Final Appraisal Determination for Sacubitril valsartan

NICE Publish Final Appraisal Determination for Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction

National Institute for Health and Care Excellence (NICE) Recommendations in Final Appraisal Determination for Sacubitril valsartan

Recommendations 1.1
Sacubitril valsartan is recommended as an option for treating symptomatic chronic heart failure with reduced ejection fraction, only in people:  with New York Heart Association (NYHA) class II to IV symptoms and  with a left ventricular ejection fraction of 35% or less and  who are already taking a stable dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor-blockers (ARBs). 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 performed by the most appropriate team member as defined in NICE’s guideline on chronic heart failure in adults: management.

Clinical effectiveness evidence 3.1
The pivotal clinical evidence presented in the company’s submission was taken from the PARADIGM-HF trial, which compared sacubitril valsartan with enalapril (an angiotensinconverting enzyme [ACE] inhibitor). The company also did a network meta-analysis to compare sacubitril valsartan with angiotensin II receptor-blockers (ARBs) for people who cannot have an ACE inhibitor. Finally, the company provided supplementary evidence in its submission from the TITRATION trial (a multicentre, randomised, double-blind, parallel group, phase II study in clinically stable outpatients or hospitalised patients), which evaluated the safety and tolerability of sacubitril valsartan at increasing doses

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