The draft guidance recommends the drug for treating chronic heart failure with reduced ejection fractioni in people with New York Heart Association class II to III symptomsii who are on a stable dose of ACE inhibitors (or angiotensin II receptor blockers for people who are intolerant of ACE inhibitors) and who have a left ventricular ejection fraction of 35% or less.
Heart failure affects about 900,000 people in the UK. It is a complex clinical syndrome of symptoms such as breathlessness, tiredness and fluid retention that suggest the heart is unable to pump enough oxygen and nutrients to meet the body's needs. The most common cause of heart failure in the UK is coronary artery disease, with many patients having had a heart attack in the past.
Heart failure is associated with significant ill-health and mortality. In 2012/13 over 30,000 people were admitted to hospital in England with heart failure with reduced left ventricular ejection fractioniii. Around 30-40% of patients diagnosed with heart failure die within a year but thereafter the mortality rate falls to less than 10% per year.
Sacubitril valsartan is an angiotensin receptor neprilysin inhibitor. Sacubitril stops the enzyme neprilysin from working properly. Neprilysin inhibits the actions of other substances called peptides in dilating (widening) 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.
Meindert Boysen, programme director, technology appraisals at NICE, said:"Drugs to treat heart failure have been available for many years. Despite this, people with this life-threatening and often debilitating condition have a poor prognosis, especially those with reduced ejection fraction. Sacubitril valsartan is an innovative drug that will offer people with this condition a further important treatment option with the potential to prevent deaths and reduce hospital admissions."
Consultees, including the company, healthcare professionals and members of the public are able to comment on the draft recommendations until 15 January 2016 via the NICE website. Comments received during this consultation will be fully considered by the Committee before the next draft guidance is issued. Until final guidance is published, NHS bodies should make decisions locally on the funding of specific treatments.
For more information, please call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813, or email [email protected].
Notes to Editors
References and explanation of terms
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.
- New York Heart Association (NYHA) Functional Classification classifies the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity:
No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc
Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m).
Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
- The National Heart Failure Audit April 2012-March 2013.
About the draft guidance
- The draft guidance on sacubitril valsartan will be available from the NICE website from 00:01 on Friday 11 December athttp://www.nice.org.uk/guidance/indevelopment/gid-tag516/documentsEmbargoed copies are available from the NICE press office on request.
- The draft 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 III chronic heart failure and
- who are already taking a stable dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor-blockers (ARBs) and
- with a left ventricular ejection fraction of 35% or less.
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 done by the heart failure specialist, or in primary care by either a GP with a special interest in heart failure or a heart failure specialist nurse.
1.3 People whose treatment with sacubitril valsartan is not recommended in this NICE guidance, but was started within the NHS before this guidance was published, should be able to continue treatment 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 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; price confirmed by company):
- 50 mg, 28 pack: £45.78
- 100 mg, 28 pack: £45.78
- 100 mg, 56 pack: £91.56
- 200 mg, 56 pack: £91.56
Costs may vary in different settings because of negotiated procurement discounts.
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