Background/Purpose: Hydroxychloroquine is a cornerstone in the treatment of Systemic Lupus Erythematosus (SLE), while corticosteroids and immunosuppressive agents are employed for moderate to severe disease [1]. The introduction of targeted biologic agents such as Belimumab for active SLE and lupus nephritis (LN), Anifrolumab for moderate to severe active SLE and Voclosporin for active LN, has expanded the therapeutic armamentarium. These advances, however, are accompanied by a substantial economic burden and increased utilization of biologic disease-modifying antirheumatic drugs (bDMARDs) [2].

Methods: We analyzed publicly available Medicare Part D and Medicaid data from the Centers for Medicare & Medicaid Services. We examined total spending, claims, beneficiary counts, average spending per claim, and per beneficiary for belimumab, anifrolumab, and voclosporin. Belimumab was FDA-approved in 2011, while anifrolumab and voclosporin were approved in 2021. Cost data from 2012–2021 were adjusted for inflation to 2022 dollars. Percent changes were calculated for 2012 and 2021 versus 2022. IRB oversight was not required due to the public nature of the data.

Results: Nationwide analysis shows sharp increases in spending and utilization of these targeted therapies (Table 1). From 2012 to 2022, Medicare spending on belimumab rose by 7,047%, and Medicaid by 1,765%. Between 2021 and 2022, increases were more modest (14.83% Medicare; 19.10% Medicaid). Anifrolumab spending jumped by 932.8% in Medicare and 3,762.03% in Medicaid from 2021 to 2022, with substantial increases in claims and beneficiaries. Voclosporin spending increased by 190.45% in Medicare and 198.8% in Medicaid, with a doubling in claims and beneficiaries. Average spending per beneficiary notably rose, especially in Medicare.

Conclusion: The rapid growth in spending reflects expanded utilization of biologics (Figure 1). Although average spending per claim showed only modest changes, the substantial rise in spending per beneficiary highlights increased reliance on these newly approved therapies (Figure 2). Patients with severe SLE exhibit elevated rates of inpatient admissions and emergency department utilization, significantly contributing to increased healthcare expenditures [3]. These findings underscore an urgent need for policy interventions aimed at regulating biologic drug pricing and improving access to effective SLE therapies, particularly for individuals insured through public programs such as Medicare and Medicaid [4].[1] Siegel CH, Sammaritano LR. Systemic Lupus Erythematosus: A Review. JAMA 2024; 331: 1480–1491.[2] Wu SS-J, Perry A, Tkacz J, et al. Clinical and economic characterization of mild, moderate, and severe systemic lupus erythematosus: Real-world observation across payer channels in the United States. J Manag Care Spec Pharm 2023; 29: 1010–1020.[3] Murimi-Worstell IB, Lin DH, Kan H, et al. Healthcare utilization and costs of systemic lupus erythematosus by disease severity in the United States. J Rheumatol 2021; 48: 385–393.[4] Pryor KP, Barbhaiya M, Costenbader KH, et al. Disparities in lupus and lupus nephritis care and outcomes among US Medicaid beneficiaries. Rheum Dis Clin North Am 2021; 47: 41–53.

Figure 1: Total Inflation-Adjusted Medicare Part D and Medicaid Spending on Biologics Since FDA Approval

Figure 2: Medicare Part D Claims and Beneficiaries of Biologics

Table 1: Medicare Part D and Medicaid (Inflation-Adjusted) Spending on Biologics

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/analysis-of-medicare-and-medicaid-utilization-and-expenditure-of-newly-approved-biologics-for-systemic-lupus-erythematosus-patients-in-the-united-states/