OBJECTIVES: To assess the clinical effectiveness, safety and cost-utility of darolutamide (Nubeqa®) versus enzalutamide in adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

METHODS: This was secondary data analysis. A literature search was conducted in the PubMed, Cochrane Library, Canadian Agency for Drugs and Technologies in Health and European Medicines Agency, and the Food and Drug Administration databases. A partitioned-survival model was adopted to project the disease course of nmCRPC for 5- and 10-year time horizons. The model with three states: non-metastatic castration-resistant prostate cancer, metastatic castration-resistant prostate cancer, and death, was constructed. Clinical data were obtained from the ARAMIS (darolutamide) and PROSPER (enzalutamide) trials. A budget impact model was developed to evaluate darolutamide and enzalutamide for a hypothetical number of patients with nmCRPC (n= 1168 in 2021-2025 and n=2884 in 2021-2030). Deterministic and probabilistic sensitivity analyses were performed to test the model.

RESULTS: At 5-year and 10-year time horizons, darolutamide was dominated by enzalutamide in quality adjusted life years (QALYs) by 0.62 and 1.45 QALY, respectively. Compared to enzalutamide, the first scenario with darolutamide showed a lower incremental cost-utility ratio (ICUR) of 20 021 995 tenges/QALY (about 46 868 USD; exchange rate of the National Bank of the Republic of Kazakhstan dated May 27, 2021: 1 USD= 427. 19 Kazakhstani tenge) and 34 037 887 tenges/QALY (about 79 677 USD). Both probabilistic (Monte Carlo simulation) and deterministic analyses confirmed the results. The budget impact analysis demonstrated that treatment costs were higher with darolutamide than with enzulatamide, but with higher QALYs.

CONCLUSIONS: Both medications demonstrated comparable clinical effectiveness for the treatment of nmCRPC, while darolutamide exhibited a favorable safety profile compared to that of enzalutamide. In comparison with enzalutamide, darolutamide was shown to be not a cost-effective medication in the context of the Kazakhstani healthcare system assuming a threshold of 30 000 USD/QALY.