Bravo Vergel Y, Hawkins N S, Claxton K, Asseburg C, Palmer S, Woolacott N, Bruce I N, Sculpher M J
Centre for Health Economics, University of York, Heslington, YO10 5DD York, UK.
Rheumatology (Oxford). 2007 Nov;46(11):1729-35. doi: 10.1093/rheumatology/kem221.
Tumour necrosis factor (TNF) antagonists have been shown to improve the outcomes in patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA). We assess the cost-effectiveness of two TNF antagonists and so-called 'palliative care' for the treatment of active PsA from the perspective of the UK National Health Service (NHS).
Bayesian statistical methods were used to synthesize evidence from three Phase III trials, identified through a systematic review, and estimate the relative efficacy of etanercept, infliximab and palliative care. A probabilistic decision analytic model was then used to compare these treatments after the failure of at least two conventional disease-modifying anti-rheumatic drugs (DMARDs), following the British Society for Rheumatology (BSR) guidelines for use. The primary outcome measure, quality-adjusted life years (QALYs), was derived from utility values estimated as a function of disability measured by the Health Assessment Questionnaire (HAQ). The deterioration experienced in HAQ at treatment withdrawal (rebound) was incorporated using alternative scenarios to represent best- and worst-case assumptions. The model was extended beyond the trial duration to a 10-yr and lifetime horizon, using available evidence and expert opinion-based assumptions on disease progression. Resource utilization was based on literature, national databases and expert opinion. Prices were obtained from routine NHS sources and published literature.
At a 10-yr time horizon, the incremental cost-effectiveness ratio (ICER) for etanercept compared with palliative care was pound sterling26 361 per QALY gained for the best-case rebound scenario, which increased to pound sterling30 628 for the worst-case. The ICERs for infliximab compared with etanercept were pound sterling165 363 and pound sterling205 345 per QALY, respectively. These findings are mainly explained by the fact that infliximab has higher acquisition and administration costs without substantially superior effectiveness compared with etanercept. Results were sensitive to estimates of rebound assumptions at withdrawal and the time horizon.
Only results for etanercept remained within the range of cost-effectiveness estimates considered to represent value for money in the NHS by the National Institute for Health and Clinical Excellence. Further research appears most valuable in relation to the short-term effectiveness, utility parameters and assumptions regarding the effect of rebound.
肿瘤坏死因子（TNF）拮抗剂已被证明可改善类风湿关节炎（RA）和银屑病关节炎（PsA）患者的治疗效果。我们从英国国家医疗服务体系（NHS）的角度评估两种TNF拮抗剂以及所谓的“姑息治疗”用于治疗活动性PsA的成本效益。
采用贝叶斯统计方法，综合通过系统评价确定的三项III期试验的证据，估计依那西普、英夫利昔单抗和姑息治疗的相对疗效。然后，根据英国风湿病学会（BSR）的使用指南，使用概率决策分析模型比较至少两种传统改善病情抗风湿药物（DMARDs）治疗失败后的这些治疗方法。主要结局指标，即质量调整生命年（QALYs），来自根据健康评估问卷（HAQ）测量的残疾情况估算的效用值。使用替代方案纳入治疗撤药时HAQ中经历的恶化（反弹）情况，以代表最佳和最坏情况假设。利用现有证据和基于专家意见的疾病进展假设，将模型的时间范围从试验持续时间扩展到10年和终身。资源利用基于文献、国家数据库和专家意见。价格来自NHS常规来源和已发表的文献。
在10年的时间范围内，最佳情况反弹情景下，依那西普与姑息治疗相比的增量成本效益比（ICER）为每获得一个QALY 26361英镑，最坏情况时增至30628英镑。英夫利昔单抗与依那西普相比的ICER分别为每QALY 165363英镑和205345英镑。这些结果主要是因为与依那西普相比，英夫利昔单抗的获取和给药成本更高，而疗效并无显著优势。结果对撤药时反弹假设的估计以及时间范围敏感。
只有依那西普的结果仍在英国国家卫生与临床优化研究所认为代表NHS性价比的成本效益估计范围内。关于短期疗效、效用参数以及反弹效应的假设，进一步的研究似乎最具价值。
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