The UK National Institute for Health and Care Excellence (NICE) has recommended sacubitril/valsartan (Entresto) in its final draft guidance for use within the UK National Health Service (NHS) as an option for treating symptomatic chronic heart failure with reduced ejection fraction in adult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 (ACE) inhibitors or angiotensin-II-receptor-blockers in the management of symptomatic chronic heart failure with reduced ejection fraction.
“Heart failure is a highly debilitating, life-threatening condition that causes patients to face a high risk of death, repeated hospitalisations and symptoms that significantly impact their quality of life,” says Nigel Rowell, general practitioner in Middlesborough and primary care lead for the North of England Cardiovascular Network. “With proven benefits in reducing the risk of death and hospitalisation, we know that sacubitril/valsartan is effective and general practitioners and patients will welcome the addition of a new cost-effective treatment.”
Nick Hartshorne-Evans, chief executive and founder of the Pumping Marvellous Foundation says, “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…we are delighted that NICE has taken on board the level of need and valued the patient input and evidence. 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.”
The final draft guidance for sacubitril/valsartan was based on a thorough review of clinical and cost effectiveness data from the PARADIGM-HF trial, the largest phase three heart failure clinical trial conducted to date. PARADIGM-HF compared the efficacy and safety of sacubitril/valsartan with enalapril in 8,399 patients with chronic heart failure with reduced ejection fraction. The primary end point of death from cardiovascular causes or first hospitalisation for worsening heart failure significantly favoured sacubitril/valsartan compared with enalapril (p<0.001). Results showed that sacubitril/valsartan, compared to enalapril, reduced the risk of death from cardiovascular-related causes or first hospitalisation for heart failure by 20% (absolute risk reduction: 4.7%). NICE also considered sacubitril/valsartan to represent a cost-effective use of NHS resources.
The NICE Technology Appraisal Guidance, the final step within the NICE approval process, is scheduled for publication in April 2016. As sacubitril/valsartan was made available in the NHS through the Early Access to Medicines Scheme (EAMS) in September 2015, the NHS in England has indicated that this guidance must be implemented 30 days after publication of the final guidance.