(330) Budget impact of darolutamide + ADT for mCSPC from a United States payer perspective

Background: : Prostate cancer is the most common cause of cancer and a leading cause of cancer death among males in the US. Darolutamide with docetaxel and androgen deprivation therapy (ADT) is approved for the treatment of metastatic castration-sensitive prostate cancer (mCSPC). Recently, the efficacy and tolerability of darolutamide + ADT was demonstrated in the ARANOTE study. In anticipation of an FDA approval, there is a need for US healthcare plans to understand the potential economic impact for expanded use of darolutamide + ADT for the treatment of mCSPC.

Objective: : To estimate the budget impact of expanded access of darolutamide + ADT from label expansion for the treatment of mCSPC from a US payer perspective.

Methods: : An Excel-based budget impact model (BIM) was developed to evaluate the incremental costs between a scenario without darolutamide + ADT approval and a scenario with approval for a 1-million-member mixed (commercial and Medicare) US plan. In the scenario without approval both real-world utilization and no utilization of darolutamide + ADT were assessed. The target population included newly diagnosed and newly progressed mCSPC patients. Comparators included doublet and triplet intensified regimens with ADT (enzalutamide, apalutamide, abiraterone, abiraterone + docetaxel, and darolutamide + docetaxel). The BIM accounted for the costs for drug acquisition, administration, adverse events (AE) management, and disease progression. Treatment dosing, efficacy, and AE rates were obtained from clinical trial publications and package inserts. Costs were reported in 2025 USD. Model outputs included annual budget impact, and per-member per-month cost (PMPM) differences calculated over a 3-year time horizon. Sensitivity analyses tested the impact of input uncertainty on outcomes.

Results: : Each year an estimated 44 men within a 1-million-member plan will be newly diagnosed or present with mCSPC progression and will receive intensified treatment. The incremental cost from approval and expanded use of darolutamide + ADT was estimated to be $57,709 in year 1 and $309,015 in year 3 ($0.005 to $0.026 PMPM respectively). In a scenario assuming no use of darolutamide + ADT without approval the budget impact was similar and ranged from $0.004 to $0.025 PMPM. Higher drug acquisition costs in the first year were partially offset by lower AE and disease progression related costs.

Conclusions: : For US health plans, providing expanded access to darolutamide + ADT for the treatment of mCSPC results in minimal budget impact.

Sponsorship:: Bayer HealthCare Pharmaceuticals Inc.