Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
■在SUSTAIN6心血管结局试验中，与安慰剂相比,每周一次司马鲁肽与主要不良心血管事件的显著减少相关.迄今为止,没有研究评估现有的糖尿病模型如何准确预测SUSTAIN6中观察到的结局.本分析的目的是调查IQVIA核心糖尿病模型在预测持续6试验结果时的表现。为了校准模型，使预测结果反映观察到的结果，并从英国医疗保健支付者的角度研究校准对每周一次semaglutide的成本效益的影响。
对IQVIA核心糖尿病模型进行了校准，以确保预测的非致命性卒中事件发生率反映了在2年时间范围内SUSTAIN6中观察到的非致命性卒中事件发生率。使用未经校准和校准的模型，在整个生命周期内进行每周一次的司马鲁肽与安慰剂加标准护理的成本效益分析，以评估对成本效益结果的影响。
■为了在SUSTAIN6中复制非致命性卒中事件发生率，通过每周一次的司马鲁肽和安慰剂应用1.07和1.65的卒中相对风险来校准模型，分别,是必需的。在长期成本效益分析中，未经校准的模型预测，每获得质量调整生命年（QALY），每周一次的司马鲁肽与安慰剂加标准护理的成本效益比增加22,262英镑，当使用校准模型时，每QALY的收益降至17,594英镑。
■需要校准以复制SUSTAIN6中观察到的结果，这表明每周一次的司马鲁肽所观察到的心血管并发症风险的降低不能仅由常规风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。
对IQVIA核心糖尿病模型进行了校准，以确保预测的非致命性卒中事件发生率反映了在2年时间范围内SUSTAIN6中观察到的非致命性卒中事件发生率。使用未经校准和校准的模型，在整个生命周期内进行每周一次的司马鲁肽与安慰剂加标准护理的成本效益分析，以评估对成本效益结果的影响。
■为了在SUSTAIN6中复制非致命性卒中事件发生率，通过每周一次的司马鲁肽和安慰剂应用1.07和1.65的卒中相对风险来校准模型，分别,是必需的。在长期成本效益分析中，未经校准的模型预测，每获得质量调整生命年（QALY），每周一次的司马鲁肽与安慰剂加标准护理的成本效益比增加22,262英镑，当使用校准模型时，每QALY的收益降至17,594英镑。
■需要校准以复制SUSTAIN6中观察到的结果，这表明每周一次的司马鲁肽所观察到的心血管并发症风险的降低不能仅由常规风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。
