Novartis and NHS England are to pioneer a population health management approach to address elevated LDL-C in patients with Atherosclerotic Cardiovascular Disease (ASCVD) across England.
The collaboration received positive final recommendation from the National Institute for Health and Care Excellence (NICE) for use of inclisiran in primary care for the treatment of adult patients within its licenced indication1 who also have persistently elevated LDL-C levels (2.6 mmol/l or more despite maximum tolerated statins with or without ezetimibe) and a history of certain cardiovascular events.
“This population health management approach is potentially game-changing, seeking to improve a nation’s health by proactively identifying individuals ‘at highest risk’ and introducing effective solutions that will improve their future health state. This represents a significant advance in patient care through effective lipid management,” said Prof Kausik Ray, Professor of Public Health at Imperial College London and Honorary Consultant Cardiologist at the Imperial College NHS Trust.
“As a clinician, I see many patients where their cholesterol levels are insufficiently controlled for their level of risk, often despite optimal use of available therapies, putting them at increased risk of a heart attack or stroke. Having faster and broader access to a medicine like inclisiran, which offers the combination of a convenient twice-a-year maintenance dosing schedule, as well as the ability to be used in primary care – where most patients are cared for – and provide sustained reductions in LDL-C is a hugely positive milestone in patient care.”
Novartis will work with the NHS Accelerated Access Collaborative and the Academic Health Science Network (with the support of NHS Digital) to help them proactively identify, treat and monitor eligible individuals with ASCVD who have experienced a cardiovascular event, such as a heart attack or stroke, and have high cholesterol despite treatment with maximal tolerated statins.
“Cardiovascular disease has long been the number one cause of human mortality, and this intractable health issue requires a reimagining of how we treat heart health,” said Vas Narasimhan, Novartis CEO.
“This pioneering collaboration with the NHS in England has the potential to spur a step-change improvement in cardiovascular health across the UK, and it demonstrates Novartis’ commitment to working with healthcare systems around the world to improve patient outcomes by co-creating novel access solutions for innovative medicines.”
With around 7.6 million people across the UK living with heart and circulatory diseases, causing more than a quarter (27%) of all deaths each year, the NHS has recognised CVD as the single biggest area in which lives can be saved over the next ten years3,4.
The NICE recommendation was based on results from the Novartis ORION clinical research program, including Phase III trials ORION-9, ORION-10 and ORION-11, which involved over 3,600 patients and assessed the safety, efficacy and tolerability of inclisiran in lowering LDL-Cholesterol levels7,8,9.
- National Institute for Health and Care Excellence. Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia [ID1647] https://www.nice.org.uk/guidance/indevelopment/gid-ta10703.
- Mach F. et al. European Heart Journal. 2020;1(41):111–188.
- British Heart Foundation. CVD Factsheet. Available at: https://www.bhf.org.uk/-/media/files/research/heart-statistics/bhf-cvd-statistics-uk-factsheet.pdf?la=en [Last accessed: August 2021].
- NHS England. Cardiovascular disease (CVD). Our ambition for CVD prevention. Available at: https://www.england.nhs.uk/ourwork/clinical-policy/cvd/ [Last accessed: August 2021].
- Data on file. INC_DOF-014.
- Stoekenbroek RM, Kallend D, Wijngaard PL, et al. Inclisiran for the treatment of cardiovascular disease: the ORION clinical development program. Future Cardiol. 2018;14(6):433–442.
- Raal F, Kallend D, Ray K, et al. Inclisiran for Heterozygous Familial Hypercholesterolemia. N Engl J Med. 2020;382(16):1520–1530.
- Ray K, Wright R, Kallend D, et al. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med. 2020;382(16):1507–1519.
- Mayo Clinic. Arteriosclerosis / atherosclerosis. Available from: https://www.mayoclinic.org/diseases-conditions/arteriosclerosis-atherosclerosis/symptoms-causes/ [Last accessed: July 2021].
- Goldstein J, Brown M. A century of cholesterol and coronaries: from plaques to genes to statins. Cell. 2015;161(1):161–172.
- World Health Organization. Cardiovascular diseases (CVDs): Factsheet [online] May 17, 2017. Available from: https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds) [Last accessed: July 2021].
- Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke Statistics–2012 update: A report from the American Heart Association. Circulation. 2012;125(1):e2–e220.
- Kim H, Kim S, Han S, et al. Prevalence and incidence of atherosclerotic cardiovascular disease and its risk factors in Korea: a nationwide population-based study. BMC Public Health. 2019;19(1):1112.
- National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(25):3143–3421.
- Inclisiran Summary of product characteristics.
Image credit: Alexandru Acea