PHS25 ECONOMIC BURDEN OF ADVERSE EVENTS ASSOCIATED WITH METASTATIC RENAL CELL CARCINOMA (mRCC) TREATMENT FROM PUBLIC AND PRIVATE HEALTH INSURANCE PERSPECTIVES IN BRAZIL. Ferreira CN, Santana CF, Rufino CS, Pfizer, Inc., São Paulo, Brazil INTRODUCTION OBJECTIVE The metastatic renal cell carcinoma (mRCC) is responsible for about 3% of all malignant neoplasms in the adult population and 90% of all renal cancer cases. Its incidence rate grew by 2% per year for a population over 65 years old. Currently, sequential treatment for mRCC is recommended with the purpose of increasing progression free survival (NCCN, 2010). This study analyzes the cost of adverse events associated with the metastatic renal cell carcinoma (mRCC) treatment drugs pazopanib and sunitinib. METHODS A cost analysis was performed based on the published data of the COMPARZ study (5). All adverse events (AEs) were identified based on the AEs reported in this study. Information about the costs related to the treatment of the most frequent adverse events (>15%) in the study population (n= 1,100 subjects) was obtained. The costs per event were described by Fernandes R.A (2.011). The events included in the analysis were increased ALT, anemia, diarrhea, fatigue, hypertension, nausea, thrombocytopenia. The analysis was performed from the perspective of the Unified Health System (SUS) and the Brazilian Supplementary Healthcare (SH). For reckoning purposes, the prices listed by Drug Market Regulation Chamber (CMED/ ANVISA) were used. RESULTS The events reported in the COMPARZ trial were considered for the analysis. Table 1– Clinical Events 6 Events Sunitinib Pazopanib Increased ALT 43% 60% Anemia 60% 31% Diarrhea 57% 63% Fatigue 63% 55% Hypertension 41% 46% Nausea 46% 45% Thrombocytopenia 78% 41% Diarrhea (sunitinib = BRL 787,41 vs pazopanib = BRL 870,29), Fatigue (sunitinib = BRL 205,51 vs pazopanib = BRL 179,42), Hypertension (sunitinib = BRL 1017,91 vs pazopanib = BRL 1142,04), Nausea (sunitinib = BRL 782 vs pazopanib = BRL 765), Thrombocytopenia (sunitinib = BRL 328,49 vs pazopanib = BRL 172,67) Graph 2. Information on costs related to the treatment of the most frequent adverse events from the private perspective. From the perspective of the SUS, the following results are reported: Increased ALT (sunitinib = BRL 107,24 vs pazopanib = BRL 149,63), Anemia (sunitinib = BRL 47,72 vs pazopanib = BRL 24,65), Diarrhea (sunitinib = BRL 231,44 vs pazopanib = BRL 255,8), Fatigue (sunitinib = BRL 22,67 vs pazopanib = BRL 19,79), Hypertension (sunitinib = BRL 618,79 vs pazopanib = BRL 694,26) Nausea (sunitinib = BRL 176,49 vs pazopanib = BRL 172,65), Thrombocytopenia (sunitinib = BRL 66,29 vs pazopanib = BRL 34,85) Graph 1. Information on costs related to the treatment of the most frequent adverse events from the perspective of the SUS (BRL). Graph 3. Total adverse event costs estimated from both the public and private perspectives (BRL). When considering the costs incurred from the perspective of private institutions, such as SH, we observed the following results: Increased ALT (sunitinib = BRL 810,84 vs pazopanib = BRL 1131,4), Anemia (sunitinib = BRL 269,31 vs pazopanib = BRL 139,14) CONCLUSIONS The therapy with less financial impact on the treatment of adverse events is sunitinib from both the public (6% decrease) and private (5%) perspectives. REFERENCES [1] BRASIL, Ministério da Saúde. Departamento de Informática do Sistema Único de Saúde (DATASUS). Procedimentos hospitalares do SUS - por local de internação - Brasil. Procedimento 0303070072 - Tratamento de doenças fígado. Período Jan - Jul/ 2013.Disponível em: http://w3.datasus.gov.br/datasus/datasus.php, acesso 09 out 2013. [2] BRASIL. Agência Nacional de Vigilância Sanitária (ANVISA). Câmara de Regulação do Mercado de Medicamentos (CMED). Preço Fábrica - ICMS 18% (PF 18%) [3] FERNANDES, RA; TAKEMOTO, MLS; SANTOS, PML; CALDAS, A; VALENTIN, J. Sequential treatment of metastatic renal cell carcinoma with targeted therapies: adverse events associated costs, from the public and private perspectives in Brazil. ISPOR 14th Annual European Congress. 2011. [4] FERNANDES, RA et al. Tratamento sequencial do carcinoma de céluas renais metastático com terapias alvo: custos associados ao manejo dos eventos adversos, sob as perspectivas pública e privada, no Brasil. CÂNCER, volume 09, número 28, 2011. [5] NATIONAL COMPREHENSIVE CANCER NETWORK (NCCN). Practice guidelines in oncology: kidney cancer (v.2.2010). Available from http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. [6] MOTZER, JR et al. Pazopanib in Locally Advanced or Metastatic Renal Cell Carcinoma. The New England Journal of Medicine 2013;369:722-31 .