Praluent and Repatha backed by NICE

 photo sanofi and amgen_zpsihile5sc.jpgNICE has reversed its rejection of Sanofi’s Praluent (alirocumab) after the manufacturer agreed to a patient access scheme for the new cholesterol-lowering drug.

The scheme includes an undisclosed discount to the NHS and allows NICE to back Praluent and Amgen’s rival Repatha (evolucumab), which had already been discounted in the new final draft guidance.

Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “We are very pleased to be able to recommend Praluent and Repatha. 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.

“However, both drugs are relatively expensive, costing over £4,000 per patient per year compared with about £350 for ezetemibe. Therefore, the draft guidance recommends Praluent and Repatha as a cost effective use of NHS resources only with the discounts agreed with the companies.”

High cholesterol levels continue to represent a major risk factor for cardiovascular disease, with 25% of all deaths in the UK attributed to it.

NICE’s backing of Praluent is based on the outcome of the Odyssey Long Term clinical trial, which showed that participants treated with 150mg of alicrocumab every two weeks, their ‘bad’ cholesterol was reduced by 61% at week 24 in comparison with an increase of 0.8% in placebo.

Praluent is currently the only PCSK9 inhibitor with dosages available in different strengths – 75mg and 150mg – and so allows healthcare professionals greater flexibility in tailoring patient’s individual treatment plans.

Meanwhile, data on the cardiovascular outcomes of Repatha show that, in combination with statin treatment, a fortnightly injection of evolocumab reduced levels of LDL cholesterol (LDL-C) by 55-75% when compared with statin treatment alone.

Commenting on the pending UK approval of Repatha, Tony Patrikios, executive medical director, Amgen UK and Ireland, said that there is a “clear clinical need for new medicines that can lower LDL-C in patients who have persistently high cholesterol, and who are living with a high risk of future cardiovascular disease”.

The final guidance for the two cholesterol-lowering treatments will be issued in June and – if both are approved, they will be available on the NHS in England by September.


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