Confusing NICE guidance on PCSK9 inhibitors

Br J Cardiol 2016;23:9 Leave a comment
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The cholesterol charity, HEART UK, has questioned NICE’s decisions on the new PCSK9 inhibitors evolocumab (Repatha®, Amgen) and alirocumab (Pralulent®, Sanofi Regeneron), which were approved in Europe in May 2015 and in the USA in August 2015 for patients who are unable to control their cholesterol with current therapies. 

Jules Payne hopes NICE will ‘see sense’ about the PCSK9 inhibitors
Jules Payne hopes NICE will 'see sense' about the PCSK9 inhibitors

In November 2015, NICE published draft guidance not recommending evolocumab as an option for people with high cholesterol (primary hypercholesterolaemia – heterozygous familial and non-familial) and mixed dylipidaemia. A similar decision for alirocumab followed in February 2016, although only a few days before, the earlier decision for evolocumab had been modified by NICE who said that it could be used for a limited number of NHS patients who are considered to be statin intolerant.

HEART UK Chief Executive Ms Jules Payne said: “NICE appear to be confused about the effectiveness of this life-saving medication. It says ‘yes’ to one medicine one week and the next it says ‘no’ to another, and both are exactly the same.

“HEART UK was at the NICE meeting when it discussed these medicines and there were no lipidologists present who could give expert advice, so it’s hardly surprising the decision is so confused.”

“This flip-flopping approach to decision-making by NICE and not drawing on clinicians who are experts in this condition, undermines public confidence and denies patients access to potentially life-saving medication”.

She hopes NICE will “see sense” as it has in the case of the cholesterol-lowering drug ezetimibe. “HEART UK is delighted that NICE has listened to the concerns raised on behalf of healthcare professionals and patients to limit access to this life-saving medication”.

She hopes continued pressure from healthcare professionals will have a similar effect for the PCSK9 inhibitors. “HEART UK believes that denying access to PCSK9 inhibitors would leave a significant portion of patients at high risk without sufficient treatment options, which will put more pressure on the already-stretched NHS when the solution could save lives”.