Pharmacoeconomic analysis of osteoporosis treatment with risedronate.

J G Brecht, H P Kruse, D Felsenberg, W Möhrke, A Oestreich, E Huppertz
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Abstract

Hip fracture is an important and costly problem. Therapy with the bisphosphonate risedronate effectively prevents hip and other fractures among women with established osteoporosis. Risedronate is a first-choice therapy option in the German Guidelines of the Dachverband Osteologie for Osteoporosis according to evidence-based medicine criteria for the treatment of postmenopausal osteoporosis, osteoporosis of the elderly (women aged > 75 years) and glucocorticoid-induced osteoporosis. There are few published economic evaluations of bisphosphonates in Germany. Therefore, an assessment of the cost-effectiveness of risedronate utilizing a state transition Markov model of established postmenopausal osteoporosis based on randomized clinical trial data was developed. Uncertainty underlying model parameters and outcomes was dealt with using traditional sensitivity analysis and stochastic sensitivity analysis to produce quasi-95% Cls. We focused on patients aged 70 years, since this population most closely matches the randomized controlled trial and is typical of osteoporosis patients in Germany. The baseline model was a cohort of 1,000 70-year-old women, who received risedronate for 3 years and were followed up for an overall observation period of 10 years, modelling transitions through estimated health states and evaluating outcomes. Over the 3-year treatment period and 10-year observation period, risedronate dominated the current average basic treatment in Germany. In the risedronate group 33 hip fractures were averted and 32 quality-adjusted life years (QALYs) were gained (discounted values). Risedronate treatment saves costs for German social insurance: the present net value of the associated costs from the perspective of German social insurance is [symbol: see text]10.66 million if risedronate treatment is used versus [symbol: see text]11 million if basic treatment is used. Thus, net savings of [symbol: see text]340,000 for the treatment group per 1,000 treated women were calculated. Furthermore, risedronate treatment is cost effective from the perspective of the statutory health insurance with costs per averted hip fracture in the analyzed population of [symbol: see text]33,856 and cost per QALY gained of [symbol: see text]35,690. Both results demonstrate cost-effectiveness and are far below the accepted threshold level of [symbol: see text]50,000. Based on this analysis, risedronate is a cost-effective treatment for postmenopausal osteoporosis within the German health care system, offering benefits for osteoporotic patients and for budget decision-makers.

利塞膦酸钠治疗骨质疏松症的药物经济学分析。
髋部骨折是一个重要且昂贵的问题。用利塞膦酸盐治疗可有效预防骨质疏松症患者髋部及其他部位骨折。根据循证医学标准,利塞膦酸钠是德国Dachverband骨科骨质疏松症指南中针对绝经后骨质疏松症、老年骨质疏松症(> 75岁女性)和糖皮质激素所致骨质疏松症的首选治疗方案。在德国,关于双膦酸盐的经济评估报告很少发表。因此,基于随机临床试验数据,利用已建立的绝经后骨质疏松症的状态转换马尔可夫模型,对利塞膦酸盐的成本-效果进行评估。采用传统敏感性分析和随机敏感性分析对模型参数和结果的不确定性进行处理,得到准95%的置信区间。我们关注的是70岁的患者,因为这一人群与随机对照试验最接近,是德国典型的骨质疏松症患者。基线模型是一个由1000名70岁妇女组成的队列,她们接受了3年的利塞膦酸钠治疗,并随访了10年的总体观察期,通过估计的健康状况和评估结果建立了过渡模型。在3年的治疗期和10年的观察期内,利塞膦酸钠在德国目前的平均基础治疗中占主导地位。利塞膦酸钠组避免了33例髋部骨折,获得了32个质量调整生命年(QALYs)(贴现值)。利塞膦酸盐治疗为德国社会保险节省了成本:从德国社会保险的角度来看,如果使用利塞膦酸盐治疗,相关成本的现值为1066万欧元,而如果使用基本治疗,则为1100万欧元。因此,计算出治疗组每1000名接受治疗的妇女净节省34万美元。此外,从法定健康保险的角度来看,利塞膦酸钠治疗具有成本效益,在所分析的人群中,每例髋部骨折转移的成本为33,856,每例QALY的成本为35,690。这两个结果都证明了成本效益,并且远远低于可接受的阈值水平50,000。基于这一分析,利塞膦酸钠是德国医疗保健系统中绝经后骨质疏松症的一种经济有效的治疗方法,为骨质疏松症患者和预算决策者提供了好处。
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