2 The technology
2.1 Fluocinolone acetonide intravitreal implant (Iluvien, Alimera Sciences) contains a corticosteroid that has anti‑inflammatory and anti‑vascular endothelial growth factor (anti‑VEGF) properties. It is administered by intravitreal injection. Each implant contains 190 micrograms of fluocinolone acetonide, releasing 0.2 micrograms/day for approximately 36 months. Fluocinolone acetonide intravitreal implant has a marketing authorisation for 'the treatment of vision impairment associated with chronic diabetic macular oedema considered insufficiently responsive to available therapies'. The summary of product characteristics states that administration in both eyes concurrently is not recommended (see summary of product characteristics sections 4.2 and 4.4).
2.2 The summary of product characteristics lists the following adverse reactions for fluocinolone acetonide intravitreal implant: cataract, increased intraocular pressure, floaters (myodesopsia), retinal detachments, vitreous haemorrhages or detachments, glaucoma and endophthalmitis. For full details of adverse reactions and contraindications, see the summary of product characteristics.
2.3 Fluocinolone acetonide intravitreal implant is available in a 190‑microgram implant at a price of £5500 (excluding VAT; 'British National Formulary' [BNF] 65th edition). Costs may vary in different settings because of negotiated procurement discounts.
2.4 The manufacturer of fluocinolone acetonide intravitreal implant has agreed a patient access scheme with the Department of Health in which fluocinolone acetonide intravitreal implant will be available with a discount (see section 5.3). The details of the scheme were provided as commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.