ABSTRACT BACKGROUND: Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects multiple joints. It is associated with psoriasis and treated with synthetic and biologic drugs. OBJECTIVE: The objective of this study was to assess the outcomes of patients who received biologic therapy with tumor necrosis factor (TNF) inhibitors in terms of effectiveness, safety, functionality, and quality of life. DESIGN AND SETTING: A prospective observational study was performed at a single center in Belo Horizonte, Brazil. METHODS: Patients with PsA who received their first TNF inhibitor treatment were followed up for 12 months. Disease activity was measured using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Clinical Disease Activity Index (CDAI). Functionality was measured using the Health Questionnaire Assessment (HAQ), and quality of life was evaluated using the European Quality of Life Five Dimensions (EQ-5D). Multiple linear regression was used to identify predictors of the clinical response at 12 months. RESULTS: A total of 143 patients treated with adalimumab or etanercept were evaluated. Most of the clinical measures were significantly improved at 12 months. However, 31%–51% of the patients did not achieve good clinical control. No differences were observed between adalimumab and etanercept, except for poor functionality at 12 months among patients treated with etanercept. The main predictors of a worse clinical response were female sex, etanercept use, poor functionality, or lower quality of life at baseline. The main adverse reactions were alopecia, headache, injection site reaction, sinusitis, flu, dyslipidemia, and infections. CONCLUSION: TNF inhibitor therapy was effective and safe. However, despite improvements in clinical measures, most patients did not achieve satisfactory control of the disease.

ABSTRACT Objective To evaluate the therapeutic response (functionality) and its associated factors in patients on biological drugs on the Public Health System for treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Methods An open prospective cohort was carried out from 2011 to 2019, in Belo Horizonte (MG). Functionality was assessed using the Health Assessment Questionnaire Disability-Index at baseline, and after 6 and 12 months of follow-up. Factors associated with poor functionality were identified through logistic regression. Results The median Health Assessment Questionnaire Disability-Index at baseline was 1.5 (interquartile range of 0.8-1.9), with poor functionality observed in patients with rheumatoid arthritis. Improved functionality was seen at 6 months of treatment for the three diseases. The predictors of poor functionality at 6 months for psoriatic arthritis and ankylosing spondylitis were female sex, low education levels, and high disease activity; and for rheumatoid arthritis and psoriatic arthritis were female sex, advanced age, and high disease activity. In 12 months, the three diseases had predictors of worse functionality: female sex, low education, and high disease activity. Conclusion There was a significant improvement in functionality during the follow-up, with better response at 6 months of treatment. Poor functionality was observed in older, female patients, with low education and high disease activity.

Background: Pharmaceutical services in Brazil provide access, supply, and rational use of drugs for all population and an effort has been made to improve the quality of these services. Biological drugs are high-cost drugs supplied in Brazil that can inhibit disease progression and improve the quality of life of psoriatic arthritis (PsA) patients. However, some patients did not achieve therapeutic goals. Objective: To evaluate the medication adherence and persistence of PsA patients treated with tumor necrosis factor inhibitors (anti-TNF) drugs and their associated factors. Methods: A prospective observational study was performed at a single-specialty pharmacy in Belo Horizonte, Brazil. Medication adherence, persistence, and clinical outcomes were evaluated at 12 months of follow-up. Medication persistence was historically compared to overall PsA patients treated in Brazil. Associated factors were identified through log-binomial regression. Results: One hundred ninety-seven PsA patients were included in the study, of whom 147 (74.6%) and 142 (72.1%) had medication adherence and persistence, respectively. Patients treated with infliximab presented the highest adherence (90.5%) and persistence rate (95.2%) in comparison to patients treated with other drugs, except for adalimumab versus infliximab for adherence outcome. All clinical measures significantly improved in patients with medication adherence and persistence. Medication persistence was higher for patients attended by specialty pharmacy than other PsA patients in Brazil. The associated factors to higher medication adherence were lower disease activity by BASDAI, being non-white race, and intravenous drug use. The associated factors to higher medication persistence were lower disease activity by Bath Ankylosing Spondylitis Activity Index (BASDAI), intravenous drug use, non-use of corticoids and non-steroidal anti-inflammatory drugs, and comorbidity. Conclusions: Patients with medication adherence and persistence had significant improvements in clinical measures, functionality, and quality of life. High medication adherence and persistence to biological therapy were observed and associated with lesser disease activity at baseline. Also, medication persistence to PsA patients attended in specialty pharmacy was higher than the overall PsA population in Brazil, which indicates the importance of pharmaceutical services to provide health care and promote the effectiveness and safety of biological therapies.

Resumo Fundamento: O transplante cardíaco é a principal alternativa terapêutica para pacientes com insuficiência cardíaca avançada. Diversos fatores de risco influenciam a sobrevivência desses pacientes, entretanto, poucos estudos acerca do tema estão disponíveis no Brasil. Objetivos: Analisar a sobrevivência de pacientes transplantados cardíacos pelo Sistema Único de Saúde no Brasil entre 2000-2015. Métodos: Trata-se de uma coorte não concorrente, aberta, de pacientes transplantados cardíacos no Brasil. A probabilidade acumulada de sobrevivência foi estimada por Kaplan-Meier e a comparação entre as curvas realizada pelo Teste de Log-Rank. O modelo de Cox foi utilizado para calcular o Hazard-Ratio (HR). As análises foram realizadas ao nível de 95% de confiança. Resultados: A mediana de sobrevivência do transplante cardíaco no Brasil no período foi 8,3 anos. Cada ano adicional na idade do receptor, a ocorrência de infecções e a realização do procedimento cirúrgico na região Sul relacionaram-se ao maior risco de perda do enxerto. Maior proporção de uso dos imunossupressores micofenolato e azatioprina atuou como fator protetor. Conclusões: As análises realizadas fornecem a primeira informação quanto ao tempo de sobrevivência mediana do transplante cardíaco no Brasil. A diferença observada entre as regiões pode estar relacionada aos diferentes protocolos de tratamento adotados no país, principalmente no início dos anos 2000. A proporção de uso de micofenolato e azatioprina como fator protetor sugere que, apesar de não haver diferença entre as estratégias terapêuticas, o uso desses medicamentos pode favorecer a sobrevida de determinados pacientes. O estudo apresenta dados epidemiológicos robustos e importantes para a saúde pública.

Abstract Background: Heart transplant is the main therapeutic alternative for advanced heart failure patients. Several risk factors affect these patients' survival; however, few studies about the topic are available in Brazil. Objectives: To review the survival rates of heart transplant patients in the Brazilian Public Health System (Sistema Único de Saúde - SUS) between 2000 and 2015. Methods: This is a non-concurrent, open cohort study, involving cardiac transplant patients in Brazil. The cumulative survival probability was estimated by the Kaplan-Meier curve, and the curve comparison was done using the Log-Rank test. The Cox model was used to calculate the Hazard-Ratio (HR). Analyses were conducted at the 95% confidence level. Results: The heart transplant survival rate median in Brazil, during the period, was 8.3 years. Each additional year in the recipient's age, the occurrence of infections, and the performance of the surgical procedure in the South Region were associated with a higher risk of graft loss. A higher use ratio of immunosuppressants mycophenolate and azathioprine acted as a protection factor. Conclusions: The analyses conducted provide the first information about the median survival time in heart transplant patients in Brazil. The difference noticed among the geographical regions may be related to the different treatment protocols adopted in the country, especially in the early 2000s. The rate of mycophenolate and azathioprine use as a protection factor suggests that, despite the absence of differences among therapeutic strategies, use of these drugs may favor survival of certain patients. The study provides robust epidemiological data, which are relevant for public health.

RESUMO Objetivo. Descrever a frequência, as características e os fatores que contribuem para o suicídio em povos indígenas brasileiros. Método. Foi realizada uma revisão sistemática da literatura a partir das bases de dados PubMed, SciELO, PsycINFO e LILACS. Foram incluídos estudos de base populacional que enfocassem suicídio em populações indígenas no território brasileiro. Resultados. A busca identificou 111 artigos, dos quais nove preencheram os critérios de inclusão. Três estudos foram realizados na região Centro-Oeste, quatro na região Norte do Brasil e dois abordaram todas as regiões do Brasil. Três estudos citaram as etnias estudadas, totalizando sete etnias (Terena, Kadiweu, Guato, Ofaie-Xavante, Guarani, Guarani-Kaiowá e Guarani-Nandeva). Os estudos demonstraram maior taxa de mortalidade por suicídio em pessoas do sexo masculino, solteiros, com 4 a 11 anos de escolaridade, na faixa etária de 15 a 24 anos, no domicílio e nos finais de semana, tendo como principal método o enforcamento. Os principais fatores de risco para o suicídio foram pobreza, fatores históricos e culturais, baixos indicadores de bem estar, desintegração das famílias, vulnerabilidade social e falta de sentido de vida e futuro. Conclusões. Todos os estudos indicaram a necessidade de desenvolvimento de estratégias em conjunto com as comunidades, considerando sua cosmovisão e os aspectos sócio-histórico-culturais de cada etnia, para minimização dos fatores de risco e redução da taxa de suicídio.

ABSTRACT Objective. To describe the frequency, characteristics, and factors contributing to suicide in indigenous populations in Brazil. Method. A systematic review of the literature was performed in PubMed, SciELO, PsycINFO, and LILACS. All population-based studies focusing on suicide among indigenous populations in Brazil were included. Results. The search identified 111 articles, of which nine met the inclusion criteria. Three of these studies were performed in the Midwest and four in the North of Brazil, while two covered all Brazilian regions. The ethnic groups investigated were specified in three studies (Terena, Kadiweu, Guato, Ofaie-Xavante, Guarani, Guarani-Kaiowá, and Guarani-Nandeva). Suicide rates were highest among males, single individuals, those with 4 to 11 years of schooling, and those aged 15 to 24 years. Suicides occurred most often in the home and on weekends, mostly by hanging. The main risk factors for suicide identified in the articles were poverty, historical and cultural factors, poor wellbeing indicators, family disintegration, social vulnerability, and lack of life or future perspective. Conclusions. All the studies indicated the need to engage communities in developing strategies, considering their cosmovision and the social, historic, and cultural view of each ethnic group to minimize risk factors and reduce suicide rates.

RESUMEN Objetivo. Describir la frecuencia y las características del suicidio y sus factores contribuyentes en los pueblos indígenas brasileños. Método. Se realizó una revisión sistemática de la bibliografía a partir de las bases de datos PubMed, SciELO, PsycINFO y LILACS. Se incluyeron estudios de base poblacional enfocados en el suicidio en las poblaciones indígenas en el territorio brasileño. Resultados. En la búsqueda se encontraron 111 artículos, de los cuales nueve se ciñeron a los criterios de inclusión. Se realizaron tres estudios en la región centro oeste y cuatro en la región norte, además de otros dos que abarcaron todas las regiones de Brasil. En tres estudios se citaron todas las siete etnias estudiadas (Terena, Kadiweu, Guato, Ofaie-Xavante, Guaraní, Guaraní-Kaiowá y E-Nandeva). En los estudios se demostró una mayor tasa de mortalidad por suicidio en personas solteras del sexo masculino, con 4 a 11 años de escolaridad, en el grupo de 15 a 24 años de edad, en el domicilio y en los fines de semana, principalmente por el método de ahorcamiento. Los principales factores de riesgo de suicidio fueron la pobreza, factores históricos y culturales, el índice de bienestar bajo, la desintegración de las familias, la vulnerabilidad social, y la falta de sentido de la vida y del futuro. Conclusiones. Todos los estudios indicaron la necesidad de formular estrategias junto con las comunidades, dentro del marco de su cosmovisión y de los aspectos sociales, históricos y culturales de cada etnia, con el fin de reducir al mínimo los factores de riesgo y la tasa de mortalidad por suicidio.

RESUMO: Introdução: O uso inadequado e o crescimento dos gastos em saúde reforçam a necessidade de ampliar o conhecimento sobre a qualidade de uso de medicamentos. Objetivos: Descrever e avaliar o perfil de utilização de medicamentos em uma amostra representativa de usuários adultos da atenção primária do Sistema Único de Saúde (SUS) de Minas Gerais. Método: Estudo transversal, com 1.159 entrevistados em 104 municípios e 253 serviços de saúde. Foram coletados dados sobre características sociodemográficas, condições de saúde e uso de medicamentos, sendo essas características estratificadas por faixas etárias. Análises univariada e multivariada, por meio de regressão logística, foram conduzidas para identificar preditores de automedicação. Para todos os testes, foi adotado o nível de significância de 5%. Resultados: A prevalência de uso de medicamentos foi de 81,8%, com média de 2,67 medicamentos por usuário, que aumenta com a faixa etária. Os medicamentos mais utilizados foram losartana, hidroclorotiazida e sinvastatina, com diferenças entre as faixas etárias. Observou-se automedicação significativa não só em adultos jovens, mas também entre idosos. Os preditores de automedicação foram: ser adulto jovem, ter maior nível de escolaridade, não apresentar doenças crônicas, ter pior autopercepção de saúde e não aderir a medicamentos prescritos. Adultos jovens e idosos apresentaram características que os tornaram mais vulneráveis em relação ao uso racional de medicamentos. Conclusão: O estudo pode contribuir para melhorar o cuidado na atenção primária, pois identificou problemas relevantes relacionados à qualidade do uso de medicamentos, especialmente entre adultos jovens e idosos em Minas Gerais.

ABSTRACT: Introduction: Inappropriate use and increase of health care spending reinforce the need to extend our knowledge about the quality of medication use. Objectives: To describe and evaluate the profile of medication use in a representative sample of adult users of primary care services in the Unified Health System (SUS) of Minas Gerais. Method: Cross-sectional study, with 1,159 interviewees in 104 municipalities and 253 health care services. Data on sociodemographic characteristics, health conditions and use of medicines were collected, and these variables were stratified by age group. Univariate and multivariate analyses, using logistic regression, were conducted to identify predictors of self-medication. We set a significance level of 5% for all tests. Results: The prevalence of medication use was 81.8%, with an average of 2.67 medicines per user, which increased with age. The most used drugs were losartan, hydrochlorothiazide and simvastatin, which differed between age groups. Significant self-medication was observed not only in young adults but also in the elderly. The predictors of self-medication were: being a young adult, having a higher level of education, not having chronic diseases, having worse self-perception of health and not adhering to prescription drugs. Young and elderly adults showed characteristics that made them more vulnerable in relation to the rational use of medicines. Conclusion: This study can contribute to improving primary care, where it identified problems related to the extent of medication use, especially among young adults and the elderly in Minas Gerais.

RESUMO: Introdução: O uso inadequado e o crescimento dos gastos em saúde reforçam a necessidade de ampliar o conhecimento sobre a qualidade de uso de medicamentos. Objetivos: Descrever e avaliar o perfil de utilização de medicamentos em uma amostra representativa de usuários adultos da atenção primária do Sistema Único de Saúde (SUS) de Minas Gerais. Método: Estudo transversal, com 1.159 entrevistados em 104 municípios e 253 serviços de saúde. Foram coletados dados sobre características sociodemográficas, condições de saúde e uso de medicamentos, sendo essas características estratificadas por faixas etárias. Análises univariada e multivariada, por meio de regressão logística, foram conduzidas para identificar preditores de automedicação. Para todos os testes, foi adotado o nível de significância de 5%. Resultados: A prevalência de uso de medicamentos foi de 81,8%, com média de 2,67 medicamentos por usuário, que aumenta com a faixa etária. Os medicamentos mais utilizados foram losartana, hidroclorotiazida e sinvastatina, com diferenças entre as faixas etárias. Observou-se automedicação significativa não só em adultos jovens, mas também entre idosos. Os preditores de automedicação foram: ser adulto jovem, ter maior nível de escolaridade, não apresentar doenças crônicas, ter pior autopercepção de saúde e não aderir a medicamentos prescritos. Adultos jovens e idosos apresentaram características que os tornaram mais vulneráveis em relação ao uso racional de medicamentos. Conclusão: O estudo pode contribuir para melhorar o cuidado na atenção primária, pois identificou problemas relevantes relacionados à qualidade do uso de medicamentos, especialmente entre adultos jovens e idosos em Minas Gerais.

ABSTRACT: Introduction: Inappropriate use and increase of health care spending reinforce the need to extend our knowledge about the quality of medication use. Objectives: To describe and evaluate the profile of medication use in a representative sample of adult users of primary care services in the Unified Health System (SUS) of Minas Gerais. Method: Cross-sectional study, with 1,159 interviewees in 104 municipalities and 253 health care services. Data on sociodemographic characteristics, health conditions and use of medicines were collected, and these variables were stratified by age group. Univariate and multivariate analyses, using logistic regression, were conducted to identify predictors of self-medication. We set a significance level of 5% for all tests. Results: The prevalence of medication use was 81.8%, with an average of 2.67 medicines per user, which increased with age. The most used drugs were losartan, hydrochlorothiazide and simvastatin, which differed between age groups. Significant self-medication was observed not only in young adults but also in the elderly. The predictors of self-medication were: being a young adult, having a higher level of education, not having chronic diseases, having worse self-perception of health and not adhering to prescription drugs. Young and elderly adults showed characteristics that made them more vulnerable in relation to the rational use of medicines. Conclusion: This study can contribute to improving primary care, where it identified problems related to the extent of medication use, especially among young adults and the elderly in Minas Gerais.

Abstract Background: Pharmaceutical Assistance (PA) is a dynamic and multidisciplinary process that aims to supply health systems, programs or services with quality medicines, enabling access and health care, in an efficient and timely manner. The objective of the study was to evaluate the profile of administrative processes for the treatment of PsA, identify the time elapsed in the flow of processes and its associated factors. Methods: A cross-sectional study of medication requests for the treatment of PsA was carried out between November 2014 and December 2016. Linear regression was used to verify the factors associated with time to delivery. Results: A total of 218 cases containing 250 drugs were analyzed. The median time between the medical appointment and the first dispensation was 66 days (interquartile range, 44-90). The State proceedings, which includes requesting the drug until the authorization of treatment, was the stage that most contributed to the total time spent. The factors associated with the longer time to delivery of medications were prescriptions coming from clinics and specialty centers, from dermatologists, non-authorized processes and non-persistent patients in the treatment in 12 months. Conclusion: The median time to receive medicines for the PsA treatment in Belo Horizonte health region after a medical prescription was higher than 2 months. The time between the solicitation of the medicines and the authorization of the treatment in the SUS (State administrative procedure) was the main component of the total time spent.

Resumo: 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.

Abstract: 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.

Resumen: 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.

Resumo: 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.

Abstract: 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.

Resumen: 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.