Avaliação da segurança e eficácia dos anticorpos monoclonais anti-CD20 no tratamento da leucemia linfocítica crônica e impacto orçamentário da incorporação do rituximabe no SUS

Abstract

A neoplasm that mainly affects the elderly, aged between 64 and 70 years, the chronic lymphocytic leukemia (CLL) is characterized by the accumulation of B lymphocytes in the blood, secondary lymphoid tissues and marrow. Its cause is unknown, it provides an increased risk for anemia, hemorrhage and infections, and the clinical course varies among patients. Combined with other first-line chemotherapy, the anti-CD20 monoclonal antibody rituximab has good results in therapy, according to some studies. Rituximab is a high-cost drug and, currently, the amount transferred by the Unified Health System (SUS) for the first-line treatment of CLL is lower than its financial value. In this scenario, it is proposed to conduct a health technology assessment (HTA), with analysis of effectiveness, safety and economic assessment through the budget impact analysis (BIA). For the evaluation, we performed a systematic review with network meta-analysis of anti-CD20 monoclonal antibodies for the treatment of CLL and an analysis of the budgetary impact of rituximab in the treatment of the disease. In the classification of the meta-analysis, the associations containing rituximab demonstrated results that were superior to the standard therapy applied in the SUS, especially regarding the outcomes of overall survival and progression-free survival, except in terms of adverse reactions. The BIA model developed showed an increase in costs with the incorporation of the drug at the end of five years, however, among the proposed scenarios, the one that estimated greater market diffusion for rituximab had a lower total cost. The BIA performed provided better future financial visualization related to the incorporation of rituximab in order to contribute, together with a cost- effectiveness analysis, with information necessary for the budget planning of the SUS.