对每周一次司美格鲁肽 SUSTAIN 6 心血管结局试验的卒中结局进行 IQVIA 核心糖尿病模型校准。
Calibration of the IQVIA Core Diabetes Model to the stroke outcomes from the SUSTAIN 6 cardiovascular outcomes trial of once-weekly semaglutide.
机构信息
Novo Nordisk Ltd, Gatwick, UK.
Novo Nordisk A/S, Søborg, Denmark.
出版信息
J Med Econ. 2023 Jan-Dec;26(1):1019-1031. doi: 10.1080/13696998.2023.2240957.
AIMS
In the SUSTAIN 6 cardiovascular outcomes trial, once-weekly semaglutide was associated with a statistically significant reduction in major adverse cardiovascular events compared with placebo. To date, no studies have assessed how accurately existing diabetes models predict the outcomes observed in SUSTAIN 6. The aims of this analysis were to investigate the performance of the IQVIA Core Diabetes Model when used to predict the SUSTAIN 6 trial outcomes, to calibrate the model such that projected outcomes reflected observed outcomes, and to examine the impact of calibration on the cost-effectiveness of once-weekly semaglutide from a UK healthcare payer perspective.
METHODS
The IQVIA Core Diabetes Model was calibrated to ensure that the projected non-fatal stroke event rates reflected the non-fatal stroke event rates observed in SUSTAIN 6 over a two-year time horizon. Cost-effectiveness analyses of once-weekly semaglutide versus placebo plus standard of care were conducted over a lifetime horizon using the uncalibrated and calibrated models to assess the impact on cost-effectiveness outcomes.
RESULTS
To replicate the non-fatal stroke event rate in SUSTAIN 6, calibration of the model through the application of relative risks for stroke of 1.07 and 1.65 with once-weekly semaglutide and placebo, respectively, was required. In the long-term cost-effectiveness analysis, the uncalibrated model projected an incremental cost-effectiveness ratio for once-weekly semaglutide versus placebo plus standard of care of GBP 22,262 per quality-adjusted life year (QALY) gained, which fell to GBP 17,594 per QALY gained when the calibrated model was used.
CONCLUSIONS
The requirement for calibration to replicate the outcomes observed in SUSTAIN 6 suggests that the reductions in risk of cardiovascular complications observed with once-weekly semaglutide cannot be solely explained by differences in conventional risk factors. Accurate estimation of the risk of diabetes-related complications using methods such as calibration is important to ensure accurate cost-effectiveness analyses are conducted.
目的
在 SUSTAIN 6 心血管结局试验中，与安慰剂相比，每周一次的司美格鲁肽可显著降低主要不良心血管事件。迄今为止，尚无研究评估现有的糖尿病模型在多大程度上准确预测 SUSTAIN 6 观察到的结局。本分析旨在研究 IQVIA 核心糖尿病模型在预测 SUSTAIN 6 试验结局时的性能，对模型进行校准，以使预测结果反映观察结果，并从英国医疗保健支付者的角度检查校准对每周一次司美格鲁肽成本效益的影响。
方法
对 IQVIA 核心糖尿病模型进行校准，以确保在两年的时间内，预测的非致死性卒中事件发生率反映 SUSTAIN 6 中观察到的非致死性卒中事件发生率。使用未经校准和校准的模型对每周一次司美格鲁肽与安慰剂加标准护理进行终生成本效益分析，以评估对成本效益结果的影响。
结果
为了复制 SUSTAIN 6 中的非致死性卒中事件发生率，需要通过应用每周一次司美格鲁肽和安慰剂的卒中相对风险 1.07 和 1.65 来校准模型。在长期成本效益分析中，未经校准的模型预测每周一次司美格鲁肽与安慰剂加标准护理相比的增量成本效益比为每获得 1 个质量调整生命年（QALY）增加 22262 英镑，而当使用校准模型时，这一数字降至每获得 1 个 QALY 增加 17594 英镑。
结论
为了复制 SUSTAIN 6 中观察到的结果而需要进行校准，这表明每周一次司美格鲁肽降低心血管并发症风险不能仅用常规危险因素的差异来解释。使用校准等方法准确估计糖尿病相关并发症的风险对于确保进行准确的成本效益分析非常重要。
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