NICE recommends Novartis’ heart failure drug, Entresto

Entresto is recommended for use 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.

Commenting on the recommendation, Dr Nigel Rowell, General Practitioner in Middlesborough and Primary Care Lead for the North of England Cardiovascular Network, said: “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.”

The final draft guidance for sacubitril/valsartan was based on a thorough review of clinical and cost effectiveness data from the PARADIGM-HF trial, the largest Phase III heart failure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. 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%. 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.

An “important milestone”

“Today’s recommendation from NICE represents an important milestone in our ambition to address high unmet need in chronic heart failure,” said Dimitrios Georgiopoulos MD, Chief Scientific Officer, Novartis Pharmaceuticals UK Ltd. “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.”

NICE’s recommendations that sacubitril/valsartan should only be offered to patients with a left ventricular ejection fraction of 35% or less is in marked contrast to recent guidance from the Scottish Medicines Consortium, which accepted sacubitril/valsartan under its full licenced indication with no restrictions earlier this month.

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. EAMS, as part of the Medicines and Healthcare products Regulatory Agency’s initiative, is designed to make unlicensed treatments available to patients in areas of significant unmet medical need.