Pharmaceutical Business review

UK health agency rejects Sanofi’s cholesterol drug

In its draft guidance, the National Institute of Health and Care Excellence said that the benefits of Praluent are uncertain.

The draft guidance has not recommended alirocumab, alone or in combination with lipid-lowering therapies, for treating primary hypercholesterolaemia or mixed dyslipidaemia in adults for whom lipid-modifying therapies have not lowered cholesterol levels enough.

NICE Centre for Health Technology Evaluation director Professor Carole Longson said: "The committee concluded that alirocumab is clinically effective in reducing LDL-c levels when compared with placebo, ezetimibe or statins in people with hypercholesterolaemia.

"However, it was concerned that alirocumab had not been compared with the combination therapy of ezetimibe plus a statin, in the large population of people with non-familial hypercholesterolaemia.

"The committee also noted that the trials were not able to provide robust information on important cardiovascular outcomes. They concluded that, although it was reasonable to infer that alirocumab would reduce cardiovascular events, the extent of this reduction was uncertain.

"The committee further recognised that most of the value-for-money analyses resulted in ICERs that exceeded the range normally considered to be a cost-effective use of NHS resources.

"In view of these concerns, the Committee concluded that alirocumab could not be considered a cost effective use of NHS resources for people with hypercholesterolaemia."

People suffering with hypercholesterolaemia and mixed dyslipidaemia have higher concentrations of cholesterol in blood. This results in build-up of fatty deposits along arteries. This eventually leads to heart attacks and strokes.

While in most cases, lifestyle factors such as smoking and lack of exercise can lead to high cholesterol but in some cases, a faulty gene can cause the cholesterol level to rise.

Amgen’s Repatha which received a rebuff from NICE last year, is being suggested as an option for patients.