Nivolumab and pembrolizumab in the treatment of metastatic melanoma: a retrospective budget impact analysis from the

Nivolumab y pembrolizumab en el tratamiento del melanoma metastásico: un análisis retrospectivo del impacto presupuestario desde la perspectiva del Sistema Nacional de Salud de Brasil, Brasil, 2019-2022

Abstract

Objective  To estimate the budget impact of using nivolumab and pembrolizumab in the treatment of metastatic melanoma in Brazil.

Methods  This was a retrospective budget impact analysis using data from the Outpatient Information System of the Brazilian National Health System. Chemotherapy authorizations issued between 2019 and 2022 were analyzed. The main measures were the number of procedures, reimbursed amounts, and the percentage variation in expenditures over the study period.

Results  The total number of chemotherapy authorizations ranged from 10,799 in the first year to 8,328 in the fourth year. Between the third and fourth year, the increase in the value of procedures resulted in a 5.96-fold rise in total expenditure, following a period of relative stability in previous years. In the last year, 1,148 authorizations for pembrolizumab and 173 for nivolumab were recorded. Only 15.8% of the authorizations included one of these two drugs. The budget impact generated by the increase in the value of procedures amounted to BRL 37,170,493.01. Considering a market share of 15.0% in the first year and its evolution to 80.0% in five years, the incremental budget impact estimated for this period would be BRL 564,233,633.28 with the expanded use of nivolumab and pembrolizumab.

Conclusion  The increase in reimbursement value, associated with the low adoption of the new immunobiologicals, produced a substantial extra expenditure with drugs prescribed before the incorporation of new technologies, which may represent a burden on the Brazilian health system.

Keywords
Melanoma; Immunotherapy; Medical Oncology; Brazil; Analysis of the Budgetary Impact of Therapeutic Advances