Novartis’ Entresto has been recommended by the National Institute for Health and Care Excellence (NICE) for the treatment of heart failure
NICE has recommend Entresto (sacubitril/valsartan) in its final draft guidance for use within the National Health Service (NHS).
NICE recognised sacubitril/valsartan as an innovative and cost-effective treatment in the management of symptomatic chronic heart failure with reduced ejection fraction, according to Novartis.
Nigel Rowell, general practitioner in Middlesborough and primary care lead for the North of England Cardiovascular Network, said: “Heart failure is a highly debilitating, life-threatening condition.
“With proven benefits in reducing the risk of death and hospitalisation, we know that sacubitril/valsartan is effective and GPs and patients will welcome the addition of a new cost-effective treatment.”
Nick Hartshorne-Evans, chief executive and founder of Pumping Marvellous Foundation, said: “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.”
The final draft guidance for sacubitril/valsartan was based on a review of clinical and cost effectiveness data from the PARADIGM-HF trial.
PARADIGM-HF compared the efficacy and safety of sacubitril/valsartan with enalapril in 8,399 patients with chronic heart failure with reduced ejection fraction.
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%)1,5,11. Based on this evidence and given the innovative nature of sacubitril/valsartan, NICE also considered sacubitril/valsartan to represent a cost-effective use of NHS resources, according to Novartis.
NICE has recommend Entresto 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-blockers1
Hartshorne-Evans, said: “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.”
Dimitrios Georgiopoulos, chief scientific officer, Novartis Pharmaceuticals UK, said: “Today’s recommendation from NICE represents an important milestone in our ambition to address high unmet need in chronic heart failure.
“Sacubitril/valsartan is now available for use in the UK for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction. 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.
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 this final guidance.