Challenges and opportunities for access to Advanced Therapy Medicinal Products in Brazil.

BACKGROUND AIMS: The marketing authorization of Advanced Therapy Medicinal Products (ATMPs) in Brazil is recent. The features of these therapies impose specialized regulatory action and are consequently challenging for developers. The goal of this study was to identify the industry's experience in clinical development, marketing authorization and access to ATMPs through the Unified Health System (SUS, acronym in Portuguese), from a regulatory perspective. METHODS: A survey containing structured questions was conducted among research participants who work at companies that commercialize ATMPs. A descriptive analysis was performed. RESULTS: We invited 15 foreign pharmaceutical companies, of which 10 agreed to participate. Overall, participants assessed that Brazil has a well-established regulatory system, especially the sanitary registration by the National Health Surveillance Agency (Anvisa), which ensures the quality, safety, and efficacy of the products. The Agency's good interaction with the regulated sector, the harmonization of sanitary and ethical assessment systems with other countries, and the analysis time in the biosafety assessment of Genetically Modified Organisms (GMOs) stand out as positive in industry's evaluation. On the other hand, it is important to advance the pricing regulation for these products since Brazilian regulations do not establish specific criteria for ATMP. One of the biggest challenges is the difficulty for the SUS in reimbursing these very high-cost therapies, especially using current Health Technology Assessment (HTA) methods. CONCLUSIONS: Considering the increasing number of approvals of cell and gene therapies in Brazil in the coming years, a close dialogue between the industry and the public sector is recommended to advance regulatory improvements (pricing and HTA). Additionally, the construction of policies to promote the national Health Economic-Industrial Complex, based on a mission-oriented vision that encourages innovative models of financing, especially those that consider risk-sharing and co-financing technologies, will help provide the population with universal, equitable and sustainable access to ATMP in the SUS.

Refractory secondary hyperparathyroidism in waiting list for parathyroidectomy: who we should operate first in a quaternary hospital in Brazil regarding survival.

BACKGROUND: Few centers in Brazil perform parathyroidectomy (PTX) for recalcitrant secondary hyperparathyroidism (SHPT) generating a long queue. There is little data regarding prioritize criteria besides chronological order and survival. OBJECTIVES: To determine the difference of clinical and laboratory factors between PTX patients and those who remained in the line despite the need for surgery and their survival. METHODS: A retrospective cohort study was conducted in a quaternary hospital in Brazil, where 43 patients with PTX indication due to severe SHPT were followed from 2009 to 2016. While 31 patients underwent PTX, 12 remained in the queue. Data on clinical and laboratory factors were collected for comparison and Kaplan-Meier and Cox regression survival analysis were used. RESULTS: PTX group was younger (40.9 vs. 49.3 years, p = .03), had higher PTH levels (2578 vs. 1937 pg/ml, p = .01) and higher CaxP product (62 vs. 47.5, p = .02). There were no percentage differences between groups of fractures, calciphylaxis and other complications due to SHPT. Patients who were not operated had a worst overall survival (5 y 62.2% vs. 96.7%, p = .04) with a HR for death of 8.08 (p = .07, PTX as a TVC). Other variables associated with decreased survival included a history of previous myocardial infarction (HR: 10.4, p = .01) and age per additional year (HR: 1.09, p = .02). CONCLUSIONS: Patients with severe SHPT are at increased risk of death while waiting for PTX. Clinical events like fracture were not used to prioritize patients beyond consecutive order. Therefore, optimizing priority criteria for PTX may result in improved survival in this population.

Student Evaluation of Distance Learning for Health Care Professionals.

Background:To meet the population's health needs, it is necessary to have health professionals highly trained and updated with the latest skills. The Brazilian government, through the Open University of Brazilian National Health System (UNA-SUS), offers continuing education with free access, in distance learning (DL) modality.Objective:This study aimed to analyze students' perceptions regarding didactic and pedagogical aspects related to the content and activities, educational resources, and tutoring in a module offered by UNA-SUS/Federal University of Maranhão (UFMA).Methods:The authors analyzed a sample of 319 students, enrolled in four postgraduate classes, who had completed the communicable diseases module, from 2013 to 2014, and responded to evaluation questions through the Integrated Management System (SIGU) questionnaire, an auxiliary system for processing and interpreting assessments of DL modules offered by UNA-SUS/UFMA. For statistical analysis, evaluation variables were dichotomized into either a positive outcome ("great" and "good") or a negative outcome ("bad" and "insufficient"). Data were analyzed using Statistical Package for the Social Sciences (SPSS®; version 18); the significance level was set at 5% (p < 0.05).Results:The authors observed that 99% of the students evaluated the module positively. Regarding the evaluation of the content and activities, 53% (169), 43.6% (139), and 3.4% (11) of students evaluated the item unit workload as great, good, and bad, respectively. The highest rated item was tutor performance, rated as great by 229 (71.8%) students.Conclusions:The results contributed to the improvement of DL courses offered by UNA-SUS/UFMA from the perspectives of controlling dropout rates and the development of public health services offered in Brazil.

Prevalence of chronic kidney disease and comorbidities in isolated African descent communities (PREVRENAL): methodological design of a cohort study.

BACKGROUND: Chronic kidney disease (CKD) is considered a serious public health problem, both in Brazil and worldwide, with an increasing number of cases observed inrecent years. Especially, CKD has been reported to be highly prevalent in those of African descent. However, Brazil lacks data from early-stage CKD population studies, and the prevalence of CKD is unknown for both the overall and African descent populations. Hence, the present study aimsto estimate the prevalence of early-stage CKD and its associated risk factors in African-Brazilians from isolated African-descent communities. Herein, the detailed methodology design of the study is described. METHODS: This population-based, prospective, longitudinal, cohort study (PREVRENAL) is performed in three stages: first, clinical, nutritional, and anthropometric evaluations; measurements of serum and urinary markers; and examinations of comorbiditieswere performed. Second, repeated examinations of individuals with CKD, systemic arterial hypertension, and/or diabetes mellitus; image screening; and cardiac risk assessment were performed. Third, long-term monitoring of all selected individuals will be conducted (ongoing). Using probability sampling, 1539 individuals from 32 communities were selected. CKD was defined asaglomerular filtration rate (GFR) ≤60 mL/min/1.73m2 and albuminuria > 30 mg/day. DISCUSSION: This study proposes to identify and monitor individuals with and without reduced GFR and high albuminuria in isolated populations of African descendants in Brazil. As there are currently no specific recommendations for detecting CKD in African descendants, four equations for estimating the GFR based on serum creatinine and cystatin C were used and will be retrospectively compared. The present report describes the characteristics of the target population, selection of individuals, and detection of a population at risk, along with the imaging, clinical, and laboratory methodologies used. The first and second stages have been concluded and the results will be published in the near future. The subsequent (third) stage is the long-term, continuous monitoring of individuals diagnosed with renal abnormalities or with CKD risk factors. The entire study population will be re-evaluated five years after the study initiation. The expectation is to obtain information about CKD evolution among this population, including the progression rate, complication development, and cardiovascular events.

The Regulation of Biosimilars in Latin America.

This article summarizes the regulatory scenario on biological medications in Latin America focusing on comparability studies, extrapolation of indications, interchangeability and pharmacovigilance issues. In the case of comparability studies, what is being discussed is the possibility of decreasing the clinical trials requirement, but that the molecule should be well characterized in the studies of pharmacokinetics and pharmacodynamics. With the worldwide-level approval of the first monoclonal antibody biosimilar, infliximab, extrapolation of indications are being discussed, since the behavior of the Latin America regulatory agencies has been different with regard to such issue. Another issue discussed by the regulatory agencies is the interchangeability between biological medications and their biosimilars, mainly due to the fact that there is a clear confusion on interchangeability and substitution concepts. Finally, the pharmacovigilance debate, according to what takes place globally, is related to the need for identifying and differentiating the reference biological medication and its biosimilars for traceability purposes.

Evidence syntheses to support decision-making related to the Covid-19 pandemic.

The COVID-19 pandemic generated a large volume of scientific productions with different quality levels. The speed with which knowledge was produced and shared worldwide imposed on health management the challenge of seeking ways to identify the best available evidence to support its decisions. In response to this challenge, the Department of Science and Technology of the Brazilian Ministry of Health started offering a service to produce and provide scientific knowledge addressing priority public health issues in the pandemic scenario. Drug treatments, non-pharmacological measures, testing, reinfection and immunological response, immunization, pathophysiology, post-COVID syndrome and adverse events are among the topics covered. In this article, we discuss the strengths and lessons learned, as well as the challenges and perspectives that present a real example of how to offer the best scientific evidence in a timely manner in order to assist the decision-making process during a public health emergency.

The Economic Burden of HIV/AIDS and myocardial infarction treatment in Brazil.

OBJECTIVE: To analyze the expenses of HIV/AIDS and acute myocardial infarction (AMI) treatment in Brazil. METHODS: A search in the Brazilian epidemiological database (DATASUS) on AMI and AIDS hospitalizations and their costs was done from January 1998 to December 2011. The number of HIV/AIDS cases and antiretroviral treatment (ART) costs was obtained from public Brazilian databases. RESULTS: In 5 years, HIV/AIDS cases increased 38.5%, mainly in patients aged 25-49. There were 180,640 patients in ART in 2007 at a cost of R$ 3,920 per patient/year. The hospitalizations due to AIDS were stable over the last 13 years; however, the hospitalizations due to AMI have increased 78%. In 2007, the expenses with hospitalizations for HIV/AIDS and AMI (25-49 years) were approximately 0.12 and 1.52% of the Ministry of Health budget allocated to reimburse inpatient costs. The expenses on ART totaled 1.5% of the total budget (all age groups). CONCLUSION: The prevalence of HIV/AIDS is still increasing in Brazil. There are scientific evidences suggesting an increased incidence of AIM in this population. Considering the high costs for the treatment of both diseases, an economic analysis is important to alert health managers to strengthen the preventive measures to guarantee the financial sustainability of such treatment.

The costs of overweight and obesity-related diseases in the Brazilian public health system: cross-sectional study.

BACKGROUND: Obesity is a major global epidemic and a burden to society and health systems. It is well known risk factor for a number of chronic medical conditions with high morbidity and mortality. This study aimed to provide an estimate of the direct costs associated to outpatient and inpatient care of overweight and obesity related diseases in the perspective of the Brazilian Health System (SUS). METHODS: Population attributable risk (PAR) was calculated for selected diseases related to overweight and obesity and with the following parameters: Relative risk (RR) ≥ 1.20 or RR ≥ 1.10 and < 1.20, but important problem of public health due its high prevalence. After a broad search in the literature, two meta-analysis were selected to provide RR for PAR calculation. The prevalence rates of overweight and obesity in Brazilians with ≥ 18 years were obtained from large national survey. The national health database (DATASUS) was used to estimate the annual cost of the Brazilian Unified Health System (SUS) with the diseases included in the analysis. The extracted values were stratified by sex, type of service (inpatient or outpatient care) and year. Data were collected from 2008 to 2010 and the results reflect the average of 3 years. Brazilian costs were converted into US dollars during the analysis using a purchasing power parity basis (2010). RESULTS: The estimated total costs in one year with all diseases related to overweight and obesity are US$ 2,1 billion; US$ 1,4 billion (68.4% of total costs) due to hospitalizations and US$ 679 million due to ambulatory procedures. Approximately 10% of these cost is attributable to overweight and obesity. CONCLUSION: The results confirm that overweight and obesity carry a great economic burden for Brazilian health system and for the society. The knowledge of these costs will be useful for future economic analysis of preventive and treatment interventions.

Cost-effectiveness analysis of medical treatment of benign prostatic hyperplasia in the Brazilian public health system.

OBJECTIVE: To perform a cost-effectiveness analysis of medical treatment of benign prostatic hyperplasia (BPH) under Brazilian public health system perspective (Unified Health System--"Sistema Unico de Saude (SUS)"). MATERIAL AND METHODS: A revision of the literature of the medical treatment of BPH using alpha-blockers, 5-alpha-reductase inhibitors and combinations was carried out. A panel of specialists defined the use of public health resources during episodes of acute urinary retention (AUR), the treatment and the evolution of these patients in public hospitals. A model of economic analysis (Markov) predicted the number of episodes of AUR and surgeries (open prostatectomy and transurethral resection of the prostate) related to BPH according to stages of evolution of the disease. Brazilian currency was converted to American dollars according to the theory of Purchasing Power Parity (PPP 2010: US$ 1 = R$ 1.70). RESULTS: The use of finasteride reduced 59.6% of AUR episodes and 57.9% the need of surgery compared to placebo, in a period of six years and taking into account a treatment discontinuity rate of 34%. The mean cost of treatment was R$ 764.11 (US$ 449.78) and R$ 579.57 (US$ 340.92) per patient in the finasteride and placebo groups, respectively. The incremental cost-effectiveness ratio (ICERs) was R$ 4.130 (US$ 2.429) per episode of AUR avoided and R$ 2.735 (US$ 1.609) per episode of surgery avoided. The comparison of finasteride + doxazosine to placebo showed a reduction of 75.7% of AUR episodes and 66.8% of surgeries in a 4 year time horizon, with a ICERs of R$ 21.191 (US$ 12.918) per AUR episodes avoided and R$ 11.980 (US$ 7.047) per surgery avoided. In the sensitivity analysis the adhesion rate to treatment and the cost of finasteride were the main variables that influenced the results. CONCLUSIONS: These findings suggest that the treatment of BPH with finasteride is cost-effective compared to placebo in the Brazilian public health system perspective.

[Analysis of cost-effectiveness of simvastatin versus atorvastatin in the secondary prevention of cardiovascular events within the Brazilian public healthcare system]. / Análise de custo-efetividade da sinvastatina versus atorvastatina na prevenção secundária de eventos cardiovasculares no Sistema Único de Saúde Brasileiro.

OBJECTIVE: The objective of this study is to perform an economic evaluation analyzing the treatment with atorvastatin and simvastatin in comparison to placebo treatment, within the Brazilian Public Healthcare System (SUS) scenario, for patients with high risk of cardiovascular disease; analyzing if the additional cost related to statin treatment is justified by the clinical benefits expected, in terms of cardiovascular event and mortality reduction. METHODS: Cardiovascular event risk and mortality risk were used as outcomes. Statin efficacy at LDL-c and cardiovascular events levels lowering data was obtained from a systematic review of literature. A decision analytic model was developed to perform a cost-effectiveness analysis comparing atorvastatin 10mg/day and simvastatin 40 mg/day to placebo treatment in patients with dyslipidemia in Brazil. The target population of this study was a hypothetic cohort of men and women with a mean age of 50 years old and high risk of cardiovascular disease. The model includes only direct costs obtained from Ambulatory and Hospital Information System and Price Database of Brazilian Ministry of Health. The comparative cost-effectiveness analysis itself was done through Excel spreadsheets covering a 5 -years time horizon. RESULTS: The result shows that atorvastatin 10mg/day in comparison to placebo has higher cost with higher effectiveness in the time horizon of 5 years (Incremental Cost Effectiveness Ratio of R$ 433.065,05 per life year gained). In this scenario atorvastatin is not cost effective in comparison to placebo. The simvastatin 40 mg/day appears to be a strategy with lower cost and higher effectiveness in comparison to placebo, in the time horizon analyzed (5 years). In the multivariate probabilistic sensitivity analysis, simvastatin showed 53% of the results in the quadrant with greater effectiveness and lower cost. CONCLUSIONS: This study is an important tool for public decision makers. The study can be used in the decision process of increasing cardiovascular disease treatment access with budgetary sustainability for Ministry of Health. In comparison to placebo, the results show that sinvastatin is a cost saving strategy while atorvastatin is not cost effective.

The costs of type 2 diabetes mellitus outpatient care in the Brazilian public health system.

OBJECTIVE: The prevalence of type 2 diabetes has shown a significant increase in parallel with health care costs. The objective of the Brazilian Study on Diabetes Costs (ESCUDI study) was to estimate direct and indirect costs of type 2 diabetes outpatient care in the Brazilian Public Health Care System. METHODS: Data were collected from different levels of health care in eight Brazilian cities in 2007. A total of 1000 outpatients were interviewed and had their medical records data analyzed. Direct medical costs included expenses with medications, diagnostic tests, procedures, blood glucose test strips, and office visits. Nonmedical direct costs included expenses with diet products, transportation, and caregivers. Absenteeism, sick leave, and early retirement were classified as indirect costs. RESULTS: Total annual cost for outpatient care was US$2108 per patient, out of which US$1335 per patient of direct costs (63.3%) and US$773 per patient of indirect costs (36.7%). Costs escalated as duration of diabetes and level of health care increased. Patients with both microvascular and macrovascular complications had higher costs (US$3199 per patient) compared to those with either microvascular (US$2062 per patient) or macrovascular (US$2517 per patient) complications only. The greatest portion of direct costs was attributed to medication (48.2%). CONCLUSIONS: Diabetes treatment leads to elevated costs both to Brazilian Public Health Care System and society. Costs increased along with duration of disease, level of care and presence of chronic complications, which suggested a need to reallocate health resources focusing on primary prevention of diabetes and its complications.

Costs of cancer attributable to excess body weight in the Brazilian public health system in 2018.

OBJECTIVES: The prevalence of excess body weight (EBW) has increased over the last decades in Brazil, where 55.4% of the adult population was overweight in 2019. EBW is a well-known risk factor for several types of cancer. We estimated the federal cost of EBW-related cancers in adults, considering the medical expenditures in the Brazilian Public Health System. METHODS: We calculated the costs related to 11 types of cancer considering the procedures performed in 2018 by all organizations that provide cancer care in the public health system. We obtained data from the Hospital and Ambulatory Information Systems of the Brazilian Public Health System. We calculated the fractions of cancer attributable to EBW using the relative risks from the literature and prevalence from a nationally representative survey. We converted the monetary values in Reais (R$) to international dollars (Int$), considering the purchasing power parity (PPP) of 2018. RESULTS: In Brazil, the 2018 federal cost for all types of cancers combined was Int$ 1.73 billion, of which nearly Int$ 710 million was spent on EBW-related cancer care and Int$ 30 million was attributable to EBW. Outpatient and inpatient expenditures reached Int$ 20.41 million (of which 80% was for chemotherapy) and Int$ 10.06 million (of which 82% was for surgery), respectively. Approximately 80% of EBW-attributable costs were due to breast, endometrial and colorectal cancers. CONCLUSION: A total of 1.76% of all federal cancer-related costs could be associated with EBW, representing a substantial economic burden for the public health system. We highlight the need for integrated policies for excess body weight control and cancer prevention.

Cost-effectiveness of mechanical thrombectomy for acute ischemic stroke in Brazil: Results from the RESILIENT trial.

BACKGROUND: The RESILIENT trial demonstrated the clinical benefit of mechanical thrombectomy in patients presenting acute ischemic stroke secondary to anterior circulation large vessel occlusion in Brazil. AIMS: This economic evaluation aims to assess the cost-utility of mechanical thrombectomy in the RESILIENT trial from a public healthcare perspective. METHODS: A cost-utility analysis was applied to compare mechanical thrombectomy plus standard medical care (n = 78) vs. standard medical care alone (n = 73), from a subset sample of the RESILIENT trial (151 of 221 patients). Real-world direct costs were considered, and utilities were imputed according to the Utility-Weighted modified Rankin Score. A Markov model was structured, and probabilistic and deterministic sensitivity analyses were performed to evaluate the robustness of results. RESULTS: The incremental costs and quality-adjusted life years gained with mechanical thrombectomy plus standard medical care were estimated at Int$ 7440 and 1.04, respectively, compared to standard medical care alone, yielding an incremental cost-effectiveness ratio of Int$ 7153 per quality-adjusted life year. The deterministic sensitivity analysis demonstrated that mRS-6 costs of the first year most affected the incremental cost-effectiveness ratio. After 1000 simulations, most of results were below the cost-effective threshold. CONCLUSIONS: The intervention's clear long-term benefits offset the initially higher costs of mechanical thrombectomy in the Brazilian public healthcare system. Such therapy is likely to be cost-effective and these results were crucial to incorporate mechanical thrombectomy in the Brazilian public stroke centers.

Fighting Against Stroke in Latin America: A Joint Effort of Medical Professional Societies and Governments.

Introduction: Stroke is one of the leading causes of death in Latin America, a region with countless gaps to be addressed to decrease its burden. In 2018, at the first Latin American Stroke Ministerial Meeting, stroke physician and healthcare manager representatives from 13 countries signed the Declaration of Gramado with the priorities to improve the region, with the commitment to implement all evidence-based strategies for stroke care. The second meeting in March 2020 reviewed the achievements in 2 years and discussed new objectives. This paper will review the 2-year advances and future plans of the Latin American alliance for stroke. Method: In March 2020, a survey based on the Declaration of Gramado items was sent to the neurologists participants of the Stroke Ministerial Meetings. The results were confirmed with representatives of the Ministries of Health and leaders from the countries at the second Latin American Stroke Ministerial Meeting. Results: In 2 years, public stroke awareness initiatives increased from 25 to 75% of countries. All countries have started programs to encourage physical activity, and there has been an increase in the number of countries that implement, at least partially, strategies to identify and treat hypertension, diabetes, and lifestyle risk factors. Programs to identify and treat dyslipidemia and atrial fibrillation still remained poor. The number of stroke centers increased from 322 to 448, all of them providing intravenous thrombolysis, with an increase in countries with stroke units. All countries have mechanical thrombectomy, but mostly restricted to a few private hospitals. Pre-hospital organization remains limited. The utilization of telemedicine has increased but is restricted to a few hospitals and is not widely available throughout the country. Patients have late, if any, access to rehabilitation after hospital discharge. Conclusion: The initiative to collaborate, exchange experiences, and unite societies and governments to improve stroke care in Latin America has yielded good results. Important advances have been made in the region in terms of increasing the number of acute stroke care services, implementing reperfusion treatments and creating programs for the detection and treatment of risk factors. We hope that this approach can reduce inequalities in stroke care in Latin America and serves as a model for other under-resourced environments.

Integrative Review of Managed Entry Agreements: Chances and Limitations.

BACKGROUND AND OBJECTIVE: Managed entry agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high-priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective of this article is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high- and middle-income countries. METHODS: An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was 'What are the health technology MEAs that have been applied around the world?' This review was supplemented with studies not retrieved in the search known to the senior-level co-authors including key South American markets. It also involved senior-level decision makers and advisers providing guidance on the potential advantages and disadvantages of MEAs and ways forward. RESULTS: Twenty-five studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%) and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. CONCLUSIONS: We are likely to see a growth in MEAs with the continual launch of new high-priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome-based MEAs could be an important tool to improve access to new innovative medicines, there are critical issues to address. Comparing knowledge, experiences, and practices across countries is crucial to guide high- and middle-income countries when designing their future MEAs.

Economic burden of diabetes in Brazil in 2014.

BACKGROUND: Diabetes and its complications produce significant clinical, economic and social impact. The knowledge of the costs of diabetes generates subsidies to maintain the financial sustainability of public health and social security systems, guiding research and health care priorities. AIMS: The aim of this study was to estimate the economic burden of diabetes in Brazilian adults in 2014, considering the perspectives of the public health care system and the society. METHODS: A prevalence-based approach was used to estimate the annual health resource utilization and costs attributable to diabetes and related conditions. The healthcare system perspective considered direct medical costs related to outpatient and hospitalization costs. The societal perspective considered non-medical (transportation and dietary products) and indirect costs (productivity loss, disability, and premature retirement). Outpatient costs included medicines, health professional visits, exams, home glucose monitoring, ophthalmic procedures, and costs related to end stage renal disease. The costs of hospitalization attributed to diabetes related conditions were estimated using attributable risk methodology. Costs were estimated in Brazilian currency, and then converted to international dollars (2014). RESULTS: Based on a national self-reported prevalence of 6.2%, the total cost of diabetes in 2014 was Int$ 15.67 billion, including Int$ 6.89 billion in direct medical costs (44%), Int$ 3.69 billion in non-medical costs (23.6%) and Int$ 5.07 billion in indirect costs (32.4%). Outpatient costs summed Int$ 6.62 billion and the costs of 314,334 hospitalizations attributed to diabetes and related conditions was Int$ 264.9 million. Most hospitalizations were due to cardiovascular diseases (47.9%), followed by diabetes itself (18%), and renal diseases (13.6%). Diet and transportation costs were estimated at Int$ 3.2 billion and Int$ 462.3 million, respectively. CONCLUSIONS: Our results showed a substantial economic burden of diabetes in Brazil, and most likely are underrated as they are based on an underestimated prevalence of diabetes. Healthcare policies aiming at diabetes prevention and control are urgently sought.

Role of Myocardial Fibrosis in Hypertrophic Cardiomyopathy: A Systematic Review and Updated Meta-Analysis of Risk Markers for Sudden Death.

BACKGROUND: Hypertrophic cardiomyopathy (HCM) is associated with sudden death (SD). Myocardial fibrosis is reportedly correlated with SD. OBJECTIVE: We performed a systematic review with meta-analysis, updating the risk markers (RMs) in HCM emphasizing myocardial fibrosis. METHODS: We reviewed HCM studies that addressed severe arrhythmic outcomes and the certain RMs: SD family history, severe ventricular hypertrophy, unexplained syncope, non-sustained ventricular tachycardia (NSVT) on 24-hour Holter monitoring, abnormal blood pressure response to exercise (ABPRE), myocardial fibrosis and left ventricular outflow tract obstruction (LVOTO) in the MEDLINE, LILACS, and SciELO databases. We used relative risks (RRs) as an effect measure and random models for the analysis. The level of significance was set at p < 0.05. RESULTS: Twenty-one studies were selected (14,901 patients aged 45 ± 16 years; men, 62.8%). Myocardial fibrosis was the major RISK MARKER (RR, 3.43; 95% CI, 1.95-6.03). The other RMs, except for LVOTO, were also predictors: SD family history (RR, 1.75; 95% CI, 1.39-2.20), severe ventricular hypertrophy (RR, 1.86; 95% CI, 1.26-2.74), unexplained syncope (RR, 2.27; 95% CI, 1.69-3.07), NSVT (RR, 2.79; 95% CI, 2.29-3.41), and ABPRE (RR, 1.53; 95% CI, 1.12-2.08). CONCLUSIONS: We confirmed the association of myocardial fibrosis and other RMs with severe arrhythmic outcomes in HCM and emphasize the need for new prediction models in managing these patients.

Sínteses de evidências para apoio à tomada de decisões relacionadas à pandemia de covid-19 / Evidence syntheses to support decision-making related to the Covid-19 pandemic

A pandemia de covid-19 gerou um numeroso volume de produções científicas com diferentes níveis de qualidade. A velocidade com que o conhecimento era produzido e compartilhado a nível mundial impôs à gestão em saúde o desafio de buscar meios de identificar as melhores evidências disponíveis para subsidiar suas decisões. Em resposta a este desafio, o Departamento de Ciência e Tecnologia do Ministério da Saúde do Brasil estabeleceu um serviço para elaborar e disponibilizar conhecimento científico abordando questões prioritárias de saúde pública no cenário da pandemia. Entre os temas abordados estão tratamentos medicamentosos, medidas não farmacológicas, testagem, reinfecção e resposta imunológica, imunização, fisiopatologia, síndrome pós-covid e eventos adversos. Neste artigo, discute-se os pontos fortes e lições aprendidas, bem como os desafios e perspectivas que fornecem um exemplo real sobre como disponibilizar as melhores evidências científicas, em tempo hábil e de forma oportuna, para auxiliar o processo decisório durante uma emergência em saúde pública.

[Demographic characteristics of elderly people provided with supplementary health care]. / Características demográficas dos idosos vinculados ao sistema suplementar de saúde no Brasil.

OBJECTIVE: To assess health coverage of elderly people receiving supplementary health care and these users' sociodemographic characteristics. METHODS: Descriptive study of elderly population living in Brazil and in the states of São Paulo and Rio de Janeiro in 2006. Data was collected from the National Supplementary Care Beneficiary Information System and the National Household Sample Survey. The following variables were studied: gender, age, distribution by federal unit, category of health insurance, type of contract and plan segmentation. RESULTS: Higher coverage of the general population was seen in the age groups 70-79 years (26.7% and 80 years and more (30.2%). Of those aged 80 years and more, 33% had private health plans among women and 25.9% among men. Nearly 80% of health insurance beneficiaries were living in southeastern and southern Brazil, of which 55% were in Rio-São Paulo axis. Health maintenance organizations covered a higher proportion of younger compared to elderly population (39% and 34.5%, respectively) and self-management care plans covered a significantly higher proportion of elderly compared to younger population in Brazil (22.8% and 13.8%, respectively). CONCLUSIONS: Elderly health care coverage was significantly high and age groups over 70 years showed the highest coverage rates among the Brazilian population, especially among women.

Estimated cost of asthma in outpatient treatment: a real-world study.

OBJECTIVE: To estimate the cost of diagnosis and treatment of asthma. METHODS: We used the perspective of society. We sequentially included for 12 months, in 2011-2012, 117 individuals over five years of age who were treated for asthma in the Pneumology and Allergy-Immunology Services of the Piquet Carneiro Polyclinic, Universidade do Estado do Rio de Janeiro. All of them were interviewed twice with a six-month interval for data collection, covering 12 months. The cost units were identified and valued according to defined methods. We carried out a sensitivity analysis and applied statistical methods with a significance level of 5% for cost comparisons between subgroups. RESULTS: The study consisted of 108 patients, and 73.8% of them were women. Median age was 49.5 years. Rhinitis was present in 83.3% of the individuals, and more than half were overweight or obese. Mean family income was U$915.90/month (SD = 879.12). Most workers and students had absenteeism related to asthma. Total annual mean cost was U$1,291.20/patient (SD = 1,298.57). The cost related to isolated asthma was U$1,155.43/patient-year (SD = 1,305.58). Obese, severe, and uncontrolled asthmatic patients had higher costs than non-obese, non-severe, and controlled asthmatics, respectively. Severity and control level were independently associated with higher cost (p = 0.001 and 0.000, respectively). The direct cost accounted for 82.3% of the estimated total cost. The cost of medications for asthma accounted for 62.2% of the direct costs of asthma. CONCLUSIONS: Asthma medications, environmental control measures, and long-term health leaves had the greatest potential impact on total cost variation. The results are an estimate of the cost of treating asthma at a secondary level in the Brazilian Unified Health System, assuming that the treatment used represents the ideal approach to the disease.