Laboratory of Medical Statistics, Kobe Pharmaceutical University, 4-19-1, Motoyamakita, Higashinada, Kobe, 658-8558, Japan.
Department of Health Care Administration and Management, Kyushu University Graduate School of Medical Sciences, 3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Osteoporos Int. 2019 Feb;30(2):299-310. doi: 10.1007/s00198-018-4798-9. Epub 2019 Jan 4.
A model-based cost-effectiveness analysis was performed to evaluate the cost-effectiveness of implementing the clinical guideline for the treatment for glucocorticoid-induced osteoporosis (GIO). The treatment indication for GIO in the current Japanese clinical guidelines is likely to be cost-effective except for the limited patients who are at low risk for fracture.
The purpose of this study was to evaluate the cost-effectiveness of implementing the clinical guideline for the treatment for glucocorticoid-induced osteoporosis (GIO) from the perspective of the Japanese healthcare system.
A patient-level state transition model was developed to predict lifetime costs and quality-adjusted life years (QALYs) in postmenopausal Japanese women with osteopenia or osteoporosis using glucocorticoid (GC). An annual discount rate of 2% for both costs and QALYs was applied. The incremental cost-effectiveness ratio (ICER) of 5-year alendronate therapy compared with no therapy was estimated with different combinations of the risk factors such as starting age (45, 55, or 65), femoral neck BMD (% young adult mean (YAM) of 70%, 75%, or 80%), dose of GC (2.5, 5, or 10 mg per day), and the presence of previous fracture (yes or no).
For 55-year-old women using GC with a BMD of 75% of YAM, the ICER ranged from $10,958 to $ 29,727 per QALY. Scenario analyses indicated that the lower age, the lower BMD, the higher dose of GC, and the presence of previous fracture associated with lower ICER. The best-case scenario was 45-year-old women with a BMD of 70% of YAM, GC dose of 10 mg per day, and previous fracture, and resulted in healthcare cost-savings. The worst-case scenario was 65-year-old women with a BMD of 80% of YAM, GC dose of 2.5 mg per day, and no previous fracture, and resulted in the ICER of $66,791 per QALY. Sensitivity analyses in the worst-case scenario showed that the annual discount rate for costs and health benefit had the strong influence on the estimated ICER. Although the ICER was influenced by other parameters such as disutility due to vertebral fracture, efficacy of alendronate, and so on, the ICERs remained more than $50,000 per QALY.
The cost-effectiveness of preventive alendronate therapy for postmenopausal women with osteopenia or osteoporosis using GC is sensitive to age, BMD, GC dose, and the presence of previous fracture. Our analysis suggested that the treatment indication for postmenopausal women with osteopenia or osteoporosis using GC in the current Japanese clinical guidelines is likely to be cost-effective except for the limited patients who are at low risk for fracture.
本研究旨在评估从日本医疗保健系统的角度来看，实施糖皮质激素诱导性骨质疏松症（GIO）治疗临床指南的成本效益。
开发了一个基于患者的状态转换模型，以预测使用糖皮质激素（GC）的绝经后骨质疏松症或骨量减少的日本女性的终生成本和质量调整生命年（QALYs）。对成本和 QALYs 均采用 2%的年度贴现率。使用不同风险因素（如起始年龄（45、55 或 65 岁）、股骨颈 BMD（年轻成人平均（YAM）的 70%、75%或 80%）、GC 剂量（2.5、5 或 10 mg/天）和既往骨折（是或否）的不同组合，估计了 5 年阿仑膦酸钠治疗与无治疗相比的增量成本效益比（ICER）。
对于使用 YAM 75%的 BMD 的 55 岁女性，ICER 范围为每 QALY 10958 美元至 29727 美元。情景分析表明，年龄越低、BMD 越低、GC 剂量越高、既往骨折与较低的 ICER 相关。最佳情况是 45 岁女性，BMD 为 YAM 的 70%，GC 剂量为 10mg/天，并有既往骨折，从而节省了医疗保健费用。最差情况是 65 岁女性，BMD 为 YAM 的 80%，GC 剂量为 2.5mg/天，且无既往骨折，ICER 为每 QALY 66791 美元。最差情况下的敏感性分析表明，成本和健康效益的年度折扣率对估计的 ICER 有很大影响。尽管 ICER 受其他参数（如椎体骨折引起的不适、阿仑膦酸钠的疗效等）的影响，但 ICER 仍超过 50000 美元/ QALY。
对于使用 GC 的绝经后骨质疏松症或骨量减少的女性，预防用阿仑膦酸钠治疗的成本效益对年龄、BMD、GC 剂量和既往骨折的存在敏感。我们的分析表明，目前日本临床指南中使用 GC 的绝经后骨质疏松症或骨量减少女性的治疗指征可能是有成本效益的，除了那些骨折风险较低的有限患者。
