Puerta del Mar University Hospital, 11009 Cadiz, Spain.
Puerto Real University Hospital, 11510 Cadiz, Spain.
Int J Environ Res Public Health. 2023 Apr 11;20(8):5462. doi: 10.3390/ijerph20085462.
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.
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.
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; < 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; = 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; = 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.
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.
在真实临床环境中比较初次接受和既往接受抗血管内皮生长因子（anti-VEGF）治疗的糖尿病黄斑水肿（DME）患者使用地塞米松玻璃体植入剂（DEX-i）的直接成本。
这是一项在真实临床场景中进行的回顾性、单中心研究。纳入 2015 年 5 月至 2020 年 12 月期间接受一次或多次 DEX-i 治疗、且至少随访 12 个月的初次接受和既往接受过血管内皮生长因子抑制剂（anti-VEGF）治疗的 DME 患者。成本分析从安达卢西亚地区医疗保健服务的角度进行。主要有效性终点是治疗 1 年后最佳矫正视力（BCVA）提高≥15 个 ETDRS 字母的概率。计算不同 BCVA 改善程度的增量成本效益比（ICER）。
49 只眼，28 只（57.1%）眼来自初次治疗组，21 只（42.9%）眼来自既往治疗组，纳入分析。初次治疗组的一年治疗总成本明显低于既往治疗组[Hodges-Lehmann 中位数差值：819.1 欧元；95%置信区间（CI）：786.9 至 1572.8 欧元；<0.0001]。初次治疗组在第 12 个月时达到 BCVA 改善≥15 个字母的概率显著高于既往治疗组（率差：0.321；95%CI：0.066 至 0.709；=0.0272）。初次治疗组在第 12 个月时达到 BCVA 改善≥15 个字母的 Cochran-Mantel-Haenszel 优势比为 3.55（95%CI：1.09 至 11.58；=0.0309）。就 ICER 而言，初次治疗组在第 12 个月和任何测量时间点达到 BCVA 改善≥15 个字母时，分别节省 7704.2 欧元和 5994.2 欧元的成本。
与既往接受过 anti-VEGF 治疗的患者相比，初次接受 DEX-i 治疗的患者更具成本效益。需要进一步的研究来确定基于患者特征的最具成本效益的治疗方法。
