IMS Health, London, UK.
Pharmacoeconomics. 2012 Feb 1;30(2):87-101. doi: 10.2165/11599370-000000000-00000.
Major orthopaedic surgery, such as total hip replacement (THR) and total knee replacement (TKR), is associated with an increased risk of venous thromboembolism (VTE).
Clinical trials have demonstrated the efficacy of rivaroxaban, a once-daily, orally administered Factor Xa inhibitor, for the prevention of VTE in patients undergoing THR or TKR. This analysis evaluated the cost effectiveness of rivaroxaban compared with enoxaparin, from a U.S. payer's perspective.
A decision-analytic model was developed to compare the costs and outcomes associated with rivaroxaban and enoxaparin for the prevention of VTE. The model replicated short-term clinical outcomes from the phase III RECORD trials. RECORD1 and RECORD2 compared rivaroxaban 10 mg daily (qd), given for 35 days, with enoxaparin 40 mg qd, given for 35 days or 10 to 14 days, respectively, in patients undergoing THR. RECORD3 compared 10 mg of rivaroxaban qd for 10 to 14 days versus 40 mg of enoxaparin qd for 10 to 14 days in patients undergoing TKR. The decision-analytic model also included data on long-term complications and sequelae as captured in observational studies and databases. It also included direct year 2010 medical costs over 1-year and 5-year time horizons. A series of sensitivity analyses were performed to determine the impact of different factors on the results of the model. Results of the cost-effectiveness analysis were reported in terms of symptomatic VTE events avoided.
Rivaroxaban was associated with cost savings of $US 511.93 per patient and prevented an average of 0.0145 symptomatic VTE events per patient in the THR population, compared with enoxaparin. For a TKR population, 10 to 14 days of rivaroxaban prophylaxis was associated with cost savings of $US 465.74 and prevented an average 0.0193 symptomatic VTE events per patient. Sensitivity analysis suggested that the results of the model were robust, with cost savings ranging from $US 133.96-629.57 in the THR population and $US 293.01-848.68 in the TKR population, depending on the variables used. Sensitivity analysis also suggested that the economic profile of rivaroxaban is improved when the time horizon of the model is extended from 1 year to 5 years. A probabilistic sensitivity analysis confirmed the findings of baseline results, showing that rivaroxaban was less costly and more effective in all model simulations for both populations.
This decision-analytic model analysis, from the U.S. payer's perspective, concluded that rivaroxaban may be cost saving in both the THR and the TKR populations, when compared with enoxaparin in the U.S.
全髋关节置换术(THR)和全膝关节置换术(TKR)等主要骨科手术会增加静脉血栓栓塞症(VTE)的风险。
临床试验已经证明,每天口服一次的因子 Xa 抑制剂利伐沙班在预防 THR 或 TKR 患者的 VTE 方面是有效的。本分析从美国支付者的角度评估了利伐沙班与依诺肝素相比的成本效益。
开发了一个决策分析模型,以比较利伐沙班和依诺肝素预防 VTE 的成本和结果。该模型复制了 III 期 RECORD 试验的短期临床结果。RECORD1 和 RECORD2 分别比较了利伐沙班 10mg 每日(qd),使用 35 天,与依诺肝素 40mg qd,分别使用 35 天或 10-14 天,用于接受 THR 的患者。RECORD3 比较了 10mg 利伐沙班 qd 用于 10-14 天与 40mg 依诺肝素 qd 用于 10-14 天,用于接受 TKR 的患者。决策分析模型还包括观察性研究和数据库中记录的长期并发症和后遗症的数据。它还包括 1 年和 5 年时间范围内的直接 2010 年医疗费用。进行了一系列敏感性分析,以确定不同因素对模型结果的影响。成本效益分析的结果以避免的有症状 VTE 事件报告。
与依诺肝素相比,利伐沙班在 THR 人群中每例患者节省 511.93 美元,并平均每例患者预防 0.0145 例有症状 VTE 事件。对于 TKR 人群,10-14 天的利伐沙班预防治疗可节省 465.74 美元,并平均每例患者预防 0.0193 例有症状 VTE 事件。敏感性分析表明,该模型的结果具有稳健性,在 THR 人群中,成本节省范围为 133.96-629.57 美元,在 TKR 人群中为 293.01-848.68 美元,具体取决于使用的变量。敏感性分析还表明,当模型的时间范围从 1 年延长到 5 年时,利伐沙班的经济状况会得到改善。概率敏感性分析证实了基线结果的发现,表明在所有模型模拟中,利伐沙班在 THR 和 TKR 人群中的成本更低,效果更好。
从美国支付者的角度来看,这项决策分析模型分析得出的结论是,与在美国使用依诺肝素相比,利伐沙班可能在 THR 和 TKR 人群中具有成本效益。