NICE has backed the novel, injectable, cholesterol-lowering drug inclisiran for patients with primary hypercholesterolaemia or mixed dyslipidaemia who have already had a cardiovascular event.
The first-in-class drug, which uses RNA interference to boost the liver’s ability to remove cholesterol from the blood, can be administered in primary care as a twice-yearly injection.
Currently, NICE has only approved the treatment for:
- Patients who have already had a prior cardiovascular event to reduce the risk of another, or
- Patients with LDL-C concentrations that are persistently above 2.6 mmol/l, despite maximum tolerated lipid-lowering therapy, i.e. statins or alternatives where statins are not tolerated.
Inclisiran can be used as monotherapy or in combination with statins or other cholesterol-lowering drugs.
Clinical trials have demonstrated that inclisiran can lower cholesterol levels when other drugs have not reduced them enough, but there are no data comparing inclisiran with other treatments such as ezetimibe, alirocumab or evolocumab. So far there is no long-term evidence for inclisiran’s effect on cardiovascular outcomes.
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.’
A price deal with manufacturer Novartis means that ‘as many as 300,000 people’ could be eligible for treatment over the next 3 years.
- The Scottish Medicines Consortium has approved use of a fixed combination of bempedoic acid and ezetemibe for patients for whom statins are not tolerated or contraindicated, where ezetimibe alone has not controlled LDL-C levels and for whom PCSK9 inhibitors are not appropriate.
NICE TA733; 6 October 2021. https://www.nice.org.uk/guidance/ta733
