Presentation (CTI)

OBJECTIVES: Although racial and ethnic disparities in healthcare access and medication use are well-documented, little is known about their impact on the utilization of orphan drugs among Medicare beneficiaries. This study evaluates the racial/ethnicity disparities in the utilization of orphan drugs defined as those used exclusively for orphan disease indications and excluding drugs with both orphan and non-orphan indications, among Medicare Part B and D beneficiaries.
METHODS: A retrospective cross-sectional study was conducted using 2022 Medicare Part B and D claims data. Orphan drugs were identified from the FDA Orphan Drug Designation Database and limited to those approved exclusively for orphan disease indications. Multivariable logistic regression models were used to assess the association between race/ethnicity and the use of any orphan drugs, adjusting for age, gender, dual eligibility, and comorbidities. All statistical analyses were performed using SAS 9.4.
RESULTS: Among Medicare Part B and D beneficiaries who used at least one orphan drug, 76.9% were White, 11.9% were Black, 3.6% were Hispanic, and 5.6% were Asian. In multivariable logistic regression, race/ethnicity was significantly associated with orphan drug utilization. Compared to White beneficiaries, Black beneficiaries had 1.1% lower odds of utilizing orphan drugs (adjusted OR: 0.989, 95% CI: 0.984-0.995), while Hispanic beneficiaries had 6.1% higher odds (adjusted OR: 1.061, 95% CI: 1.051-1.070) and Asian beneficiaries had 8.5% higher odds (adjusted OR: 1.085, 95% CI:1.074-1.096) indicating statistically significant differences in utilization across groups.
CONCLUSIONS: This study identifies significant racial disparities in orphan drug utilization among Medicare Part B and D beneficiaries. Black beneficiaries were less likely to use orphan drugs compared to Whites, while Hispanic and Asian beneficiaries were more likely. Future research should explore the underlying causes of these disparities and their impact on health outcomes for minority populations.