雷奈酸锶治疗男性骨质疏松症的成本效益。

Cost-effectiveness of strontium ranelate in the treatment of male osteoporosis.

机构信息

Department of Health Services Research, School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, The Netherlands.

出版信息

Osteoporos Int. 2013 Aug;24(8):2291-300. doi: 10.1007/s00198-013-2272-2. Epub 2013 Feb 1.

Abstract

UNLABELLED

The results of this study suggest that, under the assumption of same relative risk reduction of fractures in men as for women, strontium ranelate could be considered a cost-effective strategy compared with no treatment for the treatment of osteoporotic men from a Belgian healthcare payer perspective.

INTRODUCTION

This study was conducted to estimate the cost-effectiveness of strontium ranelate in the treatment of osteoporotic men.

METHODS

A previously validated Markov microsimulation model was adapted to estimate the cost (2,010) per quality-adjusted life-year (QALY) gained of strontium ranelate compared with no treatment. Similar efficacy data on lumbar spine and femoral neck bone mineral density (BMD) between men with osteoporosis at high risk of fracture (MALEO Trial) and postmenopausal osteoporotic women (pivotal SOTI, TROPOS trials) supports the assumption, in the base-case analysis, of the same relative risk reduction of fractures in men as for women. Analyses were conducted, from a Belgian healthcare payer perspective, in the population from the MALEO Trial who is a men population with a mean age of 73 years, and BMD T-score ≤-2.5 or prevalent vertebral fracture (PVF).

RESULTS

In the MALEO population, strontium ranelate compared with no treatment was estimated at 49,798 and 25,584 per QALY gained using efficacy data from the intent-to-treat analysis and the per-protocol analysis including only adherent patients, respectively. In men with a BMD T-score ≤-2.5 or with PVF, the cost per QALY gained of strontium ranelate fall below thresholds of 45,000 and 25,000 per QALY gained based on efficacy data from the entire population of the clinical trial and from the per-protocol analyses, respectively.

CONCLUSIONS

The results of this study suggest that, under the assumption of same relative risk reduction of fractures in men as for women, strontium ranelate could be considered cost-effective compared with no treatment for male osteoporosis.

摘要

本研究结果表明,在假设男性骨折的相对风险降低与女性相同的情况下,从比利时医疗保健支付者的角度来看,雷奈酸锶相对于不治疗可被视为治疗男性骨质疏松症的一种具有成本效益的策略。

引言

本研究旨在评估雷奈酸锶治疗男性骨质疏松症的成本效益。

方法

我们对先前验证的马尔可夫微模拟模型进行了调整,以估计雷奈酸锶相对于不治疗的成本(2010 欧元)效益比(每获得一个质量调整生命年的成本)。在高危骨折的男性骨质疏松症患者(MALEO 试验)和绝经后骨质疏松症女性(关键性 SOTI、TROPOS 试验)中,腰椎和股骨颈骨密度(BMD)的类似疗效数据支持这样一种假设,即在男性中骨折的相对风险降低与女性相同。从比利时医疗保健支付者的角度,在 MALEO 试验人群中进行了分析,该人群为平均年龄为 73 岁、BMD T 评分≤-2.5 或存在椎体骨折(PVF)的男性人群。

结果

在 MALEO 人群中,雷奈酸锶相对于不治疗的成本效益比估计值分别为 49798 欧元和 25584 欧元,这是基于意向治疗分析的疗效数据和仅纳入依从性患者的方案分析得出的。对于 BMD T 评分≤-2.5 或存在 PVF 的男性患者,雷奈酸锶的成本效益比低于 45000 欧元和 25000 欧元的阈值,这是基于临床试验的全部人群和方案分析的疗效数据得出的。

结论

本研究结果表明,在假设男性骨折的相对风险降低与女性相同的情况下,雷奈酸锶相对于不治疗可被视为治疗男性骨质疏松症的一种具有成本效益的策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8c3/3706715/445f40a53f99/198_2013_2272_Fig1_HTML.jpg

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