3 The technologies

Ranibizumab

3.1

Ranibizumab (Lucentis, Novartis) is a humanised therapeutic antibody fragment that binds to VEGF-A isoforms of VEGF thereby preventing binding of VEGF-A to receptors VEGFR-1 and VEGFR-2.

3.2

Ranibizumab has a UK marketing authorisation for the treatment of neovascular (wet) AMD. If the patient experiences a loss of greater than five letters in visual acuity (on the Early Treatment Diabetic Retinopathy Study [ETDRS] chart or one Snellen line equivalent) during this maintenance phase, a further dose of ranibizumab should be administered. The interval between two doses should not be shorter than 1 month.

3.3

The summary of product characteristics (SPC) states that adverse events commonly associated with ranibizumab include conjunctival haemorrhage, eye pain, vitreous floaters, retinal haemorrhage, increased intraocular pressure, vitreous detachment, intraocular inflammation, eye irritation, cataract, foreign body sensation in the eyes, visual disturbance, blepharitis, subretinal fibrosis, ocular hyperaemia, blurred/decreased visual acuity, dry eye and vitreitis. For full details of side effects and contraindications, see the SPC.

3.4

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 Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS. The manufacturer has agreed that the patient access scheme will remain in place until any review of this technology by NICE is published. 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.

Pegaptanib

3.5

Pegaptanib (Macugen, Pfizer) is a pegylated modified oligonucleotide that binds to VEGF-165 and inhibits its activity.

3.6

Pegaptanib has a UK marketing authorisation for the treatment of neovascular (wet) AMD. It is administered at 0.3 mg once every 6 weeks (9 injections per year) by intravitreal injection into the affected eye.

3.7

The SPC states that adverse events commonly associated with pegaptanib are anterior chamber inflammation, eye pain, increased intraocular pressure, punctate keratitis, vitreous floaters and vitreous opacities. For full details of side effects and contraindications, see the SPC.

3.8

The cost of pegaptanib is £514.00 per injection (excluding VAT; BNF 52nd edition). The 2-year cost of pegaptanib is about £9,300 (9 injections in the first year and another 9 in the second year). Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)