Ruiz-Moreno J M, de Andrés-Nogales F, Oyagüez I
Universidad de Castilla-La Mancha, Albacete, Spain.
Servicio de Oftalmología, Hospital Universitario Puerta de Hierro Majadahonda, Calle Manuel de Falla, 1, 28222, Majadahonda, Spain.
BMC Ophthalmol. 2020 Sep 17;20(1):371. doi: 10.1186/s12886-020-01637-0.
The DRCR.net Protocol T clinical trial assessed the comparative efficacy and safety of anti-VEGF treatments including aflibercept, ranibizumab and bevacizumab in diabetic macular edema (DME). Post -hoc analyses showed that after a 12-week induction period, there was still DME resolution in an increasing number of patients through week 24.
To assess clinical and cost consequences of extending the anti-VEGF loading dose from 3 to 6 monthly injections in patients with persistent DME in Spain.
From a hospital pharmacy perspective, a cost-consequence analysis model was developed to estimate the incremental cost needed to obtain an additional response at month 6. To estimate drug treatment costs, ex-factory prices (€, 2019) were considered for aflibercept, ranibizumab and bevacizumab. Response/nonresponse rates at 3/6 months were obtained from the Protocol T 24-week post hoc analysis (n = 546). Persistent DME was present in 50.8 and 31.6% of the 190 aflibercept-treated patients at month 3 and month 6, respectively. Of the 176 ranibizumab- and 180 bevacizumab-treated patients, 53.2 and 72.9%, respectively, had persistent DME at month 3, and 41.5 and 65.6%, respectively, had persistent DME at month 6. Sensitivity analysis considered the split of bevacizumab vials.
Extending the loading dose in nonresponder patients would cost €214,862.57, €208,488.98 and €134,483.16 to obtain 37, 21 and 13 additional aflibercept, ranibizumab and bevacizumab responder patients, respectively. The total number of extended injections (months 3-6) used in patients with persistent DME at month 6 was 180, 219 and 354 for aflibercept, ranibizumab and bevacizumab, respectively.
To extend the anti-VEGF loading dose from 3 to 6 injections necessitates investing €5882.77 (8 injections), €10,091.03 (14 injections) and €10,198.59 (30 injections) per additional responder patient (3-month nonresponders and 6-month responders) to aflibercept, ranibizumab and bevacizumab, respectively. For the total of patients treated, on average €7927.02 (14 injections) per additional responder patient would be needed.
DRCR.net 协议 T 临床试验评估了阿柏西普、雷珠单抗和贝伐单抗等抗 VEGF 治疗药物在糖尿病性黄斑水肿（DME）中的疗效和安全性对比。事后分析显示，在 12 周的诱导期后，直至第 24 周仍有越来越多的患者的 DME 得到缓解。
评估在西班牙，将抗 VEGF 负荷剂量从每月 3 次注射延长至 6 次注射对持续性 DME 患者的临床和成本影响。
从医院药房的角度出发，建立了一个成本效益分析模型，以估算在第 6 个月获得额外疗效所需的增量成本。为估算药物治疗成本，考虑了阿柏西普、雷珠单抗和贝伐单抗的出厂价格（欧元，2019 年）。3/6 个月时的缓解/未缓解率来自协议 T 的 24 周事后分析（n = 546）。在接受阿柏西普治疗的 190 例患者中，分别有 50.8%和 31.6%在第 3 个月和第 6 个月出现持续性 DME。在接受雷珠单抗治疗的 176 例患者和接受贝伐单抗治疗的 180 例患者中，第 3 个月分别有 53.2%和 72.9%出现持续性 DME，第 6 个月分别有 41.5%和 65.6%出现持续性 DME。敏感性分析考虑了贝伐单抗药瓶的拆分情况。
在无反应患者中延长负荷剂量，分别需要花费 214,862.57 欧元、208,488.98 欧元和 134,483.16 欧元，才能使阿柏西普、雷珠单抗和贝伐单抗的反应患者分别增加 37 例、21 例和 13 例。在第 6 个月患有持续性 DME 的患者中，用于阿柏西普、雷珠单抗和贝伐单抗的延长注射总数（第 3 - 6 个月）分别为 180 次、219 次和 354 次。
将抗 VEGF 负荷剂量从 3 次注射延长至 6 次注射，对于每增加一名反应患者（3 个月无反应且 6 个月有反应），分别需要对阿柏西普、雷珠单抗和贝伐单抗额外投入 5882.77 欧元（8 次注射）、10,091.03 欧元（14 次注射）和 10,198.59 欧元（30 次注射）。对于所有接受治疗的患者而言，平均每增加一名反应患者需要额外投入 7927.02 欧元（14 次注射）。
