Sawyer Laura M, Wonderling David, Jackson Karina, Murphy Ruth, Samarasekera Eleanor J, Smith Catherine H
Symmetron Limited, Kinetic Centre, Theobald Street, Borehamwood, Hertfordshire, WD6 4PJ, UK,
Pharmacoeconomics. 2015 Feb;33(2):163-77. doi: 10.1007/s40273-014-0226-y.
Biologic therapies have revolutionised the care of patients with psoriasis, although they come at significant extra cost. Guidance on their use in the UK National Health Service (NHS) has so far focused on patients who are "biologic naive", yet a minority of patients have poor response and require further treatment.
To assess the potential cost effectiveness of sequential biologic therapies in patients with psoriasis who have been exposed to previous biologic therapy.
A two-part model with a 10-year time horizon was built to model an initial 13.5-week "trial" phase and a longer-term "treatment" period with annual Markov cycles. Psoriasis Area and Severity Index (PASI) response rates from subgroup analyses of three randomised placebo-controlled trials evaluating biologic agents were considered. A meta-analysis of these data provided probabilities of achieving PASI response (50/75/90) in the short term, and published evidence and assumptions were used to predict outcomes over the longer term. Benefits were measured in quality-adjusted life years (QALYs), and costs (2013-14) to the UK NHS included drugs, administration, monitoring, and hospitalisation. Costs and benefits were discounted 3.5 % per annum. Cost effectiveness of sequential biologic therapy was measured using an incremental cost-effectiveness ratio (ICER) compared to best supportive care (BSC). Extensive sensitivity analyses were performed to assess the impact of alternative assumptions on the results.
Results indicate that over 10 years, switching to a second biologic following intolerance to or failure of a first is likely to generate more QALYs than BSC, but at a higher cost. Base case results suggest the ICER of the second biologic compared to BSC is £17,681 per QALY; however, sensitivity analyses indicate that changes in the efficacy of BSC, drug costs, dropout rates, and rates of hospitalisation have a significant impact, causing the ICER to range from less than £10,000 to over £50,000 per QALY.
Further biologic therapy for patients with psoriasis who have previously been treated with biologic therapy may be cost effective, although there is considerable uncertainty in the results. Future studies should be designed to evaluate the clinical efficacy of biologic therapies in this subgroup with particular attention given to short-term and longer-term responses.
生物疗法彻底改变了银屑病患者的治疗方式，尽管其成本大幅增加。英国国家医疗服务体系（NHS）关于生物疗法使用的指南目前主要针对“未使用过生物制剂”的患者，然而少数患者反应不佳，需要进一步治疗。
评估序贯生物疗法在曾接受过生物治疗的银屑病患者中的潜在成本效益。
构建了一个为期10年的两阶段模型，模拟初始13.5周的“试验”阶段和采用年度马尔可夫循环的长期“治疗”期。考虑了三项评估生物制剂的随机安慰剂对照试验亚组分析中的银屑病面积和严重程度指数（PASI）反应率。对这些数据进行的荟萃分析提供了短期内达到PASI反应（50/75/90）的概率，并利用已发表的证据和假设来预测长期结果。效益以质量调整生命年（QALYs）衡量，英国NHS的成本（2013 - 14年）包括药物、给药、监测和住院费用。成本和效益按每年3.5%进行贴现。与最佳支持治疗（BSC）相比，序贯生物疗法的成本效益采用增量成本效益比（ICER）衡量。进行了广泛的敏感性分析，以评估替代假设对结果的影响。
结果表明，在10年期间，在对第一种生物制剂不耐受或治疗失败后改用第二种生物制剂可能比最佳支持治疗产生更多的质量调整生命年，但成本更高。基础案例结果表明，与最佳支持治疗相比，第二种生物制剂的增量成本效益比为每质量调整生命年17,681英镑；然而，敏感性分析表明，最佳支持治疗的疗效、药物成本、退出率和住院率的变化有显著影响，导致增量成本效益比每质量调整生命年从不到10,000英镑到超过50,000英镑不等。
对于曾接受过生物治疗的银屑病患者，进一步的生物治疗可能具有成本效益，尽管结果存在相当大的不确定性。未来的研究应设计用于评估该亚组中生物疗法的临床疗效，尤其要关注短期和长期反应。
