(Un)Equitable distribution of health resources and the judicialization of healthcare: 10 years of experience in Brazil.

BACKGROUND: Equity has been acknowledged as a required principle for the fulfilment of the universal right to health once it seeks to tackle avoidable and unfair inequalities among individuals. In Brazil, a country marked by iniquities, this principle was adopted in the Brazilian National Health System (SUS) organization. But the phenomenon known as judicialization of healthcare, anchored in the argument of universality of the right, has been consolidated as a health policy parallel to the SUS. The analysis of these lawsuits distribution according to their beneficiaries' socio-economic profile can contribute to the verification of the judicialization's potential for reducing inequalities, thus becoming an auxiliary activity in the fulfilment of the universal and egalitarian right to health. This study aimed to assess what socioeconomic factors are associated to municipalities that had larger numbers of beneficiaries from lawsuits in health in the state of Minas Gerais, Brazil, from 1999 to 2009. METHODS: It is a descriptive quantitative study of the residence municipalities of beneficiaries registered in database regarding all deferred lawsuits against the state of Minas Gerais from 1999 to 2009. The verification of cities' socio-economic profile was performed based on information of the Brazilian Institute of Geography and Statistics' 2010 Demographic Census and on indexes derived from it. The variables studied for each municipality were: number of beneficiaries; resident population; Social Vulnerability Index (IVS); and Municipal Human Development Index (IDHm). Descriptive and statistical analysis were used to verify factors associated with a larger number of beneficiaries in a municipality. RESULTS: Out of 853 municipalities in Minas Gerais, 399 were registered as residence of at least one of the 6.906 beneficiaries of studied lawsuits. The residence non-information index was 11,5%. The minimum number of identified beneficiaries living in a municipality was 1 (one) while the maximum was 1920. The binary logistic regression revealed that high and very high IDHm (OR = 3045; IC = 1773-5228), IVS below 0.323 (OR = 2044; IC = 1099- 3800) and population size above 14.661 inhabitants (OR = 6162; IC = 3733-10,171) are statistically associated to a greater number of beneficiaries of lawsuits in health within a municipality. CONCLUSIONS: The judicialization of health care in Minas Gerais, from 1999 to 2009, didn't reach the most vulnerable municipalities. On the contrary, it favored a concentration of health resources in municipalities with better socioeconomic profiles. The register of all beneficiaries' municipalities of residence as well as individual socioeconomic data can contribute to a more conclusive analysis. Nevertheless, in general, the results of this study suggest that the judicial health policy conducted from 1999 to 2009 was not an auxiliary tool for the fulfilment of an equitable right to health in Minas Gerais.

Configuration of Health Care Networks in the SUS: analysis based on primary and hospital care components. / Configuração das Redes de Atenção à Saúde no SUS: análise a partir de componentes da atenção básica e hospitalar.

This study seeks to point out the different configurations of Health Care Networks in primary care (AB) and Hospital Care (AH), dimensioned based on coverage, quality, and resolvability characteristics in health macro-regions. Cross-sectional study used the cluster analysis and segmented 103 macro-regions into different profiles of coverage, quality and resolubility: group 1 (high coverage/AB and medium/AH; low quality AB-AH with high resolubility); group 2 (high coverage/AB and low/AH; low quality AB-AH with medium resolubility) and group 3 (high coverage/AB and medium/AH; high quality AB-AH with high resolubility). Coverage in AB was classified as high for 100% of the Brazilian population and in AH low to 9.70% and medium to 90.29%. Quality/AB-AH is low for 58.54% and high for 41.15%. Resolubility is high for 90.29% and medium for 9.70%. In Brazil, there is expansion of coverage with low quality/AB; shortage of hospital beds and low quality/HA with high resolution. However, in the Southeast and South, high AB-AH quality prevails. The structuring of health networks is still characterized by low resolution, demanding incentives for the governance of inter-federal arrangements.

O estudo procura apontar diferentes configurações de Redes de Atenção à Saúde na atenção básica e hospitalar, a partir de características de cobertura, qualidade e resolubilidade nas macrorregiões de saúde. Estudo transversal, utilizou a técnica de análise de cluster e segmentou 103 macrorregiões em distintos perfis de cobertura, qualidade e resolubilidade: grupo 1 (alta cobertura/AB e média/AH; baixa qualidade AB-AH com alta resolubilidade); grupo 2 (alta cobertura/AB e baixa/AH; baixa qualidade AB-AH com média resolubilidade); e o grupo 3 (alta cobertura/AB e média/AH; alta qualidade AB-AH com alta resolubilidade). A cobertura na AB foi classificada como alta para 100% da população brasileira, e na AH, baixa para 9,70% e média para 90,29%. Qualidade/AB-AH é baixa para 58,54% e alta para 41,15%. A resolubilidade é alta para 90,29% e média para 9,70%. No Brasil, verifica-se expansão da cobertura com baixa qualidade/AB, insuficiência de leitos hospitalares e baixa qualidade/AH com alta resolubilidade. Todavia, prevalece alta qualidade AB-AH no Sudeste e no Sul. A estruturação das redes de saúde ainda se configura de baixa resolutividade, demandando estímulos à governança de arranjos interfederativos.

Treatment of ankylosing spondylitis with TNF blockers: a meta-analysis.

Biological agents directed against tumor necrosis factor (TNF) represent therapeutic options for patients with ankylosing spondylitis with high disease activity despite use of non-steroidal anti-inflammatory drugs. To evaluate the efficacy and safety of the anti-TNF agents infliximab, etanercept, adalimumab, golimumab, and certolizumab for the treatment of ankylosing spondylitis, we performed a systematic review of randomized clinical trials on adult patients with ankylosing spondylitis using articles culled from the EMBASE, MEDLINE, Cochrane Controlled Trials Register and LILACS databases (September/2012), manual literature search, and the gray literature. Study selections and data collection were performed by two independent reviewers, with disagreements solved by a third reviewer. The following outcomes were evaluated: ASAS 20 response, disease activity, physical function, vertebral mobility, adverse events, and withdraws. The meta-analysis was performed using the Review Manager(®) 5.1 software by applying the random effects model. Eighteen studies were included in this review. No study of certolizumab was included. Patients treated with anti-TNF agents were more likely to display an ASAS 20 response after 12/14 weeks (RR 2.21; 95 % CI 1.91; 2.56) and 24 weeks (RR 2.68; 95 % CI 2.06; 3.48) compared with controls, which was also true for several other efficacy outcomes. Meta-analysis of safety outcomes and withdraws did not indicate statistically significant differences between treatment and control groups after 12 or 30 weeks. Adalimumab, infliximab, etanercept, and golimumab can effectively reduce the signs and symptoms of the axial component of ankylosing spondylitis. Safety outcomes deserve further study, especially with respect to long-term follow-ups.

Quality of life of patients in renal replacement therapy in Brazil: comparison of treatment modalities.

PURPOSE: This study aimed to analyze and compare the quality of life of renal replacement therapy patients undergoing hemodialysis, peritoneal dialysis and those with renal transplantation in Brazil. In addition, we aimed to verify factors associated with patients' quality of life and the relationship between quality of life and treatment modality, socioeconomic and demographic conditions as well as aspects related to the disease and health services. METHODS: A representative sample of the dialysis units and transplant centers was obtained. Structured questionnaires were used to interview 3,036 patients in one of three treatment modalities: hemodialysis, peritoneal dialysis and renal transplant. Information was collected about socioeconomic and demographic characteristics and quality of life measures. RESULTS: There were significant differences between renal transplants and both forms of dialysis for all dimensions of the SF-36. Hemodialysis patients showed better results in the dimensions of functional capacity, physical aspects and social aspects, compared to peritoneal dialysis patients. Renal transplant patients had the best mean score in the physical component of quality of life. There were no significant differences among treatment groups regarding the mental component of quality of life. The physical and mental components were associated with comorbidities and age; however, older patients had better mental quality of life but worse physical quality of life. Patients in a higher socioeconomic class and patients that were not hospitalized also reported better quality of life. Unmarried and male patients presented better physical quality of life. The dialysis units and transplant centers influenced the patients' quality of life. CONCLUSIONS: Renal transplant patients have the best quality of life of the three treatment modalities. It is necessary to increase access to renal transplants.

[Assessment of the coordination of primary healthcare: comparison of PMAQ-AB (Brazil) and international references]. / Avaliação da coordenação do cuidado na atenção primária à saúde: comparando o PMAQ-AB (Brasil) e referências internacionais.

This study aimed to compare the results obtained with the coordination of care through the Brazilian National Program for Improvement of Access and Quality of Basic Care (PMAQ-AB), with the parameters adopted by the Care Coordination Measures Atlas and the European Observatory on Health Systems and Policies. A cross-sectional study was performed using the dataset from the third cycle of the PMAQ-AB. Three typologies of coordination of care were created: PMAQ-AB, Atlas, and Observatory. Chi-square test was applied to compare proportions and Kruskal-Wallis and Nemenyi tests to verify and identify potential differences between the typologies. Significance was set at 5%. In all, 35,350 teams were assessed that performed some activity in care coordination. A significant difference was observed (p < 0.001) between levels of coordination, with a higher percentage between the high and medium levels in the three instruments, PMAQ-AB (56.07% and 38.35%), Atlas (52.63% and 40.66%), and Observatory (44.82% and 43.98%). In the comparison of the indicators, there was a significant difference (p < 0.001) between the typologies. For Brazil, in the PMAQ-AB typology, all the strata displayed a higher percentage between the high and medium levels; in the Atlas, stratum 1 stood out in the medium level (43.81%); the high level predominated in the Observatory. In the comparison of the indicators by strata, at least one stratum differed from the others (p < 0.001). Number 6 differed from the others (p < 0.001), and number 1 differed from all of them (p < 0.001) except number 2 (p > 0.05). The levels of coordination of care differed according to the instruments used. High and medium levels were identified, showing the need for additional studies.

O objetivo deste estudo foi comparar os resultados obtidos para a coordenação do cuidado a partir do Programa Nacional de Melhoria do Acesso e da Qualidade da Atenção Básica (PMAQ-AB), com os parâmetros adotados pelo Atlas de Medidas de Coordenação do Cuidado e pelo Observatório Europeu de Políticas e Sistemas de Saúde. Foi realizado estudo transversal, com base no banco de dados do 3º ciclo do PMAQ-AB. Foram criadas três tipologias de coordenação do cuidado: PMAQ-AB, Atlas e Observatório. O teste qui-quadrado foi aplicado para comparar as proporções; os testes de Kruskal-Wallis e de Nemenyi para verificar e identificar eventuais diferenças entre as tipologias. O nível de significância foi de 5%. Foram avaliadas 35.350 equipes que realizaram alguma atividade de coordenação do cuidado. Observou-se diferença significativa (p < 0,001), entre os níveis de coordenação, com maior percentual entre o nível alto e médio nos três instrumentos, PMAQ-AB (56,07% e 38,35%), Atlas (52,63% e 40,66%) e o Observatório (44,82% e 43,98%). Na comparação dos indicadores, houve diferença significativa (p < 0,001) entre as tipologias. Para o Brasil, na tipologia PMAQ-AB, todos os estratos exibiram maior percentual entre o nível alto e médio; no Atlas, o estrato 1 destacou-se no nível médio (43,81%) e, no Observatório, predominou o nível alto. Na comparação dos indicadores por estratos, pelo menos um estrato diferiu dos demais (p < 0,001). O 6 se distinguiu dos demais (p < 0,001), e o 1 diferiu de todos (p < 0,001), exceto do 2 (p > 0,05). Os níveis de coordenação do cuidado diferenciaram-se entre os instrumentos utilizados. Altos e médios níveis foram identificados, demonstrando a necessidade de estudos adicionais.

El objetivo de este estudio fue comparar los resultados obtenidos para la coordinación del cuidado, a partir del Programa Nacional de Mejoría de Acceso y Calidad de la Atención Básica (PMAQ-AB), con los parámetros adoptados por el Atlas de Medidas de Coordinación del Cuidado y por el Observatorio Europeo de Políticas y Sistemas de Salud. Se realizó un estudio transversal, basado en el banco de datos del 3er ciclo del PMAQ-AB. Se crearon tres tipologías de coordinación del cuidado: PMAQ-AB, Atlas y Observatorio. El test de chi-cuadrado se aplicó para comparar las proporciones, el test de Kruskal-Wallis y el de Nemenyi para verificar e identificar eventuales diferencias entre las tipologías. El nivel de significancia fue de 5%. Se evaluaron a 35.350 equipos que realizaron alguna actividad de coordinación del cuidado. Se observó una diferencia significativa (p < 0,001), entre los niveles de coordinación, con mayor porcentaje entre el nivel alto y medio en los tres instrumentos, PMAQ-AB (56,07% y 38,35%), Atlas (52,63% y 40,66%) y el Observatorio (44,82% y 43,98%). En la comparación de los indicadores, hubo una diferencia significativa (p < 0,001) entre las tipologías. Para Brasil, en la tipología PMAQ-AB todos los estratos expusieron un mayor porcentaje entre el nivel alto y medio; en el Atlas, el estrato 1 se destacó en el nivel medio (43,81%) y, en el Observatorio, predominó el nivel alto. En la comparación de los indicadores por estratos, por lo menos un estrato difirió de los demás (p < 0,001). El 6 se distinguió de los demás (p < 0,001), y el 1 difirió de todos (p < 0,001), excepto del 2 (p > 0,05). Los niveles de coordinación del cuidado se diferenciaron entre los instrumentos utilizados. Se identificaron niveles altos y medios, demostrando la necesidad de estudios adicionales.

Chronic hepatitis B treatment: the cost-effectiveness of interferon compared to lamivudine.

OBJECTIVE: To perform a cost-effectiveness evaluation from the perspective of the Brazilian National Health System of alternatives strategies (i.e., conventional interferon, pegylated interferon, and lamivudine) for the treatment of patients with chronic hepatitis B who present elevated aminotransferase levels and no evidence of cirrhosis at the beginning of treatment. METHODS: A Markov model was developed for chronic hepatitis B (hepatitis B antigen e [HBeAg] positive and negative) with 40 years' time horizon. Costs and benefits were discounted at 5%. Annual rates of disease progression, costs due to complications, and the efficacy of medicines were obtained from the literature. One-way and probabilistic sensitivity analysis evaluated uncertainties. RESULTS: For HBeAg positive patients, peginterferon (48 weeks) resulted in an increase of 0.21 discounted life-years gained compared to interferon (24 weeks). The incremental cost-effectiveness ratio (ICER) converted to US dollars using the 2009 purchasing power parity conversion factor was US$100,752.24 per life-year gained. For HBeAg negative patients, it was observed that interferon (48 weeks) compared with long-term lamivudine presented an increase of 0.45 discounted life-years gained and ICER of US$15,766.90 per life-year gained. In the sensitivity analysis, the ICER was more sensitive to variation in the probability of transition from chronic hepatitis B to compensated cirrhosis, discount rate, and medicine prices. Cost-effectiveness acceptability curve for HBeAg positive (pegylated interferon vs. conventional interferon) and negative (conventional interferon vs. lamivudine) showed that conventional interferon was cost-effective until three times the gross domestic product per capita. CONCLUSIONS: For patients with chronic hepatitis B with elevated aminotransferase levels in the pretreatment and no cirrhosis who were HBeAg positive, pegylated interferon (48 weeks) provided more life-years gained when compared to conventional interferon (24 weeks), and the ICER surpasses the country's buying power, which makes conventional interferon the chosen alternative. For HBeAg negative patients, conventional interferon (48 weeks) compared to lamivudine provided more life-years gained at a favorable ICER.

[Expenses of the Brazilian Ministry of Health for high-cost drugs: a demographic and clinical analysis]. / Gastos do Ministério da Saúde do Brasil com medicamentos de alto custo: uma análise centrada no paciente.

OBJECTIVE: To describe the expenses of the Ministry of Health of Brazil with users of High-Cost Drug Program that began treatment between 2000-2004, according to their demographic and clinical characteristics. METHODS: We made a probabilistic-deterministic linkage of national databases of drugs and mortality, resulting in a historical cohort of patients using high-cost medications in 2000-2004. The per capita spending on medicines were stratified by a follow-up period and described according to demographic, clinical and type of drug used. RESULTS: The total population atended by the program was 611,419, being 63.5% female, average age 46 years. 41.9% of patients living in the Southeast and 29.7% in the Northeast of Brazil. 24.5% of patients began treatment in 2000, 12.4% in 2001, with increasing trend until 2004. The most prevalent diagnosis referred to the genitourinary system diseases and the most common use of chemical groups were antianemic preparations. 40,941 deaths were detected (6.7% of total). The total expenditure per capita was R$4.794,34. Higher spending per capita was observed in males, aged 47, who lived in the Southeast of Brazil and began treatment in 2000, had diagnoses of infectious and parasitic diseases and used blood substitutes and perfusions solutions. CONCLUSION: The understanding of the expenses involved subsidizes restructuring actions and scheduling drug programs, also provides information for therapeutic groups which are priorities for analysis.

Why does mental health care not follow the structuring of primary care?

OBJECTIVE: To verify if primary care teams with better structured primary health care (PHC) attributes could offer better mental health (MH) care. METHODS: Cross-sectional study based on data from the external evaluation of the second cycle of the Programa de Melhoria do Acesso e da Qualidade da Atenção Básica (PMAQ-AB - Access and Quality Improvement of Primary Care Program), involving 31,587 primary care teams, between 2013 and 2014. Two typologies were built: quality of mental health care (dependent variable) and PHC structuring according to essential attributes (independent variable). We identified some contents for the construction of the mental health typology (module II of the PMAQ) and performed sums of questions for the categorization of indices. The Delphi technique rendered consensus in four rounds endorsed by experts, following the attributes of PHC structure. Multinomial logistic regression analyses verified the association between the typologies and identified which attribute most contributed to the quality of mental health care. RESULTS: We found out that 29.2% of the teams are at low levels of quality in assistance to MH, while 7.5% of the teams have a low level of structuring the PHC according to essential attributes. Regional differences are maintained, both for the structuring of the PHC and for the quality of mental health care. There was a greater chance of providing care in MH with better quality when the PHC is better structured at a high level (OR = 14.74) and at a medium level (OR = 2.193). A high level of completeness is associated with a high level of Quality of Care in MH (OR = 3.21). CONCLUSION: results indicate a predominance of low levels of quality in mental health care, out of step with the process of PHC structuring and its essential attributes.

The Budget Impact of Monoclonal Antibodies Used to Treat Metastatic Colorectal Cancer in Minas Gerais, Brazil.

INTRODUCTION: Biological medicines have increased the cost of cancer treatments, which also raises concerns about sustainability. In Brazil, three monoclonal antibodies (mAbs)-bevacizumab, cetuximab, and panitumumab-are indicated for the treatment of metastatic colorectal cancer (mCRC) but not currently funded by the Unified Health System (SUS). However, successful litigation has led to funding in some cases. OBJECTIVE: Our objective was to evaluate the budgetary impact of including the mAbs bevacizumab, cetuximab, and panitumumab in standard chemotherapy for the treatment of mCRC within the SUS of Minas Gerais (MG), Brazil. METHOD: A budget impact analysis of incorporating mAbs as first-line treatment of mCRC in MG was explored. The perspective taken was that of the Brazilian SUS, and a 5-year time horizon was applied. Data were collected from lawsuits undertaken between January 2009 and December 2016, and the model was populated with data from national databases and published sources. Costs are expressed in $US. RESULTS: In total, 351 lawsuits resulted in funding for first-line treatment with mAbs for mCRC. The three alternative scenarios analyzed resulted in cost increases of 348-395% compared with the reference scenario. The use of panitumumab had a budgetary impact of $US103,360,980 compared with the reference scenario over a 5-year time horizon, and bevacizumab and cetuximab had budgetary impacts of $US111,334,890 and 113,772,870, respectively. The use of the anti-epidermal growth factor receptor (EGFR) mAbs (cetuximab and panitumumab) is restricted to the approximately 41% of patients with KRAS mutations, so the best cost alternative for incorporation would be the combination of panitumumab and bevacizumab, with a cost of approximately $US106 million. CONCLUSION: These results highlight the appreciable costs for incorporating bevacizumab, cetuximab, and panitumumab into the SUS. Appreciable discounts are likely to be necessary before incorporation of these mAbs is approved.

National Program for the Evaluation of Health Services (PNASS) 2015-2016: an analysis on Brazil's hospitals. / Programa Nacional de Avaliação dos Serviços de Saúde (PNASS) 2015-2016: uma análise sobre os hospitais no Brasil.

AIM: The present work aims to evaluate the performance of hospitals participating on the National Program for the Evaluation of Health Services (Programa Nacional de Avaliação de Serviços de Saúde - PNASS, 2015-2016). METHODS: This is a descriptive cross-sectional quantitative study, which measured the performance of hospitals participating in the program, using data from the first PNASS 2015-2016 evaluation instrument. The processes evaluation questionnaire used in hospitals had 102 items, 17 criteria, grouped into four blocks or dimensions. RESULTS: A total of 1,681 hospitals was evaluated. The average score for each block was: Organizational management (64); technical and logistical support for care provision (73); health care and care management (64); specific services/units (72). Regarding the administrative sphere, the best average performance was of the federal sphere, followed by the state and municipal ones. The hospitals located in the Southern and Southeastern regions presented the best performance (73), followed by the Midwestern (62.7), Northeastern (61.2), and Northern (58.5) regions. CONCLUSION: The hospitals that perform highly complex procedures, just like those large and special ones, obtained a better performance. Public federal hospitals, with municipal management, also had the best results, as well as hospitals from the Southern and Southwestern regions of the country.

OBJETIVO: O estudo tem como objetivo avaliar o desempenho dos hospitais que participaram do Programa Nacional de Avaliação de Serviços de Saúde (PNASS 2015-2016). MÉTODOS: Estudo descritivo transversal quantitativo, que buscou mensurar o desempenho dos hospitais que participaram do programa com base nos dados do primeiro instrumento avaliativo do PNASS 2015-2016. O questionário de avaliação de processos aplicado aos hospitais contou com 102 itens, 17 critérios, agrupados em quatro blocos ou dimensões. RESULTADOS: Participaram 1.681 hospitais. O escore médio por bloco foi: gestão organizacional (64), apoio técnico e logístico para produção de cuidado (73), gestão da atenção à saúde e do cuidado (64) e serviços/unidades específicas (72). Com relação à esfera administrativa, o melhor desempenho médio foi obtido pela esfera federal, seguido da estadual e da municipal. Os hospitais localizados no Sul e Sudeste obtiveram o melhor desempenho (73,0), seguido do Centro-Oeste (62,7), Nordeste (61,2) e Norte (58,5). CONCLUSÃO: Os hospitais que realizam procedimentos de alta complexidade, assim como os de grande porte e especiais, obtiveram melhor desempenho. Hospitais públicos federais, de gestão municipal, também alcançaram os melhores resultados, bem como os hospitais do Sul e Sudeste do país.

Cyclosporine versus tacrolimus in immunosuppressive maintenance regimens in renal transplants in Brazil: survival analysis from 2000 to 2004.

BACKGROUND: In Brazil, the National Health System (SUS) is responsible for almost all renal transplants. SUS protocols recommend using cyclosporine, in association with azathioprine and corticosteroids, to maintain the immunosuppression that is essential for successful renal transplant. Alternatively, cyclosporine can be replaced by tacrolimus. OBJECTIVE: To evaluate the effectiveness of therapeutic schema involving cyclosporine or tacrolimus after renal transplant during a 60-month follow-up period. METHODS: A historical cohort study, from 2000 to 2004, was conducted using 5686 patients who underwent renal transplant and received cyclosporine or tacrolimus. Uni - and multivariate analyses were performed using the Cox model to examine factors associated with progression to treatment failure. RESULTS: Most of the patients were male, aged 38 years or older, for whom the most frequent primary diagnosis of chronic renal failure (CRF) was glomerulonephritis/nephritis. Higher risk of treatment failure was associated with: therapeutic regimen (tacrolimus, HR 1.38, 95% CI 1.14 to 1.67), patient age at transplantation (additional year, HR 1.01, 95% CI 1.00 to 1.02), donor type (deceased, HR 1.60, 95% CI 1.35 to 1.89), median time of dialysis prior to transplantation (>24 mo, HR 1.29, 95% CI 1.09 to 1.52), and primary CRF diagnosis (diabetes, HR 1.54, 95% CI 1.09 to 2.17). CONCLUSIONS: The risk of treatment failure of patients receiving tacrolimus was observed to be 1.38 times that of those receiving cyclosporine, after adjusting the model for possible confounding factors such as patient sex, patient age, graft origin, prior time of dialysis, and cause of CRF. Our results were obtained from an observational study, and further studies are necessary to evaluate whether compliance with SUS clinical protocols could result in more effective care for renal transplant recipients.

Risk factors associated with antineoplastic chemotherapy-induced nausea and vomiting.

OBJECTIVE: To estimate the incidence and to evaluate risk factors for antineoplastic nausea and vomiting with high and moderate emetogenic chemotherapy in adult patients in the first treatment cycle. METHODS: Prospective cohort study with follow-up of 269 adults during the first cycle of antineoplastic chemotherapy. The incidence of nausea and vomiting was evaluated in the acute phase (0-24 hours), in the late phase (24 hours-5th day) and in the total phase (0-5th day). RESULTS: In total, 152 patients underwent high emetogenic chemotherapy and 117 moderate emetogenic chemotherapy. The relative frequency of nausea was higher when compared with vomiting in the acute phase (p < 0.001) and in the late phase (p < 0.001). The risk factors identified were: age group ≤ 49 years (odds ratio = 0.47; 95%CI 0.23-0.95) and 50-64 years (odds ratio = 0.45; 95%CI 0.23-0.87), tobacco use (odds ratio = 0.35; 95%CI 0.14-0.88), and high emetogenic chemotherapy (odds ratio 0.55; 95%CI 0.31-0.95). CONCLUSION: The incidence of nausea was higher than that of vomiting, and adverse effects were more frequent in the late phase. The results suggest the risk factors for chemotherapy-induced nausea and vomiting are tobacco, age (young adults), and high emetogenic chemotherapy.

[Budget impact of the incorporation of second-line drug treatment for diabetic macular edema in the Brazilian Unified National Health System from the perspective of the Minas Gerais State Health Department, Brazil]. / Impacto orçamentário da incorporação de medicamentos para tratamento em segunda linha do edema macular diabético no SUS sob a perspectiva da Secretaria de Estado de Saúde de Minas Gerais, Brasil.

The study's objective was to perform budget impact assessment for the incorporation of second-line intravitreal antiangiogenic therapy for diabatic macular edema in the scope of the Brazilian Unified National Health System (SUS) in Minas Gerais state, Brazil, discussing the incorporation's state budget feasibility. The budget impact assessment was performed as a deterministic method according to Ministry of Health guidelines. The study included patients with probable first-line treatment failure in a five-year timeline for all the technologies assessed. The analysis included the drugs bevacizumab (off-label use), ranibizumab, and aflibercept. The populations were calculated both by observed demand and epidemiological estimate. The following sensitivity analyses were performed: a scenario with slower technology diffusion, a scenario with the market entry of biosimilar versions of bevacizumab and ranibizumab, and a scenario disregarding inflation during the period. The incremental budget impacts according to observed and epidemiologically estimated demand, respectively, were BRL 69,493,906.95 to BRL 473,226,278.78 for bevacizumab; BRL 349,319,965.60 to BRL 2,378,732,103.09 for ranibizumab; and BRL 543,867,485.47 to BRL 3,703,524,490.16 for aflibercept. Bevacizumab proved to be the most financially feasible alternative in all the scenarios of estimates and sensitivity analyses. An increment of nearly 3% was estimated, compared to the 2016 budget (observed demand). The study showed that the incorporation is feasible in the SUS, Minas Gerais State, but subject to management priorities. Price discrepancies between products with similar efficacy is intriguing and provides fertile ground for future studies.

Os objetivos foram efetuar a análise do impacto orçamentário para a incorporação de segunda linha terapêutica com terapia antiangiogênica de aplicação intravítrea, para tratamento de edema macular diabético, no âmbito do Sistema Único de Saúde (SUS) em Minas Gerais, Brasil, discutindo sua viabilidade à luz do orçamento do estado. A análise do impacto orçamentário com método determinístico, segundo diretriz do Ministério da Saúde. Foram incluídos os pacientes com provável falha ao tratamento de primeira linha, num horizonte temporal de 5 anos para todas as tecnologias avaliadas. Incluíram-se na análise os medicamentos bevacizumabe (uso off-label), ranibizumabe e aflibercepte. As populações foram calculadas tanto por demanda aferida quanto por estimativa epidemiológica. Como análises de sensibilidade efetuaram-se: cenário com difusão de tecnologia mais lenta; cenário com a entrada de bevacizumabe e ranibizumabe biossimilares no mercado; cenário com a desconsideração da inflação no período. O impacto orçamentário incremental, de acordo com as estimativas de demanda aferida e epidemiológica, respectivamente, foi de R$ 69.493.906,95-R$ 473.226.278,78 para bevacizumabe; R$ 349.319.965,60-R$ 2.378.732.103,09 para ranibizumabe e R$543.867.485,47-R$ 3.703.524.490,16 para aflibercepte. Bevacizumabe foi a alternativa financeiramente mais viável em todos os cenários das estimativas e análises de sensibilidade. Estimou-se incremento próximo a 3%, comparando com o orçamento de 2016 (demanda aferida). Avalia-se que a incorporação é viável dentro do SUS em Minas Gerais, mas sujeita às prioridades da gestão. A discrepância de preços entre produtos de eficácia semelhante é intrigante e tema fértil para estudos futuros.

El objetivo fue efectuar un análisis del impacto presupuestario en la incorporación de una segunda línea terapéutica, con terapia antiangiogénica de aplicación intravítrea, para el tratamiento de edema macular diabético, en el ámbito del Sistema Único de Salud (SUS), en Minas Gerais, Brasil, discutiendo su viabilidad respecto al presupuesto del estado. Se realizó una análisis del impacto presupuestario con un método determinístico, según la directriz del Ministerio de Salud. Se incluyeron pacientes con probable fracaso al tratamiento de primera línea, en un horizonte temporal de 5 años para todas las tecnologías evaluadas. Se incluyeron en el análisis los medicamentos bevacizumab (uso off-label), ranibizumab y aflibercept. Las poblaciones se calcularon tanto por demanda evaluada, como por estimación epidemiológica. A modo de análisis de sensibilidad se planteó un escenario con una difusión de tecnología más lenta, un escenario con la entrada de bevacizumab y ranibizumab biosimilares en el mercado, y un escenario con la desconsideración de la inflación durante el período. El incremento del impacto presupuestario, de acuerdo con las estimativas de demanda evaluada y epidemiológica, respectivamente, fue BRL 69.493.906,95-BRL 473.226.278,78 en el caso del bevacizumab; BRL 349.319.965,60-BRL 2.378.732.103,09 en el de ranibizumab y BRL 543.867.485,47-BRL 3.703.524.490,16 en el aflibercept. El bevacizumab se mostró la alternativa financiera más viable en todos los escenarios de estimaciones y análisis de sensibilidad. Se estimó un incremento cercano al 3%, comparándolo con el presupuesto de 2016 (demanda evaluada). Se considera que la incorporación es viable dentro del SUS en Minas Gerais, pero sujeta a las prioridades de la gestión. La discrepancia de precios entre productos de eficacia semejante es intrigante y un tema fértil para estudios futuros.

O fim da extensão das patentes e as Parcerias para Desenvolvimento Produtivo: reflexos no acesso a medicamentos no Brasil / The end of patent extensions and the Productive Development Partnerships: effects on access to medicines in Brazil

Resumo A covid-19 jogou luz sobre o impacto negativo da propriedade intelectual na saúde e deu nova relevância à Ação Direta de Inconstitucionalidade 5529/DF, que, acatada pelo Supremo Tribunal Federal em 2021, culminou na extinção da extensão automática de patentes no Brasil. Este estudo busca analisar o efeito do julgamento histórico da ADI 5529/DF sobre pedidos de patente e as patentes de interesse das Parcerias para Desenvolvimento Produtivo (PDP). Trata-se de um estudo com base em uma pesquisa documental de análise do andamento, até 31 de dezembro de 2020, de 90 pedidos de patente relacionados a 15 medicamentos objetos de PDP. Nos sites do Instituto Nacional de Propriedade Industrial, do Ministério da Saúde, da Anvisa e da Câmara de Regulação do Mercado de Medicamentos, foram pesquisadas variáveis para comparar o cenário patentário dos medicamentos com o das PDP. De 88 pedidos válidos, 28 patentes foram concedidas, das quais dezessete foram estendidas para mais de vinte anos (média de 24 anos e nove meses). A decisão do STF resultou em mais de 68 anos de monopólio perdidos, potencialmente desanuviando alternativas para a produção de genéricos no país. Neste momento de retomada das PDP, estratégias para a superação de barreiras patentárias deveriam ser incorporadas à política.

Abstract The COVID-19 pandemic has shed light on the negative impact of intellectual property on health and has given new relevance to the Direct Action of Unconstitutionality 5529/DF, which was ruled by the Supreme Court in 2021, resulting in the extinction of automatic patent extensions in Brazil. This documentary case study analyzes the effects of the judicial decision on patent applications and patents of interest for Productive Development Partnerships (PDP), investigating the progress of 90 patent applications related to 15 PDPs drugs of interest until Decembre 31, 2020. Variables for comparing the drug patent scenario with that of the PDPs were researched on the websites of the National Institute of Industrial Property, the Ministry of Health, ANVISA, and the Brazilian Medicines Market Regulation Chamber. Of 88 valid applications, 28 patents were granted, 17 of which had been extended to more than 20 years (24 years and 09 months average). The court decision resulted in a loss of over 68 years of monopoly, potentially opening alternatives for generic production. This resumption of the PDP policy should incorporate strategies to overcome patent barriers.

Configuração das Redes de Atenção à Saúde no SUS: análise a partir de componentes da atenção básica e hospitalar / Configuration of Health Care Networks in the SUS: analysis based on primary and hospital care components

Resumo O estudo procura apontar diferentes configurações de Redes de Atenção à Saúde na atenção básica e hospitalar, a partir de características de cobertura, qualidade e resolubilidade nas macrorregiões de saúde. Estudo transversal, utilizou a técnica de análise de cluster e segmentou 103 macrorregiões em distintos perfis de cobertura, qualidade e resolubilidade: grupo 1 (alta cobertura/AB e média/AH; baixa qualidade AB-AH com alta resolubilidade); grupo 2 (alta cobertura/AB e baixa/AH; baixa qualidade AB-AH com média resolubilidade); e o grupo 3 (alta cobertura/AB e média/AH; alta qualidade AB-AH com alta resolubilidade). A cobertura na AB foi classificada como alta para 100% da população brasileira, e na AH, baixa para 9,70% e média para 90,29%. Qualidade/AB-AH é baixa para 58,54% e alta para 41,15%. A resolubilidade é alta para 90,29% e média para 9,70%. No Brasil, verifica-se expansão da cobertura com baixa qualidade/AB, insuficiência de leitos hospitalares e baixa qualidade/AH com alta resolubilidade. Todavia, prevalece alta qualidade AB-AH no Sudeste e no Sul. A estruturação das redes de saúde ainda se configura de baixa resolutividade, demandando estímulos à governança de arranjos interfederativos.

Abstract This study seeks to point out the different configurations of Health Care Networks in primary care (AB) and Hospital Care (AH), dimensioned based on coverage, quality, and resolvability characteristics in health macro-regions. Cross-sectional study used the cluster analysis and segmented 103 macro-regions into different profiles of coverage, quality and resolubility: group 1 (high coverage/AB and medium/AH; low quality AB-AH with high resolubility); group 2 (high coverage/AB and low/AH; low quality AB-AH with medium resolubility) and group 3 (high coverage/AB and medium/AH; high quality AB-AH with high resolubility). Coverage in AB was classified as high for 100% of the Brazilian population and in AH low to 9.70% and medium to 90.29%. Quality/AB-AH is low for 58.54% and high for 41.15%. Resolubility is high for 90.29% and medium for 9.70%. In Brazil, there is expansion of coverage with low quality/AB; shortage of hospital beds and low quality/HA with high resolution. However, in the Southeast and South, high AB-AH quality prevails. The structuring of health networks is still characterized by low resolution, demanding incentives for the governance of inter-federal arrangements.

[Coordination of care and quality of healthcare for women and children in the PMAQ]. / A coordenação do cuidado na qualidade da assistência à saúde da mulher e da criança no PMAQ.

The study aimed to identify the association between coordination of care and quality of healthcare for women and children in primary healthcare in Brazil. A cross-sectional study was performed with data from 30,523 teams that participated in the Program for Improvement in Access and Quality of Basic Care (PMAQ) in 2013. Logistic regression was performed, in which the dependent variable was quality of healthcare for women and children and the independent variable was level of coordination of care. The multivariate analysis included variables that presented p < 0.05. The model's fit was assessed with the Hosmer-Lemeshow test. The study assessed the results of 28,056 teams that conducted activities in coordination and healthcare for women and children simultaneously. In Brazil, the largest percentage of teams displayed low levels of coordination (68.5%). The highest levels of coordination were found in stratum 6 (57.2%) and the lowest in stratum 1 (78.5%). Among the major geographic regions, the North of Brazil showed the highest percentage of teams with low coordination (89.1%), while the Southeast had the most teams with high coordination (37.6%). More than two-thirds (70.5%) of the teams showed low quality of care in women's health, while 63.5% showed high level of care in children's health. High level of coordination is associated with high quality of care both in women's health (OR = 11.85) and children's health (OR = 8.79). The predominance of low levels of coordination of care in Brazil and low quality of healthcare for women reflect the need for coordinated action in this area.

O objetivo foi identificar a associação do atributo coordenação do cuidado com a qualidade da assistência à saúde da mulher e da criança na atenção primária à saúde no Brasil. Foi realizado estudo transversal, baseado em dados de 30.523 equipes que participaram do Programa de Melhoria do Acesso e da Qualidade da Atenção Básica em 2013. Foi feita análise de regressão logística. A variável dependente foi o nível de qualidade da assistência à saúde da mulher e da criança, e a independente, o nível de coordenação do cuidado. A análise multivariada considerou variáveis que apresentaram p < 0,05. O ajuste do modelo foi realizado pelo teste de Hosmer-Lemeshow. Foram avaliados os resultados de 28.056 equipes que realizaram atividade de coordenação e de assistência à saúde da mulher e da criança simultaneamente. No Brasil, o maior percentual das equipes apresentou nível baixo de coordenação (68,5%). Os níveis mais altos de coordenação foram encontrados no estrato 6 (57,2%) e os mais baixos no estrato 1 (78,5%). Dentre as regiões, a Norte apresentou o maior percentual de equipes com baixo nível de coordenação (89,1%), e a Sudeste, o maior percentual com alto nível (37,6%). Para o nível de qualidade da assistência à saúde da mulher, 70,5% das equipes estava com baixo nível e, na saúde da criança, 63,5% com alto nível. Possuir alto nível de coordenação está associado a ter alto nível de qualidade da assistência, tanto na saúde da mulher (OR = 11,85) como na saúde da criança (OR = 8,79). Foi possível constatar um predomínio de baixos níveis de coordenação do cuidado no Brasil, bem como baixos níveis de qualidade da assistência à saúde da mulher, refletindo a necessidade de ações coordenadas nessa área.

El objetivo fue identificar la asociación del atributo coordinación del cuidado con la calidad de la asistencia a la salud de la mujer y del niño en la atención primaria a la salud en Brasil. Se realizó un estudio transversal, basado en datos de 30.523 equipos que participaron en el Programa de Mejora del Acceso y de la Calidad de la Atención Básica en 2013. Se realizó un análisis de regresión logística, la variable dependiente fue el nivel de calidad de la asistencia a la salud de la mujer y del niño, y la independiente el nivel de coordinación del cuidado. El análisis multivariado consideró variables que presentaron p < 0,05. El ajuste del modelo se realizó por el test de Hosmer-Lemeshow. Se evaluaron los resultados de 28.056 equipos que realizaron actividad de coordinación y de asistencia a la salud de la mujer y del niño simultáneamente. En Brasil, el mayor porcentaje de equipos presentó un nivel bajo de coordinación (68,5%). Los niveles más altos de coordinación se encontraron en el estrato 6 (57,2%) y los más bajos en el estrato 1 (78,5%). Entre las regiones el Norte presentó el mayor porcentaje de equipos con bajo nivel de coordinación (89,1%) y el Sudeste el mayor con alto nivel (37,6%). Para el nivel de calidad de la asistencia a la salud de la mujer un 70,5% de los equipos tenía bajo nivel, y en la salud del niño un 63,5% con alto nivel. Poseer un alto nivel de coordinación está asociado a tener un alto nivel de calidad de la asistencia, tanto en la salud de la mujer (OR = 11,85), como en la salud del niño (OR = 8,79). Fue posible constatar un predominio de bajos niveles de coordinación del cuidado, en Brasil, así como bajos niveles de calidad de la asistencia a la salud de la mujer, reflejando la necesidad de acciones coordinadas en esta área.

Factors associated with the receipt of pensions among older adults: ELSI-Brazil.

OBJECTIVE: To describe the prevalence of receipt of pensions and associated factors in a nationally representative sample of the Brazilian population aged 50 years and over. METHODS: We used data from 9,130 participants from the Brazilian Longitudinal Study of Aging (ELSI-Brazil) baseline survey. The outcome variable was receipt of pensions from any source. The exploratory variables were age, gender, residence by region and by urban/rural area, household arrangements, schooling, household assets, perception of income sufficiency, age when started working, number of chronic diseases, and functional limitation. The analyses were based on the Poisson and binary logistic regressions. RESULTS: The prevalence of the receipt of pension was 54.3%. In the multivariate analysis, the following factors showed statistically significant (p < 0.05) associations with the outcome: age [Prevalence Ratio (PR) = 2.59 and 3.24 for 60-69 and 70 years], rural residence (PR = 1.23 ), residence in the Northeast, South and Southeast compared to the North (PR ranging from 1.18 to 1.23), living arrangements (PR = 1.07 and 1.15 for living with one person and living alone), perception of income sufficiency (PR = 1.08 and 1.15 for sometimes and always), functional limitation (PR = 1.13) and having 1 and ≥ 2 chronic diseases (PR = 1,09 and 1,17). Negative association was observed for 5-8 years of education. No association between age when the individual started working and the outcome was observed. Younger participants (50-59 years old) with ≥ 2 diseases or functional limitation were 31% and 63% more likely to receive pensions, respectively; the strength of these associations declined with age. CONCLUSIONS: The results suggest that health conditions are important determinants of early retirement. Discussions to increase age to the retirement cannot be separated from those on improvements in the health conditions of the Brazilian population.

[Profile of spending on the treatment of rheumatoid arthritis for patients of the Unified Health System in the state of Minas Gerais - 2008-2013]. / Perfil de gastos com o tratamento da Artrite Reumatoide para pacientes do Sistema Único de Saúde em Minas Gerais, Brasil, de 2008 a 2013.

Rheumatoid arthritis (RA) is a chronic condition that affects about 1% of the adult population. In a historical cohort of Minas Gerais State, 11,573 RA patients registered in the Outpatient Information System (SIA) between 2008 and 2013 were identified. For this study we adopted the public funding body's perspective and the values were adjusted by the national inflation index (IPCA) of December 2015. Etanercept was the most expensive treatment. The mean cohort age was 52 years old and most of the patients were women. Multiple regression analysis indicated a negative association between higher expenditure and age, female sex, and diagnosis at entry in the cohort and positive association between high expenditure and the Human Development Index (HDI) of the municipality and use of tumor necrosis factor agents. This study identified the factors that have an impact on RA drug treatment expenditure. Also, we showed that methods that enable extracting demographic and expenditure data of administrative information systems may represent important tools in the construction of economic studies to subsidize economic health evaluations, especially from the standpoint of the managers.

[Integration of primary care in the healthcare network: analysis of the components in the external evaluation of the PMAQ-AB]. / Integração da atenção básica à rede assistencial: análise de componentes da avaliação externa do PMAQ-AB.

This cross-sectional study examined the integration of primary care in the healthcare network of the Brazilian Unified National Health System (SUS), using the Gradual Response Model of Item Response Theory. Based on data from 17,202 teams that participated in the National Program for Access and Quality Improvement in Primary Care (PMAQ-AB, 2012), we measured gradients of integration to identify the teams' profile by level of integration. The results show that the items pertaining to matrix support measures (medical consultations, case discussions, shared clinical action, joint elaboration of therapeutic projects, permanent educational activities, work process discussions, interventions in the territory, and visits with primary care professionals) improved the performance of primary care teams. Communications devices between teams reinforced this understanding. Still, the approximately 50% of answers associated with the worst scenario for some study items evidenced the need to upgrade the integration between primary care activities and specialized care for the consolidation of comprehensive primary healthcare.

Estudo transversal que avalia a integração entre a atenção básica e a rede assistencial do Sistema Único de Saúde (SUS), por meio do Modelo de Resposta Gradual da Teoria de Resposta ao Item. Com base nos dados de 17.202 equipes que participaram do Programa Nacional de Melhoria do Acesso e da Qualidade da Atenção Básica (PMAQ-AB), 2012, foram mensurados gradientes de integração para identificar o perfil das equipes por nível de integração. Os resultados demonstram que os itens referentes às ações de apoio matricial - consultas médicas; discussão de caso; ação clínica compartilhada; construção conjunta de projetos terapêuticos; atividade de educação permanente; discussão processo trabalho; intervenções no território e realização de visita com profissionais de atenção básica - melhoram o desempenho das equipes de atenção básica. Dispositivos de comunicação entre as equipes reforçam esse entendimento. Contudo, a frequência em torno de 50% de respostas associadas ao pior cenário para alguns itens do estudo, evidenciou a necessidade de qualificação da integração entre as ações de atenção básica e especializada para a consolidação de uma atenção primária à saúde abrangente.

Estudio transversal que evalúa la integración entre la atención básica y la red asistencial del Sistema Único de Salud brasileño, mediante el Modelo de Respuesta Gradual de la Teoría de Respuesta al Ítem. En base a los datos de 17.202 equipos que participaron en el Programa Nacional de Mejora del Acceso y Calidad de la Atención Básica (PMAQ-AB), 2012, se midieron gradientes de integración para identificar el perfil de los equipos por nivel de integración. Los resultados demuestran que los ítems referentes a las acciones de apoyo matricial - consultas médicas; discusión de caso; acción clínica compartida; construcción conjunta de proyectos terapéuticos; actividad de educación permanente; discusión del proceso de trabajo; intervenciones en el territorio y realización de visita con profesionales de atención básica - mejoran el desempeño de los equipos de atención básica. Los dispositivos de comunicación entre los equipos refuerzan este entendimiento. No obstante, la frecuencia en torno a un 50% de respuestas asociadas al peor escenario para algunos ítems del estudio, evidenció la necesidad de cualificación de la integración entre las acciones de atención básica y especializada para la consolidación de una atención primaria a la salud lo más extensa posible.

Comparative Effectiveness and Safety of Monoclonal Antibodies (Bevacizumab, Cetuximab, and Panitumumab) in Combination with Chemotherapy for Metastatic Colorectal Cancer: A Systematic Review and Meta-Analysis.

BACKGROUND: The last decade has seen the increasing use of biological medicines in combination with chemotherapy containing 5-fluorouracil/oxaliplatin or irinotecan for the treatment of metastatic colorectal cancer (mCRC). These combinations have resulted in increased progression-free survival (PFS) in patients with mCRC; however, there are remaining concerns over the extent of their effect on overall survival (OS). Published studies to date suggest no major differences between the three currently available monoclonal antibodies (MoAbs); however, there are differences in costs. In addition, there is rising litigation in Brazil in order to access these medicines as they are currently not reimbursed. OBJECTIVE: The aim was to investigate the comparative effectiveness and safety of three MoAbs (bevacizumab, cetuximab and panitumumab) associated with fluoropyrimidine-based chemotherapy regimens and compared to fluoropyrimidine-based chemotherapy alone in patients with mCRC, through an updated systematic review and meta-analysis of concurrent or non-concurrent observational cohort studies, to guide authorities and the judiciary. METHOD: A systematic review and meta-analysis was performed based on cohort studies published in databases up to November 2017. Effectiveness measures included OS, PFS, post-progression survival (PPS), Response Evaluation Criteria In Solid Tumors (RECIST), response rate, metastasectomy and safety. The methodological quality of the studies was also evaluated. RESULTS: A total of 21 observational cohort studies were included. There were statistically significant and clinically relevant benefits in patients treated with bevacizumab versus no bevacizumab mainly around OS, PFS, PPS and the metastasectomy rate, but not for the disease control rates. However, there was an increase in treatment-related toxicities and concerns with the heterogeneity of the studies. CONCLUSION: The results pointed to an advantage in favor of bevacizumab for OS, PFS, PPS, and metastasectomy. Although this advantage may be considered clinically modest, bevacizumab represents a hope for increased survival and a chance of metastasectomy for patients with mCRC. However, there are serious adverse events associated with its use, especially severe hypertension and gastrointestinal perforation, that need to be considered.