Target therapy versus dacarbazine in first-line treatment of advanced non-surgical and metastatic melanoma: budget impact analysis from the perspective of the Brazilian National Health System, 2018-2020. / Terapia-alvo versus dacarbazina no tratamento de primeira linha do melanoma avançado não cirúrgico e metastático: análise de impacto orçamentário na perspectiva do Sistema Único de Saúde, 2018-2020.

OBJECTIVE: to estimate the incremental budget impact of target therapy for first-line treatment of advanced non-surgical and metastatic melanoma compared to dacarbazine treatment. METHODS: budget impact analysis, from the Brazilian National Health System (SUS) perspective; based on demographic data and incidence estimates, the population over a three-year time horizon (2018-2020) was delimited and the direct medical costs were estimated; the reference scenario was treatment with dacarbazine, and the alternative scenarios were target therapy with vemurafenib, dabrafenib, vemurafenib + cobimetinib and dabrafenib + trametinib; uncertainty assessment was conducted through scenario analysis. RESULTS: the incremental budget impact ranged from R$ 451,867,881.00 to R$ 768,860,968.00, representing 0.70 to 1.53% of total SUS annual outpatient drugs expenditure; in best and worst scenario, results ranged from R$ 289,160,835.00 to R$ 1,107,081,926.00. CONCLUSION: the use of target therapy compared to dacarbazine implies an excessive impact on the budget, this bring unfovorable to its possible incorporation.

Custo-utilidade de terapias-alvo comparadas à dacarbazina para o tratamento de primeira linha do melanoma avançado não-cirúrgico e metastático no Sistema Único de Saúde do Brazil.

OBJECTIVE: To estimate the incremental cost-utility ratio (ICUR) of isolated and combined targeted therapy regimens compared to dacarbazine for first-line treatment of advanced and metastatic melanoma with BRAF V600 mutation. METHODS: A Markov model with three health states (no progression, progression and death), monthly duration cycle and 10-year time horizon was constructed to compare targeted therapy regimens (vemurafenib, dabrafenib, vemurafenib/cobimetinib and dabrafenib/trametinib) with dacarbazine chemotherapy under the Brazilian public health perspective. One-way and probabilistic sensitivity analyses were performed. RESULTS: Mean cost was R$5662.50 ($1490.13) for dacarbazine, R$175 937.18 (46 299.26) for vemurafenib, R$167 461.70 ($44 068.87) for dabrafenib, R$425 901 ($112 079.21) for vemurafenib/cobimetinib and R$411 799.81 ($108 368.37) for dabrafenib/trametinib, whereas QALY was 0.91 for dacarbazine, 1.08 for vemurafenib, 1.12 for dabrafenib, 1.64 for vemurafenib/cobimetinib and 1.56 for dabrafenib/trametinib. The ICUR was estimated from R$572 165.76 ($150 569.94) to R$1 012 524.56 ($266 453.83) per patient, and the most impactful parameters were risk of progression and death, and treatment cost. CONCLUSION: The incorporation of targeted therapies in the Brazilian public health system would produce an additional expenditure of at least 19 times the national GDP per capita to increase in one year the quality-adjusted survival of each patient with advanced/metastatic BRAF-mutant melanoma.

Socioeconomic status as a predictor of melanoma survival in a series of 1083 cases from Brazil: just a marker of health services accessibility?

Melanoma survival is determined by disease-related and patient-related factors; there is a growing body of evidence that other issues may play a role in this disease. In this study, the role of socioeconomic factors in the evolution of melanoma was evaluated. This was a retrospective study with incident cases of melanoma treated in an oncology center in Rio de Janeiro, Brazil, during the period of 1997-2004. The socioeconomic variable of choice was education (9 years or more vs. 8 years or less of school attendance). In this period, there were 1083 patients with primary melanoma of the skin, 58.1% with low school attendance. No difference was found in relation to the year of diagnosis with respect to overall survival. Five-year survival for the entire group was 67.0%. Men had worse survival [hazard ratio (HR) 1.91, 95% confidence interval (CI) 1.54-2.35]; a protective effect was found for whites (HR 0.64, 95% CI 0.49-0.84), higher educational level (HR 0.55, 95% CI 0.44-0.69), and upper limb lesions (HR 0.61, 95% CI 0.38-0.98). A higher risk of death was observed for patients with nodular melanoma (HR 1.96, 95% CI 1.49-2.58), acrolentiginous melanoma (HR 2.68, 95% CI 2.09-3.44), lesions in the soles and palms (HR 1.78, 95% CI 1.22-2.6), and increasing age (HR 1.02 for each year, 95% CI 1.01-1.02). In the multivariate analysis, after controlling for stage, age, sex, ethnicity, and clinical type, education remained a protective factor both for overall survival (HR 0.76, 95% CI 0.61-0.94) and for relapse-free survival (HR 0.76, 95% CI 0.61-0.94). In conclusion, socioeconomic status as measured by educational level represented an important factor related to melanoma clinical evolution in the cohort studied.

An estimate of the cost of treating melanoma disease in the state of Sao Paulo - Brazil.

OBJECTIVE: The purpose of this study was to estimate the direct cost of diagnosing and treating melanoma disease in Sao Paulo (Brazil) between the years 2000 and 2007. METHODS: The project Clinical Practice Guidelines in Oncology was used, adapted to the proceedings of SOBECCan Foundation. The estimated costs were based on the values of the medical treatment paid by the Brazilian National Health System (SUS) and private healthcare insurance companies (PHIC) in 2007. RESULTS: The total cost was estimated in R$33,012,725.1 (SUS) and R$76,133,662.8 (PHIC). Stages 0, I and II comprised about 4.2% (SUS) and 1.3% (PHIC) of the total cost; stages III and IV amounted to 95.8% and 98.7% of the total cost, respectively. CONCLUSION: The diagnosis of malignant melanoma in its initial stages reduces treatment costs generating considerable savings of resources for both National Health System and private healthcare insurance companies.

Estimativa do custo do tratamento de câncer de pele tipo melanoma no Estado de São Paulo - Brasil / An estimate of the cost of treating mlanoma disease in the state of Sao Paulo - Brazil

FUNDAMENTOS: O impacto econômico do diagnóstico e do tratamento do melanoma cutâneo não tem sido analisado no Brasil. Uma vez que crescem tanto a incidência do câncer de pele quanto a preocupação com ele, é importante que isto seja avaliado. OBJETIVO: O objetivo deste trabalho foi estimar o custo direto de diagnosticar e tratar em seus diversos estádios o melanoma cutâneo em número de casos ocorridos no Estado de São Paulo, entre 2000 e 2007. MÉTODOS: Como modelo de procedimento, foi utilizado o projeto diretriz (Clinical Practice Guidelines in Oncology), editado pelo National Comprehensive Cancer Network (NCCN) e adequado aos procedimentos da Fundação SobecCan - Hospital do Câncer de Ribeirão Preto - SP. Os custos estimados se baseiam nos valores do tratamento médico pagos pelo setor público (Sistema Único de Saúde - SUS) e pelo setor privado (convênios) em 2007. Houve 2.740 casos diagnosticados e estadiados no Estado de São Paulo no período estudado. RESULTADOS: O custo total de tratamento dos melanomas malignos diagnosticados no estádio inicial, em valores de 2007, foi estimado em R$ 33.012.725,10 para o SUS e R$ 76.133.662,80 para os convênios.Os estádios iniciais 0, I e II da doença compreendem aproximadamente 4,2 por cento (SUS) e 1, 3 por cento (convênios) do custo total; os estádios III e IV consomem 95,8 por cento e 98,7 por cento do custo total, respectivamente. CONCLUSÃO: Os resultados apresentados reforçam o argumento de que o diagnóstico do melanoma cutâneo em seus estádios iniciais reduz os custos de tratamento, gerando considerável economia tanto para o sistema público de saúde (SUS) quanto para o sistema privado (convênios).

OBJECTIVE: The purpose of this study was to estimate the direct cost of diagnosing and treating melanoma disease in Sao Paulo (Brazil) between the years 2000 and 2007. METHODS: The project Clinical Practice Guidelines in Oncology was used, adapted to the proceedings of SOBECCan Foundation. The estimated costs were based on the values of the medical treatment paid by the Brazilian National Health System (SUS) and private healthcare insurance companies (PHIC) in 2007. RESULTS: The total cost was estimated in R$33,012,725.1 (SUS) and R$76,133,662.8 (PHIC). Stages 0, I and II comprised about 4.2 percent (SUS) and 1.3 percent (PHIC) of the total cost; stages III and IV amounted to 95.8 percent and 98.7 percent of the total cost, respectively. CONCLUSION: The diagnosis of malignant melanoma in its initial stages reduces treatment costs generating considerable savings of resources for both National Health System and private healthcare insurance companies.