Division of Clinical Immunology and Rheumatology, Working Group for Health Economics and Clinical Epidemiology, Hannover Medical School, Carl-Neuberg-Strasse 1, OE 6830, 30625, Hannover, Germany.
Eur J Health Econ. 2010 Feb;11(1):95-104. doi: 10.1007/s10198-009-0205-y. Epub 2009 Dec 5.
The present health economic analysis investigated the cost-effectiveness-ratios of either (1) rituximab or (2) an alternative TNF-alpha-inhibiting agent as second line biological treatment in patients with active rheumatoid arthritis (RA) and an inadequate response to etanercept therapy.
Incremental cost per quality-adjusted life-year (QALY) gained by rituximab treatment of RA is compared to TNF-inhibitor change (standard sequence) in a Markov-model (perspective: health care payer, full life-time approach). Direct cost components taken into account were treatment costs (medication-, administration- and monitoring costs) and resource utilisation (outpatient costs, inpatient costs). Indirect costs were estimated separately by the assessment of impaired work capacity due to RA (2008 Euro currency, discount rate 3.5%). Utility measures for the different treatment options were obtained from the ACR-response rates of published pivotal clinical trials.
Direct costs amount to euro 178,373 (standard sequence) and euro 192,295 (rituximab sequence), respectively, rendering incremental direct costs of euro 13,922. Incremental utilities yield 0.57 QALYs and the incremental cost-effectiveness-ratio (ICER) of rituximab compared to the standard sequence amounts to euro 24,517. Inclusion of indirect costs leads to less incremental costs and a lower ICER of euro 15,565/QALY. Thus, ICERs stay beneath the accepted threshold of euro 50,000/QALY.
Rituximab appears to be a cost-effective treatment alternative compared to the switch between TNF-inhibitors as second line biological treatment in patients with active RA having failed etanercept.
本健康经济学分析旨在调查利妥昔单抗（rituximab）或另一种 TNF-α 抑制剂作为生物二线治疗方案，在对依那西普（etanercept）治疗应答不足的活动性类风湿关节炎（RA）患者中的成本效益比。
采用 Markov 模型（视角：医疗保健支付方，全生命周期方法），比较利妥昔单抗治疗 RA 的增量成本（每获得一个质量调整生命年（QALY）的成本）与 TNF 抑制剂转换（标准序列）的增量成本。纳入考虑的直接成本因素包括治疗成本（药物、管理和监测成本）和资源利用（门诊费用、住院费用）。间接成本通过评估因 RA 导致的工作能力受损（2008 年欧元货币，贴现率 3.5%）进行单独估算。采用已发表的关键性临床试验的 ACR 反应率来获得不同治疗方案的效用测量值。
直接成本分别为 178373 欧元（标准序列）和 192295 欧元（利妥昔单抗序列），增量直接成本为 13922 欧元。增量效用产生 0.57 QALY，与标准序列相比，利妥昔单抗的增量成本效益比（ICER）为 24517 欧元。纳入间接成本会导致增量成本降低，ICER 降低至 15565 欧元/QALY。因此，ICER 低于可接受的 50000 欧元/QALY 阈值。
与 TNF 抑制剂转换作为二线生物治疗方案相比，利妥昔单抗在对依那西普治疗应答不足的活动性 RA 患者中作为二线生物治疗方案具有成本效益。
