Evolocumab for Treating Primary Hypercholesterolaemia and Mixed Dyslipidaemia (TA394)

Technology Appraisal Guidance No. 394

Source: National Institute for Health and Care Excellence

1. Guidance

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.

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/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

1 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; chronic heart disease; ischaemic stroke; peripheral arterial disease.

2 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.

The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at www.nice.org.uk/guidance/ta394

This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

© Copyright National Institute for Health and Care Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: nice@nice.org.uk

Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia

Issue Date: June 2016

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