Patients with high cholesterol will not be getting NHS access to Sanofi/Regeneron’s PCSK9 inhibitor according to initial proposals by cost watchdog the National Institute for Health and Care Excellence.
The Institute has published draft guidance rejecting Praluent (alirocumab) as an option for people with high cholesterol (primary hypercholesterolaemia - heterozygous-familial and non-familial) and mixed dyslipidaemia, largely because of a lack of comparison data.
While the drug was considered clinically effective in reducing LDL-c levels when compared with placebo, ezetimibe (Merck & Co’s Zetia) or statins in people with hypercholesterolaemia, the Institute was concerned that Praluent “had not been compared with the combination therapy of ezetimibe plus a statin, in the large population of people with non-familial hypercholesterolaemia”.
Carole Longson MBE, Director of the NICE Centre for Health Technology Evaluation, noted that 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”.
Also, given that most cost analyses of Praluent overshot normal value-for-money thresholds, the drug could not be recommended as a cost-effective use of NHS resources, she noted.
News of the decision came hot on the heels of draft guidelines endorsing the use of Amgen’s rival PCSK9 inhibitor Repatha, though this drug had also been turned down in early recommendations last year.
Sanofi said it is disappointed with Praluent's rejection, but stressed that it remains committed to working with NICE during the consultation process to ensure that the appropriate patients get access to the drug.