• Study will test the implementation in primary care of inclisiran, a new drug to lower cholesterol.
• Up to 20 GP practices in Salford and Manchester will participate, recruiting 900 patients.
• The study aims to support reducing the time it takes to bring new medicines into practice to benefit patients.
• It comes as the NHS and Novartis announce the first “population health agreement” enabling hundreds of thousands of patients to benefit from the drug over the next three years.

Patients in Greater Manchester are taking part in a pioneering study as the NHS brings a new cholesterol-lowering injection into use.

Greater Manchester-based organisations are collaborating as part of a new study involving 900 patients testing the implementation in primary care of inclisiran, a new drug to reduce LDL cholesterol.

High levels of LDL (low-density lipoproteins) cholesterol make people more likely to suffer a heart attack or stroke. Sustained lowering of LDL cholesterol has been shown to help prevent the development and progression of Atherosclerotic cardiovascular disease (ASCVD), a potentially serious condition. It is caused by a build-up of cholesterol in the blood vessels, known as plaque, and causes narrowing and restriction of blood flow to and from the heart and other vital organs, increasing the risk of heart attack and stroke. 1

Inclisiran, a first-in-class small interfering RNA therapy, received a licence from the European Commission in December 2020 following the results of a robust clinical development program. 2 Inclisiran also gained NICE approval on 1 September 2021, recommending the drug for people with high cholesterol who have already had a previous cardiovascular event to reduce their LDL cholesterol, which is a key risk factor for them having another. 3 Trials showed that inclisiran lowers the level of the fatty and harmful substance called LDL cholesterol found in the blood by using RNA interference (RNAi) to boost the liver’s ability to remove it from the blood.

Inclisiran is part of the first NHS “population health agreement” between the NHS and Novartis to make the drug available to thousands of NHS patients and increase the treatment options available to patients to help control their cholesterol levels.4

Approximately 20 GP practices in Greater 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 are 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 ground-breaking study, titled Study in primary care evaluating Inclisiran delivery implementation + enhanced support (VICTORION-SPIRIT), is 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 VICTORION-SPIRIT Study will work with GPs and use NorthWest EHealth’s innovative digital technologies to find and recruit potential participants, track the patient journey and provide real-time monitoring. The 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. In addition by learning from the unprecedented pace and scale at which NHS England, NHS Improvement and Novartis are making inclisiran available the study will help to inform future deployment models for novel treatments.

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.”

Professor Martin Gibson, CEO of NorthWest EHealth, said: “NorthWest EHealth are excited to be supporting Novartis in their ground-breaking implementation study to inform the implementation of their new lipid lowering therapy in a community setting. Working across the Greater Manchester region and with our clinical colleagues in primary care our technology will support finding people to take part in the study and will use our unique clinical trials platform (ConneXon) to collect all of the necessary information for safety and outcomes monitoring. Using our systems means far less burden on participants and healthcare practitioners and helps to ensure that the findings of the study are relevant in the real world of everyday care.”

The industry partnership with Novartis follows the signing of a first-of-its-kind ‘Memorandum of Understanding’ (MoU) between Health Innovation Manchester (HInM) and the pharmaceutical industry in 2017. The MOU aimed to create an environment for collaboration between industry and healthcare in Greater Manchester to improve health, create a sustainable healthcare system, address challenges within the system and unlock the region’s economic potential.

Dr Tracey Vell, Clinical Director of Health Innovation Manchester, said: “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.”

Paul Wilson, Implementation Science Lead, NIHR Applied Research Collaboration Greater Manchester, said: “Identifying innovations that will benefit patients and ensuring their fast uptake in practice is a major global challenge. In VICTORION-SPIRIT, we are taking a ground-breaking approach to use research to speed up the transfer of innovation in the NHS. Our approach harnesses research based knowledge on implementation and applies it much earlier in the traditional technology development pathway to help us to identify the best ways to speed up adoption and spread across the NHS. This approach could serve as the template for accelerating innovation uptake both nationally and internationally.”

More than two in five people in England have high cholesterol which puts them at significant 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. 5

References

1. Ference et al. J Am Coll Cardiol, 2018
2. Inclisiran SmPC
3. https://www.nice.org.uk/news/article/nice-approves-ground-breaking-cholesterol-lowering-drug-inclisiran
4. https://www.england.nhs.uk/2021/09/nhs-cholesterol-busting-jab-to-save-thousands-of-lives/
5. https://www.longtermplan.nhs.uk/online-version/chapter-3-further-progress-on-care-quality-and-outcomes/better-care-for-major-health-conditions/cardiovascular-disease/