Study testing use of cholesterol lowering injection launches in Manchester

Patients in Greater Manchester are taking part in a study through the NHS to test the use of a new cholesterol-lowering injection.

Over 900 patients in Greater Manchester will take part in the VICTORION-SPIRIT Study, which will test the use inclisiran in primary care to reduce LDL cholesterol.

Developed by Novartis, inclisiran received its licence from the European Commission in December 2020 and from NICE in September this year. It is a first-in-class small interfering RNA therapy designed to treat hypercholesterolemia or abnormal levels of cholesterol and other lipids.

High levels of low-density lipoproteins (LDL) cholesterol make people more likely to suffer a heart attack or stroke. Lowering LDL cholesterol in a sustained manner can help prevent the development of Atherosclerotic cardiovascular disease (ASCVD), a potentially serious condition, which is caused by a build-up of cholesterol in the blood vessels.

More than two in five people in England have high cholesterol, placing them at risk of developing cardiovascular disease. Cardiovascular disease causes a quarter of all deaths in the UK and is the largest cause of premature mortality in deprived areas. The NHS Long Term Plan identified cardiovascular disease as a clinical priority and the single biggest condition where lives can be saved by the NHS over the next 10 years.

Inclisiran was recommended by NICE for people with high cholesterol who have already had a previous cardiovascular event to reduce their LDL cholesterol. The drug has been made part of the first NHS “population health agreement” between the NHS and Novartis to make it available to patients and increase the treatment options for those looking to control their cholesterol levels.

Approximately 20 GP practices in Salford and Manchester will participate in the implementation research study, recruiting 900 patients. The study will use research to identify the best ways to speed up adoption and spread across the NHS. It aims to support reducing the time it takes to bring new medicines into practice to benefit patients.

As part of the study, patients will be given the drug as an initial dose, and follow-up doses at three and nine months. It will be delivered via injection by GP practices, without needing to attend hospital.

The study is being run as a collaboration between Novartis, NHS England and Improvement, NorthWest EHealth, Health Innovation Manchester, and the National Institute for Health Research (NIHR) Applied Research Collaborative (ARC) Greater Manchester.

The study will work with GPs and use NorthWest EHealth’s digital technologies to find and recruit patients, track their journey and provide real-time monitoring. Any information gathered will inform recommendations on integrated care delivery models in a primary care setting using inclisiran as part of a suite of NICE approved treatments and non-pharmacological interventions, to reduce LDL cholesterol.

Chinmay Bhatt, managing director of Novartis UK, Ireland and Nordics and Country President UK, said: “This is an exciting opportunity for us to invest in and partner with Greater Manchester. Greater Manchester is in a prime position to collaborate, co-develop and accelerate innovative solutions to solve some of the city region’s more complex and chronic health needs. The study forms part of our broader population health management collaboration with NHS England and will provide valuable insights into the successful primary care implementation of inclisiran.”

Matt Whitty, chief executive of the Accelerated Access Collaborative, said: “The Accelerated Access Collaborative is committed to identifying and supporting the implementation of innovative commercial deals between the NHS and industry. The Inclisiran deal is testament to that commitment. Not only is inclisiran a novel therapy, the population health approach to getting this to patients in both primary and secondary care will mean more patients can benefit. The insight we gain through this study will be invaluable in helping us understand how it can most effectively reach patients.”

Dr Tracey Vell, clinical director of Health Innovation Manchester, added: “Health Innovation Manchester and the Greater Manchester system are delighted to be partnering on this study which will allow us to identify at risk groups digitally, and then deliver innovative long acting cholesterol lowering therapy alongside other holistic care objectives. This is pioneering in many ways, including researching a population health approach for new pharmaceuticals, delivering them immediately in a primary care setting and looking at integrated delivery models with NHS England and Improvement and Novartis as partners. Through this we are hoping to deliver better outcomes for those at risk of cardiovascular disease as well as care close to their home and community.”