Accuracy of Budget Impact Projections in Bulgarian Health Technology Assessment: A Five-Year Validation Study (2020-2025).

Background: Budget Impact Analysis is an integral part of the Health Technology Assessment in Bulgaria, informing reimbursement decisions of the National Health Insurance Fund. Inaccurate projections risk both fiscal unsustainability and restricted patient access to innovation. Yet projection accuracy methods remains uncertain, particularly given limited epidemiologic data and evolving clinical use. Objectives: This study aimed to assess the empirical validity of Health Technology Assessment budget-impact projections for medicines approved in 2019 by comparing projected patient volumes and expenditures with real-world National Health Insurance Fund reimbursements through 2025, and to identify drivers of divergence across therapeutic areas and reimbursement channels. Methods: We conducted a retrospective cohort analysis linking 2019 Health Technology Assessment submissions with monthly National Health Insurance Fund claims for both hospital and outpatient reimbursement channels. Actual utilization was calculated as the annualized median number of treated patients per month. Projected costs were derived by multiplying HTA-projected patient volumes by the observed unit cost per patient-month. We quantified deviations using observed-to-projected ratios and absolute gaps and assessed the relationship between projected and actual expenditures using a log-log regression model. Results: By September 2025, realized volumes typically exceeded projections (median ratio 1.6; range 0.02-21.3). Large overshoots were observed for Avelumab, Risankizumab, and Guselkumab; Cobimetinib and Abemaciclib remained below forecast. Expenditure deviations were driven predominantly by volume: immunology (+€17.4 million) and oncology (+€5.0 million) accounted for the largest absolute gaps. Elasticity was near proportional overall (β = 1.002; standard error = 0.24; R2 = 0.50), lower in hospitals (β = 0.79; p = 0.055) and higher in outpatient care (β = 1.30; p = 0.003). Conclusions: Health Technology Assessment Budget Impact Analyses captured broad cost scaling but systematically missed product-specific uptake, with deviations largely volume-driven. Strengthening national registries and real-world data pipelines, and adopting dynamic, indication-responsive contracting and forecasting, could materially improve budget predictability while preserving access to innovation.