2 The technology

2.1 Evolocumab (Repatha, Amgen) is a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), an enzyme involved in down-regulation of low-density lipoprotein receptors. This increases receptor density and lowers low-density lipoprotein cholesterol (LDL‑C). Evolocumab has a marketing authorisation in the UK for treating adults with primary hypercholesterolaemia (heterozygous-familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

  • in combination with a statin, or a statin plus 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 cannot tolerate or cannot be given statins.

    Evolocumab is given by subcutaneous injection. The recommended dose in the summary of product characteristics is either 140 mg every 2 weeks or 420 mg once monthly.

2.2 Commonly reported adverse reactions with evolocumab include nasopharyngitis, upper respiratory tract infection, influenza, back pain, arthralgia (joint pain) and nausea. For full details of adverse reactions and contraindications, see the summary of product characteristics.

2.3 Evolocumab costs £170.10 for a 140‑mg prefilled pen or syringe (excluding VAT; MIMS, March–May 2016). The annual cost of treatment per patient is about £4,422.60 for 140 mg every 2 weeks, and £6,123.60 for 420 mg monthly. The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of evolocumab, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.

  • National Institute for Health and Care Excellence (NICE)