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NICE provisionally backs new types of drug for cholesterol disorders

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Final draft guidance from the National Institute for Health and Care Excellence has recommended two new treatment options for patients with cholesterol conditions that up cardiovascular risk.

The final appraisal document recommends alirocumab (Praluent) and evolucumab (Repatha) for adults with primary hypercholesterolaemia or mixed dyslipidaemia to help reduce cardiovascular disease risk.

“The new PCSK9 inhibitors approved for use by NICE are a new and exciting way to reduce harmful cholesterol levels”

Peter Weissberg

NICE has recommended the drugs for patients with the conditions whose cholesterol levels are not controlled adequately using other drugs such as statins, or who cannot tolerate statins because of their side effects or other reasons.

The NICE committees heard that alirocumab reduced levels of LDL-cholesterol – so-called “bad cholesterol” – by up to 62% compared with placebo, and up to 40% compared with ezetimibe, another commonly used drug to lower cholesterol.

Both alirocumab and evolocumab are given by self-administered injection once every two weeks – once a month for the 420mg dose of evolocumab.

Alirocumab and evolocumab work by blocking a protein called PCSK9, allowing the liver to remove cholesterol from the blood.

Professor Carole Longson

Professor Carole Longson

Carole Longson

Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “People with hypercholesterolaemia or mixed dyslipidaemia who have a high risk of a heart attack or stroke, despite taking the highest tolerated dose of other cholesterol-lowering drugs, have very few treatment options.

“The committee concluded that both drugs are effective in reducing levels of ‘bad cholesterol’ when compared with placebo, ezetimibe or statins in people with hypercholesterolaemia or mixed dyslipidaemia,” she said.

However, she noted that both drugs were “relatively” expensive, costing over £4,000 per patient per year, compared with about £350 for ezetemibe.

British Heart Foundation

Professor Peter Weissberg

Peter Weissberg

Professor Peter Weissberg, medical director at the British Heart Foundation, said: “The new PCSK9 inhibitors approved for use by NICE are a new and exciting way to reduce harmful cholesterol levels.

“However, because their long term safety is still unknown, and they are yet to show reduced risk of heart attack, their use is currently restricted to patients with dangerously high cholesterol levels despite treatment with statins,” he noted.

He added: “This new class of drugs is undergoing intensive clinical investigation. Guidelines are likely to change in the future as more information is revealed surrounding their safety and effectiveness.”

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