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1.

Análise econômica do tratamento de tromboembolismo venoso com rivaroxabana em comparação com enoxaparina seguida de varfarina sob a perspectiva do Sistema de Saúde Suplementar brasileiro/ Economic analysis of the treatment of venous thromboembolism with rivaroxaban in comparison with enoxaparin plus warfarin under the perspective of the Brazilian Private Healthcare System

Piedade, Alexandra David; Paladini, Luciano; Kashiura, Diego; Lemmer, Teresa; Tobaruella, Flávia Sauer; Campos, Karisa Oliveira M
| Idioma(s): Portugués
Objetivo: O tromboembolismo venoso (TEV) está associado a um grande impacto em saúde. A rivaroxabana é uma das opções recomendadas para o tratamento de TEV, segundo diretrizes internacionais (American College of Chest Physicians ­ ACCP 2016) (Kearon et al., 2016). É um anticoagulante oral, inibidor direto do fator Xa, que possui a vantagem de não requerer monitoramento e ajuste de dose de acordo com parâmetros laboratoriais de coagulação. O objetivo deste estudo foi comparar os custos diretos da rivaroxabana com a combinação de enoxaparina/varfarina e estimar o impacto orçamentário de sua introdução no Sistema de Saúde Suplementar brasileiro. Métodos: Realizaram-se análises de custo-minimização e impacto orçamentário comparando os tratamentos com rivaroxabana e enoxaparina/varfarina, em um horizonte temporal de um ano, sob a perspectiva do Sistema de Saúde Suplementar brasileiro. Foram considerados custos médicos diretos durante o período de internação hospitalar (medicamentos, hospitalização, acompanhamento ambulatorial e eventos adversos). A população de pacientes elegíveis foi estimada a partir de uma abordagem epidemiológica, considerando o sistema de saúde privado como um todo e para diferentes portes de operadoras de saúde. Resultados: Estimou-se que o tratamento de TEV com rivaroxabana pode gerar R$ 1.996,99 de economia comparado ao tratamento com enoxaparina/varfarina, principalmente devido à redução do tempo de hospitalização. O impacto orçamentário da introdução da rivaroxabana no Sistema de Saúde Suplementar apresentou economia de recursos potencial em todos os cenários analisados. A robustez do modelo foi testada por análises de sensibilidade determinísticas e a economia de recursos promovida pela rivaroxabana foi mantida em todas as variações. Conclusão: A rivaroxabana é uma alternativa para o tratamento de TEV que possui o potencial de gerar economia de recursos ao Sistema de Saúde Suplementar brasileiro. Objective: Venous thromboembolism (VTE) is associated with a significant healthcare burden. Rivaroxaban is an oral anticoagulant, direct factor Xa inhibitor, that has the advantage of not requiring routine coagulation monitoring and dose adjustment according to laboratory parameters of coagulation. The objective of this study is to compare the direct costs of rivaroxaban with the combination of enoxaparin/warfarin and estimate the budget impact of the reimbursement by the Brazilian Private Healthcare System. Methods: A cost-minimization and a budget impact analysis were performed comparing rivaroxaban versus enoxaparin/warfarin, in one-year time horizon and under the perspective of the Brazilian Private Healthcare System. Medical direct costs were considered for the hospitalization period (drugs, hospitalization, outpatient care and adverse events). Eligible patients were estimated through an epidemiological approach for the healthcare system and stratified by health management organization profile. Results: Estimated total cost of VTE treatment with rivaroxaban may cause a R$ 1.996,99 economy comparing to enoxaparin/warfarin, mainly due to fewer hospitalization days. The budget impact of the reimbursement of rivaroxaban in the Brazilian Private Healthcare System presented potential resource in all scenarios evaluated. Robustness of the model was tested by deterministic sensitivity analysis in which the resource saving promoted by rivaroxaban was maintained in all variations. Conclusion: Rivaroxaban is an alternative for the treatment of VTE that has potential to promote resource for the Brazilian Private Healthcare System.
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2.

Utilização de medicamentos isentos de prescrição e economias geradas para os sistemas de saúde: uma revisão/ The use of over-the-counter medicines and cost savings generated for health systems: a review

Rodrigues, Antonio Cesar
| Idioma(s): Portugués
Objetivo: Entender o impacto econômico que os medicamentos isentos de prescrição (MIPs) exercem nos sistemas de saúde e populações da Europa e Américas, em especial no Brasil. Métodos: Revisão bibliográfica cobrindo um período de 20 anos, com artigos identificados pelos serviços PubMed e Lilacs, contendo os termos "automedicação", "medicamentos isentos de prescrição" e "economias", e seus equivalentes na língua inglesa. Resultados: Existe carência na literatura de estudos sobre os impactos econômicos que os MIPs trazem aos países e à sociedade. Os estudos e estatísticas mais abrangentes estão compilados pelas três maiores associações de produtores de MIPs no mundo e demonstram uma aceleração das reclassificações e geração de economias relevantes. No Brasil, um estudo de 2015 utilizando hipóteses conservadoras estimou um impacto orçamentário positivo dos MIPs no Sistema Único de Saúde (SUS) de R$ 364 milhões, aproximadamente US$ 117 milhões. Esse é o único estudo identificado cujo objetivo foi fazer uma quantificação econômica no país. Conclusão: Neste momento em que a RDC nº 98/2016 dá a possibilidade para a reclassificação como MIP de um grande número de substâncias farmacêuticas, é imperativo que sejam feitos estudos robustos que estimem todos os impactos econômicos a serem esperados, que poderão servir como elementos para as análises técnicas a serem conduzidas e até mesmo para atribuir graus de prioridade a elas. Objective: To understand the economic impact of over-the-counter medicines (OTC) medications on healthcare systems and the population in Europe and the Americas, with special focus in Brazil. Methods: Bibliographic review covering a 20-year timeframe. The articles were identified through the PubMed and Lilacs services, containing the terms "self-medication", "over-the-counter" and "savings", and their equivalents in Portuguese. Results: There is lack of publications focused on the economic impact that medicines can bring to the countries and the society. The most complete studies and statistics have been compiled by the three most important OTC manufacturers associations in the world and show an acceleration in switches and significant savings generated. In Brazil, a 2015 paper using conservative assumptions estimated a positive economic impact of OTC to the Brazilian Healthcare System (SUS) of R$ 364 million, about US$ 117 million. This is the only study that had the goal of an economic impact quantification conducted in the country. Conclusion: The new regulation RDC nº 98/2016 gives the possibility for the switch of many substances from prescription to OTC and it is imperative that robust studies are conducted to uncover all the impacts that can be expected, providing inputs for technical evaluations and even to attribute priority levels to them.
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3.

Diretriz metodológica para estudos de avaliação econômica de tecnologias em saúde no Brasil/ Methodological guidelines for economic evaluation studies of health technologies in Brazil

Ribeiro, Rodrigo Antonini; Neyeloff, Jeruza Lavanholi; Itria, Alexander; Santos, Vania Cristina Canuto; Vianna, Cid Manso de Mello; da Silva, Everton Nunes; Elias, Flávia Tavares Silva; Wichmann, Roberta Moreira; Souza, Kathiaja Miranda; Cruz, Luciane Nascimento; Azeredo-da-Silva, André Luis Ferreira
| Idioma(s): Portugués
Objetivos: Resumir os principais pontos da Diretriz de Avaliação Econômica em Saúde (AES) do Ministério da Saúde. Métodos: As diretrizes para AES no Brasil foram desenvolvidas por intermédio de múltiplas rodadas de trabalho iterativas por grupo multidisciplinar de especialistas em economia da saúde e foram submetidas à consulta pública. Resultados: O problema deve ser definido por meio de uma questão de pesquisa estruturada. O estudo pode ser baseado em dados primários ou em modelagem, em que o primeiro aumenta a validade interna dos resultados e o segundo, a capacidade de generalização do estudo. Quando o trabalho for baseado em modelagem e focado em doença crônica, o modelo de Markov pode ser usualmente empregado, quando não houver necessidades que apontem para simulação de eventos discretos (como competição dos indivíduos por recursos escassos) ou modelos de transmissão dinâmica (em vacinação e/ou doenças infecciosas com alta transmissão entre indivíduos). O horizonte temporal preferencial é o de tempo de vida, e a taxa de desconto padrão é de 5% para custo e efetividade. Os custos devem representar a perspectiva do Sistema Único de Saúde (SUS), podendo ser estimados por macrocusteio ou microcusteio. Sempre que possível, os resultados devem ser apresentados no formato de custo por ano de vida salvo ajustado para qualidade, para facilitar comparações com outros estudos. Análises de sensibilidade devem ser extensamente empregadas, de forma a avaliar o impacto da incerteza nos resultados produzidos. Conclusões: Espera-se que, com a padronização da metodologia proposta na Diretriz, a produção de AES no país tenha incremento na sua qualidade e reprodutibilidade. Objectives: To summarize the main points from the Brazilian's Ministry of Health Economic Evaluations (HEE) guideline. Methods: The guideline was developed through multiple rounds of iterative work, conducted by a multidisciplinary team of specialists in health economics, and where submitted to public consultation. Results: The decision problem should be defined through a structured research question. The study can be either primary data or model-based; in the first case, there is greater internal validity, while the second generates a superior generalizability. When the study is model-based and focused on a chronic disease, a Markov model can be usually employed, except for situations that points towards the need of a discrete event simulation (such as competition of individuals for scarce resources) or a dynamic transition model (for example, vaccination models and infectious diseases with high transmission rates between individuals). The preferred time horizon is the lifetime one, and the default discount rate is 5% for both costs and effectiveness. Costs should represent the Unified Health System (SUS) perspective and can be estimated through either gross-costing or micro-costing. Results should be presented as costs per quality adjusted life years (QALYs) whenever possible, to facilitate comparison with other studies. Sensitivity analyses should be widely employed, in order to evaluate the impact of uncertainty in the results produced by the model. Conclusions: It is expected that, with the standardization proposed in this guideline, the HEE production in Brazil has gains in quality and reproducibility.
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4.

Earmarking for health: from theory to practice

Cashin, Cheryl; Sparkes, Susan; Bloom, Danielle
| Idioma(s): Inglés
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6.

Public health impact and economic evaluation of vitamin D-fortified dairy products for fracture prevention in France.

Hiligsmann, M; Burlet, N; Fardellone, P; Al-Daghri, N; Reginster, J-Y
| Idioma(s): Inglés
The recommended intake of vitamin D-fortified dairy products can substantially decrease the burden of osteoporotic fractures and seems an economically beneficial strategy in the general French population aged over 60 years. INTRODUCTION: This study aims to assess the public health and economic impact of vitamin D-fortified dairy products in the general French population aged over 60 years. METHODS: We estimated the lifetime health impacts expressed in number of fractures prevented, life years gained, and quality-adjusted life years (QALY) gained of the recommended intake of dairy products in the general French population over 60 years for 1 year (2015). A validated microsimulation model was used to simulate three age cohorts for both women and men (60-69, 70-79, and >80 years). The incremental cost per QALY gained of vitamin D-fortified dairy products compared to the absence of appropriate intake was estimated in different populations, assuming the cost of two dairy products per day in base case. RESULTS: The total lifetime number of fractures decreased by 64,932 for the recommended intake of dairy products in the general population over 60 years, of which 46,472 and 18,460 occurred in women and men, respectively. In particular, 15,087 and 4413 hip fractures could be prevented in women and men. Vitamin D-fortified dairy products also resulted in 32,569 QALYs and 29,169 life years gained. The cost per QALY gained of appropriate dairy intake was estimated at €58,244 and fall below a threshold of €30,000 per QALY gained in women over 70 years and in men over 80 years. CONCLUSION: Vitamin D-fortified dairy products have the potential to substantially reduce the burden of osteoporotic fractures in France and seem an economically beneficial strategy, especially in the general population aged above 70 years.
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7.

Association of a Bundled-Payment Program With Cost and Outcomes in Full-Cycle Breast Cancer Care.

Wang, C Jason; Cheng, Skye H; Wu, Jen-You; Lin, Yi-Ping; Kao, Wen-Hsin; Lin, Chia-Li; Chen, Yin-Jou; Tsai, Shu-Ling; Kao, Feng-Yu; Huang, Andrew T
| Idioma(s): Inglés
Importance: Value-driven payment system reform is a potential tool for aligning economic incentives with the improvement of quality and efficiency of health care and containment of cost. Such a payment system has not been researched satisfactorily in full-cycle cancer care. Objective: To examine the association of outcomes and medical expenditures with a bundled-payment pay-for-performance program for breast cancer in Taiwan compared with a fee-for-service (FFS) program. Design, Setting, and Participants: Data were obtained from the Taiwan Cancer Database, National Health Insurance Claims Data, the National Death Registry, and the bundled-payment enrollment file. Women with newly diagnosed breast cancer and a documented first cancer treatment from January 1, 2004, to December 31, 2008, were selected from the Taiwan Cancer Database and followed up for 5 years, with the last follow-up data available on December 31, 2013. Patients in the bundled-payment program were matched at a ratio of 1:3 with control individuals in an FFS program using a propensity score method. The final sample of 17 940 patients included 4485 (25%) in the bundled-payment group and 13 455 (75%) in the FFS group. Main Outcomes and Measures: Rates of adherence to quality indicators, survival rates, and medical payments (excluding bonuses paid in the bundled-payment group). The Kaplan-Meier method was used to calculate 5-year overall and event-free survival rates by cancer stage, and the Cox proportional hazards regression model was used to examine the effect of the bundled-payment program on overall and event-free survival. Sensitivity analysis for bonus payments in the bundled-payment group was also performed. Results: The study population included 17 940 women (mean [SD] age, 52.2 [10.3] years). In the bundled-payment group, 1473 of 4215 patients (34.9%) with applicable quality indicators had full (100%) adherence to quality indicators compared with 3438 of 12 506 patients (27.5%) with applicable quality indicators in the FFS group (P < .001). The 5-year event-free survival rates for patients with stages 0 to III breast cancer were 84.48% for the bundled-payment group and 80.88% for the FFS group (P < .01). Although the 5-year medical payments of the bundled-payment group remained stable, the cumulative medical payments for the FFS group steadily increased from $16 000 to $19 230 and exceeded pay-for-performance bundled payments starting in 2008. Conclusions and Relevance: In Taiwan, compared with the regular FFS program, bundled payment may lead to better adherence to quality indicators, better outcomes, and more effective cost-control over time.
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8.

Bundling of Reimbursement for Inferior Vena Cava Filter Placement Resulted in Significantly Decreased Utilization between 2012 and 2014.

Glocker, Roan J; TerBush, Matthew J; Hill, Elaine L; Guido, Joseph J; Doyle, Adam; Ellis, Jennifer L; Raman, Kathleen; Morrow, Gary R; Stoner, Michael C
| Idioma(s): Inglés
BACKGROUND: On January 1, 2012, reimbursement for inferior vena cava filters (IVCFs) became bundled by the Centers for Medicare and Medicaid Services. This resulted in ICVF placement (CPT code 37191) now yielding 4.71 relative value units (RVUs), a decrease from 15.6 RVUs for placement and associated procedures (CPT codes 37620, 36010, 75825-26, 75940-26). Our hypothesis was that IVCF utilization would decrease in response to this change as other procedures had done once they had become bundled. METHODS: Including data from 2010 to 2011 (before bundling) and 2012 to 2014 (after bundling), we utilized 5% inpatient, outpatient, and carrier files of Medicare limited data sets and analyzed IVCF utilization before and after bundling across specialty types, controlling for total diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE) (ICD-9 codes 453.xx and 415.xx, respectively) and placement location. RESULTS: In 2010 and 2011, the rates/10,000 DVT/PE diagnoses were 918 and 1,052, respectively (average 985). In 2012, 2013, and 2014, rates were 987, 877, and 605, respectively (average 823). Comparing each year individually, there is a significant difference (P < 0.0001) with 2012, 2013, and 2014 having lower rates of ICVF utilization. Comparing averages in the 2010-2011 and 2012-2014 groups, there is also a significant decrease in utilization after bundling (P < 0.0001). CONCLUSIONS: Following the bundling of reimbursement for IVCF placement, procedural utilization decreased significantly. More data from subsequent years will be needed to show if this decrease utilization continues to persist.
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9.

Surgery for degenerative cervical myelopathy: a patient-centered quality of life and health economic evaluation.

Witiw, Christopher D; Tetreault, Lindsay A; Smieliauskas, Fabrice; Kopjar, Branko; Massicotte, Eric M; Fehlings, Michael G
| Idioma(s): Inglés
BACKGROUND CONTEXT: Degenerative cervical myelopathy (DCM) represents the most common cause of non-traumatic spinal cord impairment in adults. Surgery has been shown to improve neurologic symptoms and functional status, but it is costly. As sustainability concerns in the field of health care rise, the value of care has come to the forefront of policy decision-making. Evidence for both health-related quality of life outcomes and financial expenditures is needed to inform resource allocation decisions. PURPOSE: This study aimed to estimate the lifetime incremental cost-utility of surgical treatment for DCM. DESIGN/SETTING: This is a prospective observational cohort study at a Canadian tertiary care facility. PATIENT SAMPLE: We recruited all patients undergoing surgery for DCM at a single center between 2005 and 2011 who were enrolled in either the AOSpine Cervical Spondylotic Myelopathy (CSM)-North America study or the AOSpine CSM-International study. OUTCOME MEASURES: Health utility was measured at baseline and at 6, 12, and 24 months following surgery using the Short Form-6D (SF-6D) health utility score. Resource expenditures were calculated on an individual level, from the hospital payer perspective over the 24-month follow-up period. All costs were obtained from a micro-cost database maintained by the institutional finance department and reported in Canadian dollars, inflated to January 2015 values. METHODS: Quality-adjusted life year (QALY) gains for the study period were determined using an area under the curve calculation with a linear interpolation estimate. Lifetime incremental cost-to-utility ratios (ICUR) for surgery were estimated using a Markov state transition model. Structural uncertainty arising from lifetime extrapolation and the single-arm cohort design of the study were accounted for by constructing two models. The first included a highly conservative assumption that individuals undergoing nonoperative management would not experience any lifetime neurologic decline. This constraint was relaxed in the second model to permit more general parameters based on the established natural history. Deterministic and probabilistic sensitivity analyses were employed to account for parameter uncertainty. All QALY gains and costs were discounted at a base of 3% per annum. Statistical significance was set at the .05 level. RESULTS: The analysis included 171 patients; follow-up was 96.5%. Mean age was 58.2±12.0 years and baseline health utility was 0.56±0.14. Mean QALY gained over the 24-month study period was 0.139 (95% confidence interval: 0.109-0.170, p<.001) and the mean 2-year cost of treatment was $19,217.82±12,404.23. Cost associated with the operation comprised 65.7% of the total. The remainder was apportioned over presurgical preparation and postsurgical recovery. Three patients required a reoperation over the 2-year follow-up period. The costs of revision surgery represented 1.85% of the total costs. Using the conservative model structure, the estimated lifetime ICUR of surgical intervention was $20,547.84/QALY gained, with 94.7% of estimates falling within the World Health Organization definition of "very cost-effective" ($54,000 CAD). Using the more general model structure, the estimated lifetime ICUR of surgical intervention was $11,496.02/QALY gained, with 97.9% of estimates meeting the criteria to be considered "very cost-effective." CONCLUSIONS: Surgery for DCM is associated with a significant quality of life improvement. The intervention is cost-effective and, from the perspective of the hospital payer, should be supported.
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