2 The technology
2.1 Aflibercept solution for injection (Eylea, Bayer) is a vascular endothelial growth factor (VEGF) inhibitor. It prevents the inappropriate growth of new blood vessels in the retina. Aflibercept solution for injection has a UK marketing authorisation for 'the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO)'.
2.2 Aflibercept is administered as a single 2 mg intravitreal injection. Each vial of aflibercept contains 4 mg in 0.1 ml, providing a usable amount to deliver a single dose of 0.05 ml containing 2 mg of aflibercept. After the initial injection, treatment is given monthly. The summary of product characteristics states that the interval between 2 doses should not be shorter than 1 month. If there is no improvement in visual and anatomic outcomes over the course of the first 3 injections, continued treatment is not recommended. Monthly treatment continues until visual and anatomical outcomes are stable for 3 monthly assessments. Thereafter the need for continued treatment should be reconsidered. The summary of product characteristics states that monitoring is recommended at the injection visits and that the monitoring schedule should be determined by the doctor responsible for the patient's care based on the response of the condition to treatment. For full details of posology, see the summary of product characteristics.
2.3 Adverse reactions to treatment are mostly limited to the eye. The summary of product characteristics lists the following adverse reactions as common or very common for aflibercept solution for injection for macular oedema secondary to CRVO: conjunctival haemorrhage, increased intraocular pressure, eye pain, vitreous detachment, vitreous floaters, increased lacrimation, and ocular hyperaemia. Contraindications for aflibercept solution for injection include hypersensitivity to the active substance or any of its excipients, active or suspected ocular or periocular infection, and active severe intraocular inflammation. For full details of adverse reactions and contraindications, see the summary of product characteristics.
2.4 The list price of aflibercept 40 mg/ml solution for injection is £816.00 per 0.1-ml vial (excluding VAT; 'British national formulary' [BNF] edition 66). The manufacturer of aflibercept solution for injection has agreed a patient access scheme with the Department of Health which makes aflibercept solution for injection available with a discount applied to the list price. The level of 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.