SMC Guidance – Praluent (alirocumab)

Alirocumab is a treatment option in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, 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, with the following restrictions:

Alirocumab is for specialist use only in patients at high cardiovascular (CV) risk with LDL-C values as shown in Table 1 below.

Table 1. Treatment groups and LDL-C values for Praluent prescribing in NHS Scotland

High risk patient group	LDL-C threshold
HeFH	≥5.0mmol/L
HeFH and prior CV event	≥3.5mmol/L
Previous CV events	≥4.0mmol/L
Recurrent/polyvascular events	≥3.5mmol/L

Table adapted from SMC 1147/16 (2016)⁶

SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of Praluent and is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.