Cost-Effectiveness of the Smaller-Incision New Generation Implantable Miniature Telescope for Late-Stage Age-Related Macular Degeneration.

Objective: To assess the cost-effectiveness of the smaller-incision new-generation implantable miniature telescope (SING IMT) versus conventional standard care (CSC) from the Italian National Health Service (NHS) and societal perspectives. Design: Model-based cost-utility analysis. Subjects: A simulated cohort of patients with bilateral late-/end-stage age-related macular degeneration (AMD), based on a prospective multicenter study population (mean age, 76 years) eligible for SING IMT, compared with a clinically comparable cohort receiving CSC. Methods: A cohort Markov model with quarterly cycles and a lifetime horizon evaluated monocular SING IMT implantation, structured 6-month postoperative low-vision rehabilitation, and scheduled ophthalmologic follow-up. Costs included device acquisition, surgery, rehabilitation, follow-up, wet AMD treatment and monitoring, visual impairment and blindness, and adverse-event management. Costs and outcomes were discounted at 3% annually. Deterministic and probabilistic sensitivity analyses assessed uncertainty. Main Outcome Measures: Incremental costs, life years (LYs), quality-adjusted life years (QALYs), incremental cost-utility ratio, and net monetary benefit (NMB) at a €40,000/QALY willingness-to-pay threshold. Results: In the deterministic base case, SING IMT provided 1.59 additional LYs and 1.27 additional QALYs versus CSC. From the NHS perspective, its incremental cost was €21,760.60, yielding incremental cost-effectiveness ratios of €13,712.33 per LY and €17,137.15 per QALY gained; incremental NMB was €29,031.05. Including societal blindness-related costs, SING IMT reduced total per-patient costs (€35,446.33 vs €74,035.45; difference, -€38,589.12), primarily through lower lifetime blindness costs. Thus, from the combined NHS and societal perspective, SING IMT was dominant, with an incremental NMB of €89,380.77. Results were robust in sensitivity analyses; baseline age was the main source of variability, whereas surgical time, visit frequency, and unit costs had marginal effects. Conclusions: For appropriately selected Italian patients with late-stage AMD, SING IMT is expected to be cost-effective versus CSC, providing clinically meaningful gains in quality-adjusted survival. It is cost-effective but not cost-saving from the NHS perspective alone and becomes dominant when societal costs are included, owing mainly to avoided blindness-related expenditure. Findings are specific to the Italian health care context. Financial Disclosures: The authors have no proprietary or commercial interest in any materials discussed in this article.