BACKGROUND: Darolutamide, a structurally distinct androgen receptor inhibitor approved for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC) has been shown to increase metastasis-free survival among men with nmCRPC compared with placebo. This treatment has a novel chemical structure that may also have safety, tolerability, and efficacy advantages over other antiandrogens.
OBJECTIVE: To estimate the projected budget impact of including darolutamide on a United States (US) payer formulary as a treatment option for men with nmCRPC.
METHODS: A budget-impact model was developed to evaluate darolutamide for nmCRPC for a hypothetical 1-million-member plan over a 5-year period. Costs (drug acquisition, drug administration, and treatment-related adverse events [AEs]) were estimated for two scenarios: with and without darolutamide treatment for nmCRPC. The budget impact of darolutamide was calculated as the difference in costs for these two scenarios. An analysis for high-risk nmCRPC also was conducted. The model included treatments recommended by the National Comprehensive Cancer Network (e.g., apalutamide and enzalutamide) and potential comparators that are used but are not specifically indicated for nmCRPC. All treatments were assumed to be administered in combination with a weighted average androgen deprivation therapy comparator (consisting of luteinizing hormone-releasing hormone agonists [LHRH], LHRH antagonists, and first-generation antiandrogens). Market-share estimates were derived from interviews with physicians treating men with nmCRPC. The model includes serious AEs, and the rates were obtained from clinical trial data. Costs were taken from publicly available sources and varied in one-way sensitivity analysis.
RESULTS: For a plan with 1 million lives, there were approximately 90 incident cases of nmCRPC (46 high risk) each year, with 336 (110 high risk) treatment-eligible cases by year 5. Darolutamide’s market share increased from 3.6% in year 1 to 18% in year 5. Given the utilization of other agents, introducing darolutamide along with other targeted therapies was predicted to increase the total budget by $160,316 ($0.0134 per member per month [PMPM]) in year 1, which decreased over time to a cost savings of $150,817 ($0.0126 PMPM) by year 5. The scenario with darolutamide showed reduced AE costs each year. Similar results were observed for the high-risk nmCRPC population.
CONCLUSIONS: Adding darolutamide to a US payer formulary for the treatment of nmCRPC can result in a manageable increase in the budget that is partly offset by AE costs in the first 4 years, followed by a cost savings by year 5.
