2 The technology

2.1 Alirocumab (Praluent, Sanofi) is a monoclonal antibody that targets proprotein convertase subtilisin/kextin type 9 (PCSK9). It stops low‑density lipoprotein receptors in the liver from degrading, helping to lower levels of low‑density lipoprotein cholesterol (LDL‑C) in the blood. Alirocumab has a marketing authorisation in the UK for '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.'

Alirocumab is given by subcutaneous injection. The recommended dose is either 75 mg or 150 mg every 2 weeks. In January 2021, the licensed dosage was updated to include another option of 300 mg every 4 weeks (monthly).

2.2 Common reported adverse reactions include local injection site reactions, upper respiratory tract signs and symptoms, and pruritus. For full details of adverse reactions and contraindications, see the summary of product characteristics.

2.3 Alirocumab costs £168 for a 75 mg or 150 mg single‑use prefilled pen (excluding VAT; MIMS, January 2016). The annual cost of treatment per patient is £4,383 for 75 mg or 150 mg every 2 weeks. The company has agreed a patient access scheme with the Department of Health that will provide a simple discount to the list price of alirocumab 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 would not constitute an excessive administrative burden on the NHS.