Custo-efetividade do pazopanibe comparado ao sunitinibe para câncer renal metastático na perspectiva de um hospital do Sistema Único de Saúde / Cost-effectiveness between pazopanib and sunitinib for metastatic renal cancer from the perspective of the Brazilian Unified National Health System / Costo-efectividad entre el pazopanib y el sunitinib para el cáncer renal metastásico desde la perspectiva del Sistema Único de Salud

Resumo: O câncer renal é a 13ª neoplasia mais frequente no mundo. Entre 2012 e 2016, representou 1,48% das mortes por câncer no Brasil. A terapia de escolha para o tratamento de câncer renal metastático são os inibidores de tirosina quinase (ITK), sunitinibe e pazopanibe. Este artigo avalia o custo-efetividade do pazopanibe comparado ao sunitinibe no tratamento de câncer renal metastático. Foi realizada uma análise de custo-efetividade sob a perspectiva de um hospital federal do Sistema Único de Saúde. No modelo de árvore de decisão foram aplicados os desfechos de efetividade e segurança dos ITK. Os dados clínicos foram extraídos de prontuários e os custos diretos consultados em fontes oficiais do Ministério da Saúde. O custo de 10 meses de tratamento, englobando o valor dos ITK, procedimentos e manejo de eventos adversos, foi de R$ 98.677,19 para o pazopanibe e R$ 155.227,11 para o sunitinibe. Os medicamentos apresentaram efetividade estatisticamente equivalente e diferença estatisticamente significativa para o desfecho de segurança, no qual o pazopanibe obteve o melhor resultado. O pazopanibe, nesse contexto, é a tecnologia dominante quando os custos de tratamento são associados aos de manejo de eventos adversos.

Abstract: Renal cancer is the 13th most frequent neoplasm in the world. From 2010 to 2014, renal cancer accounted for 1.43% of cancer deaths in Brazil. The treatment of choice for metastatic renal cancer is tyrosine kinase inhibitors (TKI) sunitinib and pazopanib. This article assesses cost-effectiveness between pazopanib and sunitinib in the treatment of metastatic renal cancer. A cost-effectiveness study was performed from the perspective of a federal hospital under the Brazilian Unified National Health System (SUS). TKI effectiveness and safety outcomes were applied to the decision tree model. Clinical data were extracted from patient charts, and direct costs were consulted from official Ministry of Health sources. The cost of 10 months of treatment, including the costs of the TKI, procedures and management of adverse events, was BRL 98,677.19 for pazopanib and BRL 155,227.11 for sunitinib. The drugs displayed statistically equivalent effectiveness and statistically different safety outcomes, with pazopanib displaying better results. In this setting, pazopanib is the dominant technology when the treatment costs are analyzed together with the costs of managing adverse events.

Resumen: El cáncer renal es la 13ª neoplasia más frecuente en el mundo. Entre 2010 y 2014, representó un 1,43% de las muertes por cáncer en Brasil. La terapia de elección para el tratamiento de cáncer renal metastásico son los inhibidores de tirosina quinasa (ITK), sunitinib y pazopanib. Este artículo evalúa el costo-efectividad entre pazopanib y sunitinib en el tratamiento de cáncer renal metastásico. Se realizó un análisis de costo-efectividad desde la perspectiva de un hospital federal del Sistema Único de Salud. En el modelo de árbol de decisión se aplicaron los desenlaces de efectividad y seguridad de los ITK. Los datos clínicos se extrajeron de registros médicos, y los costos directos consultados en fuentes oficiales del Ministerio de Salud. El costo de 10 meses de tratamiento, englobando el valor de los ITK, procedimientos y gestión de eventos adversos, fue de BRL 98.677,19 con el pazopanib y BRL 155.227,11 con el sunitinib. Los medicamentos presentaron efectividad estadísticamente equivalente y diferencia estadísticamente significativa para el desenlace de seguridad, en el que el pazopanib obtuvo el mejor resultado. El pazopanib, en este contexto, es la tecnología dominante cuando los costes de tratamiento están asociados a los de la gestión de eventos adversos.

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 / Terapia dirigida versus dacarbazina en el tratamiento de primera línea del melanoma avanzado no quirúrgico y metastásico: análisis de impacto presupuestario en la perspectiva del Sistema Nacional de Salud de Brasil, 2018-2020 / 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

Objetivo: estimar o impacto orçamentário incremental da terapia-alvo para tratamento de primeira linha do melanoma avançado não cirúrgico e metastático, em comparação à dacarbazina. Métodos: análise de impacto orçamentário na perspectiva do Sistema Único de Saúde (SUS) do Brasil; a partir de dados demográficos e estimativas da incidência, foi delimitada a população no horizonte temporal de três anos (2018-2020) e estimados os custos diretos médicos; foi considerado cenário de referência o tratamento com dacarbazina, e como cenários alternativos a terapia-alvo com vemurafenibe, dabrafenibe, vemurafenibe + cobimetinibe e dabrafenibe + trametinibe; a avaliação das incertezas foi conduzida mediante análise por cenários. Resultados: o impacto orçamentário incremental variou de R$ 451.867.881,00 a R$ 768.860.968,00, representando 0,70 a 1,53% dos gastos anuais totais com medicamentos ambulatoriais no SUS; no melhor e no pior cenário, os resultados variaram de R$ 289.160.835,00 a R$ 1.107.081.926,00. Conclusão: a terapia-alvo, comparada à dacarbazina, implica impacto excessivo no orçamento, desfavorecendo eventual incorporação.

Objetivo: estimar el impacto presupuestario incremental de la terapia dirigida para tratamiento de primera línea del melanoma avanzado no quirúrgico y metastásico comparado con la dacarbazina. Métodos: análisis de impacto presupuestario, en la perspectiva del Sistema Único de Salud (SUS) de Brasil; a partir de datos demográficos y estimaciones de incidencia se delimitó la población en un horizonte temporal de tres años (2018-2020) y se estimaron los costos directos médicos. El escenario de referencia fue el tratamiento con dacarbazina y los escenarios alternativos la terapia dirigida con vemurafenib, dabrafenib, vemurafenib + cobimetinib y dabrafenib + trametinib; la evaluación de incertidumbre se llevó a cabo mediante análisis por escenarios. Resultados: el impacto presupuestario incremental varió de R$ 451.867.881,00 a R$ 768.860.968,00, representando 0,70 a 1,53% de gastos anuales totales con medicamentos de ambulatorios en el SUS; en el mejor y el peor escenario los resultados variaron de R$ 289.160.835,00 a R$ 1.107.081.926,00. Conclusión: el uso de terapia dirigida comparado a la dacarbazina implica en impacto excesivo en el presupuesto, desfavoreciendo una eventual incorporación.

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.

Compras federais de antineoplásicos no Brasil: análise do mesilato de imatinibe, trastuzumabe e L-asparaginase, 2004-2013 / Federal procurement of antineoplastic drugs in Brazil: analysis of imatinib mesylate, trastuzumab and L-asparaginase, 2004-2013

Resumo Objetivo: Analisar o perfil das compras realizadas por órgãos federais brasileiros dos antineoplásicos mesilato de imatinibe, trastuzumabe e L-asparaginase, entre janeiro/2004 e dezembro/2013. Métodos: Dados de compras foram extraídos do Sistema Integrado de Administração de Serviços Gerais-SIASG. Foram analisados: quantidade, preço unitário, data e tipo de compra e órgão comprador. Para permitir comparação de preços, os valores correntes foram corrigidos para dezembro/2013, pelo IPCA. Resultados: As quantidades adquiridas do imatinibe e trastuzumabe aumentaram progressivamente, sendo o Ministério da Saúde (MS) o principal comprador. Seus preços médios ponderados (PMP) apresentaram tendência de queda. Observou-se redução nos PMP do imatinibe, mesmo antes da centralização da compra pelo MS. O PMP do transtuzumabe foi reduzido em 57% após a incorporação pela CONITEC e a centralização de compras. As quantidades e preços da L-asparaginase variaram entre os órgãos. Diferentemente dos outros medicamentos, verificou-se significativa elevação de 117% no PMP da L-asparaginase, refletindo o desabastecimento no mercado mundial. Conclusões: A inclusão em Parcerias de Desenvolvimento Produtivo e a centralização das compras pelo MS parecem justificar as reduções de preço do imatinibe e trastuzumabe, reforçando a tese do uso do poder de compra do Estado. Estas reduções podem contribuir na ampliação de seu acesso no SUS.

Abstract Objective: To analyze the Brazilian federal procurement profile for imatinib mesylate, trastuzumab and L-asparaginase from January 2004 to December 2013. Methods: Information was extracted from the Brazilian Federal Government procurement database and included volume, unit price, date and type of purchase, government agency buyer. Prices were deflated to December 2013 by the Brazilian Pricing Index. Results: Purchase volumes of imatinib and trastuzumab increased progressively. The Ministry of Health was the main buyer. Weighted average prices (WAP) for these medicines showed a downward trend. A WAP reduction for imatinibe occurred before centralized purchases by the Ministry of Health began. After incorporation by CONITEC and centralized purchases in 2012, trastuzumab WAP was reduced by 57%. For L-asparaginase volumes and prices varied among different government agencies, but contrary to the two other medicines, L-asparaginase presented a 117% WAP increase, possibly reflecting stockouts in the international market. Conclusions: The setting of Productive Development Partnerships (PDPs) and centralized purchasing by the Brazilian Ministry of Health suggest a decrease in prices for imatinib and trastuzumab, underlining the government´s purchasing power. These reductions may contribute to availability of these medicines in the Brazilian Public Health System.

A preliminary analysis of the reduction of chemotherapy waste in the treatment of cancer with centralization of drug preparation / Uma análise preliminar da redução do resíduo de quimioterapia no tratamento do câncer com a centralização no preparo da medicação

SummaryIntroduction:chemotherapy is essential to treat most types of cancer. Often, there is chemotherapy waste in the preparation of drugs prescribed to the patient. Leftover doses result in toxic waste production.Objective:the aim of the study was to analyze chemotherapy waste reduction at a centralized drug preparation unit.Methods:the study was cross-sectional, observational and descriptive, conducted between 2010 and 2012. The data were obtained from chemotherapy prescriptions made by oncologists linked to a health insurance plan in Curitiba, capital of the state of Paraná, in southern Brazil. Dose and the cost of chemotherapy waste were calculated in each application, considering the dose prescribed by the doctor and the drug dosages available for sale. The variables were then calculated considering a hypothetical centralized drug preparation unit.Results:there were 176 patients with a cancer diagnosis, 106 of which underwent treatment with intravenous chemotherapy. There were 1,284 applications for intravenous anticancer medications. There was a total of 63,824mg in chemotherapy waste, the cost of which was BRL 448,397.00. The average cost of chemotherapy waste per patient was BRL 4,607.00. In the centralized model, there was 971.80mg of chemotherapy waste, costing BRL 13,991.64. The average cost of chemotherapy waste per patient was BRL 132.00.Conclusion:the use of centralized drug preparation units may be a strategy to reduce chemotherapy waste.

ResumoIntrodução:a quimioterapia é essencial no tratamento da maioria dos tipos de câncer. No processo de preparo da quimioterapia, com frequência, parte da medicação precisa ser descartada para se atingir a dose prescrita pelo médico. A dose excedente da medicação resulta na produção de resíduo tóxico.Objetivo:analisar a redução do resíduo de quimioterapia obtida por meio da centralização do preparo da medicação.Metodologia:foi realizado um estudo transversal observacional e descritivo entre 2010 e 2012, a partir da análise das prescrições de quimioterapia, pela auditoria médica de um plano de saúde, no estado do Paraná. Foi calculada a dose de quimioterapia desprezada e o seu custo, em cada aplicação, considerando a dose prescrita pelo médico e as apresentações comerciais das drogas. A mesma análise foi realizada em um modelo hipotético centralizado de preparo de quimioterapia.Resultados:foram identificados 176 pacientes, com diagnóstico de câncer, sendo que 106 pacientes realizaram um total de 1.284 aplicações endovenosas. Houve um total de 63.824 mg de resíduo de quimioterapia com custo de R$ 448.397,00. O custo médio de quimioterapia desprezada por paciente foi de R$ 4.607,00. No modelo centralizado de preparo houve 971,80 mg de resíduo com custo de R$ 13.991,64. Nesse modelo, o custo médio de quimioterapia desprezada por paciente seria de R$ 132,00.Conclusão:conclui-se que a centralização no preparo da medicação para o tratamento do câncer pode ser uma estratégia para reduzir os resíduos de quimioterapia.

An economic evaluation of trastuzumab as adjuvant treatment of early HER2-positive breast cancer patients in Colombia / Evaluación económica del trastuzumab como tratamiento adyuvante en cáncer de mama HER2- positivo en Colombia

Objective: Trastuzumab (Herceptin®), a recombinant, humanized, monoclonal antibody targeting HER2 is well established as an effective treatment for HER2-positive breast cancer. Evidence from developed countries showed that trastuzumab was cost-effective; but there are few evidences in developing countries. This study assesses the cost-effectiveness of adjuvant trastuzumab treatment in Colombia. Methods: A Markov health-state transition model was built to estimate clinical and economic outcomes in HER2-positive breast cancer with or without 12 months trastuzumab adjuvant chemotherapy over a lifetime perspective with annual transition cycles. The model incorporated five health states (diseasefree, local recurrence, distant recurrence, cardiac failure, and death). Baseline event rates and 3-year hazard ratio (HR=0.51, IC 95% 0.44-0.59; p<0.0001) were derived from 4-year follow up of the N9831 and NSABP B-31 trial. Costs and utility weights were obtained from the literature and were discounted by 5% annually. Results: The model showed that the utilization of adjuvant trastuzumab treatment in early breast cancer can prolong 0.80 quality-adjusted life-years (QALY), compared with standard chemotherapy, an incremental cost-effectiveness ratio (ICER) of US$ 71,491 per QALY gained. Conclusion: The results suggest that 1-year adjuvant Trastuzumab treatment is not cost-effective in Colombia, using the definition of WHO cost-effectiveness threshold of 3 times GDP per capita.

Introducción. El trastuzumab es un anticuerpo monoclonal de reconocida efectividad para el tratamiento en mujeres con cáncer de mama positivo para HER2. Sin embargo, la mayoría de estudios de costo-efectividad se han llevado a cabo en países desarrollados. Objetivo. Determinar el costo-efectividad del tratamiento adyuvante con trastuzumab en mujeres con cáncer de mama HER2+ en Colombia. Materiales y métodos. Se construyó un modelo de Markov, con ciclos de transición anuales y desde la perspectiva del pagador, para estimar los resultados clínicos y económicos derivados de la administración de trastuzumab en mujeres con HER2 positivo. El modelo incorpora cinco estados de transición: libre de enfermedad, recurrencia local, metástasis, falla cardiaca y muerte. La tasa de eventos y la razón de tazas instantáneas (0,51; IC 95% 0,44-0,59; p<0,0001) se derivaron del reporte a cuatro años de los ensayos clínicos controlados N9831 y NSABP B-31. Los costos y las utilidades se estimados a partir de la literatura científica, utilizando una tasa de descuento del 5 % anual. Resultados. El modelo revela que la utilización de trastuzumab como tratamiento adyuvante prolonga la expectativa de vida ajustada por calidad en 0,8 años, en comparación con la quimioterapia sin trastuzumab; a una razón de costo efectividad incremental (sic.) de US$ 71.491 por año de vida ganado ajustado por calidad de vida. Conclusión. El tratamiento con trastuzumab durante un año no es costo-efectivo en Colombia, utilizando la definición de costo-efectividad de la OMS de menos de dos a tres veces el PIB per cápita por año de vida ganado ajustado por calidad de vida.

direct medical costs of breast cancer in Iran: analyzing the patient's level data from a cancer specific hospital in Isfahan

Breast cancer is one of the main causes of mortality and morbidity world-wide. The estimation of the direct medical costs of breast cancer can help payers of the cost to understand the burden of breast cancer on their limited financial resources as well as the society. We used a cross-sectional study to calculate the direct medical costs of breast cancer among women in Isfahan, Iran. The medical records of all patients which were registered in Seyed Al-Shohada Hospital between March 2005 and March 2010 were reviewed. The relevant data from patients' profiles extracted. The direct medical costs of received services were calculated with both public and private tariffs. The total numbers of 467 patients in various disease stages were included into the study. The average age of patients was 49 years. The average direct cost per patient per month in stages I to IV were 222.17, 224.61, 316.51 and 828.52 US$, respectively. The surgery cost was the main cost driver for stages I and II with private tariffs. However for stages III and IV, the medication cost was the main cost component for managing breast cancer. The direct economic cost of breast cancer in Iran is very high; nonetheless, as the age of breast cancer in Iran is nearly 10 years lower than Western countries, the burden of the disease in Iran is expected to be significantly high. Medication therapy is the main cost component of the breast cancer

Periocular basal cell carcinoma: cost of topical immunotherapy versus estimated cost of surgical treatment / Carcinoma basocelular periocular: custo da imunoterapia tópica versus custo estimado do tratamento cirúrgico

PURPOSE: The objective of this study was to compare the estimated cost of clinical and surgical treatment for basl cell carcinoma of the eyelid. METHODS: This was a pilot study of 12 patients with basal cell carcinoma receiving treatment with 5% imiquimod cream at the ocular plastic surgery center, medical school University of São Paulo (HC-FMUSP, Brazil). The cost of clinical treatment was estimated based on the time of treatment and amount of medication consumed by patients in the home setting. The cost of surgical treatment was estimated by ophthalmologists with experience in reconstructive plastic surgery based on analysis of images of the same patients. Surgeons responded to a questionnaire with four questions about surgical technique, surgical materials required, estimated duration of surgery and type of anesthesia. RESULTS: Immunotherapy lasted from 8 to 12 weeks.All patients reported each coldstored sachet with 5% imiquimod cream lasted 3 days.According to the institution, a box with 12 sachets costs BRL 480.00. Patients required 1.58-3.11 boxes for complete treatment, corresponding to a total cost of BRL 758.401,492.80. Based on image analysis, surgeons evaluated surgery would require 1-3 hours. The estimated cost of surgery room and staff was BRL 263.00, to which the cost of supplies was added. Thus, the total cost of surgical treatment was BRL 272.61-864.82. On the average, immunotherapy was 57,64% more costly than surgical treatment. CONCLUSIONS: Malignant eyelid tumors are a common finding in clinical ophthalmology. Surgery is still the treatment of choice at our institution, but immunotherapy with 5% imiquimod cream may be indicated for patients with multiple lesions or high surgical risk and for patients declining surgery for reasons of fear or esthetic concerns.The ability to estimate costs related to the treatment of malignant eyelid tumors is an important aid in the financial planning of health care institutions. Further studies should evaluate the possibility of institutions equating the cost of immunotherapy and surgical treatment by acquiring similar but less expensive medications.

OBJETIVO: O objetivo deste estudo foi comparar os custos do tratamento clínico e cirúrgico para carcinoma basocelular palpebral. MÉTODO: Neste estudo piloto, doze pacientes com carcinoma basocelular atendidos no departamento de Plástica Ocular do Hospital das Clínicas da Universidade de São Paulo (HC-FMUSP) foram tratados com imiquimode creme 5%. O Custo do tratamento clínico foi estimado baseado no tempo de tratamento e quantidade de medicação utilizada pelo paciente no domicilio. O custo do tratamento cirúrgico foi baseado na análise das imagens dos mesmos pacientes submetidos ao tratamento clínico, por Oftalmologistas experientes em cirurgia plástica reconstrutiva. Os profissionais responderam um questionário com quatro perguntas relacionadas à técnica cirúrgica, à quantidade de material gasto, ao tempo cirúrgico estimado e anestesia utilizada. RESULTADOS: O tempo de tratamento clínico variou entre 8 a 12 semanas.Todos os pacientes referem que um sachê dura 3 dias e armazenaram na geladeira. O valor informado pela instituição na compra do imiquimode creme 5% foi de 40,00 reais/sachê, portanto o custo da caixa medicação foi de R$ 480,00 a caixa.A média de caixas consumidas por tratamento variou de 1,58 a 3,11 caixas, portanto o custo do tratamento clínico variou de R$ 758,40 a R$1.492,80. Os cirurgiões avaliaram as imagens dos pacientes submetidos ao tratamento clínico e informaram que o tempo estimado de cirurgia para cada paciente seria de 1 a 3 horas se a opção fosse cirúrgica.Foi estimado um custo de centro cirúrgico, incluindo espaço físico e pessoal de R$ 263,00 ao qual foi acrescido o valor do material que seria utilizado.Assim, observou-se que o valor variou entre R$ 272,61 a R$ 864,82 para o tratamento cirúrgico. O tratamento clínico em média foi de 57,64% superior ao tratamento cirúrgico. CONCLUSÃO: As lesões palpebrais malignas são responsáveis por uma porção importante na prática clínica oftalmológica. A cirurgia continua ...

Uso racional de medicamentos antineoplásicos e ações judiciais no Estado de São Paulo / Uso racional de medicamentos antineoplásicos y acciones judiciales en el estado de Sao Paulo, Sureste de Brasil / Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, southeastern Brazil

OBJETIVO: Avaliar a racionalidade das ações judiciais e pedidos administrativos recebidos pela Secretaria de Estado da Saúde de São Paulo segundo evidências científicas de eficácia e segurança. MÉTODOS: Estudo descritivo, transversal, baseado em informações da Secretaria de Saúde sobre os medicamentos antineoplásicos solicitados por via judicial, com maior impacto financeiro para o Sistema Único de Saúde em 2006 e 2007. Os fármacos foram avaliados quanto às evidências clínicas de eficácia e segurança, com base na classificação do Micromedex®, em metanálises e revisões sistemáticas. As indicações foram confrontadas com aquelas aprovadas em agências reguladoras. RESULTADOS: Os medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe e temozolomida geraram gastos superiores a R$ 40 milhões para atender 1.220 solicitações, com custo médio de R$ 33,5 mil por paciente. Os estudos selecionados não recomendam parte das indicações dos medicamentos prescritos. Cerca de 17 por cento dos pedidos não tinham evidência para a indicação mencionada no pleito, o que equivale a um gasto inadequado de, no mínimo, R$ 6,8 milhões...

OBJECTIVE: To assess the rationality of legal suits and administrative requests requiring anticancer drugs filed against and submitted to the São Paulo State Department of Health, in view of scientific evidence on efficacy and safety. METHODS: A descriptive cross-sectional study was carried out based on information on lawsuits filed by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest financial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on efficacy and safety, based on Micromedex® categorization, on systematic reviews and meta-analyses. Indications present in the legal documentation were compared to the indications approved by regulatory agencies. RESULTS: Bevacizumab, capecitabine, cetuximab, erlotinib, rituximab, imatinib, and temozolomide accounted for expenses over R$ 40 million to meet 1220 requests and lawsuits, at an average cost of R$ 33,500 per patient. Selected studies do not recommend all the indications for the prescribed drugs. Approximately 17 percent of requests and lawsuits did not provide evidence for the required indication, and these amounted to inappropriate expenses of, at least, R$ 6.8 million...

OBJETIVO: Evaluar la racionalidad de las acciones judiciales y pedidos administrativos recibidos por la Secretaria Estatal de Salud de Sao Paulo según evidencias científicas de eficacia y seguridad. MÉTODOS: Estudio descriptivo, transversal basado en informaciones de la Secretaria sobre los medicamentos antineoplásicos solicitados por vía judicial, con mayor impacto financiero para el Sistema Único de Salud en 2006 y 2007. Los fármacos fueron evaluados considerando las evidencias clínicas de eficacia y seguridad, con base en la clasificación de Micromedx®, metanálisis y revisiones sistemáticas. Las indicaciones fueron confrontadas con las aprobadas en agencias reguladoras. RESULTADOS: Los medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe y temozolomida generaron gastos superiores a R$ 40 millones para atender 1.220 solicitudes, con costo promedio de R$ 33,5 mil por paciente. Los estudios seleccionados no recomiendan parte de las indicaciones de los medicamentos prescritos. Cerca de 17 por ciento de los pedidos no tenían evidencia para la indicación mencionada en el pleito, lo que equivale a un gasto inadecuado de, mínimo, R$ 6,8 millones...

Potential economic impact of the 21-gene expression assay on the treatment of breast cancer in brazil / Potencial impacto econômico do painel de expressão de 21 genes no tratamento adjuvante do câncer de mama no Brasil

OBJECTIVE: The 21-gene expression assay may support the decision regarding use of chemotherapy in early breast cancer. We sought to investigate the potential impact of incorporating the 21-gene expression assay into private practice in Brazil, from the perspective of third party payers. METHODS: We conducted a web-based survey with 30 (of a total of approximately 700) Brazilian medical oncologists, who were stratified by State according to the proportion of patients with breast cancer and private health insurance. We evaluated the possible treatment of first choice for patients with lymph-node-negative, estrogen-receptor-positive breast cancer, regardless of menopausal status. Interviewees were not aware of the objective of the study. Responses permitted a quantitative assessment of the care patterns regarding use of different chemotherapy regimens, type of premedication, use of growth factors, and use of intravenous antibiotics for febrile neutropenia. We calculated medication costs using the manufacturer's recommended prices. Other direct medical expenses, indirect medical costs, and non-medical costs were not included. RESULTS: Considering a hypothetical cohort of 100 patients without access to the 21-gene expression assay, the survey showed that 84 patients would receive chemotherapy. Reclassifying patient eligibility for chemotherapy according to the 21-gene expression assay would lower this number to 49. For a hypothetical cohort of 100 patients with access to the test, US$ 79,361.43 would be saved in main direct medical costs. Such results, however, would greatly vary according to tumor size: the 21-gene expression assay could increase direct medical costs in T1 tumors, and decrease costs in cases with T >2 cm. CONCLUSION: Considering the current price for the 21-gene expression assay in Brazil, our economic analysis suggests that such testing is an overall cost-saving, from the perspective of third party payers. Further, optimal ...

OBJETIVO: O índice de recorrência (IR), também conhecido como painel de 21 genes, pode apoiar decisões com relação ao uso de quimioterapia (QT) no câncer de mama precoce. Procuramos investigar o impacto potencial da incorporação do IR na prática privada no Brasil, a partir da perspectiva das fontes pagadoras. MÉTODOS: Conduzimos uma pesquisa com 30 oncologistas brasileiros (de um total de aproximadamente 700), que foram estratificados por Estado de acordo com a proporção de pacientes com câncer de mama e com cobertura pelo sistema de saúde suplementar. Avaliamos o tratamento de primeira escolha para pacientes com câncer de mama com axila negativa e expressão positiva do receptor de estrógeno, independente do estado menopausal. Os entrevistados não estavam cientes do objetivo do estudo. As respostas permitiram uma avaliação quantitativa dos padrões de cuidado, considerando o uso de diferentes regimes de QT, o tipo de pré-medicações, o uso de fatores de crescimento e o tratamento hospitalar da neutropenia febril. Calculamos o custo dos medicamentos usando o Brasíndice, e o custo do IR foi fixado em R$ 3.900,00 (MammaGene®). Outras despesas médicas diretas, custos médicos indiretos e custos não-médicos não foram considerados. RESULTADOS: Numa corte hipotética de 100 pacientes sem acesso ao teste de IR, 84 iriam receber quimioterapia. Reclassificando a elegibilidade das pacientes para QT de acordo com o IR, esse número cairia para 49. Para uma coorte hipotética de 100 pacientes com acesso ao IR, seriam economizados R$ 134.915,00 em despesas médicas diretas. CONCLUSÃO: Considerando o preço atual para avaliação do IR no Brasil, nossa análise econômica sugere que este teste economizaria custos, pela perspectiva das fontes pagadoras do setor privado. Além disso, o uso otimizado de recursos poderia requerer o emprego do painel de 21 genes de forma racional.

Costo directo de la farmacoterapia de la leucemia aguda en el Hospital Clínico Regional de Valdivia, Chile: análisis del período 2003 a 2006 / Direct costs of pharmacotherapy for acute leukemia at a Regional Hospital in Chile

Background: In Chile, leukemia is one of the diseases whose treatment is guaranteed by a special law called AUGE (universal access and explicit guaranties). Therefore, the knowledge of its treatment costs is of utmost importance. Aim: To determine and to characterize the direct costs of pharmacotherapy for leukemia at a regional hospital in Chile. Material and methods: Data were retrospectively obtained from electronic and manual records of the hospital for all patients treated for leukemia between 2003 and 2006. Patients were classified into four groups: pediatric and adult patients treated for acute lymphocytic leukemia (ALL children and ALL adults, respectively), and pediatric and adult patients treated for acute myelogenous leukemia (AML children and AML adults, respectively). Results: Total accumulated costs of pharmacotherapy for acute leukemia between 2003 and 2006 were 304,724,845 Chilean pesos (USD 574,952). The higher total or per patient costs, were generated by drugs for chemotherapy compared to other required medications. The exception were AML children, where support drugs, such as antimicrobials, ant emetic drugs and colony stimulating factors, generated the higher costs per patient. Among ALL adults, AML children and AML adults, the costs were concentrated in the first 6 months of treatment. NO children followed this tendency concentrating the costs between the seventh and twenty-fourth months. Conclusions: Annual costs of pharmacotherapy per patient for acute leukemia in this regional hospital were approximately USD 4,717. Chemotherapy was the item with the greatest impact on cost.

Aspectos clínico-econômicos da quimioterapia adjuvante no câncer de mama HER-2 positivo / Clinical and economic issues in adjuvant chemotherapy for HER-2 positive breast cancer

OBJETIVO: Avaliar o impacto clínico e os custos do tratamento adjuvante para câncer de mama com superexpressão do receptor 2 do Fator de Crescimento Epidérmico (HER-2). MÉTODOS: Foram obtidas medidas de eficácia (sobrevida livre de doença em 3 anos) dos ensaios de fase III com trastuzumabe para o câncer de mama HER-2 positivo: um estudo finlandês (FinHER), dois americanos (National Surgical Adjuvant Breast and Bowel Project - NSAPB-31 e North Central Cancer Treatment Group N9831) e dois multinacionais (Herceptin Adjuvant, HERA e Breast Cancer International Research Group, BCIRG-006), e calculadas medidas de impacto clínico: redução de risco e número necessário para tratar (NNT). Foram estimados os custos com medicamentos antineoplásicos nestes diferentes regimes terapêuticos. RESULTADOS: A redução absoluta de risco com uso do trastuzumabe foi maior no estudo FinHER (11,7 por cento; IC 95 por cento: 2,2 por cento a 21,2 por cento). O NNT no FinHER foi 8 (IC 95 por cento: 3 a 28), 8 (IC 95 por cento: 7 a 11) no NSABP-31/N9831, 12 (IC 95 por cento: 9 a 18) no HERA, 14 (IC 95 por cento: 11 a 24) no BCIRG/com antraciclinas e 17 (IC 95 por cento: 12 a 34) no BCIRG/sem antraciclinas. O custo para evitar um caso de recidiva seria R$ 418.285,44 com o regime FinHER, R$ 1.716.789,44 no NSABP-31/N9831, R$ 2.481.891,58 no HERA, R$ 2.963.634,62 no BCIRG/com antraciclinas e R$ 3.930.520,43 no BCIRG/sem antraciclinas. CONCLUSÃO: Restringir o uso do trastuzumabe à fase inicial de quimioterapia adjuvante (FinHER) permite beneficiar, do ponto de vista econômico, quatro a nove vezes mais pacientes que a monoterapia adjuvante prolongada como usada nos demais protocolos.

PURPOSE: To examine efficacy figures and drug expenditure for adjuvant chemotherapy in human epidermal growth factor receptor 2 (HER-2) positive breast cancer, in the Brazilian supplemental health insurance market. METHODS: We obtained efficacy data (disease free survival at 3-years) and drug cost estimate for current adjuvant strategies in HER-2 positive breast cancer: Finland Herceptin (FinHER), National Surgical Adjuvant Breast and Bowel Project (NSAPB-31), North Central Cancer Treatment Group (N9831), Herceptin Adjuvant (HERA) and Breast Cancer International Research Group (BCIRG-006). We estimated clinical impact measures - number needed to treat (NNT) and absolute risk reduction (ARR) - and total drug cost by protocol to avoid one single cancer recurrence. RESULTS: The largest ARR was 11.7 percent (95 percent CI: 2.2 percent to 21.2 percent) in the FinHER study, and the smallest in the nonanthracycline arm of the BCIRG trial, 4.9 percent (95 percent CI: 1.8 percent to 8.1 percent). The NNT was 8 (95 percent CI: 3 to 28) in the FinHER, 8 (95 percent CI: 7 to 11) in the NSABP-31/N9831, 12 (95 percent CI: 9 to 18) in the HERA, 14 (95 percent CI: 11 to 24) in the BCIRG/Anthracycline, and 17 (CI 95 percent CI: 12 to 34) in the BCIRG/Nonanthracycline. Drug cost to avoid one single cancer recurrence would be R$ 418,285.44 with the FinHER regimen, R$ 1,716,789.44 with the NSABP-31/N9831, R$ 2,481,891.58 with the HERA, R$ 2,963,634.62 with the BCIRG/Anthracicline, and R$ 3,930,520.43 with the BCIRG/Nonanthracycline (exchange rate: R$ 1.00 = USD 0.56). CONCLUSION: From an economic viewpoint, four to seven times more patients could benefit by using a short-course of trastuzumab at the initial adjuvant chemotherapy cycles (FinHER regimen) than by the prolonged trastuzumab administration as used in other adjuvant schedules.

Implicações clínicas e econômicas da quimioterapia adjuvante no câncer de mama her-2/neu positivo / Clinical and economical issues of adjuvant chemotherapy in Her-2 positive breast cancer

Tal estudo visou a avaliar a eficácia e os custos da quimioterapia adjuvante para mulheres com câncer de mama com superexpressão HER-2/neu. Obteve-se a estimativa de eficácia (sobrevida livre de doença em três anos) dos estudos com trastuzumabe no tratamento adjuvante de mulheres com câncer de mama HER-2/neu positivo (FinHER, N9831 e HERA). Estas foram convertidas em medidas de impacto clínico: redução de risco e número necessário tratar para evitar um desfecho (NNT). Estimaram-se os custos com medicamentos antineoplásicos nesses diferentes cenários terapêuticos. A redução absoluta de risco foi de 11,7% (IC 95%: 2,2%-21,2%) no Estudo FinHER, 6,8% (IC 95%: 3,3%-10,2%) no N9831 e 6,3% (IC 95%: 3,5%-9,1%) no HERA. O NNT no Estudo FinHER foi 9 (IC 95%: 5-45), no N9831 foi 15 (IC 95%: 10-30) E no HERA foi 16 (IC 95%: 11-29). O custo com medicamentos para se evitar um caso de recidiva da doença seria de R$ 471.570,63 no protocolo FinHER, R$ 3.301.244,59 no N9831 e R$ 3.316.224,19 no HERA. Restringir o uso do trastuzumabe à fase inicial de quimioterapia adjuvante (FinHER) permitiria, do ponto de vista econômico, beneficiar sete vezes mais pacientes que a monoterapia adjuvante como empregada nos protocolos N9831 ou HERA.

This study intended to examine efficacy figures and drug expenditure for adjuvant chemotherapy in HER-2/neu positive breast cancer. Thsi is a descriptive study on clinical impact and drug cost estimate for current adjuvant strategies in HER-2/neu positive breast cancer. Efficacy data (disease free survival at 3-year) of clinical trials on the role of trastuzumab in that setting were abstracted to estimate clinical impact measures - number needed to treat (NNT) and absolute risk reduction (ARR) - and we obtained drug cost of different therapeutic regimens for those trials. The ARR was 11.7% (95% CI: 2.2% to 21.2%) in the FinHER study, 6.8% (95% CI: 3.3% to 10.2%) in the N9831, and 6.3% (95% CI: 3.5% to 9.1%) in the HERA trial. The NNT was 9 (95% CI: 5 to 45), in the FinHER, 15 (95% CI: 10 to 30) in the N9831, and 16 (95% CI: 11 to 29) in the HERA. Drug cost to avoidd one cancer recurrence would be R$ 471,570.63 with the FinHER regimen, R$ 3,301,244.59 with the N9831protocol, and R$ 3,316,224.19 with the HERA schedule (USD 1.00 = R$2.10) From an economical viewpoint, we could benefit seven times more patients using a short-course of trastuzumab at the initial adjuvant chemotherapy cycles (FinHER regimen) than with a prolonged trastuzumab administration after adjuvant chemotherapy (N9831 or HERA protocol).

Trastuzumab: is the new evidence revolutionary?

A few years back, the survival benefit of trastuzumab in HER 2 positive breast cancer patients presenting with metastatic disease was proven in a randomized setting. Recently a number of randomized trials have reported their results in the adjuvant setting in HER 2 positive patients. These trials have been considered by some as a landmark in the evolution of breast cancer management. Although the data is encouraging, it need to be seen in a proper perspective keeping in mind the limitations and the side effects reported. This article stresses the use of Herceptin in carcinoma breast patients in adjuvant setting with a cautionary eye.

Análises parciais de custos ditretos nos esquemas terapêuticos oncológicos em pediatria / Partial analyses of costs directs in projects oncological therapeutical

Atualmente, os sistemas de saúde do Brasil, tanto públicos como privados deparan-se com a dificuldade de gerenciar os custos dos tratamentos diante das receitas obtidas pelos mesmos. O objetivo deste trabalho foa a realizar uma análise parcial dos custos diretos, envolvendo os medicamentos e materiais médico-hospitalares, utilizados em diferentes esquemas terapêuticos em pediatria oncológica. Os resultados foram obtidos através da realização de cálculos de custo dos medicamentos antineoplásicos, antiéméticos, fatores estimulantes de colônias de granulócitos utilizados nos diferentes esquemas terapêuticos utilizados no Hospital Erasto Gaertner. O custo médio mensal dos medicamentos antineoplásicos utilizados foi de 2.022,82 reais para o esquema de tratamento de carcinoma de supra renal , estádio IV; 538, 12 reais para o tratamento de sarcoma de Ewing - "EWI-92"; 219,52 reais para tratamento de LLA - GBTLI/99 - alto risco ; 300,90 reais para o esquema de tratamento de linfoma de Hodgkin - ABVD; 1577,73 reais para o tratamento de osteossarcoma recidivado e 3.899,40 reais para o tratamento de glioma. Desta maneira, conclui-se que o custo da terapia antineoplásica difere para cada tipo de neoplasia e esquema terapêutico adotado. Os protocolos ABVD, GBTLI/99, EWI-92 e osteossarcoma recidivado tiveram os custo com antineoplásicos, antieméticos, fator de crescimento de granulócitos, antibióticos e MMH, cobertos pelo valor da receita pela APACS E AIHS. O esquema de quimioterapia utilizado para o carcinoma de supra renal apresenta custo elevado, que ultrapassa o valor previsto na APAC. O tratamento quimioterápico para glioma com temozolamida apresenta um custo que representa 3,18 vezes o valor repassado pela APAC.

Fight against cancer in countries with limited resources: the post-genomic era scenario.

The enormous advances in science and technology in the 20th century have facilitated the process of globalization with the aim of a better quality of life for all. Paradoxically, the gap between the rich and the poor, for both nations and people, is constantly widening. The actual trends in human genome research are leading towards promising genomic medicine, but it will be expensive and inaccessible for many. Also, it may not offer a quick fix "cure" for various types of cancers. The biggest challenge before the clinicians now is the management of the rising incidence of cancer in developing countries, with little prospect of more resources becoming available to fight the disease. The death rate from cancer in the developing countries is set to rise at least 3-fold by the year 2025 largely due to the increased life expectancy, containment of infectious diseases and changing lifestyles. It is estimated that about 50% of cancers are curable if they are detected early and treated appropriately. Screening has a major role in early diagnosis. However, in the developing world around 80% of cancer patients have late stage incurable disease when they are diagnosed. Moreover, in a developing country like India, about 70% of the population obtain medical help from private practitioners. Nearly half of those who seek medical help utilize alternative and traditional systems of medicine. Appalling poverty, poor hygiene and complex social dynamics, pose major hurdles in this regard. Many in the private sector who call themselves doctors have no medical degree. By 2030 tobacco is expected to kill 10 million people worldwide, out of which 70% of the deaths will occur in the developing countries. Control of usage of tobacco has still not achieved a conducive atmosphere. It is now realized that the research information and knowledge generated in the west may neither be relevant nor applicable to developing countries, due to differences in social and cultural attitudes, lifestyles and lack of sophisticated technologies. Though the sequencing of the human genome will have a major impact on the prevention, diagnosis, treatment, monitoring, and outcome of cancer, the cancer scenario in the developing countries for the next 20 years is likely to be more or less the same, rather than presenting a radically different picture. Cancer awareness and screening programs for early detection thus should be continue to be given utmost attention.

Generating finances for the chemotherapy of children with cancer.

BACKGROUND: To develop and evaluate a system of obtaining financial assistance for the treatment of children with solid tumours by involving individual members of society. METHODS: This prospective project was carried out at the Paediatric Solid Tumours Clinic of the Department of Paediatric Surgery, All India Institute of Medical Sciences, New Delhi, from January 1994 to December 1998. Donor families were enlisted by talking to affluent people. Families who agreed to help in this effort were told that they could 'adopt' a child for the purpose of his/her treatment and that they should purchase the prescribed chemotherapeutic drugs and give them to the family of the affected child. Therapy was started once the drug was received at the hospital. This process was repeated at each subsequent visit. RESULTS: Of the 291 children with solid tumours registered at the clinic, 45 (15.5%) received financial assistance by this method. The proportion of children receiving financial assistance increased from 8.6% in 1994 to 23% in 1998. Of all those who received assistance, 20 (44.4%) have completed therapy and are surviving, 11 are still on therapy, 12 died and 2 decided to discontinue therapy because of progressive disease. CONCLUSIONS: The advantages of this system far outweigh its disadvantages. This method of generating finances for children with cancer can be recommended to all doctors treating such children.

Los medicamentos antineoplásicos y sus perspectivas en los países del tercer mundo / The antineoplastic drugs and their perspectives in the Third World countries

El cáncer es la segunda causa de muerte de la población en la mayoría de los países del mundo, incluyendo en éstos a algunos países subdesarrollados. Sin embargo, los países desarrollados tienen acceso a la mayoría de los medicamentos antineoplásicos en comparación con el que tienen los países del Tercer Mundo; donde existe una gran diferencia en el nivel de consumo por enfermo. Para que se tenga una magnitud de esta problemática, se realiza una evaluación económica estimada de los casos de cáncer en el Tercer Mundo y los costos promedio de los tratamientos quimioterapéuticos; también se realizan una comparación entre los niveles estimados del consumo actual y el consumo necesario para satisfacer las necesidades prioritarias de los países pobres en materia de medicamentos antineoplásicos. Sobre la base de este panorama, los países subdesarrollados sólo tienen una alternativa que es el autoabastecimiento de sus necesidades a partir de la producción nacional de fármacos para el cáncer. Esto no es más, que la adquisición de una planta productora de formas terminadas de medicamentos a partir de la materia prima importada

Criterios sobre la evaluacion economica de los medicamentos antineoplasicos / Critreria on the economic evaluation of antineoplastic drug

El presente trabajo tiene como objetivo, exponer la situacion que presentan los medicamentos antineoplasicos en el mercado mundial, el monopolio comercial que tienen las empresas multinacionales (EMN) sobre ellos y la repercusion que tienen los precios de estos farmacos sobre los costos de los tratamientos quimioterapeuticos para el cancer. Se hizo necesario realizar la evaluacion economica de los medicamentos antineoplasicos para obtener un alto grado de eficiencia y efectividad de los resultados en los sistemas nacionales de salud, principalmente en los programas para el control de esta enfermedad. Ademas, se exponen los resultados de algunos trabajos de analisis y comparacion de los costos para los diferentes tratamientos quimioterapeuticos para el cancer, asi como de la relacion costo-efectividad y costo-utilidad en distintos paises del mundo