Department of Psychiatry & Behavioral Sciences, New York Medical College , Valhalla, NY , USA.
J Med Econ. 2014 Aug;17(8):567-76. doi: 10.3111/13696998.2014.917089. Epub 2014 May 12.
To develop a decision-analytic model to estimate the cost-effectiveness of initiating maintenance treatment with aripiprazole once-monthly (AOM) vs paliperidone long-acting injectable (PLAI) once-monthly among patients with schizophrenia in the US.
A decision-analytic model was developed to evaluate a hypothetical cohort of patients initiating maintenance treatment with AOM or PLAI. Rates of relapse, adverse events (AEs), and direct medical costs were estimated for 1 year. Patients either remained on initial treatment or discontinued treatment due to lack of efficacy, AEs, or other reasons, including non-adherence. Data from placebo-controlled pivotal trials and product prescribing information (PI) were used to estimate treatment efficacy and AEs. Analyses were performed assuming dosing of clinical trials, real-world practice, PIs, and highest therapeutic dose available, because of variation in practice settings. The main outcome of interest was incremental cost per schizophrenia hospitalization averted with AOM vs PLAI.
Based on placebo-controlled pivotal trials' dosing, AOM improved clinical outcomes by reducing schizophrenia relapses vs PLAI (0.181 vs 0.277 per person per year [pppy]) at an additional cost of US$1276 pppy, resulting in an incremental cost-effectiveness ratio (ICER) of US$13,280/relapse averted. When PI dosing was assumed, this ICER increased to US$19,968/relapse averted. When real-world dosing and highest available dosing were assumed, AOM was associated with fewer relapses and lower overall treatment costs vs PLAI.
AOM consistently provided favorable clinical benefits. Under various dosing scenarios, AOM results indicated fewer relapses at lower overall costs or a reasonable cost-effectiveness threshold (i.e., less than the cost of a hospitalization relapse) vs PLAI. Given the heterogeneous nature of schizophrenia and variability in treatment response, health plans may consider open access for treatments like AOM. Since model inputs were based on data from separate placebo-controlled trials, generalization of results to the real-world setting is limited.
开发一种决策分析模型，以估计美国精神分裂症患者中每月一次的阿立哌唑维持治疗（AOM）与每月一次的帕利哌酮长效注射剂（PLAI）相比的成本效益。
开发了一种决策分析模型，以评估起始维持治疗使用 AOM 或 PLAI 的假设患者队列。1 年内估计复发率、不良事件（AE）和直接医疗费用。由于疗效不佳、AE 或其他原因（包括不依从），患者要么继续初始治疗，要么停止治疗。来自安慰剂对照的关键性试验和产品处方信息（PI）的数据用于估计治疗效果和 AE。分析假设为临床试验、真实世界实践、PI 和可获得的最高治疗剂量进行剂量，因为实践环境存在差异。主要的关注结果是与 PLAI 相比，AOM 避免的每例精神分裂症住院治疗的增量成本。
基于安慰剂对照的关键性试验的剂量，与 PLAI 相比，AOM 通过减少精神分裂症复发来改善临床结果（0.181 与 0.277 每患者每年），额外费用为 1276 美元，增量成本效益比（ICER）为 13280 美元/复发避免。当假设 PI 剂量时，这一 ICER 增加到 19968 美元/复发避免。当假设真实世界剂量和最高可用剂量时，AOM 与 PLAI 相比，复发次数较少，总治疗费用较低。
AOM 始终提供有利的临床效益。在各种剂量情况下，AOM 结果表明，与 PLAI 相比，复发次数较少，总费用较低，或者具有合理的成本效益阈值（即低于住院复发的成本）。鉴于精神分裂症的异质性和治疗反应的可变性，健康计划可能会考虑对 AOM 等治疗方法开放获取。由于模型输入是基于来自单独的安慰剂对照试验的数据，因此结果的推广到真实世界环境是有限的。
