• 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)1

    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.

    UNMET NEED

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    ODYSSEY OUTCOMES

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    1. SMC (2016). Alirocumab 75 mg and 150 mg solution for injection in pre-filled pen (Praluent) (SMC No. 1147/16).