COPE Health Solutions, Los Angeles, CA.
Eversana, Burlington, ON, Canada.
J Manag Care Spec Pharm. 2024 Sep;30(9):917-928. doi: 10.18553/jmcp.2024.24025. Epub 2024 Aug 7.
BACKGROUND: Reducing the risks of complications is a primary goal of diabetes management, with effective glycemic control a key factor. Glucose monitoring using continuous glucose monitoring (CGM) technology is an important part of diabetes self-management, helping patients reach and maintain targeted glucose and glycated hemoglobin (HbA1c) levels. Although clinical guidelines recommended CGM use, coverage by Medicaid is limited, likely because of cost concerns. OBJECTIVE: To assess the cost-effectiveness of FreeStyle Libre CGM systems, compared with capillary-based self-monitoring of blood glucose (SMBG), in US individuals with type 2 diabetes mellitus using basal insulin. METHODS: A patient-level microsimulation model was used to compare CGM with SMBG for a population of 10,000 patients. A 10-year horizon was used, with an annual discount rate of 3.0% for costs and utilities. Model population characteristics were based on US national epidemiology data. Patient outcomes were based on published clinical trials and real-world studies. Annual costs, reflective of 2023 values, included CGM and SMBG acquisition costs and the costs of treating diabetic ketoacidosis, severe hypoglycemia, and diabetes complications. The effect of CGM was modeled as a persistent 1.1% reduction in HbA1c relative to SMBG based on US real-world evidence. Disutilities were based on published clinical trials and other relevant literature. The primary outcome was cost per quality-adjusted life-year (QALY) gained. Sensitivity analyses were performed to test the validity of the model results when accounting for a plausible variation of inputs. RESULTS: In the base case analysis, CGM was dominant to SMBG, providing more QALYs (6.18 vs 5.97) at a lower cost ($70,137 vs $71,809) over the 10-year time horizon. A $10,456 increase in glucose monitoring costs was offset by a $12,127 reduction in treatment costs. Cost savings reflected avoidance of acute diabetic events (savings owing to reductions in severe hypoglycemia and diabetic ketoacidosis were $271 and $2,159, respectively) and a reduced cumulative incidence of diabetes complications, particularly renal failure (saving $5,292), myocardial infarction (saving $1,996), and congestive heart failure (saving $1,061). Scenario analyses were consistent with the base case results, and the incremental cost-effectiveness ratio for CGM vs SMBG ranged from dominant to cost-effective. In probabilistic analysis, CGM was 100% likely to be cost-effective at a willingness-to-pay threshold of $50,000/QALY. CONCLUSIONS: CGM is cost-effective compared with SMBG for US patients with type 2 diabetes mellitus receiving basal insulin therapy. This suggests that state Medicaid programs could benefit from broader coverage of CGM.
背景:降低并发症风险是糖尿病管理的首要目标,有效控制血糖是关键因素。使用连续血糖监测(CGM)技术进行血糖监测是糖尿病自我管理的重要组成部分,有助于患者达到并维持目标血糖和糖化血红蛋白(HbA1c)水平。尽管临床指南推荐使用 CGM,但医疗补助的覆盖范围有限,这可能是由于成本问题。
目的:评估基于瞬感自由动态血糖仪系统(FreeStyle Libre CGM)与毛细血管血糖自我监测(SMBG)相比,在使用基础胰岛素的美国 2 型糖尿病患者中的成本效益。
方法:使用患者水平的微模拟模型比较了 CGM 与 SMBG 对 10000 名患者的影响。使用 10 年的时间范围,成本和效用的年度贴现率为 3.0%。模型人群特征基于美国国家流行病学数据。患者结局基于已发表的临床试验和真实世界研究。反映 2023 年价值的年度成本包括 CGM 和 SMBG 的购置成本以及治疗糖尿病酮症酸中毒、严重低血糖和糖尿病并发症的成本。基于美国真实世界证据,将 CGM 的效果建模为与 SMBG 相比 HbA1c 持续降低 1.1%。失效益用基于已发表的临床试验和其他相关文献。主要结局是每获得一个质量调整生命年(QALY)的成本。进行敏感性分析以测试当考虑输入的合理变化时模型结果的有效性。
结果:在基础案例分析中,与 SMBG 相比,CGM 具有优势,在 10 年时间内提供了更多的 QALYs(6.18 比 5.97),成本更低(70137 美元比 71809 美元)。血糖监测成本增加 10456 美元,被治疗成本降低 12127 美元所抵消。节省的成本反映了急性糖尿病事件的避免(严重低血糖和糖尿病酮症酸中毒的减少分别节省了 271 美元和 2159 美元),以及糖尿病并发症的累积发生率降低,特别是肾衰竭(节省 5292 美元)、心肌梗死(节省 1996 美元)和充血性心力衰竭(节省 1061 美元)。方案分析与基础案例结果一致,CGM 与 SMBG 的增量成本效益比从具有优势到具有成本效益。在概率分析中,CGM 在支付意愿阈值为 50000 美元/QALY 时,有 100%的可能性具有成本效益。
结论:与 SMBG 相比,基于瞬感自由动态血糖仪系统对接受基础胰岛素治疗的美国 2 型糖尿病患者具有成本效益。这表明州医疗补助计划可以从更广泛的 CGM 覆盖中受益。
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