OBJECTIVES: A single injection of the FAc implant (ILUVIEN(r)) continuously releases 0.2 µg per day of FAc for up to 36 months. It is indicated in Europe for the treatment of chronic DMO that is insufficiently responsive to available therapies, and NICE restricted its use in the UK to pseudophakic eyes. In order to assess the cost-effectiveness in patients with a phakic lens and a cataract, a new model was developed.

METHODS: A Markov model was developed to predict costs and QALYs over 15 years in patients treated with FAc implant, compared to usual care, consisting of laser photocoagulation and anti-VEGFs. The model captured changes in best-corrected visual acuity level, DMO status, lens status and treatment phase in both eyes. Transition probabilities were obtained from multinomial models estimated from the FAME clinical trial. Patient baseline characteristics, resource utilisation and treatment patterns were obtained from real-world data, collected in the Iluvien Clinical Evaluation-UK (ICE-UK) study and the literature. Costs were evaluated from the UK National Health Service perspective and included treatment acquisition and administration, disease monitoring, adverse events management and cost of blindness.

RESULTS: The FAc strategy was more expensive compared to usual care, with differences of £1,597 and £1,647 per patient with pseudophakic and phakic study eyes, and produced more QALYs (+0.18 and +0.09 per patient, respectively). Predicted numbers of anti-VEGF injections avoided in these eyes in the 12 months after FAc administration were 6.27 and 6.69. Incremental cost-effectiveness ratios (ICER) were estimated at £8,653 and £17,740 /QALY gained. Sensitivity analyses showed that the ICER was sensitive to usual care costs, vision-related utility decrements and transition probabilities. The probabilities of FAc being cost-effective were 78% and 51.5% at a threshold of £20,000 per QALY gained, respectively.

CONCLUSIONS: The FAc implant is cost-effective in patients with chronic DMO irrespective of lens status.