Budget impact from the incorporation of positron emission tomography - computed tomography for staging lung cancers / Impacto orçamentário da incorporação da tomografia de emissão de pósitrons - tomografia computadorizada para estadiamento de câncer pulmonar

OBJECTIVE To estimate the budget impact from the incorporation of positron emission tomography (PET) in mediastinal and distant staging of non-small cell lung cancer.METHODS The estimates were calculated by the epidemiological method for years 2014 to 2018. Nation-wide data were used about the incidence; data on distribution of the disease´s prevalence and on the technologies' accuracy were from the literature; data regarding involved costs were taken from a micro-costing study and from Brazilian Unified Health System (SUS) database. Two strategies for using PET were analyzed: the offer to all newly-diagnosed patients, and the restricted offer to the ones who had negative results in previous computed tomography (CT) exams. Univariate and extreme scenarios sensitivity analyses were conducted to evaluate the influence from sources of uncertainties in the parameters used.RESULTS The incorporation of PET-CT in SUS would imply the need for additional resources of 158.1 BRL (98.2 USD) million for the restricted offer and 202.7 BRL (125.9 USD) million for the inclusive offer in five years, with a difference of 44.6 BRL (27.7 USD) million between the two offer strategies within that period. In absolute terms, the total budget impact from its incorporation in SUS, in five years, would be 555 BRL (345 USD) and 600 BRL (372.8 USD) million, respectively. The costs from the PET-CT procedure were the most influential parameter in the results. In the most optimistic scenario, the additional budget impact would be reduced to 86.9 BRL (54 USD) and 103.8 BRL (64.5 USD) million, considering PET-CT for negative CT and PET-CT for all, respectively.CONCLUSIONS The incorporation of PET in the clinical staging of non-small cell lung cancer seems to be financially feasible considering the high budget of the Brazilian Ministry of Health. The potential reduction in the number of unnecessary surgeries may cause the available resources to be more efficiently allocated.

OBJETIVO Estimar o impacto orçamentário da incorporação da tomografia por emissão de pósitrons (PET) no estadiamento mediastinal e à distância do câncer pulmonar de células não pequenas.MÉTODOS As estimativas foram calculadas pelo método epidemiológico para os anos de 2014 a 2018. Utilizaram-se dados nacionais de incidência; de distribuição de doença e acurácia das tecnologias procedentes da literatura, e de custos, de estudo de microcustos e das bases de dados do Sistema Único de Saúde. Analisaram-se duas estratégias de uso da PET: oferta a todos os pacientes recém-diagnosticados, e restrita àqueles que apresentassem resultados negativos de tomografia computadorizada (TC) prévia. Foram realizadas análises de sensibilidade univariadas e por cenários extremos para avaliar influência de fontes de incertezas nos parâmetros utilizados.RESULTADOS A incorporação da PET-TC ao Sistema Único de Saúde implicaria na necessidade de recursos adicionais de R$158,1 (US$98,2) milhões para oferta restrita a R$202,7 (US$125,9) milhões para oferta abrangente em cinco anos, com diferença entre as duas estratégias de oferta de R$44,6 (US$27,7) milhões no período. Em termos absolutos, o impacto orçamentário total da incorporação no Sistema Único de Saúde, em cinco anos, seria de R$555 (US$345) e R$600 (US$372,8) milhões, respectivamente. Custos do procedimento PET-TC foram o parâmetro de maior influência nos resultados. No cenário por extremos mais otimista, os impactos orçamentários incrementais reduzir-se-iam para R$86,9 (US$54) e R$103,8 (US$64,5) milhões, considerando PET-TC para TC negativa e PET-TC para todos, respectivamente.CONCLUSÕES A incorporação da PET no estadiamento clínico do câncer pulmonar de células não-pequenas parece ser financeiramente factível frente à magnitude do orçamento do Ministério da Saúde. A potencial redução no número de cirurgias desnecessárias pode produzir maior eficiência na alocação dos recursos disponíveis.

Cost-effectiveness of para-aortic lymphadenectomy before chemoradiotherapy in locally advanced cervical cancer / 부인종양

OBJECTIVE: To evaluate the cost-effectiveness of nodal staging surgery before chemoradiotherapy (CRT) for locally advanced cervical cancer in the era of positron emission tomography/computed tomography (PET/CT). METHODS: A modified Markov model was constructed to evaluate the cost-effectiveness of para-aortic staging surgery before definite CRT when no uptake is recorded in the para-aortic lymph nodes (PALN) on PET/CT. Survival and complication rates were estimated based on the published literature. Cost data were obtained from the Korean Health Insurance Review and Assessment Service. Strategies were compared using an incremental cost-effectiveness ratio (ICER). Sensitivity analyses were performed, including estimates for the performance of PET/CT, postoperative complication rate, and varying survival rates according to the radiation field. RESULTS: We compared two strategies: strategy 1, pelvic CRT for all patients; and strategy 2, nodal staging surgery followed by extended-field CRT when PALN metastasis was found and pelvic CRT otherwise. The ICER for strategy 2 compared to strategy 1 was $19,505 per quality-adjusted life year (QALY). Under deterministic sensitivity analyses, the model was relatively sensitive to survival reduction in patients who undergo pelvic CRT alone despite having occult PALN metastasis. A probabilistic sensitivity analysis demonstrated the robustness of the case results, with a 91% probability of cost-effectiveness at the willingness-to-pay thresholds of $60,000/QALY. CONCLUSION: Nodal staging surgery before definite CRT may be cost-effective when PET/CT imaging shows no evidence of PALN metastasis. Prospective trials are warranted to transfer these results to guidelines.

Costo-efectividad de 18FDG-PET/CT vs CT al final del tratamiento en pacientes pediátricos con Linfoma Hodgkin / 18FDG-PET/CT cost-effectiveness compared to CT at the end of treatment in pediatric Hodgkin's lymphoma patients

Objetivo Estimar la costo-efectividad de 18FDG-PET/CT comparado con CT seguido de 18FDG-PET/CT como prueba confirmatoria de un caso positivo en la evaluación al final del tratamiento en pacientes menores de 18 años con Linfoma Hodgkin (LH). Métodos Se construyó un árbol de decisión donde se comparó el uso de 18FDG-PET/CT con CT seguido de 18FDG-PET/CT como prueba confirmatoria de un caso positivo en la detección de lesión residual. El resultado se midió en Años de Vida Ganados (AVG). Se calculó la razón de costo-efectividad incremental. Se utilizó como umbral 3 veces el PIB per cápita por año AVG. Valores expresados en pesos colombianos de 2010 (1 US dólar = $ 1 897,89) Se realizaron análisis de sensibilidad univariados, bivariados y probabilísticos. Resultados Suponiendo un diferencial en AVG entre verdaderos positivos y falsos negativos de 13 meses, el costo de un AVG adicional con 18FDG-PET/CT comparado con CT seguido de 18FDG-PET/CT como prueba confirmatoria de un caso positivo en la evaluación al final del tratamiento en pacientes pediátricos con LH fue $ 34 508 590. Conclusión Si el diferencial de esperanza de vida entre verdaderos positivos y falsos negativos es de al menos un 1,03 años, el uso de 18FDG-PET/CT en la evaluación al final del tratamiento de pacientes pediátricos con LH, es una estrategia costo-efectiva para Colombia.

Objective Estimating the cost-effectiveness of 18FDG-PET/CT (positron emission tomography) compared to computer tomography (CT) followed by 18FDG-PET/CT as a confirmatory test for a positive case at the end of treatment in Hodgkin's lymphoma (HL) patients under 18 years-old. Methods A decision tree was built for comparing 18FDG-PET/CT to CT followed by 18FDG-PET/CT as a confirmatory test for a positive case in detecting residual lesions; outcome was measured in life years gained (LYG). The cost-effectiveness ratio was calculated; the threshold was 3 times the per capita GDP per LYG. Values were expressed in Colombian pesos for 2010 (1 US dollar=$ 1,897.89) and submitted to deterministic and probabilistic sensitivity analysis. Results Assuming a difference of 13 months in true positives' life expectancy compared to that for false negatives, the cost of an additional LYG with 18FDG-PET/CT compared to CT followed by 18FDG-PET/CT as a confirmatory test for a positive case when evaluating the end of pediatric HL patients' treatment was $ 34,508,590 (COP). Conclusion If differential life-expectancy between true positives and false negatives is at least 1.03 years, then using 18FDG-PET/CT for evaluating the end of HL pediatric patients' therapy is a cost-effective strategy for Colombia.

Análise dos custos do procedimento PET-TC com 18 F-FDG na perspectiva do SUS provedor: estudo em uma unidade pública de saúde do Rio de Janeiro, Brasil / Cost analysis of 18 F-FDG PET-CT from the perspective of the Brazilian Unified National Health System as healthcare provider: a study in a public healthcare center in Rio de Janeiro, Brazil / Análisis de costes del procedimiento PET-TC con 18 F-FDG desde la perspectiva del SUS proveedor: estudio en una unidad pública de salud de Río de Janeiro, Brasil

A tomografia de emissão de pósitrons (PET) é de uso recente no Brasil e há necessidade de se estimar os custos do procedimento, de forma a subsidiar estudos de avaliação econômica sobre a tecnologia. O trabalho analisou o processo de produção da PET-TC utilizando 18 F-FDG e estimou seus custos na perspectiva de um provedor público de serviços de saúde. Utilizou- se a técnica de microcustos, com identificação, quantificação e valoração de todos os insumos consumidos na produção do procedimento. As estimativas de custo consideraram a observação de 85 exames realizados no Instituto Nacional de Câncer, de março/julho de 2012. O caso de referência considerou pacientes oncológicos adultos, volume de produção de 5 exames/dia e uso de uma dose de 18 F-FDG por paciente. Os custos unitários do procedimento foram de R$ 3.150,30, na perspectiva salarial da carreira de Ciência & Tecnologia, e de R$ 2.927,19 na do Ministério da Saúde. O elemento de maior impacto nos custos correspondeu ao volume diário de produção dos exames. Foram explorados elementos que podem impactar no custo do exame nas instituições públicas de saúde.

Positron emission tomography (PET) has been introduced recently in Brazil and requires costs analysis to support economic evaluation studies on its use. The current study analyzed the use of 18 F-FDG PET-CT and estimated its costs from the perspective of a public healthcare provider. The micro-costing technique was used, identifying, quantifying, and valuing all the inputs used to perform the procedure. Cost estimates considered 85 tests performed at the Brazilian National Cancer Institute from March to June 2012. Reference cases were defined as adult cancer patients, output of five tests per day, and one dose of 18 F-FDG per patient. Unit cost for the procedure was BRL 3,150.30 based on career wages under the Ministry of Science and Technology and BRL 2,927.19 based on Ministry of Health career wages. The factor with the heaviest cost impact was daily output of tests. Other factors that could impact the test’s cost in public healthcare institutions were also examined.

La tomografía por emisión de positrones (PET) es de uso reciente en Brasil y es necesario estimar sus costes, con el fin de subsidiar estudios de evaluación económica sobre esta tecnología. El trabajo examina el proceso de producción de PET-TC con 18F-FDG y se estimaron sus costes desde la perspectiva de un prestador público de servicios de salud. Se empleó la técnica de microcostes, con la identificación, cuantificación y valoración de los insumos consumidos en la producción del procedimiento. Las estimaciones consideran la observación de 85 exámenes entre marzo y julio de 2012. El “caso base” considera pacientes adultos de cáncer, con una producción de 5 exámenes/día y el uso de una dosis de 18F-FDG por paciente. Los costes unitarios del procedimiento fueron, respectivamente, R$ 3.150.30 y R$ 2.927.19, desde la perspectiva del Ministerio de Ciencia y Tecnología y del Ministerio de Salud. El volumen diario de producción fue el elemento de mayor impacto en los costes. Además, se analizaron los factores que pueden repercutir en el coste del examen en instituciones de salud pública.

(18)FDG PET/CT en linfoma primario de mama y cáncer de mama / (18)FDG PET/CT imaging in primary breast lymphoma and breast cancer

BACKGROUND: Of women between 15 and 29 years of age, 13.6% will die from breast cancer. For women between 30 and 64 years of age, 19% will die from breast cancer. METHODS: We studied 1728 oncological patients and 295 patients were included, 293 with breast cancer (17%) and two patients with primary breast lymphoma (0.1%). RESULTS: There were 98% females and 2% males. SUVmax for the primary tumor was 4.2 +/- 2.6 SD. Mean SUVmax for patients with primary breast lymphoma were 3.2 and 1.4. Sites of metastases were lymph nodes in the neck (4.4% SUVmax 2.7), internal mammary lymph nodes (5% SUVmax 5.3), mediastinum (8.3% SUVmax 5.0), retroperitoneal (6 % SUVmax 5.4), ipsilateral axilla (94% SUVmax 4.5), contralateral axilla (4.4% SUVmax 2.8), pectoral muscle (10.2% SUVmax 2.6), pleura (4.4% SUVmax 3.9), lung (32.3% SUVmax 2.9), liver (19.1% SUVmax 4.5), bone (36.7%), adrenal gland (4.4% SUVmax 2.4), brain (4.4%), spleen and contralateral breast, one case each. One patient presented thymic hyperplasia after chemotherapy. Mean SUVmax for blastic lesions was 5.4 +/- 2.9 SD, for lytic lesions it was 6.7 +/- 2.4 SD and for lesions not apparent on the CT it was 4.6 +/- 2.4 SD. The incidence of a second primary was 4.7%, 2.1% ovarian, 1.4% lung, 0.3% lymphoma, 0.3% endometrium, 0.3% pancreas and 0.3% thyroid. CONCLUSIONS: Mean SUVmax for the primary tumor was similar to that reported in the literature. Values for metastatic bone lesions are higher in this study. Inclusion of PET/CT in the followup of breast lesions is cost efficient.