2 The technology
2.1 Ranibizumab (Lucentis, Novartis) belongs to a class of drugs that blocks the action of vascular endothelial growth factor (VEGF)‑A. By blocking the action of VEGF‑A, ranibizumab prevents abnormal blood vessels developing, thereby limiting visual loss and improving vision. Ranibizumab has a marketing authorisation for 'the treatment of visual impairment due to choroidal neovascularisation secondary to pathologic myopia'.
2.2 Ranibizumab is administered as a single 0.5 mg intravitreal injection. Each vial of ranibizumab contains 2.3 mg in 0.23 ml; overfilling is considered necessary to achieve an injectable dose of 0.5 mg. The summary of product characteristics states that monitoring is recommended monthly for the first 2 months and at least every 3 months thereafter during the first year. If monitoring reveals signs of disease activity, for example, reduced visual acuity and/or signs of lesion activity, further treatment is recommended.
2.3 Adverse reactions to treatment are mostly limited to the eye. Those commonly reported in clinical trials include vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, eye pain, vitreous floaters, conjunctival haemorrhage, eye irritation, sensation of a foreign body in the eye, increased production of tears, blepharitis, dry eye, ocular hyperaemia, itching of the eye and increased intraocular pressure. Nasopharyngitis, arthralgia and headaches are also commonly reported. Contraindications to ranibizumab include known hypersensitivity to the active substance or to any of its excipients, active or suspected ocular or periocular infections, 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 ranibizumab 10 mg/ml is £742.17 per 0.23‑ml vial (excluding VAT; 'British national formulary' [BNF] edition 66). The manufacturer of ranibizumab (Novartis) has agreed a patient access scheme with the Department of Health, revised in the context of Ranibizumab for treating diabetic macular oedema (NICE technology appraisal guidance 274), which makes ranibizumab available with a discount applied to all invoices. The level of the discount is commercial‑in‑confidence (see section 5.3). The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.