(152) Budget impact of risperidone for adults with Autistic Spectrum Disorder in Brazil: a comparative analysis study between epidemiological demand and real-world data

Publication Number: 813

Background: Budget Impact Analysis (BIA) of medicines helps managers to promote more sustainable health systems. However, it is not clear whether theoretical data BIA are compatible with actual data.

Objectives: To compare risperidone expenditures for adults with Autistic Spectrum Disorder (ASD) estimated by theoretical and real-world data.

Methods: The analyzes were performed based on the Brazilian Clinical Protocol and Therapeutic Guidelines for ASD. The perspective adopted was the Brazilian Unified Public Health System (SUS), considering a time horizon of 5 years (2022-2026). Three possible scenarios were adopted based on the maximum daily dose of risperidone being 3mg/day. Direct and indirect expenses were considered. For the theoretical calculation, prevalence data from the scientific literature were adopted and the population was estimated from the Brazilian demographic census. Actual data on risperidone use were extracted from the SUS database. Descriptive statistics were used to characterize the three scenarios and the estimated population in both methods. A non-parametric test was used to compare the methods.

Results: The population estimated by the theoretical model (n=1,637,478) was overestimated when compared to real-life data (n=908,943) with statistical significance (p < 0.001). Similarly, the 5-year budget impact by the theoretical model (Scenario I: US$63,093,337.32; Scenario II: US$64,154,423.07; Scenario III: US$49,299,222.65) versus the real-life model (Scenario I: US$ 35,022,300.94; Scenario II: US$ 35,611,296.01; Scenario III US$ 27,365,365.11) was overestimated with statistical significance (p < 0.001).

Conclusions: The higher estimates of the theoretical BIA suggest that SUS need to consider methodological advances that include real-life values for more assertive calculations.