NICE says no to Sanofi cholesterol drug Praluent

The National Institute for Health and Care Excellence has published draft guidance saying it will not recommend Sanofi and Regeneron’s cholesterol drug Praluent.

The cost watchdog says that while Praluent (alirocumab), a PCSK9 inhibitor, is clinically effective in reducing LDL-c levels when compared with placebo, Merck & Co’s Zetia (ezetimibe) or statins in people with hypercholesterolaemia, the drug has not been compared with the combination therapy of Zetia plus a statin, in the large population of people with non-familial hypercholesterolaemia.

Carole Longson, director of the NICE Centre for Health Technology Evaluation, said the trials “were not able to provide robust information on important cardiovascular outcomes”, leading the committee to conclude that, “although it was reasonable to infer that alirocumab would reduce cardiovascular events, the extent of this reduction was uncertain”.

She added that most of the value-for-money analyses on Praluent “exceeded the range normally considered to be a cost-effective use of NHS resources”.

The news came days after NICE issued a revised appraisal backing Amgen’s rival PCSK9 inhibitor Repatha (evolucumab), reversing a rejection issued last year.

NICE has recommended Repatha, alone or in combination with other lipid-lowerers but that is dependent on a discount to the price agreed by Amgen through a patient access scheme.