On Aug. 31, 2021, Novartis announced 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 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.

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.

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 10 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 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.