NICE backs Alimera’s three-year uveitis implant

An implant developed by Alimera Sciences has been recommended by NICE to treat an inflammatory eye disease that can cause permanent vision loss.

The UK cost-effectiveness watchdog says there is evidence that Iluvien – a formulation of the steroid fluocinolone acetonide that is injected into the eye and lasts three years – should be available on the NHS for non-infectious posterior uveitis (NIPU), which affects the back of the eye.

In its appraisal document, NICE says that using Iluvien “could mean fewer hospital visits for patients who receive current treatments,” which include corticosteroid injections, immunosuppressant drugs, and implants based on dexamethasone and AbbVie’s TNF inhibitor Humira (adalimumab).

Alimera reported three-year data with Iluvien earlier this year which showed that the implant extended the time to recurrence in NIPU patients to 94 weeks from 10 weeks with placebo, and reduced the number of recurrences from 5.3 to 1.7 over the study period.

NICE said that the recurrence rates reported in the trial were likely to be overestimated, and there were no direct comparisons with other therapies, but cost-effectiveness modelling based on one eye being treated fell within its £30,000 per quality-adjusted life year (QALY) threshold for “most scenarios.”

At the moment, the treatments available for NIPU typically involve frequent hospital visits for treatment administration and monitoring that can be burdensome and disruptive to daily life for both patients and their carers.

NICE notes that around 8,500 people in England have non-infectious uveitis affecting the back of the eye, although with recurrent disease those who would be eligible for this treatment are far fewer. Iluvien has a list price of £5,500 ($7,000) per eye, and NICE has agreed a confidential discount for NHS England patients.

NIPU is most commonly caused by an underlying autoimmune disorder, and causes eye pain, redness of the eye, vision problems, sensitivity to light, and headaches. If left untreated it can lead to glaucoma, cataracts, macular oedema and even blindness.

Iluvien has been approved as a treatment for diabetic macular oedema since 2014, but has only just been given the green light for the uveitis indication in Europe. In March, the UK’s MHRA approved the drug as the reference EU country, kicking off the mutual recognition procedure in the other member states.