Trial‐based cost‐effectiveness analysis of ultrathin Descemet stripping automated endothelial keratoplasty (UT‐DSAEK) versus DSAEK

PURPOSE: To evaluate the cost‐effectiveness of ultrathin Descemet stripping automated endothelial keratoplasty (UT‐DSAEK) versus standard DSAEK. METHODS: A cost‐effectiveness analysis using data from a multicentre randomized clinical trial was performed. The time horizon was 12 months postoperatively. Sixty‐four eyes of 64 patients with Fuchs’ endothelial dystrophy were included and randomized to UT‐DSAEK (n = 33) or DSAEK (n = 31). Relevant resources from healthcare and societal perspectives were included in the cost analysis. Quality‐adjusted life years (QALYs) were determined using the Health Utilities Index Mark 3 questionnaire. The main outcome was the incremental cost‐effectiveness ratio (ICER; incremental societal costs per QALY). RESULTS: Societal costs were €9431 (US$11 586) for UT‐DSAEK and €9110 (US$11 192) for DSAEK. Quality‐adjusted life years (QALYs) were 0.74 in both groups. The ICER indicated inferiority of UT‐DSAEK. The cost‐effectiveness probability ranged from 37% to 42%, assuming the maximum acceptable ICER ranged from €2500–€80 000 (US$3071–US$98 280) per QALY. Additional analyses were performed omitting one UT‐DSAEK patient who required a regraft [ICER €9057 (US$11 127) per QALY, cost‐effectiveness probability: 44–62%] and correcting QALYs for an imbalance in baseline utilities [ICER €23 827 (US$29 271) per QALY, cost‐effectiveness probability: 36–59%]. Furthermore, the ICER was €2101 (US$2581) per patient with clinical improvement in best spectacle‐corrected visual acuity (≥0.2 logMAR) and €3274 (US$4022) per patient with clinical improvement in National Eye Institute Visual Functioning Questionnaire‐25 composite score (≥10 points). CONCLUSION: The base case analysis favoured DSAEK, since costs of UT‐DSAEK were higher while QALYs were comparable. However, additional analyses revealed no preference for UT‐DSAEK or DSAEK. Further cost‐effectiveness studies are required to reduce uncertainty.