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期刊来源：Ann Intern Med

原文链接：https://doi.org/10.7326/M23-1492

摘要内容如下：

背景

在美国，抗糖尿病药物的成本超过3270亿美元。

目的

系统评价新型抗糖尿病药物治疗2型糖尿病的成本效益分析（CEA）。

数据源

2010年1月1日至2023年7月13日的书目数据库，仅限英文。

研究选择

非行业资助的CEA，从美国的角度来看，估计新的抗糖尿病药物每质量调整生命年（QALY）的成本。两名审稿人对文献进行筛选；与第三位审阅者解决了分歧。

数据提取

对治疗比较、模型输入和结果的成本效益分析进行了审查。使用德拉蒙德标准评估CEAS的偏倚风险（ROB），使用GRADE（建议评估、开发和评价的分级）评估证据的确定性（Coe）。证据的确定性使用美国医师学会临床指南委员会预先确定的每QALY成本阈值来确定。与备选方案相比，每QALY的价值较低（>$150000）、中等（$50至$150000）或较高（<$50000）。

数据综合

9个CEA符合条件（2个低，1个高，6个涉及ROB），评估胰高血糖素样肽-1激动剂（GLP1A）、二肽基肽酶-4抑制剂（DPP4I）、钠-葡萄糖协同转运蛋白-2抑制剂（SGLT2I）、葡萄糖依赖性促胰岛素肽激动剂（GIP/GLP1A）和胰岛素。对照药物为二甲双胍、磺脲类药物、中性鱼精蛋白（NPH）、胰岛素等。与二甲双胍相比，GLP1A和SGLT2I作为一线治疗的价值较低（高Coe），但与不添加任何药物（低Coe）相比，添加到二甲双胍或背景治疗中可能具有中等价值。胰岛素类似物可能同样有效，但比NPH胰岛素（低Coe）更昂贵。GIP/GLP1A值不确定（Coe不足）。

局限性

成本效益分析在方法、假设和药物比较方面各不相同。CEA的偏倚风险和评级方法尚未建立。

结论

胰高血糖素样肽-1激动剂和SGLT2I作为一线治疗的价值较低，但与不添加任何药物相比，添加到二甲双胍或其他背景治疗中可能具有中等价值。其他药物和比较的价值较低或不确定。结果对药物有效性和成本假设敏感。

主要资金来源

美国内科医师学会。（普洛斯彼罗：CRD42022382315）。

英文原文如下：

Abstracts

BACKGROUND  In the United States, costs of antidiabetes medications exceed $327 billion.

PURPOSE  To systematically review cost-effectiveness analyses (CEAs) of newer antidiabetes medications for type 2 diabetes.

DATA SOURCES  Bibliographic databases from 1 January 2010 through 13 July 2023, limited to English.

STUDY SELECTION  Nonindustry-funded CEAs, done from a U.S. perspective that estimated cost per quality-adjusted life-year (QALY) gained for newer antidiabetic medications. Two reviewers screened the literature; disagreements were resolved with a third reviewer.

DATA EXTRACTION  Cost-effectiveness analyses were reviewed for treatment comparisons, model inputs, and outcomes. Risk of bias (RoB) of the CEAs was assessed using Drummond criteria and certainty of evidence (CoE) was assessed using GRADE (Grading of Recommendations Assessment, Development, and Evaluations). Certainty of evidence was determined using cost per QALY thresholds predetermined by the American College of Physicians Clinical Guidelines Committee; low (>$150 000), intermediate ($50 to $150 000), or high (<$50 000) value per QALY compared with the alternative.

DATA SYNTHESIS  Nine CEAs were eligible (2 low, 1 high, and 6 some concerns RoB), evaluating glucagon-like peptide-1 agonists (GLP1a), dipeptidyl peptidase-4 inhibitors (DPP4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucose-dependent insulinotropic peptide agonist (GIP/GLP1a), and insulin. Comparators were metformin, sulfonylureas, neutral protamine Hagedorn (NPH) insulin, and others. Compared with metformin, GLP1a and SGLT2i are low value as first-line therapy (high CoE) but may be of intermediate value when added to metformin or background therapy compared with adding nothing (low CoE). Insulin analogues may be similarly effective but more expensive than NPH insulin (low CoE). The GIP/GLP1a value is uncertain (insufficient CoE).

LIMITATIONS  Cost-effectiveness analyses varied in methodological approach, assumptions, and drug comparisons. Risk of bias and GRADE method for CEAs are not well established.

CONCLUSION  Glucagon-like peptide-1 agonists and SGLT2i are of low value as first-line therapy but may be of intermediate value when added to metformin or other background therapy compared with adding nothing. Other drugs and comparisons are of low or uncertain value. Results are sensitive to drug effectiveness and cost assumptions.

PRIMARY FUNDING SOURCE  American College of Physicians. (PROSPERO: CRD42022382315).

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