Budget Impact Analysis of an Epigenetic Test Used for Diagnosing Fetal Alcohol Spectrum Disorder from the Perspective of a Laboratory Budget Holder in Manitoba, Canada.

BACKGROUND AND AIMS: Fetal alcohol spectrum disorder (FASD) is a condition that results from prenatal alcohol exposure. Though diagnosis is important for individuals with FASD to receive appropriate care, diagnosis can be difficult to obtain. Accurate diagnoses can be impeded because of an inability to confirm prenatal alcohol exposure. This is particularly problematic in instances when family cannot confirm prenatal alcohol exposure. DNA methylation testing represents a novel approach to identifying prenatal alcohol exposure via epigenetic biomarkers. The objective was to assess the impact on laboratory expenditures from adopting DNA methylation additively to the diagnostic workup for patients suspected of having FASD for whom prenatal alcohol exposure cannot be otherwise confirmed. METHODS: A budget impact model was developed that incorporates laboratory cost data, population data for Manitoba Canada, literature, and expert opinion. Probabilistic analysis was conducted for the primary analysis and deterministic sensitivity analyses were conducted to assess the sensitivity of the budget impact to changes in model parameters. The perspective of the present study is that of the laboratory budget holder at a centralized laboratory in Manitoba, Canada. RESULTS: Over a 5-year period, it was estimated that there would be 500 DNA methylation tests and the predicted budget impact to the laboratory budget holder was $207,574 (95% credible interval: 70,208-408,161) in Canadian dollars (CAD). Over a 10-year period, it was estimated that there would be 1017 DNA methylation tests and the predicted budget impact to the laboratory budget holder was CAD$439,470 (95% credible interval: 148,902-867,328). CONCLUSIONS: Findings provide insight into the impact that DNA methylation testing would have on laboratory budgets if used in the diagnostic workup for FASD in individuals for whom prenatal alcohol exposure cannot be confirmed otherwise.