Breakthrough drug for heart failure now available in the UK

Novartis has announced Entresto™ (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF) is now available in the UK.

Sacubitril/valsartan significantly reduces the risk of cardiovascular death and first hospitalisation for heart failure by 20% when compared to ACE-inhibitor, enalapril¹ (absolute risk reduction: 4.7%).

“The availability of this new treatment in heart failure could change how heart failure patients are treated,” said Professor Iain Squire, Professor of Cardiovascular Medicine, University of Leicester and Honorary Consultant Physician, University Hospitals of Leicester NHS Trust and Chair of British Society for Heart Failure. “For many patients with heart failure, outcomes remain poor and there is clear room for therapies that improve on what we have available at the moment. Doctors can now offer suitable patients an option that has been shown in a large clinical trial to cut the risk of death and reduce the number of hospitalisations.”

Sacubitril/valsartan was studied in the largest heart failure trial conducted to date, PARADIGM-HF, involving 8442 patients with HFrEF. The trial was stopped early due to a clear benefit of sacubitril/valsartan over enalapril. The study demonstrated that sacubitril/valsartan was superior to enalapril in reducing the risks of cardiovascular mortality and first hospitalisation for heart failure. Analysis of safety data showed that sacubitril/valsartan had a similar tolerability profile to enalapril.^1,4

Heart failure is a highly debilitating, life-threatening condition, which affects around 550,000 people in the UK.⁵ On average, a general practitioner looks after 30 patients with heart failure and will diagnose 10 new heart failure patients annually. However, despite being such a common condition, most people fail to recognise the symptoms.⁶

Heart failure costs the NHS about £2.3bn a year, accounts for 1 million inpatient bed-days and 5% of all emergency and medical admissions to UK hospitals; hospital admissions are projected to rise by 50% over the next 25 years, largely as a result of an ageing population.⁷

Novartis is working with NICE and the Scottish Medicines Consortium (SMC) to ensure as many eligible patients as possible will be able to benefit from sacubitril/valsartan once it has been appraised. Entresto was the first non-oncology drug to be entered into the Government’s Early Access to Medicines Scheme (EAMS) and as such, any guidance from NICE should be implemented by the NHS within 30 days.

“There is a real need for new and effective treatments that can reduce the number of hospitalisations and mortality in patients with heart failure,” said Dimitrios Georgiopoulos MD, Chief Scientific Officer, Novartis Pharmaceuticals UK Ltd. “Despite use of current treatments and availability of clinical guidelines, 40% of patients die within a year of first hospital admission for heart failure and survival rates are worse than certain types of cancer, such as breast and prostate. In an area of high unmet need, sacubitril/valsartan gives doctors a new option that can potentially improve the outcomes of many of their heart failure patients.”

References:

1. McMurray JJV et al. Angiotensin-Neprilysin Inhibition versus Enalapril in Heart Failure. N Engl J Med 2014;371:993–1004.
2. NHS England, 2015. About the National Health Service (NHS). Available at: http://www.nhs.uk/NHSEngland/thenhs/about/Pages/overview.aspx. Last accessed December 2015.
3. NICE, 2010. Costing report for NICE Clinical Guideline 108, Chronic Heart Failure. Available at: https://www.nice.org.uk/guidance/cg108/resources/costing-report-134800813. Last accessed December 2015.
4. Packer M et al. Angiotensin Receptor Neprilysin Inhibition Compared With Enalapril on the Risk of Clinical Progression in Surviving Patients With Heart Failure. Circulation 2014;131(1):54–61.
5. British Heart Foundation. Treating heart failure patients in the community with intravenous diuretics. Available at: https://www.bhf.org.uk/~/media/files/publications/healthcare-and-innovations/iv-diuretics-in-the-community_sirivd1.pdf. Last accessed November 2015.
6. National Clinical Guideline Centre. Chronic heart failure: National clinical guideline for diagnosis and management in primary and secondary care. 2003. Available at: http://www.nice.org.uk/guidance/cg108/documents/chronic-heart-failure-partial-update-prepublication-check-appendix-m2. Last accessed December 2015.
7. British Heart Foundation. An integrated approach to managing heart failure in the community. Available at: https://www.bhf.org.uk/~/media/files/publications/healthcare-and-innovations/an-integrated-approach-to-managing-heart-failure-in-the-community—sirhf1.pdf. Last accessed December 2015.