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heartdisorderMay 4 2015

Over 100,000 patients may benefit from a novel therapy for chronic heart failure, following NICE approval of a new combination medicine, sacubitril valsartan.

The product, marketed by Novartis as Entresto, is the first angiotensin receptor neprilysin inhibitor (ARNI). With a cost of under £3 per day, NICE has endorsed its use within the NHS as an option for treating symptomatic chronic heart failure with reduced ejection fraction in adults:

  • with New York Heart Association class II to IV symptom (mild to severe symptoms);
  • with a left ventricular ejection fraction of 35% or less; and
  • who are taking a stable dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-II-receptor-blockers (ARBs).

Treatment, which will need dose titration and monitoring, should be initiated by a heart failure specialist with access to a multidisciplinary heart failure team.

Supporting the approval for NHS use is data from the PARADIGM-HF trial. This concluded that “sacubitril valsartan was statistically significantly more clinically effective than enalapril at reducing hospitalisations and improving both overall mortality and cardiovascular mortality.” In addition the NICE 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.”

Professor Carole Longson, 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.

“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.”

However, Professor Longson noted that there was insufficient 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.

NICE points out that over 30,000 people were admitted to hospital in England with heart failure with reduced left ventricular ejection fraction in 2012-13. In addition, “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.”

Professor Peter Weissberg, the British Heart Foundation’s Medical Director, said: “There is currently no cure for heart failure and we welcome the news that this drug will now be available to some patients to help control and manage their condition. In the UK, over half a million people are living with this crippling illness which can cause chronic breathlessness and fatigue, leaving patients with a long and difficult fight for life.

“Through generous donations to our Mending Broken Hearts Appeal, we have been able to fund around £25 million of regenerative medicine research. Recent advances in this field have shown that repairing the heart after a heart attack, something that is currently impossible, is a realistic goal. But we must fund more research to develop promising discoveries made in the lab into treatments for people living with debilitating heart failure.”

Links:

NICE announcement

NICE technology appraisal guidance [TA388] ‘Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction’

Novartis statement

BHF statement

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