Cost-effectiveness of hypofractionated versus conventional fractionated radiotherapy for the treatment of men with early glottic cancer: a study in the Brazilian public and private health system.

BACKGROUND: This study aims to evaluate whether hypofractionated radiotherapy (HYPOFRT) is a cost-effective strategy than conventional fractionated radiotherapy (CFRT) for early-stage glottic cancer (ESGC) in the Brazilian public and private health systems. METHODS: Adopting the perspective of the Brazilian public and private health system as the payer, a Markov model with a lifetime horizon was built to delineate the health states for a cohort of 65-year-old men after with ESGC treated with either HYPOFRT or CFRT. Probabilities of controlled disease, local failure, distant metastasis, and death and utilities scores were extracted from randomized clinical trials. Costs were based on the public and private health system reimbursement values. RESULTS: In the base case scenario, for both the public and private health systems, HYPOFRT dominated CFRT, being more effective and less costly, with a negative ICER of R$264.32 per quality-adjusted life-year (QALY) (public health system) and a negative ICER of R$2870.69/ QALY (private health system). The ICER was most sensitive to the probability of local failure, controlled disease, and salvage treatment costs. For the probabilistic sensitivity analysis, the cost-effectiveness acceptability curve indicates that there is a probability of 99.99% of HYPOFRT being cost-effective considering a willingness-to-pay threshold of R$2,000 ($905.39) per QALY (public sector) and willingness-to-pay threshold of R$16,000 ($7243.10) per QALY (private sector). The results were robust in deterministic and probabilistic sensitivity analyses. CONCLUSIONS: Considering a threshold of R$ 40,000 per QALY, HYPOFRT was cost-effective compared to CFRT for ESGC in the Brazilian public health system. The Net Monetary Benefit (NMB) is approximately 2,4 times (public health system) and 5,2 (private health system) higher for HYPOFRT than CFRT, which could open the opportunity of incorporating new technologies.

Efficacy and safety of left atrial appendage closure procedure in patients with non-valvular atrial fibrillation with contraindication and/or failure for oral anticoagulants: A systematic review and meta-analysis.

BACKGROUND: With the aim of reducing the risk of Cerebrovascular Accident (CVA) in patients with Non-Valvular Atrial Fibrillation (NVAF), Left Atrial Appendage Occlusion (LAAO) devices are emerging as an alternative to oral anticoagulants. OBJECTIVE: To analyze the efficacy and safety of the LAAO procedure in patients with NVAF and contraindications and/or failure for oral anticoagulants. METHOD: The search for evidence was carried out in the electronic databases Medline and Embase till January 2024. Additional searches were conducted on Google Scholar. The clinical trials registry database was also consulted. Two blinded investigators performed the search, study selection, and data collection, and assessed quality and risk of bias using the Cochrane tool for randomized clinical trials. Meta-analyses of eligible trials were performed using RevMan 5.4.1 software. The random effects model was used for all analyses. RESULTS: Five articles were selected, among which three were non-inferiority randomized clinical trials that analyzed the performance and safety of LAAO devices compared to the use of Vitamin K Antagonists (AVKs) or Novel Oral Anticoagulants (NOACs). No randomized clinical trials were found that analyzed populations with absolute contraindications to oral anticoagulants. Having as primary outcomes analyzed the occurrence of stroke (ischemic or hemorrhagic), cardiovascular or unexplained death and systemic embolism, the non-inferiority of the LAAO procedure compared to the use of oral anticoagulants was verified. CONCLUSIONS: For patients with an absolute contraindication to anticoagulation and/or failure to use oral anticoagulants, evidence for the use of LAAO devices is scarce.

Budget impact analysis of cabergoline for medical treatment of Cushing's disease in Brazil.

Objective: The aim of this study was to estimate the budget impact of adding cabergoline to the Brazilian Unified Health System (SUS) formulary for the treatment of patients with Cushing's disease (CD) who do not achieve disease control after transsphenoidal surgery. Materials and methods: We conducted a budget impact analysis (BIA) from the perspective of the Brazilian SUS over a 5-year time horizon. We compared two scenarios: ketoconazole (Scenario 1) versus including cabergoline as a treatment option (Scenario 2). All analyses were conducted using Microsoft Excel. Uncertainty was explored in univariate sensitivity analyses. Results: The total costs were BRL $25,596,729 for Scenario 1 and BRL $32,469,169 for Scenario 2. The budget impact of adding cabergoline to the formulary for CD treatment within the SUS would be BRL $6,091,036 over 5 years. On univariate analyses, variations in the rates of surgical failure and CD recurrence had the greatest potential to affect the final costs associated with cabergoline. Conclusions: The estimated budget impact of adding cabergoline to the formulary for CD treatment within the Brazilian SUS would be about BRL $6 million. While cost savings cannot be expected, the budget impact of adding cabergoline would be lower than that of adding other treatment options for CD.

Cost-effectiveness of stereotactic body radiotherapy versus conventional radiotherapy for the treatment of surgically ineligible stage I non-small cell lung cancer in the Brazilian public health system.

Background: The Brazilian public health system does not pay for the use of Stereotactic body radiotherapy (SBRT) due to its costs and the absence of cost-effectiveness analysis showing its benefit. The present study aims to evaluate whether the SBRT is a more cost-effective strategy than the conventional fractionated radiotherapy (CFRT) for surgically ineligible stage I non-small cell lung cancer (NSCLC) in the Brazilian public health system. Methods: Adopting the perspective of the Brazilian Unified Healthcare System (SUS) as the payer, a Markov model with a lifetime horizon was built to delineate the health states for a cohort of 75-years-old men with medically inoperable NSCLC after treatment with SBRT or CFRT. Transition probabilities and health states utilities were adapted from the literature. Costs were based on the public health system reimbursement values and simulated in the private sector. Findings: The SBRT strategy results in more quality-adjusted life-year (QALYs) and costs with an incremental cost-effectiveness ratio (ICER) of R$ 164.86 (U$ 65.16) per QALY and R$ 105 (U$ 41.50) per life-year gained (LYG). This strategy was cost-effective, considering a willingness-to-pay of R$ 25,000 (U$ 9,881.42) per QALY. The net monetary benefit (NMB) was approximately twice higher. The outcomes were confirmed with 92% of accuracy in the probabilistic sensitivity analysis. Interpretation: Using a threshold of R$25,000 per QALY, SBRT was more cost-effective than CFRT for NSCLC in a public health system of an upper-middle-income country. SBRT generates higher NMB than CFRT, which could open the opportunity to incorporate new technologies. Funding: Varian Medical Systems.

Effectiveness of non-pharmacological strategies in the management of type 2 diabetes in primary care: a protocol for a systematic review and network meta-analysis.

INTRODUCTION: Despite the increasing number of drugs and various guidelines on the management of type 2 diabetes mellitus (T2DM), several patients continue with the disease uncontrolled. There are several non-pharmacological treatments available for managing T2DM, but various of them have never been compared directly to determine the best strategies. OBJECTIVE: This study will evaluate the comparative effects of non-pharmacological strategies in the management of T2DM in primary care or community settings. METHODS AND ANALYSIS: We will perform a systematic review and network meta-analysis (NMA), and will include randomised controlled trials if one of the following interventions were applied in adult patients with T2DM: nutritional therapy, physical activity, psychological interventions, social interventions, multidisciplinary lifestyle interventions, diabetes self-management education and support (DSMES), technology-enabled DSMES, interventions delivered only either by pharmacists or by nurses, self-blood glucose monitoring in non-insulin-treated T2DM, health coaching, benchmarking and usual care. The primary outcome will be glycaemic control (glycated haemoglobin (HbA1c) (%)), and the secondary outcomes will be weight loss, quality of life, patient satisfaction, frequency of cardiovascular events and deaths, number of patients in each group with HbA1c <7, adverse events and medication adherence. We have developed search strategies for Embase, Medline, Latin American and Caribbean Health Sciences Literature, Cochrane Central Register of Controlled Trials, Trip database, Scopus, Web of Science, Cumulative Index to Nursing and Allied Health Literature Australasian Medical Index and Chinese Biomedical Literature Database. Four reviewers will assess the studies for their eligibility and their risk of bias in pairs and independently. An NMA will be performed using a Bayesian hierarchical model, and the treatment hierarchy will be obtained using the surface under the cumulative ranking curve. To determine our confidence in an overall treatment ranking from the NMA, we will follow the Grading of Recommendations Assessment, Development and Evaluation approach. ETHICS AND DISSEMINATION: As no primary data collection will be undertaken, no formal ethical assessment is required. We plan to present the results of this systematic review in a peer-reviewed scientific journal, conferences and the popular press. PROSPERO REGISTRATION NUMBER: CRD42019127856.

Efficacy and safety of left atrial appendage closure procedure in patients with non-valvular atrial fibrillation with contraindication and/or failure for oral anticoagulants: A systematic review and meta-analysis

Abstract Background: With the aim of reducing the risk of Cerebrovascular Accident (CVA) in patients with Non-Valvular Atrial Fibrillation (NVAF), Left Atrial Appendage Occlusion (LAAO) devices are emerging as an alternative to oral anticoagulants. Objective: To analyze the efficacy and safety of the LAAO procedure in patients with NVAF and contraindications and/or failure for oral anticoagulants. Method: The search for evidence was carried out in the electronic databases Medline and Embase till January 2024. Additional searches were conducted on Google Scholar. The clinical trials registry database was also consulted. Two blinded investigators performed the search, study selection, and data collection, and assessed quality and risk of bias using the Cochrane tool for randomized clinical trials. Meta-analyses of eligible trials were performed using RevMan 5.4.1 software. The random effects model was used for all analyses. Results: Five articles were selected, among which three were non-inferiority randomized clinical trials that analyzed the performance and safety of LAAO devices compared to the use of Vitamin K Antagonists (AVKs) or Novel Oral Anticoagulants (NOACs). No randomized clinical trials were found that analyzed populations with absolute contraindications to oral anticoagulants. Having as primary outcomes analyzed the occurrence of stroke (ischemic or hemorrhagic), cardiovascular or unexplained death and systemic embolism, the non-inferiority of the LAAO procedure compared to the use of oral anticoagulants was verified. Conclusions: For patients with an absolute contraindication to anticoagulation and/or failure to use oral anticoagulants, evidence for the use of LAAO devices is scarce.

Risk of ageism in the use of cost-effectiveness thresholds in the recommendations of the national commission for incorporation of technologies in the Brazilian Unified Health System / Risco de idadismo no uso de limiares de custo-efetividade nas recomendações da comissão nacional de incorporações de tecnologias no Sistema Único de Saúde no Brasil

Government agencies perform health technology assessment when evaluating requests to incorporate technologies in public health systems. To promote participation in this decisionmaking process, the National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC) makes its recommendations available for public consultation for 20 days, which may occasionally be reduced or extended. Recently, CONITEC published its recommendations about the use of cost-effectiveness thresholds in health care decisionmaking. When reviewing the criteria for alternative cost-effectiveness thresholds, given that they promote innovation and equity in the Brazilian Unified Health System, we realized that the criterion "diseases affecting individuals at the end of life" was excluded from the list. This viewpoint article is a request for CONITEC to reconsider this position. The report disregards technical aspects related to the use of quality-adjusted life years as a metric in patients with low life expectancy, indicating the potential to discriminate against older adults and ignore the practical considerations of international organizations on this topic.

A avaliação de tecnologias em saúde (ATS) subsidia as agências governamentais voltadas à avaliação dos pedidos de incorporação de tecnologias junto aos seus respectivos sistemas públicos de saúde. Para promover a participação da sociedade no processo de tomada de decisão para a incorporação de novas tecnologias, a Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde (CONITEC) disponibiliza suas recomendações em consulta pública por um prazo de 20 dias, que pode ser excepcionalmente reduzido ou estendido. Recentemente, a CONITEC disponibilizou para consulta pública suas recomendações sobre o uso de Limiar de Cursto-Efetividade (LCE) nas decisões em saúde. Ao revisar os critérios previamente considerados no início das discussões sobre contextos passíveis de LCE alternativos, por promoverem a inovação e equidade em saúde para o Sistema Único de Saúde (SUS), percebemos que o critério "doenças acometendo indivíduos no final da expectativa de vida" foi excluído da lista de critérios de flexibilização. Este artigo de ponto de vista discute o pedido de reconsideração enviado à CONITEC para que a posição seja revista. O entendimento expresso no relatório desconsidera aspectos técnicos relacionados ao uso do QALY como métrica em pacientes com baixa expectativa de vida, além disso, tem potencial discriminatório em relação à população geriátrica e ignora considerações práticas de órgãos internacionais em relação ao tema.