Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, 3335 S. Figueroa St., Unit A, University Park Campus, UGW-Unit A, Los Angeles, CA 90089-7273, USA.
Pharmacoeconomics. 2013 Sep;31(9):823-39. doi: 10.1007/s40273-013-0078-x.
Limited information is available on the cost effectiveness of ustekinumab and alternative biologic treatments in a United States (US) setting. Given the recent head-to-head clinical trial study of ustekinumab and etanercept, an economic model comparing the two treatments can be constructed. Etanercept and ustekinumab are indicated for the treatment of chronic moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy.
Clinical trials have evaluated the efficacy of ustekinumab, an anti-cytokine biologic, for the treatment of moderate to severe psoriasis. This study evaluated the cost effectiveness of ustekinumab compared with etanercept from a US societal perspective.
A Markov model was constructed to simulate the incremental cost per quality-adjusted life-year (QALY) gained every 12 weeks over a base-case 3-year time horizon. A hypothetical patient cohort was based on the characteristics of the phase III Active Comparator Psoriasis Trial (ACCEPT). The main outcome measures were costs and QALYs, which were estimated from the US societal perspective. Costs, utilities, treatment strategy, and resource use estimates were obtained from relevant literature. All costs were adjusted to 2011 US dollars. A 3 % annual discount rate was applied to costs and QALYs. Incremental cost-effectiveness ratios were in US dollars per QALY gained.
For the base-case 3-year time horizon, the incremental cost-effectiveness ratio comparing ustekinumab 90 mg with etanercept 50 mg was US$384,401 per QALY gained. Ustekinumab 45 mg dominates etanercept 50 mg for the same time horizon. These results were robust to sensitivity analyses involving treatment strategy, transition probabilities, valuing outcomes, and resource use and costs. The probabilistic sensitivity analysis suggests ustekinumab 90 mg has a minimal (4 %) chance of being cost effective compared with etanercept 50 mg at a willingness-to-pay threshold of US$150,000 per QALY improvement. For the same threshold, ustekinumab 45 mg has a high (88 %) chance of being cost effective compared with etanercept 50 mg.
Under typical US willingness-to-pay cutoffs, ustekinumab 90 mg is not cost effective compared with etanercept 50 mg therapy in moderate to severe psoriasis patients for the base-case 3-year time horizon. Ustekinumab 45 mg dominates etanercept 50 mg therapy for an equivalent patient psoriasis severity and time horizon.
在美国（US）环境下，乌司奴单抗和其他生物制剂治疗的成本效益信息有限。鉴于乌司奴单抗和依那西普的最新头对头临床试验研究，可以构建比较两种治疗方法的经济模型。依那西普和乌司奴单抗均适用于候选光疗或全身治疗的慢性中度至重度斑块状银屑病成年患者。
临床试验已评估乌司奴单抗（一种抗细胞因子的生物制剂）治疗中度至重度银屑病的疗效。本研究从美国社会角度评估乌司奴单抗与依那西普相比的成本效益。
构建了一个马尔可夫模型，以模拟每 12 周增量成本每获得 1 个质量调整生命年（QALY）的情况，时间范围为基础案例的 3 年。基于 III 期活性对照银屑病试验（ACCEPT）的特征，建立了一个假设的患者队列。主要结局指标为每 12 周增量成本和每获得 1 个 QALY 的增量成本效益比。成本、效用、治疗策略和资源使用估算值均来自相关文献。所有成本均按 2011 年美元进行调整。每年 3%的贴现率适用于成本和 QALY。增量成本效益比以每获得 1 个 QALY 的美元数表示。
在基础案例的 3 年时间范围内，乌司奴单抗 90mg 与依那西普 50mg 相比的增量成本效益比为每获得 1 个 QALY 需 384,401 美元。乌司奴单抗 45mg 在相同时间范围内优于依那西普 50mg。这些结果在涉及治疗策略、过渡概率、结果赋值和资源使用和成本的敏感性分析中具有稳健性。概率敏感性分析表明，乌司奴单抗 90mg 在支付意愿阈值为每获得 1 个 QALY 改善 150,000 美元的情况下，与依那西普 50mg 相比，其具有最小（4%）的成本效益的可能性。对于相同的阈值，乌司奴单抗 45mg 与依那西普 50mg 相比，具有较高（88%）的成本效益的可能性。
在典型的美国支付意愿截止点下，乌司奴单抗 90mg 在中度至重度银屑病患者的 3 年基础案例时间范围内，与依那西普 50mg 治疗相比，不具有成本效益。乌司奴单抗 45mg 在相同的患者银屑病严重程度和时间范围内优于依那西普 50mg 治疗。
