Following an agreement reached between Novartis and the NHS, adults across England who have a history of certain cardiovascular events such as heart attack or stroke* and have persistently high cholesterol (2.6 mmol/l or more despite diet and treatment with maximally tolerated statins), are set to be able to access a new treatment (within its licensed indication†) on the NHS to lower their LDL cholesterol.
Long-term elevated Low Density Lipoprotein cholesterol (LDL-C) is a known cause of atherosclerotic cardiovascular disease (ASCVD) and a key modifiable risk factor in the prevention of cardiovascular disease.
Cardiovascular disease (CVD) is recognised by the NHS as the single biggest area in which lives can be saved over the next 10 years. Without government intervention, there may be 12,000 additional heart attacks and strokes in England, over the next five years. This collaboration aims to contribute towards meeting the goals of the NHS Long Term Plan which calls for a proactive approach to identifying and treating patients with high-risk conditions to help prevent cardiovascular disease.
The treatment – inclisiran▼(Leqvio®) – a first-in-class small interfering RNA therapy, administered as a 6-monthly maintenance dose‡, has been recommended for use in this patient population by NICE. 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 levels,,.
The medicine will be delivered through a rapid, large-scale roll-out involving primary care as part of a world-first agreement which pioneers a population health management approach, aiming to reach around 300,000 eligible patients across three years through a central national budget.
“We are pleased that NICE has approved the use of inclisiran on the NHS in England,” said Chinmay Bhatt, Managing Director of Novartis UK, Ireland & Nordics and Country President UK. “Our partnership with the NHS will see us reach patients in ways never seen before in the treatment of CVD. In the coming years, we will continue to deepen our collaboration with the NHS, academia and patient groups, as we pursue our purpose to reimagine medicine”.
Hear from Vas Narasimhan, Novartis CEO, in the clip below, as he explores the importance of this pioneering collaboration in addressing unmet patient needs in lipid management and the rising burden of CVD across England:
"The availability of inclisiran represents a significant and exciting milestone in managing those with established cardiovascular disease." Commented Dr Jim Moore, President of the UK Primary Care Cardiovascular Society. "As a GP, I care for many patients in the community setting who have had heart attacks or strokes and who are therefore at higher risk of further cardiovascular events. A medicine that can be introduced after standard therapy to deliver a sustained reduction in LDL cholesterol, thereby addressing unmet needs in lipid management is very welcome and will ultimately improve cardiovascular care for this high risk population."
The Novartis and NHS collaboration comes at a time when bold action is needed to turn the tide back and improve public health outcomes. This is especially important in the context of COVID-19. The events of last year led to a significant reduction in NHS Health Checks, which test cholesterol levels in adults to identify predictors of cardiovascular disease.
* The criteria set out by NICE are for use in patients only if:
There is a history of any of the following cardiovascular events:
Acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation
Coronary or other arterial revascularisation procedures
Coronary heart disease
Ischaemic stroke or
Peripheral arterial disease, and:
Low density lipoprotein cholesterol (LDL-C) concentrations are persistently 2.6 mmol/l or more, despite maximum tolerated lipid-lowering therapy (that being either maximum tolerated statins or maximum tolerated statins with ezetimibe).
† Inclisiran is licensed in Europe for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
along or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
‡ Inclisiran is administered by a healthcare professional as a subcutaneous injection and dosed initially, again at three months and then once every six months thereafter.
 Leqvio Summary of Product Characteristics. 2020.