fluocinolone acetonide (Iluvien)

following a resubmission:

fluocinolone acetonide intravitreal implant (Iluvien®) is accepted for restricted use within NHS Scotland.

Indication under review: treatment of vision impairment associated with chronic diabetic macular oedema, considered insufficiently responsive to available therapies.

SMC restriction:

• only in patients in whom the affected eye is pseudophakic (has an artificial lens after cataract surgery) and;
• retreatment would take place only if the patient had previously responded to treatment with fluocinolone acetonide and subsequently best corrected visual acuity had deteriorated to less than 20/32.

The safety and efficacy of fluocinolone intravitreal implant was assessed in two randomised double-masked controlled phase III studies in patients with diabetic macular oedema. Significantly more patients treated with fluocinolone acetonide had a clinically meaningful improvement in visual acuity at two and three years versus sham injection.  Subgroup analyses supported this finding in patients with chronic diabetic macular oedema (median duration at least three years) and in patients who were pseudophakic at baseline.  Raised intraocular pressure is an important safety issue.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of fluocinolone. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower.