Novartis Secures World-First NHS Partnership for Inclisiran Population Health Management
核心洞察
Novartis has established a groundbreaking population health management agreement with NHS England to provide inclisiran access to approximately 300,000 high-risk cardiovascular patients over three years.
The collaboration follows NICE's positive recommendation and represents the first-of-its-kind approach to proactively identify and treat eligible patients with atherosclerotic cardiovascular disease (搜索) across England.
Inclisiran, a twice-yearly siRNA therapy that demonstrated over 50% LDL cholesterol (搜索) reduction in Phase III trials, will be administered in primary care settings to patients with persistently elevated cholesterol despite maximum statin therapy.
Novartis has reached a landmark commercial agreement with the NHS in England to implement a first-of-its-kind population health management approach for cholesterol management, targeting approximately 300,000 patients at high risk of cardiovascular events over three years with inclisiran (Leqvio®).
The collaboration moves into implementation following the positive final recommendation from the National Institute for Health and Care Excellence (NICE) for inclisiran use in primary care. The agreement commits to delivering access to the twice-yearly siRNA therapy for adult patients with persistently elevated LDL cholesterol (搜索) levels (2.6 mmol/l or more) despite maximum tolerated statins (搜索) with or without ezetimibe, who also have a history of specific cardiovascular events.
Revolutionary Population Health Approach
"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," said Prof Kausik Ray, Professor of Public Health at Imperial College London and Honorary Consultant Cardiologist at the Imperial College NHS Trust.
Novartis will collaborate with the NHS Accelerated Access Collaborative and the Academic Health Science Network, supported by NHS Digital, to proactively identify, treat and monitor eligible individuals with atherosclerotic cardiovascular disease (搜索) (ASCVD) who have experienced cardiovascular events such as heart attacks or strokes and have high cholesterol despite treatment with maximal tolerated statins (搜索).
Addressing Critical Unmet Need
Cardiovascular disease (搜索) causes more than one in four deaths across the UK and places considerable financial burden on the NHS and wider society. An estimated 3.5 million people live with ASCVD in the UK, while around 7.6 million people across the UK live with heart and circulatory diseases, causing 27% of all deaths annually.
"Cardiovascular disease (搜索) 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."
Clinical Evidence Supporting Access
The NICE recommendation was based on results from the comprehensive 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 (搜索) levels.
The trials demonstrated that inclisiran achieved potent and durable LDL cholesterol (搜索) reduction of more than 50% on top of standard of care, with an excellent safety profile. ORION-11 showed 54% LDL cholesterol lowering with time-adjusted reductions of 50% sustained over 18 months of treatment, while ORION-10 demonstrated 58% observed LDL cholesterol lowering with time-adjusted reductions of 56% sustained over 18 months.
Innovative Therapeutic Mechanism
Inclisiran represents the first and only small interfering RNA (siRNA) therapy for cholesterol reduction, working through an RNA interference mechanism to prevent production of the PCSK9 protein in the liver. This enhances the liver's ability to remove LDL cholesterol (搜索) from the bloodstream, thereby lowering LDL cholesterol levels.
The therapy offers a unique twice-yearly subcutaneous dosing regimen after an initial three-month lead-in period, administered by healthcare professionals in primary care settings where most patients receive care. This convenient dosing schedule is designed to improve patient adherence and provide sustained cholesterol reductions.
Strategic Healthcare System Partnership
The NHS has recognized cardiovascular disease (搜索) as the single biggest area where lives can be saved over the next 10 years. This collaboration aims to contribute toward 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.
"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 and provide sustained reductions in LDL cholesterol (搜索) is a hugely positive milestone in patient care," Ray noted.
The agreement demonstrates Novartis' commitment to increasing access to innovative medicines through pioneering partnerships with health systems, representing a significant advance in patient care through effective lipid management on a population scale.