• NICE GUIDANCE

    Alirocumab is recommended as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia, only if LDL-C concentrations are persistently above the thresholds specified in the table below despite maximal tolerated lipid-lowering therapy1 and the company provides alirocumab with the discount agreed in the patient access scheme.

    Table 1. Treatment groups and LDL-C thresholds for alirocumab prescribing (Adapted from NICE TA393)1

    Patient populations Without CVD With CVD
    High risk of CVD† Very high risk of CVD ‡
    Primary non-familial hypercholesterolaemia or mixed dyslipidaemia Not recommended at any LDL-C concentration Recommended only if LDL-C concentration is persistently above 4.0mmol/L Recommended only if LDL-C concentration is persistently above 3.5 mmol/L
    Primary heterozygous-familial hypercholesterolaemia Recommended only if LDL-C concentration is persistently above 5.0 mmol/L Recommended only if LDL-C concentration is peristently above 3.5 mmol/L

    NICE recommended lipid-lowering pathway
    † High risk of cardiovascular disease is defined as a history of any of the following: acute coronary syndrome (such as myocardial infarction or unstable angina requiring hospitalisation), coronary or other arterial revascularisation procedures, coronary heart disease, ischaemic stroke, peripheral arterial disease.
    ‡ Very high risk of cardiovascular disease is defined as recurrent cardiovascular events or cardiovascular events in more than 1 vascular bed (that is, polyvascular disease).

    Some patients with hypercholesterolaemia or mixed dyslipidaemia, including those with heterozygous familial hypercholesterolaemia (HeFH), do not reach NICE-recommended LDL-C goals despite lifestyle changes and maximal treatment with standard therapy (statins with or without ezetimibe)2-4

    NICE did not make separate recommendations for patients with statin intolerance. NICE considered that people who cannot take statins may have higher than average LDL-C levels, and therefore may meet the LDL-C thresholds needed to start treatment with alirocumab.

    NICE assessment

    • The Technology Appraisal Guidance (TA393) for alirocumab was issued on 22 June 2016

    SMC GUIDANCE

    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)5

    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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    * LDL-C concentrations must be persistently above defined thresholds
    Abbreviations: CVD, cardiovascular disease; LDL-C, low-density lipoprotein cholesterol.

    1. NICE (2016). Technology Appraisal Guidance (TA393). Available at https://www.nice.org.uk/guidance/ta393. Accessed August 2021.
    2. NICE (2015). Clinical Guideline (CG181) Cardiovascular disease: risk assessment and reduction, including lipid modification. Available at https://www.nice.org.uk/guidance/cg181. Accessed August 2021.
    3. NICE (2008). Clinical Guideline (CG71) Familial hypercholesterolaemia: identification and management. Available at https://www.nice.org.uk/guidance/cg71. Accessed August 2021.
    4. NICE. Technology appraisal guidance TA385. Ezetimibe for treating primary heterozygous-familial and non-familial hypercholesterolaemia. 2016. Available at https://www.nice.org.uk/guidance/ta385. Accessed August 2021.
    5. SMC (2016). Alirocumab 75 mg and 150 mg solution for injection in pre-filled pen (Praluent) (SMC No. 1147/16).