Novartis response to the NICE TAG announcement on Entresto (sacubitril/valsartan)
Apr 27, 2016
Novartis welcomes the publication of the final National Institute for Health and Care Excellence (NICE) Technology Appraisal Guidance (TAG) for Entresto™ (sacubitril/valsartan) 1,2 an innovative first-in-class* treatment for adult patients with symptomatic chronic heart failure with reduced ejection fraction.
Clinical commissioning groups now have an obligation to ensure that sacubitril/valsartan is made available to appropriate patients within 30 days and no later than 27 May 2016. This accelerated implementation is a result of sacubitril/valsartan being awarded Early Access to Medicines Scheme status in September 20153. The typical implementation period of NICE guidance for any given treatment is within 90 days of publication of the final TAG.
“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,” said Dimitrios Georgiopoulos MD, Chief Scientific Officer, Novartis Pharmaceuticals UK Ltd. “Sacubitril/valsartan has been recommended by NICE and accepted by SMC within 5 months of EMEA approval. This demonstrates both the treatment innovation of sacubitril/valsartan and Novartis’ commitment to addressing unmet patient needs.”
Sacubitril/valsartan, recognised as a cost-effective treatment by NICE, is recommended for use within the NHS as an option for treating symptomatic chronic heart failure with reduced ejection fraction in adult patients with New York Heart Association class II to IV symptoms, a left ventricular ejection fraction of 35% or less and who are taking a stable dose of angiotensin-converting enzyme inhibitors or angiotensin-II-receptor-blockers4.
Nick Hartshorne-Evans, Chief Executive and Founder of Pumping Marvellous Foundation said, “Treatment goals for symptomatic chronic heart failure with reduced ejection fraction are to reduce symptoms, improve quality of life and decrease the rate of hospitalisation. For many patients, the condition has a negative impact across different aspects of their daily life. We are pleased to see that sacubitril/valsartan should be made available to patients on the NHS in as little as 30 days.”
* Entresto (sacubitril/valsartan is an angiotensin receptor-neprilysin inhibitor (ARNI) and has a unique mode of action, which is thought to reduce the strain on the failing heart. It acts to enhance the protective neurohormonal systems of the heart (natriuretic peptide (NP) system) while simultaneously suppressing the harmful system (renin-angiotensin-aldosterone system or RAAS)5
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