1 Recommendations

1.1 Alirocumab is recommended as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia, only if:

  • Low‑density lipoprotein concentrations are persistently above the thresholds specified in table 1 despite maximal tolerated lipid‑lowering therapy. That is, either the maximum dose has been reached or further titration is limited by intolerance (as defined in NICE's guideline on familial hypercholesterolaemia: identification and management).

  • The company provides alirocumab with the discount agreed in the patient access scheme.

Table 1 Low‑density lipoprotein cholesterol concentrations above which alirocumab is recommended

Without CVD

With CVD

High risk of CVD 1

Very high risk of CVD 2

Primary non‑familial hypercholesterolaemia or mixed dyslipidaemia

Not recommended at any LDL‑C concentration

Recommended only if LDL‑C concentration is persistently above 4.0 mmol/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 persistently above 3.5 mmol/l

1High 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.

2Very high risk of cardiovascular disease is defined as recurrent cardiovascular events or cardiovascular events in more than 1 vascular bed (that is, polyvascular disease).

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

1.2 This guidance is not intended to affect the position of patients whose treatment with alirocumab was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.

  • National Institute for Health and Care Excellence (NICE)