Merck & Co, Inc, Kenilworth, New Jersey.
Washington University, St Louis, Missouri.
Clin Infect Dis. 2018 Jan 18;66(3):355-362. doi: 10.1093/cid/cix809.
Clostridium difficile infection (CDI) is the most commonly recognized cause of recurrent diarrhea. Bezlotoxumab, administered concurrently with antibiotics directed against C. difficile (standard of care [SoC]), has been shown to reduce the recurrence of CDI, compared with SoC alone. This study aimed to assess the cost-effectiveness of bezlotoxumab administered concurrently with SoC, compared with SoC alone, in subgroups of patients at risk of recurrence of CDI.
A computer-based Markov health state transition model was designed to track the natural history of patients infected with CDI. A cohort of patients entered the model with either a mild/moderate or severe CDI episode, and were treated with SoC antibiotics together with either bezlotoxumab or placebo. The cohort was followed over a lifetime horizon, and costs and utilities for the various health states were used to estimate incremental cost-effectiveness ratios (ICERs). Both deterministic and probabilistic sensitivity analyses were used to test the robustness of the results.
The cost-effectiveness model showed that, compared with placebo, bezlotoxumab was associated with 0.12 quality-adjusted life-years (QALYs) gained and was cost-effective in preventing CDI recurrences in the entire trial population, with an ICER of $19824/QALY gained. Compared with placebo, bezlotoxumab was also cost-effective in the subgroups of patients aged ≥65 years (ICER of $15298/QALY), immunocompromised patients (ICER of $12597/QALY), and patients with severe CDI (ICER of $21430/QALY).
Model-based results demonstrated that bezlotoxumab was cost-effective in the prevention of recurrent CDI compared with placebo, among patients receiving SoC antibiotics for treatment of CDI.
艰难梭菌感染（CDI）是最常见的复发性腹泻的原因。贝洛妥珠单抗与针对艰难梭菌的抗生素（标准治疗[SoC]）同时给药，与单独使用 SoC 相比，已被证明可降低 CDI 的复发率。本研究旨在评估贝洛妥珠单抗与 SoC 联合给药与单独使用 SoC 相比，在 CDI 复发风险较高的患者亚组中的成本效益。
设计了基于计算机的 Markov 健康状态转移模型，以跟踪 CDI 感染患者的自然病史。患者队列进入模型时患有轻度/中度或重度 CDI 发作，并接受 SoC 抗生素联合贝洛妥珠单抗或安慰剂治疗。该队列在终身时间范围内进行随访，各种健康状态的成本和效用用于估计增量成本效益比（ICER）。使用确定性和概率敏感性分析来测试结果的稳健性。
成本效益模型表明，与安慰剂相比，贝洛妥珠单抗可获得 0.12 个质量调整生命年（QALY），并且在预防整个试验人群的 CDI 复发方面具有成本效益，ICER 为每获得 1 QALY 花费 19824 美元。与安慰剂相比，贝洛妥珠单抗在≥65 岁的患者亚组（ICER 为 15298 美元/QALY）、免疫功能低下的患者亚组（ICER 为 12597 美元/QALY）和患有严重 CDI 的患者亚组（ICER 为 21430 美元/QALY）中也具有成本效益。
基于模型的结果表明，与安慰剂相比，贝洛妥珠单抗在接受 SoC 抗生素治疗 CDI 的患者中预防复发性 CDI 具有成本效益。
