Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia

  • Technology appraisal guidance
  • TA394
  • Published: 
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1 Recommendations

1.1

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

  • The dosage is 140 mg every 2 weeks.

  • 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).

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

Table 1 Low-density lipoprotein cholesterol concentrations above which evolocumab is recommended
− Without CVD With CVD: With CVD:

Primary non-familial hypercholesterolaemia or mixed dyslipidaemia

Not recommended at any LDL‑C concentration

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

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

Primary heterozygous-familial hypercholesterolaemia

Recommended only if LDL‑C concentration is persistently above 5.0 mmol/litre

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

Note: In this table high risk of CVD is defined as a history of any of the following: acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation); coronary or other arterial revascularisation procedures; coronary heart disease; ischaemic stroke; peripheral arterial disease; very high risk of CVD 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 evolocumab 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.