From Clinical to Non-clinical Outcomes in the Treatment of HIV: An Economic and Organizational Impact Assessment.

Objective: The aim of this study was to define the economic and organizational impacts related to a broader utilization of bictegravir/emtricitabine/alafenamide (BIC/FTC/TAF) in Italian clinical practice.

Methods: A budget impact analysis-representing the evolution of the Italian National Healthcare Service (NHS) healthcare expenditure over 3 years-was developed, considering the overall Italian population treated for human immunodeficiency virus (HIV). Model input variables were treatment history, therapeutic regimen, development of adverse events, achievement of an undetectable viral load and total direct healthcare costs. Besides the BIA, an organizational impact assessment was conducted to determine the impact on the use of healthcare resources, assessing the release of organizational hospital assets, focusing on the management of drug-related adverse events. Data were collected from scientific evidence, Italian national and regional legislations and healthcare professionals' reports. To verify the robustness of the economic and organizational impact assessment, sensitivity analyses were performed.

Results: Results demonstrate economic savings of about 26 million euros in total health spending, assuming a higher penetration rate for BIC/FTC/TAF. This change in the current case mix would lead to a reduction in the specific costs related to adverse event management (0.9 million euros; - 2.09%) and in the medical management of patients (38 million euros; - 7.79%), with a positive impact on the achievement of virological control. From an organizational perspective, a wider use of BIC/FTC/TAF generates a reduction in the utilization of healthcare resources due to a decrease in adverse events and complications. The model estimated a 19.64% reduction in HIV-related inpatient days, which freed up healthcare professional time.

Conclusions: Capable of improving both economic and organizational sustainability for the entire HIV care continuum, BIC/FTC/TAF is an efficient therapeutic strategy for people with HIV.