Abstract

To evaluate the cost-effectiveness of nivolumab therapy in relation to dacarbazine as first-line treatment in advanced metastatic melanoma, from the perspective of the Brazilian Public Healthcare System (SUS). A cost-effectiveness analysis was conducted to compare accrued life years and direct medical costs over a 30-year horizon for the population with advanced melanoma attended by SUS. The three-state model employed a partitioned survival analysis approach in which progression-free and overall survival were modeled based on the data from the pivotal clinical studies CheckMate 066 and 067 using a Gompertz parametric function, since this function yielded the lowest values of AIC (Akaike Information Criterion) and BIC (Schwarz Bayesian Criterion) among other commonly used parametric functions. Sensitivity analysis were performed to evaluate the overall robustness of the results. Nivolumab presented 5.57 accrued Life Years Gained (LYG) and a total cost of BRL 334,571.14. While dacarbazine presented 1.20 LYG and a total cost of BRL 8,902.24. Resulting in an incremental cost-effectiveness ratio of BRL 74,578.04/LYG when compared to dacarbazine. Considering the Brazilian Ministry of Health's Economic Assessment Guideline, technologies with ICERs up to three times GDP (gross domestic product) per capita are considered cost-effective (3 x GDP = BRL 98.241,00). To this end, the results show that nivolumab is a cost-effective intervention. Sensitivity analyses show that nivolumab has a 95.9% likelihood of being cost-effective, demonstrating the robustness of the obtained result. These data suggest that commissioning nivolumab for this population would generate more life years and be an efficient use of Brazilian Public healthcare resources.

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