robust evaluation of the clinical value and the cost-effectiveness of new treatments, and we applaud the SMC for accepting the use of sacubitril/valsartan under its licensed indication with no restriction."
The SMC carried out an evaluation of the clinical and cost effectiveness of sacubitril/valsartan and based its advice on data from the PARADIGM-HF study, the largest Phase 3 heart failure clinical trial conducted to date. The study compared the efficacy and safety of sacubitril/valsartan with enalapril, in 8,399 patients with chronic heart failure with reduced ejection fraction. Results showed that sacubitril/valsartan, compared to enalapril, reduced the risk of death from heart-related causes or first hospitalisation for heart failure by 20% (absolute risk reduction: 4.7%)1. Based on this evidence, the SMC concluded that the introduction of sacubitril/valsartan would offer an alternative treatment to ACE inhibitors or angiotensin II receptor blockers (ARB) in patients with heart failure with reduced ejection fraction1.
Sacubitril/valsartan is now available for use in the UK for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction. Following publication of the SMC's advice, NHS Boards in Scotland will now decide whether sacubitril/valsartan should be added to their formulary. Novartis is also working with NICE 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 that works in a unique way by reducing the strain on the failing heart. The active substances works in two complementary ways; valsartan blocks the angiotensin II type-1 receptor, suppressing the harmful effects of angiotensin II on the cardiovascular system, while sacubitril blocks an enzyme known as neprilysin to enhance the protective neurohormonal systems of the heart7.
In the pivotal PARADIGM-HF study, 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 enalapril6.
Fewer patients on sacubitril/valsartan discontinued study medication for any adverse event compared to those on enalapril. The sacubitril/valsartan group had more hypotension (significant difference) and a greater number of reports of non-serious angioedema (non-significant difference) but less renal impairment, hyperkalemia and cough than the enalapril group6.
About heart failure Heart failure is a complex condition that is challenging to treat. There is no cure and current treatments aim primarily to reduce mortality. In Scotland, from 01 October 2013 to 30 September 2014, the average in-hospital mortality rate for heart failure patients in Scotland was 18%4. Heart diseases, including heart failure, remain the second highest cause of death in Scotland after cancer8.
Heart failure happens when the heart muscle weakens or stiffens. It often occurs when the heart muscle has been injured. This can happen following a heart attack or other illnesses affecting the heart, or by damage that occurs more gradually and is due to conditions such as diabetes, high blood pressure, coronary artery disease, high cholesterol, excessive alcohol consumption, or drug abuse. In most cases heart failure does not have a single cause9.
The symptoms of heart failure include difficulty breathing, severe fatigue, weight gain due to fluid build-up, and swollen lower limbs due to build-up of fluid 9,10.
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