The yet to be approved drug inclisiran, a treatment to lower cholesterol, will be studied in UK patients as part of a large-scale NHS clinical trial expected to start later this year. Additionally in a world-first, the drug is expected to be available through a population-level agreement – pioneering a game-changing approach to reducing the risk of heart disease.
Early results from clinical trials suggest that if inclisiran is given to 300,000 patients annually, it could help prevent 55,000 heart attacks and strokes, and has the potential of saving 30,000 lives in the next 10 years.
Heart disease is the world’s biggest killer and the second biggest cause of death in the UK, with over three million people suffering from atherosclerotic cardiovascular disease and two and a half million currently relying on statins to lower their cholesterol. Recent trials have shown inclisiran can halve bad cholesterol in just two weeks.
Inclisiran, a bi-annual injection, is expected to be filed for approval as a preventative add-on treatment to statins for patients who have already been diagnosed with cardiovascular disease later this year.
It will also be put through the National Institute for Health and Care Excellence’s (NICE) approval programme at the earliest opportunity possible and NHS England will agree a population-level commercial arrangement with the company to make it widely available to patients as soon as 2021.
The agreement will make a significant contribution towards meeting the NHS long term plan commitment to preventing 150,000 cardiovascular deaths over 10 years.
Sir John Bell, Regius Professor of Medicine at Oxford University, said: 'The discovery and development of Inclisiran marks an important change in the approach to pharmaceutical interventions for public health. This program has introduced the use of health care system data from the NHS to dramatically reduce costs by rapidly identifying patient populations through health records.
'I am excited by this collaboration which is likely to have far-reaching impact on the way population level disease therapies are developed in the life sciences sector.'
The collaboration between Novartis, NHS England, the National Institute for Health Research (NIHR), and the Nuffield Department of Population Health (NDPH) at Oxford University represents an innovative approach to tackling major public health issues and positions the UK as a world-leading destination to develop revolutionary medicines.
The innovative collaboration was announced on Monday 13th January 2020 by the Chair of NHS England Lord Prior at the J.P Morgan healthcare conference in San Francisco.
The collaboration also includes the creation of an industry and academic consortium to improve efficiency in manufacturing this form of innovative medicine in the UK.
The unique population health model used by the UK will enable the collaboration to address the needs of patients and health systems that have previously not been able to be met on a large scale. The new cost-effective process will lead the way for innovative approaches to helping meet large-scale, public health concerns.
This highlights the UK as a prime destination to get new medicines to patients faster and more cost-effectively. Its appetite for innovation, unrivalled infrastructure and world-leading joined-up healthcare system offers the opportunity for similar deals to be done for other drug development projects of this scale.
The UK plans to remain at the forefront of the global life sciences industry, giving NHS and patients faster access to innovative medicines while supporting the growth of the sector.
Professor of Medicine and Epidemiology at Oxford's Nuffield Department of Population Health, Martin Landray, said: 'This trial provides an opportunity to demonstrate how highly streamlined research can be conducted in the UK using design elements that have worked well in previous trials such as ORION-4, combined with features developed for UK Biobank, such as the use of large, conveniently located clinics. The trial will provide a very reliable test of the efficacy and safety of inclisiran to support a population-health approach to the management of cholesterol, and act as an exemplar for future trials of other treatments in the UK.'