Florbetaben PET in the Early Diagnosis of Alzheimer's Disease: A Discrete Event Simulation to Explore Its Potential Value and Key Data Gaps

Abstract

The growing understanding of the use of biomarkers in Alzheimer's disease (AD) may enable physicians to make more accurate and timely diagnoses. Florbetaben, a beta-amyloid tracer used with positron emission tomography (PET), is one of these diagnostic biomarkers. This analysis was undertaken to explore the potential value of florbetaben PET in the diagnosis of AD among patients with suspected dementia and to identify key data that are needed to further substantiate its value. A discrete event simulation was developed to conduct exploratory analyses from both US payer and societal perspectives. The model simulates the lifetime course of disease progression for individuals, evaluating the impact of their patient management from initial diagnostic work-up to final diagnosis. Model inputs were obtained from specific analyses of a large longitudinal dataset from the New England Veterans Healthcare System and supplemented with data from public data sources and assumptions. The analyses indicate that florbetaben PET has the potential to improve patient outcomes and reduce costs under certain scenarios. Key data on the use of florbetaben PET, such as its influence on time to confirmation of final diagnosis, treatment uptake, and treatment persistency, are unavailable and would be required to confirm its value.

Aβ imaging with 18F-florbetaben in prodromal Alzheimer's disease: a prospective outcome study

“…This allows an earlier diagnosis with a high level of confidence. Economic models have suggested that shortening the time to diagnosis of AD by confirming the presence of AD pathology with FBB PET may be cost-effective 29. There was an excellent inter-rater reliability for the visual reads as well as an almost perfect concordance with the classification of a scan as positive or negative for Aβ by semiquantitative assessment with the neocortical SUVR, supporting its use in routine clinical settings.…”

Clinical Use and Utility of Amyloid Imaging

“…Sixteen studies concerning the clinical utility of amyloid PET imaging were found in the literature (17,(34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44)(45)(46)(47)(48). Supplemental Table 3 summarizes these studies.…”

“…However, 3 model simulation studies on that topic have been published: Guo et al (36) modeled the outcome effect of 18 F-florbetaben in predementia and dementia subjects. For both subgroups, that study found that amyloid imaging brought about estimated gains of 0.27 and 0.03 in quality-adjusted life years (QALYs; a measure combining the quality and the quantity of life lived), as compared with a scenario without amyloid imaging.…”

“…Relevant parameters in this context are the cost savings by the procedure, the costs per QALY, the cost-efficiency ratio (portion of subjects in whom amyloid imaging is cost-effective based on national willingness-to-pay thresholds for one QALY), and the incremental cost-effectiveness ratio (another parameter describing the relation between the costs and the effect of amyloid imaging). The 3 previously cited model simulation studies dealing with the effect of amyloid imaging on outcome also dealt with these matters: Guo et al (36) simulated the cost effectiveness of 18 Fflorbetaben in the United States, and Hornberger et al (43,48) performed a respective modeling for 18 F-florbetapir in Spain and France. In the study of Guo et al, cost savings by amyloid imaging were estimated at $13,018 and $11,389 per subject over a lifetime in predementia and dementia subjects, respectively.…”

Current issues and future research priorities for health economic modelling across the full continuum of Alzheimer's disease

“…The few available models starting in predementia stages of AD commonly assume a relative risk reduction of conversion to dementia in subjects on treatment, followed by a simulation model of disease progression throughout the dementia stages [44,[51][52][53]. However, conversion to both MCI and dementia are uncertain and highly dependent on the study methods.…”