Prevalence of normal weight obesity in young adults of Western Uttar Pradesh – A community-based study

Background: Obesity is described as a build-up of abnormal or excessive fat that risks life. A body mass index (BMI) is a screening tool for overweight and obesity. For a long time, BMI has been used as a marker to measure obesity. However, a significant limitation of using BMI is its failure to differentiate between a high body fat content and preserved or increased lean mass, especially in patients or subjects with a BMI <30 kg/m2. Normal weight obese (NWO) is such individuals who have high fat content but a normal BMI. To identify such individuals and to save them from morbidity associated with obesity, this study was carried out. Aims and Objectives: The objective of the study was to estimate the prevalence of NWO in healthy young adults (aged between 18 and 30 years) and to suggest the methods of primary prevention for obesity. Materials and Methods: In this observational cross-sectional study, the 324 subjects were selected randomly from the residents, students, and employees of Swami Vivekananda Subharti University. Subjects were chosen according to the study’s inclusion and exclusion criteria and also, based on the self-structure questionnaire. A general and systemic examination was carried out. The body composition of these subjects was done by bioelectric impedance analyzer BODY STAT QUAD SCAN 4000. Data were analysis using R-software (1.25 version), and unpaired t-test was applied. P < 0.05 was taken as significant in this study. Results: The prevalence of NWO in males was found to be 24.6% and females to be 13.4%. The body composition parameters of NWO and NWNO differed significantly. Conclusion: The increase rate of NWO is reason for concern and routine screening of body composition parameters should be done at health setups to identify that these NWO individuals and timely interventions can be made.

Impacto orçamentário da incorporação do rituximabe para o tratamento de leucemia linfocítica crônica no SUS / Budget impact of the incorporation of rituximab for the treatment of chronic lymphocytic leukemia in Brazil

Objetivo: O presente estudo objetiva desenvolver um modelo de análise de impacto orçamentário (AIO) relacionada à incorporação do rituximabe no tratamento de primeira linha da leucemia linfocítica crônica (LLC) no Sistema Único de Saúde (SUS). Métodos: A elaboração da AIO foi realizada de acordo com as recomendações metodológicas das diretrizes brasileiras, considerando a perspectiva do SUS, horizonte temporal de cinco anos, população a ser tratada, diferentes cenários de market share do rituximabe e custos diretos envolvidos no tratamento atual e no tratamento proposto, e também foi executada uma análise de sensibilidade para avaliar possíveis incertezas futuras. Resultados: A cada ano e ao final do horizonte temporal de cinco anos, a incorporação do rituximabe promoverá aumento dos custos, quando comparado com o valor de ressarcimento do SUS para o tratamento de primeira linha da LLC. No cenário de maior participação de mercado do rituximabe, os custos totais foram menores em relação ao cenário de menor market share. Dado que a estimativa da AIO é para gastos futuros, incertezas relacionadas como a possível elevação do custo do medicamento foi o fator que promoveu o cenário de maiores gastos. Conclusões: A projeção de custos estimados pela AIO demonstrou menores gastos financeiros no cenário de maior difusão do medicamento, o que pode ter correlação com o atraso da progressão da doença ao utilizar o rituximabe, e consequentemente menos pacientes irão requerer segunda linha de tratamento, que tem custo mais elevado.

Objective: This study aims to develop a budget impact analysis (BIA) model related to the incorporation of rituximab in the first-line treatment of chronic lymphocytic leukemia (CLL) in the Unified Health System (SUS). Methods: The preparation of the BIA was carried out in accordance with the methodological recommendations of the Brazilian guidelines, considering the perspective of the SUS, a time horizon of five years, population to be treated, different market share scenarios for rituximab and direct costs involved in the current treatment and treatment proposed, a sensitivity analysis was also performed to assess possible future uncertainties. Results: Each year and at the end of the five-year time horizon, the incorporation of rituximab will increase costs, when compared to the SUS reimbursement value for the first-line treatment of CLL. In the scenario of higher market share for rituximab, total costs were lower compared to the scenario of lower market share. Given that the BIA estimate is for future expenses, uncertainties related to the possible increase in the cost of the drug were the factor that promoted the scenario of higher expenses. Conclusions: The projection of costs estimated by the BIA showed lower financial expenses in the scenario of greater diffusion of the drug, which may be correlated with the delay in the progression of the disease when using rituximab and, consequently, fewer patients will require second-line treatment, which has a higher cost.

Qual a qualidade da análise de impacto regulatório elaborada por agências reguladoras do Brasil? / ¿Cuál es la calidad del análisis de impacto regulatorio elaborado por las agencias reguladoras brasileñas? / What is the quality of the regulatory impact analysis prepared by Brazilian regulatory agencies?

Resumo A análise de impacto regulatório (AIR) é uma ferramenta que busca identificar os impactos relevantes que uma política regulatória pode ter, com vistas a subsidiar a tomada de decisão. O seu uso tornou-se obrigatório no Brasil, mas não há estudos que tenham investigado se a qualidade da análise tem alcançado o nível desejado no país. Assim, o objetivo da presente pesquisa foi avaliar a qualidade das AIRs realizadas por agências reguladoras federais brasileiras. Para a condução deste trabalho, foi desenvolvido e aplicado um instrumento com 50 critérios para a verificação da qualidade de um conjunto de 21 AIRs. Os resultados indicaram boa qualidade das AIRs em alguns aspectos, como na definição de problemas e objetivos, mas apontaram fragilidades em outros, como na análise de impactos e na comparação de alternativas. Como agenda para pesquisas futuras, foi proposta investigação de hipóteses e fatores que podem explicar a ausência de um padrão de qualidade da AIR no país.

Resumen El análisis de impacto regulatorio (AIR) es una herramienta que busca identificar los impactos relevantes que puede tener una política regulatoria, con miras a apoyar la toma de decisiones. Su uso se ha vuelto obligatorio en Brasil, pero no hay estudios que hayan investigado si la calidad del análisis ha alcanzado el nivel deseado en el país. Así, el objetivo de la presente investigación fue evaluar la calidad de los AIR realizados por las agencias reguladoras federales brasileñas. Para realizar la investigación se elaboró y aplicó un instrumento con 50 criterios de evaluación de la calidad en un conjunto de 21 AIR. Los resultados indicaron buena calidad de los AIR en algunos aspectos, como en la definición de problemas y objetivos, pero señalaron debilidades en otros, como en el análisis de impactos y en la comparación de alternativas. Como agenda de estudios futuros, se propusieron investigaciones de hipótesis y factores que puedan explicar la ausencia de un estándar de calidad del AIR en el país.

Abstract The regulatory impact analysis - RIA is a tool that seeks to identify the regulatory policy's relevant impacts to support decision-making. Its use has become mandatory in Brazil, but no studies have investigated whether the quality of the analysis has reached the desired level in the country. Thus, the objective of this research was to evaluate the quality of RIAs carried out by Brazilian federal regulatory agencies. An instrument was developed and applied with 50 criteria for quality assessment in a set of 21 RIAs. The results indicated the good quality of the RIAs in some aspects, such as the definition of problems and objectives, but they pointed out weaknesses in others, such as the analysis of impacts and the comparison of alternatives. As an agenda for future studies, investigations of hypotheses and factors that may explain the absence of a quality standard for RIA in the country were proposed.

Calculation Method of Medical Insurance Fund Expenditure of Intervention Scheme for Cross-year Survival Patients Based on Survival Data of Cohort Model / 中国药房

OBJECTIVE：To construct a calculation method which can accurately reflect the medical insurance fund expenditure of intervention scheme for cross-year survival patients ，and to provide reference for the research of medical insurance budget impact analysis（BIA）. METHODS ：Based on survival data of cohort model ，taking the patients diagnosed in each cycle in each year as a cohort，the number of per capita survival cycle of cohort patients in each state in the study year was calculated ，i.e. the average survival time ；on this basis ，the total cost of patients in all cohorts in the study year was calculated according to the number of people in each cohort and the per capita cost each cycle in each state. Taking the intervention scheme of a cancer as an example ， the calculation was carried out by the established algorithm ，and the calculation results were compared with the results of several common algorithms ；at the same time ，the application suggestions were put forward for the expansion of the constructed algorithm in special cases. RESULTS & CONCLUSIONS ：Compared with the several common algorithms ，the calculation process of the constructed algorithm is more in line with the process of medical insurance fund expenditure related to drug intervention scheme in the real world ，and it can flexibly adapt to the calculation needs in a variety of special situations. This algorithm can more accurately calculate the medical insurance fund expenditure of a intervention scheme in a specific year ，and to a certain extent solve the problem of inaccurate prediction of medical insurance fund expenditure due to insufficient consideration of cross-year survival patients or simple and rough calculation process. It can provide a more accurate method choice for the research of medical insurance BIA in China.

Cladribina oral para o tratamento da esclerose múltipla remitente-recorrente altamente ativa: análise de impacto orçamentário sob a perspectiva do sistema brasileiro de saúde suplementar / Cladribine tablets for the treatment of highly active recurrent multiple sclerosis: budget impact analysis from the perspective of the Brazilian supplementary health system

Objetivo: Avaliar o impacto orçamentário da inclusão da cladribina oral no tratamento de esclerose múltipla remitente-recorrente em alta atividade da doença (EMRR HDA) no Sistema de Saúde Suplementar (SSS). Métodos: Foi conduzida uma análise de impacto orçamentário, sob a perspectiva do SSS, com horizonte temporal de quatro anos, considerando a abordagem de coorte aberta na qual o número de pacientes elegíveis para tratamento varia em cada ano com a introdução de novos pacientes diagnosticados de EMRR HDA e a retirada de indivíduos prevalentes devido a morte ou progressão secundária. Foram considerados custos médicos diretos, incluindo a aquisição e administração de medicamentos, monitoramento, eventos adversos e surtos. Os comparadores utilizados na análise foram: alentuzumabe, fingolimode, natalizumabe e ocrelizumabe. Os custos foram apresentados em real brasileiro (BRL). Resultados: O custo incremental da inclusão da cladribina oral para o SSS foi estimado em 463.265 BRL, 739.691 BRL, -1.414.963 BRL, -3.719.007 BRL, nos anos 1, 2, 3 e 4, respectivamente. Isso resultou em um custo incremental total de -3.931.015 BRL no período analisado, representando 1,5% da redução orçamentária total no tratamento de EMRR HDA. Conclusão: A inclusão da cladribina oral para o tratamento de pacientes com diagnóstico de EMRR HDA poderia gerar uma economia substancial para o sistema brasileiro de saúde suplementar, atingindo um valor de cerca de 3,9 milhões de BRL em um período de quatro anos

Objective: To evaluate the budget impact of adopting cladribine tablets as a treatment strategy for relapsing remitting multiple sclerosis with high disease activity (RRMS HDA), from the Brazilian private healthcare system perspective. Methods: A budget impact analysis, under private healthcare system perspective, with a 4-years time horizon was conducted, considering the open cohort approach in which the number of patients eligible for treatment varies each year with the introduction of newly diagnosed RRMS HDA patients and the drop out of prevalent individuals due to death or secondary progression. Direct medical costs, including acquisition, drug administration, monitoring, adverse events and relapses were considered. Comparators used in the analysis were: alentuzumab, fingolimod, natalizumab and ocrelizumab. Costs were presented in Brazilian real (BRL). Results: The incremental cost of incorporating cladribine tablets into the private healthcare system was estimated at 463,265BRL, 739,961BRL, -1,414,963 BRL, -3,716,007 BRL, in years 1, 2, 3 and 4, respectively. This resulted in a total incremental cost of -3,931,015 BRL over the period analyzed, representing 1.5% of the total budget reduction in the treatment of RRMS HDA. Conclusion: Incorporation of cladribine tablets for the management of RRMS HDA could generate substantial savings for the private healthcare system, reaching a value of approximately 3.9 million BRL in a 4-years period

Nimotuzumab (CIMAher®) en pacientes cubanos con cáncer de cabeza y cuello estadios III/IV: Análisis de impacto presupuestario / Nimotuzumab (CIMAher®) in Cuban patients with head and neck cancer stage III/IV: Budget impact analysis

En Cuba, el cáncer es la segunda causa de muerte con 24.902 defunciones en el 2018; de ellas, 795 fueron por tumores de laringe y 826 por tumores de labio, cavidad bucal y faringe. El anticuerpo monoclonal nimotuzumab (CIMAher®) está registrado como tratamiento combinado con radioterapia o quimioterapia para el cáncer de células escamosas de cabeza y cuello estadios avanzados. Del mismo se conoce su efectividad y perfil de seguridad, no así el impacto económico que acarrearía la incorporación del mismo al Sistema Nacional de Salud (SNS) cubano; de forma tal de asignar y reajustar presupuestos en la esfera de medicamentos. Por tanto, se hizo necesario realizar un análisis de impacto presupuestario, con el objetivo de estimar el impacto financiero de la incorporación del nimotuzumab (CIMAher®) al paquete de beneficios del SNS cubano. Se tomaron los datos de prevalencia e incidencia de la enfermedad en los estadios III/IV. Se estableció un escenario actual con la terapia radio/quimioterapia secuencial y una tasa de penetración de 100%. El escenario futuro fue radio/quimioterapia secuencial + nimotuzumab (CIMAher®) con tasa anual de penetración 20, 40, 60, 80 y 100 por ciento. La perspectiva fue desde el SNS y un horizonte temporal de 5 años (2019-2023). El análisis de impacto presupuestal mostró que, desde perspectiva, horizonte y tasa de penetración establecidos, el SNS debe invertir aproximadamente de 10 a 65 millones de pesos cubanos (CUP); cifras menores al presupuesto destinado a salud pública(AU)

In Cuba, cancer is the second cause of death with 24,902 deaths in 2018; 795 were due to laryngeal tumors and 826 due to tumors of the lip, oral cavity and pharynx. The monoclonal antibody nimotuzumab (CIMAher®) is registered as a combined treatment with radiotherapy or chemotherapy for advanced squamous cell carcinoma of the head and neck. Its effectiveness and safety profile are known, but not their economic impact into the Cuban National Health System (NHS); in order to allocate and readjust budgets in the field of medicines. Therefore, it was necessary to perform a budget impact analysis in order to estimate the financial impact of the incorporation of nimotuzumab (CIMAher®) into the benefits package of the Cuban NHS. Data on prevalence and incidence of the disease in stages III / IV were taken into account. The current scenario was with the therapy radio/sequential chemotherapy and penetration rate of 100 percent. The future scenario was radio/sequential chemotherapy + nimotuzumab (CIMAher®) and annual penetration rate of 20, 40, 60, 80 and 100 percent. The perspective was from the NHS and a time horizon of five years (2019-2023). The budget impact analysis showed that from an established perspective, horizon and penetration rate, the NHS must invest 10-65 million Cuban pesos (CUP) approximately; lower values than the budget allocated to Public Health(AU)

Development of Budget Impact Analysis of Orphan Drugs / 中国药学杂志

Budget impact analysis of drugs for rare diseases in different countries are reviewed. There are more than 7 000 kinds rare disease characterized by low incidence, serious influence on patients and society, difficulty in diagnosis, less effective intervention and therapeutic drugs. With the orphan drug legislation of the United States, the European Union and other countries, the number of drugs for rare diseases is increasing. At present, the United States has approved more than 600 drugs for rare diseases, and the European Union has approved more than 100 drugs for rare diseases. The types of rare diseases, the number of patients receiving treatment, the number of approved drugs for rare diseases, the annual cost of drug treatment for rare diseases and the availability of drugs are the main factors affecting the budget. The study shows that with the increase in the number of drugs approved for rare diseases, the proportion of drugs expenditure for rare diseases in the total drug expenses showed a slow rising trend, and there are national and regional differences. The overall budget impact of orphan drugs is small and fairly stable relative to total pharmaceutical expenditure. In addition, a small number of rare diseases drugs used to treat tumors and metabolic diseases have a greater impact on the total drug cost.

Construction of the Evaluation System of the Research Quality of Medical Insurance Budget Impact Analysis / 中国药房

OBJECTIVE：To construc t the evaluation system of the research quality of medical insurance budget impact analysis （BIA），and to provide feasible evaluation tool for related departments as medical insurance department. METHODS ：Based on BIA guidance documents and relevant empirical literatures of ISPOR ，Canada，Poland，the United States and other countries ， combined with expert interview ，the relevant elements of medical insurance negotiation BIA material were confirmed （including key elements and adjuctive elements ）. The scale and system was established to calculate total score of BIA research quality evaluation. RESULTS ：Key elements included three data blocks as target population ，market situation and treatment cost ，involving 14 key elements such as total population ，new drug scenario market share ，treatment cost ，etc.. According to the degree of compliance，0-3 points were assigned and the lowest score after normalization was taken as the basic score of BIA research quality. The adjunctive elements included five data blocks as title & abstract ，research background ，analysis framework ，result presentation and other ，including 23 adjunctive elements such as title ，abstract，research angle ，research time limit ，etc.. According to whether there is quality grade difference ，the elements were divided into type A and type B ；the grade score （0-4 points）and 0/1 score（1 point for yes and 0 point for no ）were used respectively ，and the additional score of BIA research quality was obtained after calculation and addition. According to the addition of different weights （0.67 and 0.33）of basic score and additional score ，the total score system of BIA research quality evaluation could be calculated. CONCLUSIONS ：This study successfully constructed a new BIA quality evaluation system ，which can be used for the quality evaluation of BIA research submitted by medical insurance drug negotiation.

Study on the Medical Insurance Budget Impact Analysis Guideline in Some European Countries and Its Enligh- tenment to China / 中国药房

OBJECTIVE：To study the m edical insurance budget impact analysis （BIA）guidelines or nomative documents of some European countries ，and to provide the suggestions for the formulation and implementation of medical insurance BIA guidelines in China. METHODS ：Medical insurance BIA guidelines or related documents in European countries such as Ireland ， France，Poland，Belgium and UK were retrieved to summarize and comparatively analyze the general analysis framework and special specification. The formulation of medical insurance BIA guideline in China and the suggestions were put forward. RESULTS & CONCLUSIONS ：The above-mentioned medical insurance BIA guidelines or documents of the five European countries generally study the impact of the cost of health technology on resources within 3-5 years from the perspective of budget holders. The analysis framework of the guidelines or documents is basically the same ，but the guidelines or documents are adjusted according to the characteristics of national health system in terms of the positioning of medical insurance BIA ，the scope of cost data inclusion ， model design ，population subgroup analysis and so on. For example ，Ireland had special requirements on cost data inclusion ， sensitivity analysis and data source ，while France had detailed regulations on medical insurance BIA model ，sensitivity analysis and presentation of medical insurance BIA results. Our country should pay attention to the role of medical insurance BIA in medical and health decision-making ，formulate China ’s medical insurance BIA guidelines to standardize empirical research ，and combine the characteristics of China ’s health system when formulate the guideline. It is suggested that China ’s medical insurance BIA guidelines should at least include research perspective ，research time limit and discount ，reference situation ，target population ， cost，market share ，data source ，uncertainty analysis and other overall framework or basic elements to ensure the smooth operation of medical and health funds.

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

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

Objective: 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 with a variation of 15%. Results: The sFlt-1:PlGF ratio test has the potential to save -R$ 4.532,04 per patient compared to no test scenario. Considering the incorporation of the test in SSS, the sFlt1:PlGF ratio test can promote an economy of -R$ 6.375.865,68 in 2021 and -R$ 136.495.533,87 in accumulated five years of. Conclusion: The use of sFlt-1:PlGF ratio test to help rule-out pre-eclampsia has the potential to improve clinical decision and therefore to reduce unnecessary hospitalizations. The incorporation of the test can promote a substantial saving to the private healthcare system.

Quality Evaluation of the Literatures about Medical Insurance Budget Impact Analysis in China and the United States / 中国药房

OBJECTIVE： To provide experience and reference for the study of medical insurance budget impact analysis （BIA） in China. METHODS： Retrieved from PubMed， ProQuest， CNKI， Wanfang database and CBM， related literatures about medical insurance BIA research in China and the United States were collected since the establishment of the database. The basic information， analysis results and data sources were summarized and sorted out， and descriptive analysis of the included literature was carried out on basis of seven key elements such as model design， research perspective， treatment cost， reference scenario， target population， research time limit and discount/inflation， sensitivity analysis. RESULTS： A total of 72 literatures were included in this study， involving 24 （33.33％） studies in China， 48 （66.67％） studies in the United States； the indications of 45 studies were chronic diseases （62.50％）， and those of 21 studies were acute diseases （37.50％）. Among the research methods， 49 studies （68.06％） used BIA alone and 23 studies （31.94％） adopted BIA combined with pharmaceutical economics. In terms of model design， 50 studies （69.44％） adopted cost calculation models. In terms of research perspective， 60 studies （81.94％） were based on the perspective of medical insurance department research. In the calculation of treatment cost， 69 studies （95.84％） included drug cost. In terms of reference scenarios， 61 studies （84.72％） compared the economics of different drug-based treatment groups. For target population， only 31  （43.06％） studies used real world data. In terms of research duration and discount/inflation， 14 studies （19.44％） used treatment or length of hospitalization to indicate research duration， and 19 studies （26.39％） used discount rate or inflation rate to adjust costs. As for sensitivity analysis， 62 studies （86.11％） conducted sensitivity analysis， of which 49 （68.06％） used single factor sensitivity analysis. CONCLUSIONS： There are still some limitations in medical insurance BIA research literature in China and the United States， such as unreasonable use of data， incomplete coverage of the cost， and unreasonable setting of sensitivity analysis variables. It is recommended that BIA research should standardize data sources to improve the quality of budget evidence quality， reasonably evaluate market size to improve the authenticity of prediction， scientifically set variables and their scope of change to improve the stability of results， establish BIA research paradigms or evaluating standards so as to guide BIA research scientifically.

Budget Effect Analysis of Ivabradine in the Treatment of Heart Failure on Medical Insurance Fund in China / 中国药房

OBJECTIVE： To evaluate the effects of ivabradine in the treatment of heart failure on medical insurance fund budget in China， and to provide support evidence of related economical evaluation for medical insurance department to solve the problem of reimbursement admission of the drug in hospital outpatient department and the establishment of drug list in hospital. METHODS： Excel decision tree model was used. Pharmacoeconomic analysis was conducted based on the data reported in domestic literatures over the years. Firstly， according to the prevalence rate of heart failure in China， the number of patients with heart failure was estimated， which accorded with NYHA cardiac function class Ⅱ-Ⅳ， systolic blood pressure dysfunction and ivabradine indication. Then the cost of ivabradine was estimated. Secondly， the total number of hospitalizations and the cost of hospitalization due to heart failure were estimated. Finally， the cost of ivabredine and the cost of treatment saved by avoiding re-hospitalization due to the use of ivabredine were considered comprehensively. Static budget impact analysis was conducted to evaluate the effects of the use of ivabredine on medical insurance fund budget. RESULTS： The prevalence rate of heart failure in China was raised to 1.3％ in 2013. It was estimated that the number of heart failure patients between 35-75 years old in China could be about 8.51 million and total hospitalization times was about 4.32 million per year. The economic burden of hospitalization in heart failure patients was about 168.940 billion yuan in whole country. Since 18％ of patients could be avoided re-hospitalization after treatment with ivabradine， the cost of hospitalization could be saved by about 30.410 billion yuan， while the total cost of taking ivabradine was about 17.525 billion yuan. Therefore， the use of ivabradine could save the hidden medical cost budget by about 12.886 billion yuan， which had obvious cost-effectiveness. Static budget impact analysis results showed that by 2019-2020， the expected proportion of patients with heart failure covered by ivabradine would increased to 8.70％， and the total consumption sum would reach about 1.797 billion yuan. The incremental cost savings ratio （ICSR） showed that the cost of hospitalization could be saved by about 11 951 yuan for each additional case of heart failure treated with ivabradine； there could be 5 711 yuan of balance by deducting drug cost 6 240 yuan of ivabradine. CONCLUSIONS： The cost savings of hospitalization treated by ivabradine is not only enough to offset the cost of ivabradine itself， but also has a premium effect. The drug is of certain economy for the treatment of heart failure in China.

Análise de impacto orçamentário: uma revisão prática de conceitos e aplicações para o gestor / Budget impact analysis: a practical review of concepts and applications for the manager

Avaliações econômicas em saúde são essenciais para a tomada de decisão de gestores, visto que as inovações no setor nem sempre podem ser incorporadas conforme as expectativas dos usuários e da indústria. Logo, a análise de impacto orçamentário (AIO), uma das principais ferramentas da avaliação de tecnologias em saúde (ATS), permite aos gestores estimar o potencial número de indivíduos elegíveis para determinada tecnologia ao longo dos anos, prever quanto será necessário gastar para incorporar a tecnologia ou, eventualmente, se haverá economia nos cofres do pagador com a inclusão dela. Com a crescente publicação de artigos científicos sobre AIO no Brasil, surge a preocupação a respeito da qualidade metodológica desses estudos. O objetivo desta revisão é apresentar recomendações-chave para a elaboração de uma AIO adequada e expor a utilidade prática da AIO para a tomada de decisão de gestores de saúde por meio da análise de quatro estudos publicados. O formato de apresentação de uma AIO possibilita rápido entendimento e possui atributos que permitem evidenciar o maior valor de produtos e serviços de saúde junto aos tomadores de decisão em saúde, contribuindo para as melhores escolhas do ponto de vista clínico e econômico, nos sistemas público e privado. Porém, cabe ressaltar que alguns estudos ainda carecem de evidências de mundo real ou dados epidemiológicos para as estimativas e trabalham de maneira insuficiente as ferramentas para a redução de incertezas paramétricas.

Health economics evaluations are essential for decision makers, since innovations can not always be incorporated according to expectations of users and industry. Therefore, the Budget Impact Analysis (BIA), one of the main tools in Health Technology Assessment (HTA), allows managers to estimate the potential number of individuals eligible for a given technology over the years, to predict how much it will be necessary to spend for incorporate the technology or, eventually, whether there will be savings in the payer's coffers with the inclusion of the same. With the growing publication of scientific articles on BIA in Brazil, there is concern about the methodological quality of these studies. The objective of this review is to present key recommendations to elaborate an adequate BIA, commenting on four published studies, aiming to expose the practical utility of BIA for health managers. The presentation format of the BIA provides a quick understanding and has attributes that allows evidence of the highest value of health products and services among health decision makers, contributing to the best clinical and economic choices in public and private health systems. However, it should be noted in some studies there is still a lack of real-world evidence or epidemiological data for the estimates and insufficient using of tools to reduce parametric uncertainties.

Study on International Experience of Medical Insurance Budget Impact Analysis and Its Enlightenment to China / 中国药房

OBJECTIVE:To put forward relevant suggestions for formulating and implementing medical insurance budget impact analysis(BIA)research guideline in China. METHODS:The medical insurance BIA guidelines or relevant documents were retrieved from ISPOR,Canada and the United States. Their similarities and differences were compared. The experiences of them were summarized in respects of research framework,data source and report format of medical insurance BIA. RESULTS &CONCLUSIONS:ISPOR,Canada,USA and other guidelines or relevant documents have some similarities in normalization requirements of research perspectives,target population calculation based on natural reason and epidemiological data,3-5 years as the research time limit and some other respects. But the calculation of additional costs as drug price addition,distribution fee should be specifically adjusted according to the unique characteristics of the health systems of countries or regions. Based on the actual conditions of our own health care system,our country can draw up the guidelines for medical insurance BIA impact analysis,which contain model design,research perspective,target population,current use of intervention measures,prediction on the effects of new intervention measure introduction on the market,cost,time range,discount and uncertainty analysis of current and new interventions,situational analysis and verification,so as to better play its role in the formulation and adjustment of medical insurance catalogues and in drug price negotiations.

The influence of The Law of Traditional Chinese Medicine in People's Republic of China in the traditional Chinese medicine apprentice education / 国际中医中药杂志

As the The Law of Traditional Chinese Medicine in People's Republic of China has been carried out, the gradual implementation and the development of traditional Chinese medicine apprentice education were increasing. This paper described the current situation and development of traditional Chinese medicine apprentice education.Based on the The Law of Traditional Chinese Medicine in People's Republic of China,the development and trendency of traditional Chinese medicine apprentice education in our country were explored, and the supporting foundation of policy of traditional Chinese medicine apprentice education were analyzed, in order to give some relevant suggestion.

Budget Impact Analysis of Free Influenza Vaccination for Elderly People Over 60 Years Old in Guangzhou / 中国药房

OBJECTIVE:To evaluate the economic efficiency of the Guangzhou government's free vaccination of influenza vaccine for elderly people over 60 years old from perspective of government,and to provide reference for decision-making depart-ment. METHODS:The static budget impact analysis model was constructed to estimate the healthcare expenses of self-paid vaccina-tion and free vaccination,and analyze the change of total government expenditure. RESULTS:The healthcare costs by government was estimated to be 40785594 yuan when the influenza vaccination was self-paid;it would rise up to 54744715 yuan when the government provided the influenza vaccine freely,so the government needed to invest more than 13959121 yuan each year,but in-fluenza patients could be reduced by about 39845 people. The sensitivity analysis showed that the health cost additionally invested by government was not more than 20 million yuan every year. CONCLUSIONS:It is economical for the government of Guangzhou to provide free vaccination for elderly people over 60 years old. If the government is financially affordable,it may consider providing free influenza vaccine for the elderly in the city so as to protect the elderly from influenza and its complications to a greater extent.

The cost-effectiveness and budget impact of a community-based universal newborn hearing screening program in the Philippines

@#<p style="text-align: justify;"><strong>BACKGROUND:</strong> In 2000, the World Health Organization recommended implementation of universal hearing screening. The Philippines enacted this policy into law in 2009 as it was found to be cost-effective for the Philippines. The model at the time used a hospital-based approached to screening. This paper examines the cost-effectiveness and budget impact of implementing a community-based universal hearing screening program.<br /><strong>METHODS:</strong> A model was developed following a community-based hearing screening program. Parameters were obtained through literature review, secondary data analysis, and consultation with experts. Cost-effectiveness was assessed for a single birth cohort from a public payer and societal perspective.<br /><strong>RESULTS:</strong> A community-based universal hearing screening program was found to be cost-saving. One-way sensitivity analysis showed that results were sensitive only to treatment rate and follow-up rate. The program is also a high budget impact program.<br /><strong>CONCLUSION:</strong> A community-based hearing screening program is cost-saving for the Philippines. Ensuring treatment and good follow-up in testing will ensure cost-effectiveness.</p>

Net present value as an instrument to simplificate the decision making process in health technologies economic evaluation / O Valor Presente Líquido como instrumento de simplificação do processo de tomada de decisão nas análises econômicas de tecnologias em saúde

Objectives: The study aims to highlight the Present Value (PV) as a financial analysis tool which could simplify the decision making process of introducing health technologies. The financial evaluation can be extended as necessary, including outcomes and utility. As a model, the instrument was applied to the economic analysis of a robotic-assisted surgery equipment acquisition at José de Alencar Gomes da Silva National Cancer Institute (INCA ? Ministry of Health ? Brazil). Methods: The economic analysis of a robotic-assisted surgery equipment acquisition in an institute for oncology using the PV. Quantitative data was simulated to allow the development of an economic model, considering prostatectomy as a basis. The PV was calculated using MS EXCEL®. The results allowed us to formulate the goals of a Budget Impact Analysis (BIA) or other health economics evaluation within the process of public choice in a Beveridge model health care system. Results: The PV in this model was positive. Data collection and processing was simple and extrinsic macroeconomics variables, such as inflation and change, were important to reflect their impact to the budget. Cost information reflected the local market. A negative PV provided information on the financial resourceamount to introduce technology by justified use. Conclusions: The PV has proved to be a useful and robust instrument to evaluate financial risks, especially those related to the introduction of a recent technology. This financial perspective as performed helped to set the goals of a societal perspective in a unified health care system through the health economics evaluation.

Objetivos: O trabalho procura oferecer uma visão sobre a aplicação do valor presente (VP) como um instrumento de análise financeira que poderia simplificar o processo de tomada de decisão para a introdução de tecnologias de saúde. A partir do resultado da análise financeira, o processo de tomada de decisão poderá ser ampliado de acordo com a necessidade, incluindo as análises sobre desfecho e utilidade. O modelo descrito foi utilizado como instrumento de avaliação econômica da aquisição do equipamento de cirurgia robótica no Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA ? Ministério da Saúde ? Brasil). Métodos: Análise econômica da introdução de equipamento de cirurgia robótica em um instituto de atenção oncológica, utilizando o valor presente. As informações quantitativas foram simuladas para permitir o desenvolvimento do modelo econômico, considerando o procedimento de prostatectomia. O valor presente foi calculado com o auxílio do programa MS EXCEL®. O resultado possibilita a formulação dos objetivos de uma análise de impacto orçamentário (AIO) ou a de outra avaliação de econômica em saúde dentro do processo de escolha pública em um sistema de saúde do tipo Beveridge. Resultados: No modelo apresentado, o valor presente foi positivo. Foifácil levantar e manusear as informações e as variáveis econômicasextrínsecas como inflação e taxa de câmbio se deixam refletir nadeterminação das necessidades orçamentárias. Informações sobre custo refletem o mercado onde estará sendo utilizada a tecnologia. Um valor presente negativo irá oferecer informação sobre a necessidade orçamentária para introdução da tecnologia no caso de utilidade relevante para a sociedade. Conclusões: O valor presente comprovou ser uma ferramenta robusta e útil para avaliar o risco financeiro, principalmente na introdução de tecnologias pioneiras. Da maneira como é analisada a perspectiva financeira, facilita a determinação de objetivos relacionados à perspectiva social dentro de um sistema universal de saúde e que poderão ser acoplados a avaliação econômica de saúde.

Case study of abdominal aortic aneurysm screening programs in other countries and feasibility study of a national screening program for South Korea

Abdominal aortic aneurysm (AAA) is a disease in which the abdominal aorta is swollen to a diameter as large as 3.0cm or even more. Although the symptoms are usually not prominent, it is fatal once it bursts. If AAA is diagnosed early and treated, the majority of deaths from ruptured AAA can be prevented. It is screened for with ultrasonography, which is a fast, cheap and safe diagnosis tool. Most patients can also tolerate the screening well. Several countries are operating national AAA screening programs in efforts to reduce AAA-related deaths. For instance, the Screening Abdominal Aortic Aneurysms Very Efficiently program in the United States and the National Health Service Abdominal Aortic Aneurysm Screening Programme in the United Kingdom are some of the prominent programs currently available. If Korea conducts AAA screening programs for a target population similar to these cases, the cost is estimated to be 25.7 billion Korean won (23.4 million US dollars [USD]). If the target population is extended to males 65 years of age and above with experience smoking more than 5 pack-years of cigarettes, the cost is estimated to be 36.4 billion Korean won (33.1 million US dollars [USD]). However, considering the actual screening rate of the current national cancer screening program, the realistic costs are estimated to be 10.6 billion Korean won (9.7 million US dollars [USD]) and 15.0 billion Korean won (13.7 million US dollars [USD]), respectively. Given the success of AAA screening programs in other countries, it is necessary to introduce a national AAA screening program in Korea.

Modelos de impacto presupuestario. una nueva herramienta de evaluación para drogas de alto costo en oncología / Models budgetary impact. a new evaluation tool for high-cost drugs in oncology

Dentro de las evaluaciones fármaco-económicas habituales de nuevas drogas, se ha generalizado el uso del análisis de impacto presupuestario, que es un complemento de las evaluaciones más conocidas de costo-efectividad y costo-utilidad y tiene una importancia fundamental al momento de decidir la incorporación de una nueva molécula (o intervención terapéutica) al formulario terapéutico de una organización o subsistema de salud. Varios factores, no utilizados habitualmente en evaluaciones de costo-efectividad, son necesarios para los análisis de impacto presupuestario, incluyendo el tamaño de la población pasible de recibir tratamiento y las tasas de difusión en el mercado de la nueva intervención, entre otros. Se presenta en este artículo un prototipo básico de modelo de impacto presupuestario (MIP) y se discute la relevancia de los datos que se obtienen de ellos y su utilidad para quien toma las decisiones dentro de las organizaciones de salud.

In recent years, budget impact analysis have become morecommon among pharmaco-economic evaluations, this typeof analysis is complementary to the more traditional healthtechnology assessments like cost effectiveness analysisand cost utility analysis, and have an important role toplay when making decisions regarding the incorporationof a new drug (or technology) to the therapeutic formularyof a health organization. Several factors not usedin standard cost effectiveness analysis are needed whenperforming a budget impact analysis, including the sizeof the whole population able to be treated with the newdrug and the penetration rates of the new technology inthe target population. In this paper, a basic prototype of abudget impact model is presented, and the relevance forthe decision makers of the data obtained by the budgetimpact models is discussed.