26 April 2016
NICE gives green light to new 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 recommends the £3 per day treatment for this life-threatening condition in over 100,000 people with moderate to very severe symptoms i whose heart is only able to pump a reduced amount of oxygenated blood around the body (known as a reduced ejection fractionii), 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 can 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 Englandiii, of whom nearly three quarters (295,800) have heart failure with a reduced ejection fractioniv. 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.
Ends
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Notes to Editors
References and explanation of terms
- Symptoms are described according to New York Heart Association (NYHA) Functional Classification. It places patients in one of four categories based on how much they are limited during physical activity:
NYHA Class |
Symptoms |
I |
No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc |
II |
Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. |
III |
Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m). |
IV |
Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. |
- This is called the ejection fraction and is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction. A normal heart pumps a little more than half the heart’s blood volume with each beat. A normal left ventricular ejection fraction ranges from 55-70%. A left ventricular ejection fraction of 65%, for example, means that 65% of the total amount of blood in the left ventricle is pumped out with each heartbeat. An ejection fraction of less than 35% increases the risk of life-threatening irregular heartbeats that can cause sudden cardiac arrest (loss of heart function) and sudden cardiac death.
About the guidance
- The guidance on sacubitril valsartan is available from the NICE website at http://www.nice.org.uk/guidance//ta388
- The guidance states that:
1.1 Sacubitril valsartan is recommended as an option for treating people with heart failure with reduced ejection fraction, only in people:
- with New York Heart Association (NYHA) class II to IV symptoms and
- with a left ventricular ejection fraction of 35% or less and
- who are already taking a stable dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor-blockers (ARBs).
1.2 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 team member as defined in NICE’s guideline on chronic heart failure in adults: management.
1.3 This guidance is not intended to affect the position of patients whose treatment with sacubitril valsartan was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.
- The Committee concluded that, for the population included in the PARADIGM-HF trial, sacubitril valsartan was statistically significantly more clinically effective than enalapril at reducing hospitalisations and improving both overall mortality and cardiovascular mortality.
- The Committee considered that, given the innovative nature of sacubitril valsartan, the most plausible ICERs of £29,500 and £30,100 per QALY gained for sacubitril valsartan compared with ACE inhibitors and ARBs (for people in whom an ACE inhibitor is unsuitable), respectively, represented a cost effective use of NHS resources.
About sacubitril valsartan
- Sacubitril valsartan works by stopping an enzyme called neprilysin from working properly. Neprilysin stops other substances called peptides from widening (dilating) the blood vessels. By restricting the action of neprilysin, sacubitril allows the blood vessels to relax, reducing blood pressure and therefore decreasing the heart’s workload. Valsartan belongs to a class of drugs called angiotensin II receptor blockers (ARBs) and also works by lowering blood pressure.
- Sacubitril valsartan has a UK marketing authorisation for ‘the treatment of symptomatic chronic heart failure with reduced ejection fraction’.
- Sacubitril valsartan is administered orally. The recommended starting dose is either 100 mg twice daily, or 50 mg twice daily for patients not currently taking (or on low doses of) an ACE inhibitor or an ARB. The dose is to be doubled every 2 to 4 weeks to the target of 200 mg twice daily, as tolerated by the patient.
- The acquisition cost of sacubitril valsartan is as follows (excluding VAT; MIMS, April 2016):
- 24 mg/26 mg (containing 24.3 mg sacubitril and 25.7 mg valsartan), 28 pack: £45.78
- 49 mg/51 mg (containing 48.6 mg sacubitril and 51.4 mg valsartan), 28 pack: £45.78
- 49 mg/51 mg (containing 48.6 mg sacubitril and 51.4 mg valsartan), 56 pack: £91.56
- 97 mg/103 mg (containing 97.2 mg sacubitril and 102.8 mg valsartan), 56 pack: £91.56
Treatment with sacubitril valsartan is estimated to cost around £1,200 per person per year.
Costs may vary in different settings because of negotiated procurement discounts.
About NICE
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