IMS Health Inc., Falls Church, VA 22046, USA.
Curr Med Res Opin. 2010 Jan;26(1):151-62. doi: 10.1185/03007990903400071.
Stakeholders in the US and elsewhere are interested in country-specific and cohort-specific information with which to assess the long-term value of self-monitoring of blood glucose (SMBG) for patients with type 2 diabetes mellitus (T2DM) on oral anti-diabetes drugs (OADs). This study modeled the cost-effectiveness of SMBG at frequencies of once, twice, or three times per day for this population, and included those who had used SMBG in the prior year.
Based on clinical findings of a longitudinal Kaiser Permanente study, a validated model was used to project 40-year clinical and economic outcomes for SMBG at (averages of) once, twice, or three times per day versus no SMBG. Baseline HbA1c (7.6%), age and gender represented the Kaiser study 'prevalent' SMBG users cohort. Unit costs came primarily from a 2003 published article; inflated to US$2006. Outcomes were discounted at 3% per annum, with sensitivity analyses on discount rates and time horizons. Analyses were conducted from a third-party payer perspective in the US, including only direct costs.
Primary outcomes were differences in total costs, cumulative incidence of complications, quality-adjusted life years (QALYs); and incremental cost-effectiveness ratios (ICERs).
For patients using SMBG once, twice, or three times per day, relative risks over 40 years were lower for 14 of 16 complications and slightly higher for 2 complications. Compared to 'no SMBG,' QALYs increased with SMBG frequency: 0.047, 0.116, and 0.132 QALYs for SMBG once, twice, and three times per day, respectively. Some increased costs with SMBG were offset by reductions in costs for several diabetes-related complications. Corresponding ICERs were $26,206, $18,572 and $25,436/QALY gained. Results were most sensitive to time horizon, with SMBG not cost-effective over a 5-year simulation period.
Study limitations include the use of relatively short-term observational data, unknown levels of patient adherence, and assumptions regarding the duration of clinical effects. Results showed that compared to no SMBG, base case ICERs for each of the three SMBG frequencies examined were below $30,000, and that a portion of the increased costs associated with SMBG were offset by reductions in complication costs, and by modest increases in QALYs. Results add to the literature addressing the cost-effectiveness of SMBG as a component of care for T2DM patients on OADs, and in particular those with monitoring experience within the previous year.
美国和其他国家的利益相关者对特定国家和特定队列的信息感兴趣，这些信息可用于评估 2 型糖尿病（T2DM）患者在使用口服抗糖尿病药物（OAD）时自我监测血糖（SMBG）的长期价值。本研究针对该人群每天监测血糖 1 次、2 次或 3 次的成本效益进行建模，包括过去一年中使用过 SMBG 的患者。
基于凯萨医疗机构一项纵向研究的临床发现，使用经过验证的模型预测每天监测血糖 1 次、2 次或 3 次与不进行 SMBG 相比的 40 年临床和经济结局。基线糖化血红蛋白（HbA1c）（7.6%）、年龄和性别代表了凯萨研究中“现患”SMBG 用户队列。单位成本主要来自于 2003 年发表的一篇文章；按 2006 年的美元进行了通货膨胀调整。结果以 3%的年利率进行贴现，对贴现率和时间范围进行了敏感性分析。该分析从美国第三方付款人的角度进行，仅包括直接成本。
主要结局是总费用、并发症累积发生率、质量调整生命年（QALYs）和增量成本效益比（ICERs）的差异。
对于每天使用 SMBG 1 次、2 次或 3 次的患者，在 40 年内，16 种并发症中有 14 种的相对风险较低，2 种并发症的相对风险略高。与“不进行 SMBG”相比，SMBG 频率越高，QALYs 越高：SMBG 每天 1 次、2 次和 3 次的 QALYs 分别为 0.047、0.116 和 0.132。一些 SMBG 相关成本的增加被几种糖尿病相关并发症成本降低所抵消。相应的 ICER 分别为 26206 美元、18572 美元和 25436 美元/QALY 获益。结果对时间范围最为敏感，在 5 年模拟期间，SMBG 不具有成本效益。
研究局限性包括使用相对短期的观察数据、未知的患者依从性水平以及关于临床效果持续时间的假设。结果表明，与不进行 SMBG 相比，三种 SMBG 频率中的每一种的基础案例 ICER 均低于 30000 美元，并且 SMBG 相关成本的一部分增加被并发症成本的降低和 QALYs 的适度增加所抵消。结果增加了文献中关于 SMBG 作为 OAD 治疗 T2DM 患者治疗一部分的成本效益的内容，特别是在过去一年中有监测经验的患者。
