{"title":"托法替尼治疗希腊活动性强直性脊柱炎的成本效益","authors":"","doi":"10.1007/s40261-023-01333-z","DOIUrl":null,"url":null,"abstract":"<h3>Abstract</h3> <span> <h3>Background and Objective</h3> <p>Ankylosing spondylitis is a chronic, progressive, inflammatory, multidimensional, musculoskeletal disease primarily involving the axial skeleton. In addition, ankylosing spondylitis is associated with increased morbidity and mortality, significantly affecting productivity and overall quality of life. The aim of the present study was to evaluate the cost effectiveness of tofacitinib compared to currently marketed biologic treatment in patients with active ankylosing spondylitis who have responded inadequately to conventional therapy (biologic-naïve population) or previous biologic therapy (biologic-experienced population) in Greece.</p> </span> <span> <h3>Methods</h3> <p>A published model comprising a decision tree and a three-state Markov model was adapted from a public payer perspective over a lifetime horizon. Adalimumab and secukinumab, having the highest market shares among biologics for the treatment of ankylosing spondylitis in Greece (standard practice), were selected as comparators in the analysis. Clinical parameters captured treatment response defined per Assessment of Spondyloarthritis International Society 20 response, short-term and long-term changes in Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores, long-term biologic treatment discontinuation, and adverse events. Efficacy, safety data, and utility values were elicited from the published literature. Direct costs pertaining to drug acquisition, monitoring, adverse events, and disease management costs were considered in the analysis (€2022). Model outcomes were patients’ quality-adjusted life-years, total costs, and incremental cost-effectiveness ratios. All future outcomes were discounted at 3.5% per annum. A probabilistic sensitivity analysis was conducted to account for model uncertainty.</p> </span> <span> <h3>Results</h3> <p>In a biologic-naïve population, compared with adalimumab, tofacitinib produced an estimated 0.06 additional quality-adjusted life-years [QALYs] (10.67 vs 10.73), at additional costs of €2403 (€147,096 vs €149,500) resulting in an incremental cost-effectiveness ratio of €41,378 per QALY gained. In a biologic-experienced population, the total cost per patient for tofacitinib and secukinumab was estimated to be €151,371 and €145,757, respectively. In terms of health outcomes, tofacitinib was associated with a 0.13 increment in QALYs compared with secukinumab resulting in an incremental cost-effectiveness ratio of €42,784 per QALY gained. The probabilistic sensitivity analysis confirmed the deterministic results for both populations.</p> </span> <span> <h3>Conclusions</h3> <p>Tofacitinib was estimated to be a cost-effective option for the treatment of active ankylosing spondylitis in Greece for both biologic-naive and biologic-experienced patients.</p> </span>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":"24 1","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2023-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Cost Effectiveness of Tofacitinib for the Treatment of Active Ankylosing Spondylitis in Greece\",\"authors\":\"\",\"doi\":\"10.1007/s40261-023-01333-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<h3>Abstract</h3> <span> <h3>Background and Objective</h3> <p>Ankylosing spondylitis is a chronic, progressive, inflammatory, multidimensional, musculoskeletal disease primarily involving the axial skeleton. In addition, ankylosing spondylitis is associated with increased morbidity and mortality, significantly affecting productivity and overall quality of life. The aim of the present study was to evaluate the cost effectiveness of tofacitinib compared to currently marketed biologic treatment in patients with active ankylosing spondylitis who have responded inadequately to conventional therapy (biologic-naïve population) or previous biologic therapy (biologic-experienced population) in Greece.</p> </span> <span> <h3>Methods</h3> <p>A published model comprising a decision tree and a three-state Markov model was adapted from a public payer perspective over a lifetime horizon. Adalimumab and secukinumab, having the highest market shares among biologics for the treatment of ankylosing spondylitis in Greece (standard practice), were selected as comparators in the analysis. Clinical parameters captured treatment response defined per Assessment of Spondyloarthritis International Society 20 response, short-term and long-term changes in Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores, long-term biologic treatment discontinuation, and adverse events. Efficacy, safety data, and utility values were elicited from the published literature. Direct costs pertaining to drug acquisition, monitoring, adverse events, and disease management costs were considered in the analysis (€2022). Model outcomes were patients’ quality-adjusted life-years, total costs, and incremental cost-effectiveness ratios. All future outcomes were discounted at 3.5% per annum. A probabilistic sensitivity analysis was conducted to account for model uncertainty.</p> </span> <span> <h3>Results</h3> <p>In a biologic-naïve population, compared with adalimumab, tofacitinib produced an estimated 0.06 additional quality-adjusted life-years [QALYs] (10.67 vs 10.73), at additional costs of €2403 (€147,096 vs €149,500) resulting in an incremental cost-effectiveness ratio of €41,378 per QALY gained. In a biologic-experienced population, the total cost per patient for tofacitinib and secukinumab was estimated to be €151,371 and €145,757, respectively. In terms of health outcomes, tofacitinib was associated with a 0.13 increment in QALYs compared with secukinumab resulting in an incremental cost-effectiveness ratio of €42,784 per QALY gained. The probabilistic sensitivity analysis confirmed the deterministic results for both populations.</p> </span> <span> <h3>Conclusions</h3> <p>Tofacitinib was estimated to be a cost-effective option for the treatment of active ankylosing spondylitis in Greece for both biologic-naive and biologic-experienced patients.</p> </span>\",\"PeriodicalId\":10402,\"journal\":{\"name\":\"Clinical Drug Investigation\",\"volume\":\"24 1\",\"pages\":\"\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2023-12-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Drug Investigation\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40261-023-01333-z\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Drug Investigation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40261-023-01333-z","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
摘要
摘要 背景和目的 强直性脊柱炎是一种慢性、进行性、炎症性、多发性肌肉骨骼疾病,主要累及轴向骨骼。此外,强直性脊柱炎还与发病率和死亡率的增加有关,严重影响工作效率和整体生活质量。本研究的目的是评估托法替尼与目前市场上销售的生物制剂治疗相比,在希腊对常规治疗(生物制剂无效人群)或既往生物制剂治疗(有生物制剂治疗经验人群)反应不佳的活动性强直性脊柱炎患者中的成本效益。 方法 从公共支付者的角度出发,对已发表的包含决策树和三态马尔可夫模型的终身范围模型进行了调整。在希腊治疗强直性脊柱炎的生物制剂中,阿达木单抗和secukinumab的市场份额最高(标准疗法),因此被选为分析中的比较药。临床参数包括按脊柱关节炎国际协会 20 项反应评估定义的治疗反应、巴斯强直性脊柱炎疾病活动指数和巴斯强直性脊柱炎功能指数评分的短期和长期变化、长期生物制剂治疗停药情况以及不良事件。疗效、安全性数据和效用值均来自已发表的文献。分析中考虑了与药物购买、监测、不良事件和疾病管理成本相关的直接成本(2022 欧元)。模型结果为患者的质量调整生命年、总成本和增量成本效益比。所有未来结果的贴现率为每年 3.5%。为考虑模型的不确定性,进行了概率敏感性分析。 结果 在生物制剂无效人群中,与阿达木单抗相比,托法替尼估计可增加0.06个质量调整生命年(10.67 vs 10.73),额外成本为2403欧元(147096欧元 vs 149500欧元),因此每获得一个质量调整生命年的增量成本效益比为41378欧元。在有生物治疗经验的人群中,托法替尼和赛库单抗的每位患者总成本估计分别为151,371欧元和145,757欧元。在健康结果方面,与secukinumab相比,托法替尼的QALYs增加了0.13,因此每QALY获得的增量成本效益比为42,784欧元。概率敏感性分析证实了两种人群的确定性结果。 结论 据估计,在希腊,对于无生物制剂治疗经验和有生物制剂治疗经验的患者而言,托法替尼是治疗活动性强直性脊柱炎的一种具有成本效益的选择。
Cost Effectiveness of Tofacitinib for the Treatment of Active Ankylosing Spondylitis in Greece
Abstract
Background and Objective
Ankylosing spondylitis is a chronic, progressive, inflammatory, multidimensional, musculoskeletal disease primarily involving the axial skeleton. In addition, ankylosing spondylitis is associated with increased morbidity and mortality, significantly affecting productivity and overall quality of life. The aim of the present study was to evaluate the cost effectiveness of tofacitinib compared to currently marketed biologic treatment in patients with active ankylosing spondylitis who have responded inadequately to conventional therapy (biologic-naïve population) or previous biologic therapy (biologic-experienced population) in Greece.
Methods
A published model comprising a decision tree and a three-state Markov model was adapted from a public payer perspective over a lifetime horizon. Adalimumab and secukinumab, having the highest market shares among biologics for the treatment of ankylosing spondylitis in Greece (standard practice), were selected as comparators in the analysis. Clinical parameters captured treatment response defined per Assessment of Spondyloarthritis International Society 20 response, short-term and long-term changes in Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores, long-term biologic treatment discontinuation, and adverse events. Efficacy, safety data, and utility values were elicited from the published literature. Direct costs pertaining to drug acquisition, monitoring, adverse events, and disease management costs were considered in the analysis (€2022). Model outcomes were patients’ quality-adjusted life-years, total costs, and incremental cost-effectiveness ratios. All future outcomes were discounted at 3.5% per annum. A probabilistic sensitivity analysis was conducted to account for model uncertainty.
Results
In a biologic-naïve population, compared with adalimumab, tofacitinib produced an estimated 0.06 additional quality-adjusted life-years [QALYs] (10.67 vs 10.73), at additional costs of €2403 (€147,096 vs €149,500) resulting in an incremental cost-effectiveness ratio of €41,378 per QALY gained. In a biologic-experienced population, the total cost per patient for tofacitinib and secukinumab was estimated to be €151,371 and €145,757, respectively. In terms of health outcomes, tofacitinib was associated with a 0.13 increment in QALYs compared with secukinumab resulting in an incremental cost-effectiveness ratio of €42,784 per QALY gained. The probabilistic sensitivity analysis confirmed the deterministic results for both populations.
Conclusions
Tofacitinib was estimated to be a cost-effective option for the treatment of active ankylosing spondylitis in Greece for both biologic-naive and biologic-experienced patients.
期刊介绍:
Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes:
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