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NICE gives green light to Novartis’s heart drug Entresto

Published on 27/04/16 at 12:15pm

NICE has published final guidance recommending heart failure drug Entresto (sacubritil/valsartan).

The drug, developed by Novartis, has performed well in Phase III trials and earned a provisional yes from NICE at the end of last year.

The guidance recommends the £3 per day treatment for this life-threatening condition in over 100,000 people with moderate to very severe symptoms. In cases such as these, the heart is only able to pump a reduced amount of oxygenated blood around the body, and cannot be adequately controlled by commonly used drugs such as ACE inhibitors or ARBs.

The NICE committee concluded that Entresto is an innovative drug that has the potential to reduce the more than 30,000 hospital admissions each year for this condition, as well as save many lives.

The drug is the first non-cancer drug to be fast-tracked through the Early Access to Medicines Scheme, run by the Medicines and Healthcare Products Regulatory Agency.

Professor Carole Longson, Director of the NICE health technology evaluation centre, says: “We are pleased to recommend this innovative new treatment for those people with a severely reduced ejection fraction and whose symptoms 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.”

However, not all patients will be granted access to Entresto. As Longson points out: “There was not enough evidence to show the clinical and cost effectiveness of [Entresto] 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.”

Clinical commissioning groups now have an obligation to ensure that Entresto is made available to appropriate patients within 30 days.

Dimitrios Goergiopoulos, chief scientific officer at Novartis UK, reacts: “This guidance from NICE gives us the final stamp of approval to offer patients with symptomatic chronic heart failure a much needed additional treatment option. [Entresto] has been recommended by NICE and accepted by SMC within five months of EMEA approval. This demonstrates both the treatment innovation of [Entresto] and Novartis’s commitment to addressing unmet patient needs.”

Sean Murray

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