Novartis, a Swiss-headquartered pharmaceutical company, announced on Wednesday that it has reached a commercial agreement with the NHS in England as part of a collaboration to pioneer a first-of-its-kind population health management approach to address elevated LDL-C in eligible patients with atherosclerotic cardiovascular disease (ASCVD) across England.

The NHS and Novartis collaboration moves into the implementation phase following the 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 indication 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, MD, 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 says that it 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.

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.