Alirocumab is licensed for use for the above indication as an adjunct to diet:• in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
The SMC further restricts use only in patients at high cardiovascular risk as follows:
• patients with heterozygous familial hypercholesterolaemia (HeFH) and LDL-C ≥5.0mmol/L, for primary prevention of cardiovascular events or,
• patients with HeFH and LDL-C ≥3.5mmol/L, for secondary prevention of cardiovascular events or,• patients at high risk due to previous cardiovascular events and LDL-C ≥4.0mmol/L or,• patients with recurrent/polyvascular disease and LDL-C ≥3.5mmol/L.
NICE TA 393 recommends alirocumab as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia, only if low density lipoprotein concentrations are persistently above specified thresholds despite maximal tolerated lipid lowering therapy. That is, either the maximum dose has been reached or further titration is limited by intolerance.