NICE clears both Amgen's Repatha and Sanofi's Praluent

NICE has recommended funding for new PCSK9 inhibitor cholesterol drugs from Sanofi and Amgen, reversing an earlier decision to reject the French company's medicine after it agreed a discount.

The final draft guidance recommends Sanofi's Praluent (alirocumab) and Amgen's Repatha (evolocumab) for adults with primary hypercholesterolaemia or mixed dyslipidaemia to help reduce risk of cardiovascular disease.

NICE recommended the drugs, which were both launched around the same time last autumn for people who are not controlled adequately using other drugs such as statins, or who can't tolerate statins because of their side effects or if contra-indicated.

The guidance also restricts use of the drugs to certain cholesterol concentration and prevents their use in non-familial hypercholesterolaemia or mixed dyslipidaemia without cardiovascular disease.

Amgen initially stole a march on Sanofi by offering an undisclosed discount and getting Repatha recommended in first draft guidance in February.

But Sanofi has also offered an undisclosed discount since then, prompting NICE to recommend funding in its latest draft.

Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: "Both drugs are relatively expensive, costing over £4,000 per patient per year compared with about £350 for ezetemibe.

"Therefore the draft guidance recommends alirocumab and evolocumab as a cost effective use of NHS resources only with the discounts agreed with the companies and only for people with hypercholesterolaemia or mixed dyslipidaemia whose cholesterol is still not under control despite making changes to their lifestyle and taking other cholesterol-lowering drugs."

In a separate development, NICE recommended AbbVie's Humira (adalimumab) in final guidance in an additional indication, for active moderate to severe hidradenitis suppurativa in adults with an inadequate response to conventional therapy.

NICE had originally rejected the drug in first draft in the skin disease but then recommended it after AbbVie offered an undisclosed discount.

Until final guidance is issued, NHS bodies in England should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.

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