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expert reaction to announcement that a new heart disease drug, inclisiran, will be available for NHS patients pending approval

It has been announced that a collaboration between the NHS and the company Novartis will see the drug inclisiran will be made available to some NHS patients.

 

Dr Richard Francis, Head of Research, the Stroke Association, said:

“We’re excited to see promising research that could provide a new treatment to help people avoid a life-shattering stroke. High cholesterol is one of the biggest causes of stroke and many people are treated with statins to reduce their risk. However, statins don’t remove the risk of stroke for everyone. This new medication, inclisiran, shows promise in reducing damaging levels of cholesterol. This announcement of a collaborative approach provides hope that, if the treatment does work, those that need it, can get it as soon as possible. If you’re worried about your cholesterol or risk of stroke, there are things you can do right now. Talk to your GP or go to www.stroke.org.uk.”

 

Dr Riyaz Patel, Associate Professor and Consultant Cardiologist, Clinical lead for the CVD Prevention Service, Barts Health NHS Trust, said:

“This as a really exciting announcement that changes the way we bring new medicines to patients earlier and also propel the NHS and the UK as a world leader in this sort of clinical research.

“Inclisiran is a new class of drug that works in a neat way to stop the production of a molecule (PCSK9) to lower bad cholesterol (LDL-C) levels in the blood. Previous studies have shown it can safely reduce this type of cholesterol by over 50%, with very few side effects. A big advantage is that as it is taken very infrequently, it will be much easier for patients to take the medicine long term.

“What has been missing so far is evidence that it really prevents heart attacks and strokes over time and most new drugs need to show this before they are accepted for use by the wider medical community. What is different here is that the drug will be evaluated as it is being used, which is acceptable as it is proven to be safe but also because data in recent years has shown that however you lower cholesterol the benefit will be the same.  And given this drug lowers cholesterol so potently we fully expect it to have a big outcome benefit.

“Whether it will save 30,000 lives depends on many factors. It is an estimate based on extrapolation from existing data with multiple assumptions. The trials for example included only specific patients (high risk or with known heart disease), and typically not everyone may be eligible to get the drug as there will be exclusions.  Also, it was used only in people who were maximally treated already with statins or other drugs – so this was very much an add-on to help people lower their cholesterol when it remained high on treatment.

“Currently, statins remain the most important drug we have for lowering cholesterol and is unlikely to be replaced.  It has been around for many years and we know its safety profile well and its effects long term. Patients should not expect this new drug to replace statins for the foreseeable future.

“Ultimately this is an exciting way for pharmaceutical companies to work with the NHS, to evaluate a safe new therapy for the benefit of patients.  We will need to see the exact details of how it will work with research and clinical issues, but it is certainly a welcome step forwards to get exciting new drugs to patients quickly and safely.”

 

Prof Stephen MacMahon, Principal Director, The George Institute for Global Health, said:

“Inclisiran clearly has great potential to improve outcomes in patients with cardiovascular disease.  The ORION-4 trial is designed to test this and assess the drug’s safety.  However, before concluding that 30,000 lives might be saved in the UK, it might be prudent to await the results of the trial and not prejudge its outcome.”

 

Dr Svetlana Reilly, University Research Lecturer, University of Oxford, said:

“Based on the reported evidence, the cholesterol-lowering effects of inclisiran seem very intriguing. However, one should remain sceptical until further peer-reviewed research into any potential unexpected side effects has been carried out to make sure that the proposed treatment is effective and safe in a long term.”

 

Prof Robert Storey, Professor of Cardiology, University of Sheffield, said:

“Bad cholesterol is a major cause of heart attacks and strokes. Statins have proven effective in lowering this but not everyone achieves the low levels of bad cholesterol that are desirable, sometimes because they can’t tolerate statins at high doses or even at all. Consequently, new ways of lowering cholesterol are urgently needed to prevent these conditions and save lives.

“Inclisiran looks very promising for cholesterol control, normally given in addition to statins. Ongoing clinical trials such as ORION 4 will provide the best evidence about whether inclisiran lives up to its promise but it is appropriate to plan for widespread use of the drug if benefits and safety are confirmed in a large clinical trial and NICE confirms cost effectiveness.

“Strong collaborations between the NHS, Universities and the pharmaceutical industry combined with acceptable pricing of drugs for the NHS offers a good way forward for reducing the risk of cardiovascular disease in the UK and improving life expectancy. This collaboration on the development of inclisiran with its potential to lead to improved cholesterol control in the future, is welcome and it will be interesting to see whether this provides a model for future cardiovascular drug development.”

 

Prof Kausik Ray, Professor of Public Heath, Imperial College London, said:

“Inclisiran is an investigational drug which is unapproved at present but could be here as early as 2021. The ORION 1 and 11 trials which I led showed the potential of twice yearly dosing to reduce LDL cholesterol by 50%. The potential of this therapy is enormous from a convenience point of view and has the potential to overcome a huge issue which is non-adherence to medications which need to be taken daily. So far, the data suggests the drug is safe and the ongoing ORION 4 trial is testing the possibility that this approach. This approach promises to revolutionise cardiovascular disease prevention.”

 

Prof Naveed Sattar, Professor of Metabolic Medicine, University of Glasgow, said:

“Doctors are excited by inclisiran and the potential to ‘vaccinate’ against high cholesterol in some patients, with obvious benefits to compliance and uptake. However, many would also like to see longer term safety data from ongoing trials and to be told the cost of this new drug before they consider implications for care.”

 

Prof Jacob George, Professor of Cardiovascular Medicine and Therapeutics, University of Dundee, said:

“Inclisiran works on the same pathway as two very effective lipid lowering drugs already available on the NHS but is much longer acting meaning patients only need two doses per year. Whilst Inclisiran has not yet been assessed by the European Medicines Agency or the FDA, giving patients access to these innovative new medications within the safety confines of a large scale trial is welcome news. I hope patients in Scotland, Wales and Northern Ireland are given the opportunity to participate in these trials also.”

 

Declared interests

NEW Dr Riyaz Patel: “No COI or financial relationship with Novartis or Inclisiran. I have received honoraria and consulted for companies producing other types of cholesterol drugs.”

NEW Dr Svetlana Reilly: “I have no conflict of interest.”

NEW Prof Robert Storey: “Previous consultancy work for Novartis and The Medicines Company (more than 2 years ago); consultancy work with numerous other pharmaceutical companies; site investigator for the ORION 4 study in Sheffield.”

Prof Kausik Ray: “I was PI on ORION 1, 3, 11, and part of 9, 10 and 4 funded by the Medicines Company.”

Prof Naveed Sattar: “Consulted for Amgen and Sanofi in the lipid-lowering area.”

Prof Jacob George: “No interests to declare.”

None others declared.

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