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NICE backs Novartis' Entresto for heart failure

But approves narrower indication than has been authorised by Scotland's SMC

NovartisThe National Institute for Health and Care Excellence (NICE) has confirmed that Novartis' Entresto will be covered by the NHS for some patients with chronic heart failure (CHF).

The final guidance on Entresto (sacubitril/valsartan) indicates that the drug can be used to treat adults with symptomatic New York Heart Association class II to IV CHF - but only for those with a left ventricular ejection fraction of 35% or less and who are on a stable dose of ACE inhibitors or angiotensin II receptor blockers.

That is a narrower indication than has been approved by the Scottish Medicines Consortium (SMC), which has given its blessing for the drug's approved indication in the EU, so access to Entresto will be different depending on the area of the UK in which patients live.

Dimitrios Georgiopoulos, Novartis Pharmaceuticals UK's chief scientific officer, said: "Today's recommendation from NICE represents an important milestone in our ambition to address high unmet need in CHF.

"However, due to NICE's restrictions on eligible patients, not all patients will have access to this breakthrough treatment on the NHS in England," he added.

Heart failure affects around 550,000 people in the UK and is a leading cause of hospital admission in patients aged over 65, swallowing up £2.3bn of the NHS' annual budget and accounting for a million in-patient bed days.

Entresto was the first CHF therapy to show an improvement over ACE inhibitors - the gold-standard therapy for decades - in improving survival.  The results of the PARADIGM-HF study showed that patients treated with the drug were 20% less likely to die from a cardiovascular cause or be hospitalised and were also 16% less likely to die from any cause.

Entresto is expected to become a cornerstone of CHF therapy, with predictions that it will become a $5bn-plus brand at peak.

Nick Hartshorne-Evans, CEO and founder of Pumping Marvellous Foundation, said: "With ACE inhibitors being the gold standard treatment for almost 25 years, there is a high unmet need for new effective treatments that improve the quality of life, morbidity and mortality for seriously ill patients.

"This is a very positive development and we are delighted that NICE has taken on board the level of need and valued the patient input and evidence."

But he added: "Even though this guidance means that now some people with chronic heart failure with reduced ejection fraction will have access to sacubitril/valsartan, we are disappointed that with the restrictions in place not all patients covered by the marketing authorisation will receive this vital treatment option."

Article by
Phil Taylor

22nd March 2016

From: Regulatory

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