NICE approves life-saving cholesterol drug for NHS

pharmafile | September 1, 2021 | News story | Research and Development  

NICE has approved the ground-breaking cholesterol-lowering drug inclisiran, made by Novartis, for use on the NHS.

This is an option for people with primary hypercholesterolaemia or mixed dyslipidaemia who have already had a previous cardiovascular event such as a heart attack or stroke.  

NHS England says inclisiran, given as a twice-a-year injection, could save about 30,000 lives within a decade.

It normally costs nearly £2,000 per dose but Novartis, which makes it, has agreed an undisclosed discount.

Inclisiran works in a new way to previous treatments. It is the first of a new type of cholesterol-lowering treatment which uses RNA interference (RNAi) to boost the liver’s ability to remove harmful cholesterol from the blood.

People with primary hypercholesterolaemia and people who have abnormally high levels of fats in their blood called mixed dyslipidaemia are at increased risk of cardiovascular events. Current standard treatment includes dietary changes, statins, and other cholesterol lowering drugs, alone or in combination.

Clinical trial evidence shows that inclisiran may help lower cholesterol levels when other treatments have not reduced them enough. However, there is no data directly comparing inclisiran with the other treatments, ezetimibe, alirocumab or evolocumab. There is also no long-term evidence yet on inclisiran’s effect on cardiovascular outcomes.

Despite these uncertainties, inclisiran is still considered cost-effective in people who have previously had a cardiovascular event and whose cholesterol levels remain high after they have had the maximum tolerated lipid lowering therapy.

Meindert Boysen, NICE Deputy Chief Executive and Director of the Centre for Health Technology Evaluation, said: “Inclisiran represents a potential game-changer in preventing thousands of people from dying prematurely from heart attacks and strokes.

“We’re therefore pleased to be able to recommend it as a cost-effective option on the NHS supported by the ground-breaking deal between NHS England and NHS Improvement and Novartis − a deal that could see as many as 300,000 people with high cholesterol or mixed dyslipidaemia who have already had a previous cardiovascular event receive the drug over the next 3 years.” 

Vas Narasimhan, Novartis CEO, said: “Cardiovascular disease has long been the number one cause of human mortality, and this intractable health issue requires a reimagining of how we treat heart health, said Vas Narasimhan, Novartis CEO.

“This pioneering collaboration with the NHS in England has the potential to spur a step-change improvement in cardiovascular health across the UK, and it demonstrates Novartis’ commitment to working with healthcare systems around the world to improve patient outcomes by co-creating novel access solutions for innovative medicines.”

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