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 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 manufacturer of branded ranibizumab (Lucentis, Novartis) has agreed a patient access scheme with the Department of Health, revised in the context of NICE's technology appraisal guidance on ranibizumab for treating diabetic macular oedema, which makes ranibizumab available with a discount applied to all invoices. The level of the discount is commercial in confidence. The manufacturer has agreed that the patient access scheme will remain in place until any review of this technology by NICE is published. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS. NHS England has completed a national procurement for medical retinal vascular medicines, which includes the biosimilar versions of ranibizumab. Prices paid for the originator or biosimilar ranibizumab should be in line with the national procurement outcome and should be no higher than that provided through the original PAS.

  • National Institute for Health and Care Excellence (NICE)