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Abstract：
BACKGROUND: Recent developments in blood biomarkers (BBM) have shown promising results in diagnosing amyloid pathology in Alzheimer\'s Disease (AD). However, information on how these BBMs can best be used in clinical settings to optimise clinical decision-making and long-term health outcomes for individuals with AD is still lacking.
OBJECTIVE: We aim to assess the potential value of BBM in AD diagnosis within the context of disease-modifying treatment (DMT).
METHODS: We developed a decision analytic model to evaluate the long-term health outcomes using BBM in AD diagnosis. We compared standard of care (SOC) diagnosis workflow to the integration of BBM as a (1) referral decision tool in primary health center (PHC) and (2) triaging tool for invasive CSF examination in specialist memory clinic (MC). We combined a decision tree and a Markov model to simulate the patient\'s diagnostic journey, treatment decisions following diagnosis and long-term health outcomes. Input parameters for the model were identified from published literature and registry data analysis. We conducted a cost-utility analysis from the societal perspective using a one-year cycle length and a 30-year (lifetime) horizon.
METHODS: We reported the simulated outcomes in the percentage of correct diagnosis, costs (in 2022 Euros), quality-adjusted life year (QALY), and incremental cost-effectiveness ratios (ICER) associated with each diagnosis strategy.
RESULTS: Compared to SOC, integrating BBM in PHC increased patient referrals by 8% and true positive AD diagnoses by 10.4%. The lifetime costs for individuals diagnosed with AD were € 249,685 and €250,287, and QALYs were 9.5 and 9.52 in SOC and PHC pathways, respectively. The cost increments were €603, and QALYs gained were 0.01, resulting in an ICER of €48,296. Using BBM in MC reduced the exposure to invasive CSF procedures and costs but also reduced true positive AD diagnoses and QALYs.
CONCLUSIONS: Using BBM at PHC to make referral decisions might increase initial diagnostic costs but can prevent high costs associated with disease progression, providing a cost-effective DMT is available, whereas using BBM in MC could reduce the initial evaluation cost but incur high costs associated with disease progression.
OBJECTIVE: We aim to assess the potential value of BBM in AD diagnosis within the context of disease-modifying treatment (DMT).
METHODS: We developed a decision analytic model to evaluate the long-term health outcomes using BBM in AD diagnosis. We compared standard of care (SOC) diagnosis workflow to the integration of BBM as a (1) referral decision tool in primary health center (PHC) and (2) triaging tool for invasive CSF examination in specialist memory clinic (MC). We combined a decision tree and a Markov model to simulate the patient\'s diagnostic journey, treatment decisions following diagnosis and long-term health outcomes. Input parameters for the model were identified from published literature and registry data analysis. We conducted a cost-utility analysis from the societal perspective using a one-year cycle length and a 30-year (lifetime) horizon.
METHODS: We reported the simulated outcomes in the percentage of correct diagnosis, costs (in 2022 Euros), quality-adjusted life year (QALY), and incremental cost-effectiveness ratios (ICER) associated with each diagnosis strategy.
RESULTS: Compared to SOC, integrating BBM in PHC increased patient referrals by 8% and true positive AD diagnoses by 10.4%. The lifetime costs for individuals diagnosed with AD were € 249,685 and €250,287, and QALYs were 9.5 and 9.52 in SOC and PHC pathways, respectively. The cost increments were €603, and QALYs gained were 0.01, resulting in an ICER of €48,296. Using BBM in MC reduced the exposure to invasive CSF procedures and costs but also reduced true positive AD diagnoses and QALYs.
CONCLUSIONS: Using BBM at PHC to make referral decisions might increase initial diagnostic costs but can prevent high costs associated with disease progression, providing a cost-effective DMT is available, whereas using BBM in MC could reduce the initial evaluation cost but incur high costs associated with disease progression.
摘要：
背景：血液生物标志物（BBM）的最新发展在诊断阿尔茨海默病（AD）的淀粉样蛋白病理学中显示了有希望的结果。然而,目前仍缺乏有关如何在临床环境中最好地使用这些BBMs来优化AD患者的临床决策和长期健康结局的信息.
目的：我们的目的是在疾病改善治疗（DMT）的背景下评估BBM在AD诊断中的潜在价值。
方法：我们开发了一个决策分析模型来评估在AD诊断中使用BBM的长期健康结果。我们将标准护理（SOC）诊断工作流程与BBM作为（1）初级健康中心（PHC）的转诊决策工具和（2）专科记忆诊所（MC）的侵入性CSF检查的分类工具进行了比较。我们结合决策树和马尔可夫模型来模拟病人的诊断过程，诊断和长期健康结果后的治疗决定。从已发表的文献和注册表数据分析中确定模型的输入参数。我们从社会的角度进行了成本效用分析，使用一年的周期长度和30年（寿命）期限。
方法：我们以正确诊断的百分比报告了模拟结果，成本（2022年欧元），质量调整寿命年(QALY)，以及与每种诊断策略相关的增量成本效益比(ICER)。
结果：与SOC相比，在PHC中整合BBM使患者转诊率增加8%,AD诊断真阳性率增加10.4%.诊断为AD的个体的终生成本分别为249,685欧元和250,287欧元，SOC和PHC途径的QALYs分别为9.5和9.52。分别。费用增量为603欧元，QALY增加0.01欧元，导致ICER为48,296欧元。在MC中使用BBM减少了对侵入性CSF程序的暴露和成本，但也减少了真阳性AD诊断和QALY。
结论：在PHC使用BBM进行转诊决策可能会增加初始诊断成本，但可以防止与疾病进展相关的高成本，提供具有成本效益的DMT是可用的，而在MC中使用BBM可以降低初始评估成本，但会导致与疾病进展相关的高成本。
目的：我们的目的是在疾病改善治疗（DMT）的背景下评估BBM在AD诊断中的潜在价值。
方法：我们开发了一个决策分析模型来评估在AD诊断中使用BBM的长期健康结果。我们将标准护理（SOC）诊断工作流程与BBM作为（1）初级健康中心（PHC）的转诊决策工具和（2）专科记忆诊所（MC）的侵入性CSF检查的分类工具进行了比较。我们结合决策树和马尔可夫模型来模拟病人的诊断过程，诊断和长期健康结果后的治疗决定。从已发表的文献和注册表数据分析中确定模型的输入参数。我们从社会的角度进行了成本效用分析，使用一年的周期长度和30年（寿命）期限。
方法：我们以正确诊断的百分比报告了模拟结果，成本（2022年欧元），质量调整寿命年(QALY)，以及与每种诊断策略相关的增量成本效益比(ICER)。
结果：与SOC相比，在PHC中整合BBM使患者转诊率增加8%,AD诊断真阳性率增加10.4%.诊断为AD的个体的终生成本分别为249,685欧元和250,287欧元，SOC和PHC途径的QALYs分别为9.5和9.52。分别。费用增量为603欧元，QALY增加0.01欧元，导致ICER为48,296欧元。在MC中使用BBM减少了对侵入性CSF程序的暴露和成本，但也减少了真阳性AD诊断和QALY。
结论：在PHC使用BBM进行转诊决策可能会增加初始诊断成本，但可以防止与疾病进展相关的高成本，提供具有成本效益的DMT是可用的，而在MC中使用BBM可以降低初始评估成本，但会导致与疾病进展相关的高成本。
