Cost-Effectiveness of Dexamethasone Intravitreal Implant in Naïve and Previously Treated Patients with Diabetic Macular Edema.

PURPOSE: To compare the direct costs associated with the dexamethasone intravitreal implant (DEX-i) in treatment-naïve and previously treated eyes with diabetic macular edema (DME) in a real clinical setting. METHODS: Retrospective and single-center study conducted in a real clinical scenario. Consecutive DME patients, either naïve or previously treated with vascular endothelial growth factor inhibitors (anti-VEGF), who received treatment with one or more DEX-i between May 2015 and December 2020, and who were followed-up for a minimum of 12 months, were included in the study. The cost analysis was performed from the perspective of the Andalusian Regional Healthcare Service. The primary effectiveness endpoint was the probability of achieving an improvement in best-corrected visual acuity (BCVA) ≥ 15 ETDRS letters after 1 year of treatment. The incremental cost-effectiveness ratio (ICER) of different improvements in BCVA was calculated. RESULTS: Forty-nine eyes, twenty-eight (57.1%) eyes from the treatment-naïve group and twenty-one (42.9%) from the previously treated group, were included in the analysis. The total cost of one year of treatment was significantly lower in the treatment-naïve eyes than in the previously treated eyes [Hodges-Lehmann median difference: EUR 819.1; 95% confidence interval (CI): EUR 786.9 to EUR 1572.8; p < 0.0001]. The probability of achieving a BCVA improvement of ≥15 letters at month 12 was significantly greater in the treatment-naïve group than in the previously treated group (rate difference: 0.321; 95% CI: 0.066 to 0.709; p = 0.0272). The Cochran-Mantel-Haenszel Odds Ratio of achieving a BCVA improvement of ≥15 letters at month 12 was 3.55 (95% CI: 1.09 to 11.58; p = 0.0309). In terms of ICER, the treatment-naïve group showed cost savings of EUR 7704.2 and EUR 5994.2 for achieving an improvement in BCVA ≥ 15 letters at month 12 and at any of the measured time points, respectively. CONCLUSIONS: DEX-i was found to be more cost-effective in treatment-naïve eyes than in those previously treated with anti-VEGF. Further studies are needed to determine the most cost-effective treatment based on patient profile.

Intravitreal dexamethasone implant in naïve and previously treated patients with diabetic macular edema: a retrospective study.

AIM: To assess the effect of the intravitreal dexamethasone implant (DEX) Ozurdex on the best corrected visual acuity (BCVA) and central retinal thickness (CRT) in patients with diabetic macular edema (DME). METHODS: Totally 43 eyes (24 naïve and 19 previously treated) were included in the study. Retrospective and single-center study involved patients with a clinical diagnosed of DME, who received treatment with DEX implant and had a follow-up of at least 12mo. Primary endpoints included changes in BCVA and CRT. RESULTS: At month 12, mean improvement in BCVA from baseline was 20.4±20.8 letters and 6.8±6.9 letters in naïve and previously treated patients, respectively (P=0.0132). The naïve patients achieved the BCVA improvement significantly faster (2.4±1.5mo) than the previously treated ones (3.5±2.4mo, P=0.0298; Mann-Whitney test). The proportion of eyes gaining ≥15 letters was 54.2% and 21.1% in the non-previously treated and previously treated groups, respectively (P=0.0293). CRT was significantly reduced from 484.0±119.8 and 487.5±159.9 µm to 272.0±39.2 and 233.5±65.7 µm in the naïve and previously treated patients, respectively; P<0.0001 each, respectively. The presence of subretinal fluid was significantly associated with the proportion of patients achieving a BCVA improvement ≥5 letters [HR (95%CI), 1.23 (1.04 to 1.45), P=0.0145]; ≥10 letters [HR (95%CI), 1.75 (1.10 to 2.77), P=0.0182]; and ≥15 letters [HR (95% CI), 2.04 (1.03 to 4.02), P=0.0407]. Naïve patients received less DEX implants throughout the study than the previously treated ones (1.8±0.6 vs 2.3±0.6, P=0.0172, respectively). Totally 9 patients (20.9%) have developed ocular hypertension, which was successfully controlled with topical hypotensive drugs. Of the 23 phakic eyes at baseline, 5 eyes (21.7%) either had new onset lens opacity or progression of an existing opacity during the study follow-up. Four of them (2 in the naïve group and 2 in the previously treated one) required cataract surgery at months 4, 6, 6, and 6, respectively. CONCLUSION: The results obtained in this study may support the early use of DEX Ozurdex as first line therapy in naïve patients.

Úlcera ocular por Moraxella nonliquefaciens / Ocular ulcer due to Moraxella nonliquefaciens

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