Brecht J G, Kruse H P, Felsenberg D, Möhrke W, Oestreich A, Huppertz E
InForMed GmbH-Outcomes Research and Health Economics, Schwanthaler Str. 28, 85049 Ingolstadt, Germany.
Int J Clin Pharmacol Res. 2003;23(4):93-105.
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.
髋部骨折是一个重要且代价高昂的问题。使用双膦酸盐利塞膦酸钠进行治疗可有效预防已患骨质疏松症女性的髋部及其他骨折。根据绝经后骨质疏松症、老年骨质疏松症（75岁以上女性）和糖皮质激素诱导的骨质疏松症治疗的循证医学标准，利塞膦酸钠是德国骨科学会骨质疏松症指南中的首选治疗方案。德国关于双膦酸盐的已发表经济评估较少。因此，基于随机临床试验数据，利用已患绝经后骨质疏松症的状态转换马尔可夫模型对利塞膦酸钠的成本效益进行了评估。使用传统敏感性分析和随机敏感性分析来处理模型参数和结果的不确定性，以生成近似95%置信区间。我们关注70岁的患者，因为该人群与随机对照试验最为匹配，且是德国骨质疏松症患者的典型代表。基线模型是一组1000名70岁女性队列，她们接受利塞膦酸钠治疗3年，并进行为期10年的总体观察期随访，通过估计的健康状态模拟转变并评估结果。在3年治疗期和10年观察期内，利塞膦酸钠在德国优于当前的平均基础治疗。在利塞膦酸钠组中，避免了33例髋部骨折，并获得了32个质量调整生命年（QALY）（贴现后的值）。利塞膦酸钠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，如果使用利塞膦酸钠治疗，相关成本的当前净值为1066万欧元，而使用基础治疗时为1100万欧元。因此，计算得出每1000名接受治疗的女性治疗组净节省34万欧元。此外，从法定医疗保险的角度来看，利塞膦酸钠治疗具有成本效益，在所分析人群中，每避免一例髋部骨折的成本为33856欧元，每获得一个QALY的成本为35690欧元。这两个结果都证明了成本效益，且远低于公认的50000欧元阈值水平。基于此分析，在德国医疗保健系统中，利塞膦酸钠是治疗绝经后骨质疏松症的一种具有成本效益的治疗方法，对骨质疏松症患者和预算决策者都有益处。
