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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 hypercholesterolaemiaRecommended only if LDL-C concentration is persistently above 5.0 mmol/LRecommended 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


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 and prior CV event


Previous CV events


Recurrent/polyvascular events


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.

* LDL-C concentrations must be persistently above defined thresholds


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Abbreviations: CVD, cardiovascular disease; LDL-C, low-density lipoprotein cholesterol.

1. NICE (2016). Technology Appraisal Guidance (TA393). Available at Accessed October 2023.
2. NICE (2015). Clinical Guideline (CG181) Cardiovascular disease: risk assessment and reduction, including lipid modification. Available at Accessed October 2023.
3. NICE (2008). Clinical Guideline (CG71) Familial hypercholesterolaemia: identification and management. Available at Accessed October 2023.
4. NICE. Technology appraisal guidance TA385. Ezetimibe for treating primary heterozygous-familial and non-familial hypercholesterolaemia. 2016. Available at Accessed October 2023.
5. SMC (2016). Alirocumab 75 mg and 150 mg solution for injection in pre-filled pen (Praluent) (SMC No. 1147/16).

MAT-XU-2204595 (v3.0) Date of Preparation: October 2023