Department of Public Health, Epidemiology, and Health Economics, University of Liège, Liège, Belgium.
J Bone Miner Res. 2013 Apr;28(4):807-15. doi: 10.1002/jbmr.1819.
Bazedoxifene is a novel selective estrogen receptor modulator (SERM) for the prevention and treatment of osteoporosis. In addition to the therapeutic value of a new agent, evaluation of the cost-effectiveness compared with relevant alternative treatment(s) is an important consideration to facilitate healthcare decision making. This study evaluated the cost-effectiveness of bazedoxifene compared with raloxifene for the treatment of postmenopausal women with osteoporosis. The cost-effectiveness of treatment for 3 years with bazedoxifene was compared with raloxifene using an updated version of a previously validated Markov microsimulation model. Analyses were conducted from a Belgian healthcare payer perspective and, the base-case population was women (aged 70 years) with bone mineral density T-score ≤ -2.5. The effects of bazedoxifene and raloxifene on fracture risk were derived from the 3-year results of a randomized, double-blind, placebo-controlled and active-controlled study, including postmenopausal women with osteoporosis. The cost-effectiveness analysis based on efficacy data from the overall clinical trial indicated that bazedoxifene and raloxifene were equally cost-effective. When the results were examined based on the subgroup analysis of women at higher risk of fractures, bazedoxifene was dominant (lower cost for higher effectiveness) compared with raloxifene in most of the simulations. Sensitivity analyses confirmed the robustness of the results, which were largely independent of starting age of treatment, fracture risk, cost, and disutility. In addition, when the cost of raloxifene was reduced by one-half or when incorporating the raloxifene effects on reducing breast cancer, bazedoxifene remained cost-effective, at a threshold of €35,000 per quality-adjusted life-years gained, in 85% and 68% of the simulations, respectively. Under the assumption of improved antifracture efficacy of bazedoxifene over raloxifene in women with high risk of fractures, this study suggests that bazedoxifene can be considered cost-effective, and even dominant, when compared with raloxifene in the treatment of postmenopausal osteoporotic women.
巴多昔芬是一种新型的选择性雌激素受体调节剂（SERM），用于预防和治疗骨质疏松症。除了评估新药物的治疗价值外，比较其与相关替代治疗方法的成本效益也是促进医疗保健决策的一个重要考虑因素。本研究评估了巴多昔芬与雷洛昔芬治疗绝经后骨质疏松症女性的成本效益。使用先前验证的马尔可夫微模拟模型的更新版本，比较了巴多昔芬治疗 3 年的成本效益与雷洛昔芬。分析从比利时医疗保健支付者的角度进行，基础人群为骨密度 T 评分≤-2.5 的 70 岁女性。巴多昔芬和雷洛昔芬对骨折风险的影响来自一项随机、双盲、安慰剂对照和阳性对照研究的 3 年结果，该研究包括骨质疏松症绝经后妇女。基于整个临床试验的疗效数据进行的成本效益分析表明，巴多昔芬和雷洛昔芬具有同等的成本效益。当根据骨折风险较高的女性亚组分析结果进行检查时，在大多数模拟中，巴多昔芬比雷洛昔芬具有优势（更高的效果，更低的成本）。敏感性分析证实了结果的稳健性，结果在很大程度上独立于治疗开始年龄、骨折风险、成本和不良效用。此外，当雷洛昔芬的成本降低一半或纳入雷洛昔芬对降低乳腺癌的影响时，巴多昔芬在 85%和 68%的模拟中，在每获得 1 个质量调整生命年成本 35000 欧元的阈值内，仍具有成本效益。在假设巴多昔芬对骨折风险较高的女性具有优于雷洛昔芬的抗骨折疗效的前提下，本研究表明，与雷洛昔芬相比，巴多昔芬在治疗绝经后骨质疏松症女性方面具有成本效益，甚至具有优势。
