Novartis announced that its investigational heart failure treatment LCZ696 (sacubitril valsartan) has been given a positive scientific opinion under the Medicines and Healthcare products Regulatory Agency (MHRA) Early Access to Medicines Scheme (EAMS) for patients with significant unmet medical need.
This allows LCZ696 (sacubitril valsartan) to be made available to eligible patients before a final European licensing decision is made.
It is the first time a drug not intended to treat cancer has been recognised under EAMS.
Heart failure affects around 550,000 people in the UK and costs the NHS about £2.3bn a year. (1,2) Heart failure has a poor prognosis: around 60% of patients diagnosed with heart failure die within five years (3) and survival rates are worse than certain cancers, such as breast and prostate. (4)
“This is great news for patients with heart failure. The EAMS positive scientific opinion ensures patients with this debilitating condition can access sacubitril valsartan earlier than expected,” said Prof Iain Squire, Professor of Cardiovascular Medicine, University of Leicester and Honorary Consultant Physician, University Hospitals of Leicester NHS Trust. “Based on what we’ve seen in clinical trials, access to this new medicine will help patients live longer and keep them out of hospital, compared to currently available treatment.”
The MHRA has given LCZ696 (sacubitril valsartan) a positive scientific opinion based on the high level of unmet need in heart failure and data from the PARADIGM-HF study that showed LCZ696 (sacubitril valsartan) significantly improved patient outcomes compared to the current gold standard treatment, including a reduction both in cardiovascular deaths and hospitalisations due to heart failure. (5)
Hugh O’Dowd, General Manager at Novartis UK & Ireland, said: “Despite widespread use of available treatments and implementation of NICE guidelines, outcomes remain poor for those diagnosed with heart failure. So it’s very encouraging that LCZ696 (sacubitril valsartan) will be available via the EAMS, allowing patients in the UK with this debilitating condition to gain benefit. We are working closely with the NHS to ensure eligible patients have rapid access under the scheme while we await the final European licensing decision.”
Life Sciences Minister George Freeman said: “Heart failure is a devastating condition that affects hundreds of thousands of people in the UK, so I am delighted that patients will now be able to access this life-enhancing treatment. The UK’s Early Access to Medicines Scheme is making a real difference in speeding up access to drugs and almost 300 patients with complex conditions have already received innovative treatments earlier than they otherwise would have thanks to the scheme.”
- British Heart Foundation. At-home treatment for heart failure patients eases burden for families and for NHS. 9 June 2015. Available at: https://www.bhf.org.uk/news-from-the-bhf/news-archive/2015/june/at-home-treatment-for-heart-failure-patients-eases-burden-for-families-and-for-nhs. (last accessed August 2015).
- NHS Choices. The NHS in England. About the National Health Service (NHS). January 2015. Available at: http://www.nhs.uk/NHSEngland/thenhs/about/Pages/overview.aspx. (last accessed August 2015).
- Sutherland K. Bridging the quality gap: heart failure. 2010. London. Health Foundation. Available at: http://www.health.org.uk/sites/default/files/BridgingTheQualityGapHeartFailure_0.pdf. (last accessed August 2015).
- National Clinical Guideline Centre. Chronic heart failure: the management of chronic heart failure in adults in primary and secondary care. 2010. London: National Clinical Guideline Centre. Available at: http://guidance.nice.org.uk/CG108/Guidance/pdf/English. (last accessed August 2015).
- McMurray JJV et al. Angiotensin-Neprilysin Inhibition versus Enalapril in Heart Failure. N Engl J Med 2014;371:993–1004.
- Langenickel TH, Dole WP. Angiotensin receptor-neprilysin inhibition with LCZ696: a novel approach for the treatment of heart failure. Drug Discov Today Ther Strateg 2012;9:e131–e139.
- Packer M et al. Angiotensin-Neprilysin Inhibition and Clinical Progression in Surviving Patients with Heart Failure Circulation 2015;131:54–61.