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.

We aim to assess the potential value of BBM in AD diagnosis within the context of disease-modifying treatment (DMT).

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 U.S. Food & Drug Administration (FDA) Food & Drug Administration. 2021 [cited 2022 Oct 6]. FDA’s Decision to Approve New Treatment for Alzheimer’s Disease fdas-decision-approve-new-treatment-alzheimers-disease

Cliccare qui per andare alla sezione Riferimenti) referral decision tool in primary health center (PHC) and (2 U.S. Food & Drug Administration (FDA) Food & Drug Administration. 2023 [cited 2023 Sep 22]. FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval fda-converts-novel-alzheimers-disease-treatment-traditional-approval

Cliccare qui per andare alla sezione Riferimenti) 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.

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.

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.

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.