Background/Objectives: Until now, no meta-analysis has been published to evaluate the diagnostic performance of next-generation sequencing (NGS) panel using circulating tumor (ctDNA) in patients with advanced non-small cell lung cancer (aNSCLC). The aim of the study was to carry out a systematic review and a meta-analysis in order to determine the accuracy of NGS of ctDNA to detect six oncogenic driver alterations: epidermal growth factor receptor (EGFR); anaplastic lymphoma kinase (ALK); ROS proto-oncogene 1, receptor tyrosine kinase (ROS-1); serine/threonine-protein kinase B-RAF (BRAF); RET proto-oncogene (RET); and MET proto-oncogene, receptor tyrosine kinase (MET) exon 14 in patients with aNSCLC.
Methods: MEDLINE/PubMed, Cochrane Library, Latin American and Caribbean Health Sciences Literature (LILACS), and Centre for Reviews and Dissemination databases and articles obtained from other sources were searched for relevant studies that evaluate the accuracy (sensitivity and specificity) of NGS using ctDNA in patients with aNSCLC. The studies were eligible when NGS of ctDNA was compared with tissue tests to detect at least one of the six oncogenic driver alterations. Diagnostic measures (sensitivity and specificity) were pooled with a bivariate diagnostic random effect. All statistical analyses were performed with software R, v.4.0.0.
Results: Ten studies were eligible for data extraction. The overall pooled estimates of sensitivity and specificity were 0.766 (95% CI: 0.678-0.835); 0.999 (95% CI: 0.990-1.000), respectively.
Conclusions: The analysis has demonstrated that the NGS panel using ctDNA has a high accuracy to identify the six actionable oncogenic driver alterations in patients with aNSCLC. Therefore, it can be considered a reliable alternative to guide the patients with aNSCLC to the right treatment who cannot undergo an invasive procedure or have insufficient tissue material for molecular tests.
Análise de impacto orçamentário do uso da razão dos testes sFlt-1:PlGF na exclusão de pré-eclâmpsia em mulheres com suspeita clínica na perspectiva do sistema de saúde suplementar Budget impact analysis of sFlt-1/PlGF ratio to help rule-out pre-eclampsia in women presenting with clinical suspected in the private healthcare system perspective in Brazil RESUMO Objetivo: O objetivo do estudo foi avaliar o impacto econômico da incorporação da razão dos testes tirosina quinase-1 solúvel (sFlt-1):fator de crescimento placentário (PlGF) no auxílio da exclusão da pré-eclâmpsia na perspectiva do Sistema de Saúde Suplementar do Brasil (SSS). Métodos: Foi desenvolvido um modelo de decisão com o intuito de simular as decisões clínicas do manejo das pacientes com suspeita de pré-eclâmpsia entre a 24ª semana e a 36ª semana + 6 dias de gestação utilizando a razão dos testes sFlt-1:PlGF em comparação com cenário sem o teste. Os dados clínicos utilizados no modelo foram derivados do estudo PROGNOSIS. A análise incluiu apenas custos diretos que foram baseados na Tabela CBHPM (Classificação Brasileira Hierarquizada de Procedimentos Médicos) e na Tabela CMED PF 18% (Câmara de Regulação do Mercado de Medicamentos). Uma análise de sensibilidade univariada foi conduzida com variação de 15% dos parâmetros. Resultados: A razão dos testes sFlt-1:PlGF apresentou um potencial de economia de -R$ 4.532,04 por paciente comparado ao cenário sem teste. Considerando a incorporação no SSS, a razão dos testes sFlt-1:PlGF pode promover uma economia de -R$ 6.375.865,68 em 2021 e um acumulado de -R$ 136.495.533,87 em cinco anos. Conclusão: O uso da razão sFlt-1:PlGF no auxílio da exclusão da pré-eclâmpsia tem potencial de melhorar as decisões clínicas e, consequentemente, evitar hospitalizações desnecessárias. A incorporação do teste pode promover uma economia substancial para o sistema de saúde suplementar.
ABSTRACTObjective: The aim of this study was to evaluate the economic impact of the incorporation of the soluble fms-like tyrosine kinase (sFlt-1) to placental growth factor (PlGF) ratio test in the private healthcare system in Brazil (SSS). Methods: A decision model was developed in order to simulate the clinical decisions of the management of women with suspected pre-eclampsia between 24 weeks and 36 weeks plus 6 days with sFlt-1:PlGF ratio test, compared with no test scenario. The clinical data used in the model were derived from PROGNOSIS study. The analysis included only direct costs that were based on CBHPM (Classificação Brasileira Hierarquizada de Procedimentos Médicos) and CMED PF 18% (Câmara de Regulação do Mercado de Medicamentos). A univariate sensitivity analysis was conducted Instituição onde o trabalho foi executado: Roche Diagnóstica do Brasil Ltda. Financiamento: Este estudo não teve financiamento. Palavras-chave: análise de impacto orçamentário, razão dos testes sFlt:PlGF, pré-eclâmpsia Keywords: budget impact analysis, sFlt-1:PlGF ratio test, pre-eclampsia 245 J Bras Econ Saúde 2019;11(3): 244-54Análise de impacto orçamentário d...
A875 substantially higher objective response rates favouring patients receiving nivolumab (25.1% vs 5.4%; odds ratio: 5.98, P< 0.001) was observed in this trial. The aim of this analysis was to compare the monthly cost per responder with nivolumab versus everolimus in the Brazilian private healthcare system perspective. Methods: This analysis was based on investigator-based patient-level data from a randomized phase III trial. ORR was defined as the proportion of patients who achieved a partial or complete response. Costs were calculated based on drug, administration, and managing of grade 1-4 treatment related adverse events (TRAEs) reported on Checkmate 025. Drug costs for nivolumab and everolimus were obtained from the official Brazilian price list (Feb/2017) by CMED. The management of TRAEs was obtained through a Delphi panel, followed by microcosting of resources obtained from public sources (Kairos and Simpro Magazine n105/2016 for drugs and materials, CBHPM 2016 for medical appointments and procedures, and UNIDAS National Research 2015 for hospitalizations). Monthly cost per objective response was calculated by dividing the average monthly cost per patient by ORR. Results: Median duration of treatment was 5.
To perform a treatment cost comparison of pirfenidone versus nintedanib on the treatment of idiopathic pulmonary fibrosis (IPF) under the Brazilian private healthcare system perspective. MethOds: Both treatment's ex-factory prices were obtained from official published lists, by the Brazilian Ministry of Health, considering the incidence of taxes (ICMS 18%). Annual treatment cost was calculated based on the dosage of pirfenidone (2.403 mg/day) and nintedanib (150 mg BID) obtained from their respective Brazilian labels. A year was assumed to be 12 months with 30 days each. Results were shown for 2 scenarios: first year (including initial dose ramp up for pirfenidone) and maintenance phases. Results: Pirfenidone and nintedanib unitary costs were BRL 9,144 (BRL 33.87 per 267 mg tablet) and BRL 14,916 (BRL 248.60 per 150 mg tablet), respectively, according to their list prices. Pirfenidone showed an annual treatment cost of BRL 107,591 and BRL 109,724 on the first year and subsequent years of treatment, respectively. Nintedanib incurred an annual cost of BRL 178,988 independent of year of treatment. Those results led to savings of approximately BRL 70,000 per year per patient treated with pirfenidone compared to those treated with nintedanib (a relative reduction of approximately 40%). Pirfenidone's dose ramp up, on the first year of treatment, did not decrease significantly the treatment cost, implying on a reduction of just 2% when compared to subsequent years. cOnclusiOns: Pirfenidone was lower than the cost of nintedanib.
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