1 Recommendations

1.1 The committee was minded not to recommend fluocinolone acetonide intravitreal implant as an option for preventing relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye in adults.

1.2 The committee recommends that NICE requests further clarification and analyses from the company, which should be made available for the second appraisal committee meeting, and should include a revised cost-effectiveness model that:

  • considers both eyes (see section 3.7)

  • compares the fluocinolone acetonide implant with the dexamethasone implant, both as single and repeated implants (see section 3.8) and

  • includes disutility values calculated based on the length and severity of each adverse event (see section 3.11).

Why the committee made these recommendations

Treatments for recurrent non-infectious uveitis affecting the posterior segment of the eye include systemic corticosteroids, immunosuppressants and dexamethasone implants. These treatments can be disruptive to daily life, needing frequent hospital visits.

The clinical trial results are difficult to interpret and very uncertain. The trial didn't measure health-related quality of life and the number of recurrences reported may be overestimated. Also, people in the control group didn't have any treatment after 3 months in the trial, which is not what is likely to happen in the NHS in England.

Because of the uncertainty in the trial results, the cost-effectiveness estimates are also uncertain. Also, the analyses do not include the dexamethasone implant, which is a relevant comparator. So more analyses are needed.