Botteman M F, Hay J W, Luo M P, Curry A S, Wong R L, van Hout B A
Pharmerit North America LLC, Bethesda, MD, USA.
Rheumatology (Oxford). 2007 Aug;46(8):1320-8. doi: 10.1093/rheumatology/kem031. Epub 2007 Jun 2.
This study evaluated the cost effectiveness of adalimumab vs conventional therapy in patients with active ankylosing spondylitis (AS).
The analysis was based on pooled data from two Phase III studies of adalimumab in active AS. Patients with an inadequate response to >/=1 NSAID received adalimumab 40 mg every other week (n = 246) or placebo (n = 151) for 24 weeks. A microsimulation model was developed with patients being treated with adalimumab according to the International ASAS Consensus Statement and BSR guidelines. The pooled adalimumab data, as well as data from the Outcome Assessment in AS International Study (OASIS) database and the literature, were used to model patients' BASDAI and BASFI scores and costs and health-related quality of life associated with various degrees of disease activity. Costs (in 2004 British pound) of AS, drug, administration, monitoring, hospitalization and AEs were calculated from the perspective of the UK NHS. Discounting was applied at 3.5% per year for costs and benefits as per the NICE reference case for economic evaluations. Uncertainty was addressed via sensitivity analyses.
The incremental cost-effectiveness ratio (ICER) of adalimumab vs conventional therapy was estimated to improve with longer time horizons (48 weeks to 5 and 30 yrs). The central estimate was that, over 30 yrs, adalimumab therapy yielded 1.03 more quality-adjusted life-years (QALYs) per patient initiating therapy. Some AS treatment-related costs were estimated to be offset by adalimumab (at 10,750 pounds/patient), leaving a total incremental cost (adalimumab vs conventional therapy) at 23,857 pounds per patient. The 30-yr ICER of adalimumab vs conventional therapy was estimated at 23 pounds 097/QALY. Sensitivity analyses demonstrated robustness of results. When indirect costs were also included (analysis from societal perspective), ICER improved to 5093 pounds/QALY.
This analysis indicates that adalimumab, when used according to UK treatment guidelines, is cost-effective vs conventional therapy for treating AS patients.
本研究评估了阿达木单抗与传统疗法治疗活动性强直性脊柱炎（AS）患者的成本效益。
该分析基于阿达木单抗治疗活动性AS的两项III期研究的汇总数据。对≥1种非甾体抗炎药反应不足的患者接受每两周一次40mg阿达木单抗治疗（n = 246）或安慰剂治疗（n = 151），为期24周。根据国际ASAS共识声明和英国风湿病学会（BSR）指南，开发了一个微观模拟模型，对接受阿达木单抗治疗的患者进行建模。汇总的阿达木单抗数据，以及来自AS国际研究中的结果评估（OASIS）数据库和文献的数据，用于模拟患者的巴斯强直性脊柱炎疾病活动指数（BASDAI）和巴斯强直性脊柱炎功能指数（BASFI）评分、成本以及与不同疾病活动程度相关的健康相关生活质量。从英国国家医疗服务体系（NHS）的角度计算AS、药物、给药、监测、住院和不良事件的成本（以2004年英镑计）。根据英国国家卫生与临床优化研究所（NICE）经济评估参考案例，成本和效益均按每年3.5%进行贴现。通过敏感性分析处理不确定性。
阿达木单抗与传统疗法相比的增量成本效益比（ICER）估计会随着时间跨度延长（48周至5年和30年）而改善。核心估计是，在30年期间，每例开始治疗的患者接受阿达木单抗治疗可多获得1.03个质量调整生命年（QALY）。估计阿达木单抗可抵消一些与AS治疗相关的成本（每位患者10,750英镑），使每位患者的总增量成本（阿达木单抗与传统疗法相比）为23,857英镑。阿达木单抗与传统疗法相比的30年ICER估计为23,097英镑/QALY。敏感性分析表明结果具有稳健性。当纳入间接成本时（从社会角度分析），ICER改善至5093英镑/QALY。
该分析表明，按照英国治疗指南使用时，阿达木单抗治疗AS患者相对于传统疗法具有成本效益。
