2 The technology

2.1 Aflibercept (Eylea, Bayer Pharma) is a soluble vascular endothelial growth factor (VEGF) receptor fusion protein that binds to all forms of VEGF‑A, VEGF‑B, and the placental growth factor. VEGF is involved in the pathogenesis of diabetic macular oedema (DMO). Aflibercept has a UK marketing authorisation for 'the treatment of adults with visual impairment due to diabetic macular oedema'.

2.2 In the summary of product characteristics the most frequent adverse reactions to aflibercept treatment include subconjunctival haemorrhage (bleeding under the membrane covering the white of the eye), reduction in visual acuity, eye pain at the injection site, an increase in intraocular pressure and cataract formation. For full details of adverse reactions and contraindications, see the summary of product characteristics.

2.3 Aflibercept is given as a single 2 mg intravitreal injection every month for 5 consecutive months, followed by 1 injection every 2 months with no requirement for monitoring between visits. After the first 12 months, the treatment interval may be extended based on visual and anatomic outcomes. The schedule for monitoring should be determined by the treating physician. Aflibercept should be discontinued if the patient is not benefiting from continued treatment.

2.4 The list price of aflibercept is £816.00 per vial (excluding VAT; British national formulary [BNF] edition January 2015). The total cost for treating a patient in the first year is £6936 (based on 8.5 aflibercept injections). The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of aflibercept, 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.