IMS Health, Inc. Falls Church, VA 22046, USA.
Curr Med Res Opin. 2010 Jan;26(1):163-75. doi: 10.1185/03007990903429765.
Stakeholders in Europe remain interested in assessments of country-specific value of self-monitoring of blood glucose (SMBG) for patients with type 2 diabetes treated with oral anti-diabetes drugs (OADs). This study used the IMS-CORE Diabetes Model to project the long-term (40-year) cost-effectiveness of SMBG at once, twice, or three times per day (vs. no SMBG) for this population from national reimbursement system perspectives in France, Germany, Italy, and Spain.
SMBG input costs (strips, lancets, meters, nurse training) were supplied by LifeScan in 2007 euro values and applied as appropriate for each country's reimbursement policy. Cohort characteristics and assumed Hb(A1c) effects came from a US Kaiser Permanente longitudinal analysis of new SMBG users. Country-specific estimations for use of screening programs and several concomitant medications, as well as mortality rates were used. Country-specific complication costs from published sources were inflated to 2007 euro. Base case outcomes were discounted at 3% per annum for France, Germany, and Italy; 6% for Spain. Sensitivity analyses varied time horizon and discount rates for each country. They also included a -0.036 dis-utility for SMBG in year 1.
Primary outcomes included total direct costs, gains in quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over 40 years.
ICERs were largest in France (with meter costs included), and in Italy (with highest reimbursed costs for strips/lancets). ICERs for SMBG once, twice, and three times per day were 12,114 euros, 6282 euros, and 7958 euros (respectively) in France; and 12,694 euros, 11,934 euros, and 15,368 euros in Italy. ICERs for SMBG once or twice per day were <2000 euros in Germany and <4000 euros in Spain. ICERs for SMBG three times per day were <6000 euros/QALY in both countries. Results were most sensitive to the 5-year time horizon, although ICERs for SMBG once per day were below 50,000 euros/QALY in all countries but Italy (ICER = 77,064 euros). Five-year ICERs for SMBG twice per day were below 40,000 euros/QALY for all four countries, and those for SMBG three times per day were below 45,000 euros/QALY. With the SMBG dis-utility, ICERs increased modestly (321 euros- 2264 euros/QALY) in all scenarios except SMBG once per day in France (9578 euros increase) and Italy (5979 euros increase). Study limitations include the use of relatively short-term data from a single US observational study for SMBG clinical effects, unknown levels of patient adherence, and assumptions regarding the duration of clinical effects.
With cost assumptions reflecting current reimbursement levels in France, Germany, Italy, and Spain, SMBG was found to be cost-effective across a 40-year time horizon, with all base case ICERs <16,000/QALY. This study adds to the literature on the country-specific, long-term value of SMBG for type 2 diabetes patients treated with OADs. Under current model assumptions, variations in cost-effectiveness results stemmed primarily from payer reimbursement practices for SMBG within each country.
欧洲的利益相关者仍然对评估口服抗糖尿病药物治疗 2 型糖尿病患者的自我血糖监测（SMBG）的国家特定价值感兴趣。本研究使用 IMS-CORE 糖尿病模型，从国家报销系统的角度出发，在法国、德国、意大利和西班牙，对每天一次、两次或三次（与不进行 SMBG 相比）进行 SMBG 的长期（40 年）成本效益进行了预测。
SMBG 的输入成本（条带、 lancets、 meters、护士培训）由 LifeScan 于 2007 年欧元价值提供，并根据每个国家的报销政策进行适当应用。队列特征和假设的 Hb(A1c)影响来自美国 Kaiser Permanente 对新 SMBG 用户的纵向分析。使用了特定国家的筛查计划和几种伴随药物的使用情况以及死亡率的估计值。使用已发表的资源对国家特定的并发症成本进行了膨胀处理，以达到 2007 年的欧元水平。基础情况的结果按每年 3%的贴现率贴现，法国、德国和意大利为 3%；西班牙为 6%。敏感性分析针对每个国家的时间范围和贴现率进行了变化。它们还包括在第 1 年对 SMBG 的 -0.036 不舒适。
主要观察结果包括在 40 年内的总直接成本、质量调整生命年（QALYs）的增加和增量成本效益比（ICERs）。
在包含血糖仪成本的法国，以及在最高补偿带/ lancets 成本的意大利，ICERs 最大。在法国，SMBG 每天一次、两次和三次的 ICER 分别为 12114 欧元、6282 欧元和 7958 欧元；在意大利，ICER 分别为 12694 欧元、11934 欧元和 15368 欧元。在德国，SMBG 每天一次或两次的 ICER 低于 2000 欧元，在西班牙，ICER 低于 4000 欧元。在这两个国家，SMBG 每天三次的 ICER 低于 6000 欧元/QALY。结果对 5 年时间范围最为敏感，尽管在所有国家（意大利除外，ICER = 77064 欧元），SMBG 每天一次的 ICER 低于 50000 欧元/QALY。在所有四个国家中，SMBG 每天两次的 5 年 ICER 低于 40000 欧元/QALY，SMBG 每天三次的 5 年 ICER 低于 45000 欧元/QALY。在考虑 SMBG 不舒适的情况下，除了法国（增加 9578 欧元）和意大利（增加 5979 欧元）每天一次 SMBG 的情况下，所有情况下的 ICER 都适度增加（321 欧元-2264 欧元/QALY）。研究的局限性包括使用相对较短的来自单一美国观察性研究的数据来评估 SMBG 的临床效果、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。
在反映法国、德国、意大利和西班牙当前报销水平的成本假设下，SMBG 在 40 年的时间范围内具有成本效益，所有基础情况的 ICER 都<16000 欧元/QALY。本研究增加了关于口服抗糖尿病药物治疗 2 型糖尿病患者 SMBG 的国家特定、长期价值的文献。在当前模型假设下，成本效益结果的变化主要源于每个国家的 SMBG 报销实践。
