Resource utilization and costs related to the management of obstructive hypertrophic cardiomyopathy under the Brazilian supplementary healthcare system´s perspective: results from a modified Delphi panel / Utilização de recursos e custos relacionados ao manejo da cardiomiopatia hipertrófica obstrutiva sob a perspectiva do sistema de saúde suplementar brasileiro: resultados de um painel Delphi modificado

Objective: To generate data on the costs associated with the diagnosis and treatment of obstructive ypertrophic cardiomyopathy (HCM) from the perspective of the private health system in Brazil. Methods: A modified Delphi panel including seven different specialists (three clinical cardiologists with experience in obstructive HCM, two hemodynamicists with experience in septal ablation and two cardiac surgeons with expertise in myectomy), from two Brazilian states (São Paulo and Pernambuco), was conducted between August and November 2022. Two rounds of questions about the use of healthcare resources according to the functional class (NYHA I-IV) and a panel in a virtual platform were conducted to obtain the final consensus. Micro-costing defined costs and unit values were determined based on official price lists. Results: The total diagnosis cost per patient was estimated at BRL 11,486.81. The obstructive HCM management costs analysis showed average annual costs per patient of BRL 17,026.74, BRL 19,401.46, BRL 73,310.07, and BRL 94,885.75 for the functional classes NYHA I, NYHA II, NYHA III, and NYHA IV, respectively. The average costs per patient related to procedures in a year were BRL 12,698.53, BRL 13,462.30, BRL 58,841.67, and BRL 75,595.90 for the functional classes NYHA I, II, III, and IV, respectively. Conclusions: The annual costs of HCM management increased according to the functional class, highlighting the need for safe and effective strategies to improve patient's NYHA functional class while promoting a decrease in the need for invasive therapies.

Objetivo: Gerar dados acerca dos custos associados ao diagnóstico e tratamento da cardiomiopatia hipertrófica (CMH) obstrutiva, sob a perspectiva do sistema de saúde privado no Brasil. Métodos: Um painel Delphi modificado incluindo sete especialistas (três cardiologistas clínicos com experiência em CMH obstrutiva, dois hemodinamicistas com experiência em ablação de septo e dois cirurgiões cardíacos com experiência em miectomia) de dois estados brasileiros (São Paulo e Pernambuco) foi conduzido entre agosto e novembro de 2022. Foram realizadas duas rodadas de perguntas acerca da utilização de recursos de acordo com a classe funcional (NYHA I-IV) e uma reunião virtual para obtenção do consenso final. Os custos foram definidos por meio de microcusteio, e os valores unitários foram definidos com base em listas de preço oficiais. Resultados: O custo total do diagnóstico por paciente foi estimado em R$ 11.486,81. A análise de custos de manejo da CMH obstrutiva mostrou custos médios anuais por paciente de R$ 17.026,74, R$ 19.401,46, R$ 73.310,07 e R$ 94.885,75 para as classes funcionais NYHA I, NYHA II, NYHA III e NYHA IV, respectivamente. Os custos médios por paciente relacionados a procedimentos em um ano foram de R$ 12.698,53, R$ 13.462,30, R$ 58.841,67 e R$ 75.595,90 para as classes NYHA I, II, III e IV, respectivamente. Conclusões: Os custos anuais com o manejo da CMH aumentam de acordo com a classe funcional, destacando a necessidade de estratégias seguras e eficazes capazes de melhorar a classe funcional NYHA do paciente, ao mesmo tempo que promove diminuição da necessidade de terapias invasivas.

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

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

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

Tratamento do HIV/AIDS no Brasil: impacto da adesão sobre a utilização de recursos e custos / HIV/AIDS treatment in Brazil: impact of adherence on resource utilization and costs

Objetivo: Determinar o impacto da adesão ao tratamento antirretroviral sobre a utilização de recursos e custos relacionados ao manejo do HIV/AIDS no Brasil. Métodos: Uma revisão sistemática da literatura foi conduzida em dezembro/2019. Foram incluídos estudos com pacientes adultos, brasileiros, com diagnóstico de HIV/AIDS, que apresentassem dados de adesão terapêutica, utilização de recursos e custos associados ao tratamento. Resultados: Foram localizadas 964 referências, três delas elegíveis para inclusão. O custo total foi estimado em 227.362,00 BRL em seis meses (N = 100 ­ custos diretos e indiretos) e em 579.264,80 BRL por ano (N = 157 ­ custos diretos) em indivíduos aderentes ao tratamento. Já em 40 pacientes não aderentes, o custo total estimado, considerando apenas os custos diretos, foi de 136.023,25 BRL por ano. Ao padronizar essas estimativas pelo período de análise e tamanho amostral, pacientes não aderentes demonstram um menor custo total quando comparados àqueles aderentes ao tratamento [170.029,06 BRL (custos diretos) versus 184.479,24 BRL (custos diretos) e 227.362,00 BRL (custos diretos e indiretos)]. No entanto, o grupo de pacientes não aderentes ao tratamento demonstrou maior custo, com diferença estatisticamente significativa para consultas e necessidade de internação hospitalar. A razão de custo-efetividade incremental para indivíduos aderentes à terapia antirretroviral (7.622 BRL por resposta clínica) foi menor quando comparada ao grupo de indivíduos não aderentes (9.716 BRL por resposta clínica). Conclusões: Apesar da escassez de estudos que avaliem a relação entre a adesão ao tratamento e os custos com o manejo do HIV/AIDS no Brasil, os achados corroboram a hipótese de que a não adesão ao tratamento pode gerar um maior custo.

Objective: To determine the impact of adherence to antiretroviral treatment on resource utilization and costs in the management of HIV/AIDS patients in Brazil. Methods: A systematic review was conducted in December 2019. Eligibility criteria considered Brazilian adults with HIV/AIDS, presenting data on treatment adherence, resource utilization, and treatment-associated costs. Results: The search retrieved 964 references and three were eligible for inclusion. Total cost was estimated at 227,362.00 BRL in six months (N = 100 ­ direct and indirect costs) and 579,264.80 BRL per year (N = 157 ­ direct costs) in individuals adhering to the treatment. In 40 non-adherent patients, estimated total cost, considering only direct costs, was 136,023.25 BRL per year. When estimates were standardized by the analysis period and sample size, non-adherent patients demonstrate a lower total cost when compared to those adhering to the treatment [170,029.06 BRL (direct costs) versus 184,479.24 BRL (direct costs) and 227,362.00 BRL (direct and indirect costs)]. However, the group of patients who did not adhere to the treatment showed a higher cost, with a statistically significant difference, for consultations and the need for hospitalization. Incremental cost-effectiveness ratio for adherent (7,622 BRL per clinical response) was smaller when compared to non-adherent group (9,716 BRL per clinical response). Conclusions: Despite the scarcity of studies evaluating the relationship between adherence to treatment and costs with the management of HIV/AIDS in Brazil, data found corroborates the hypothesis that non-adherence to treatment may be associated with higher costs.

Incidence and risk factors of lymphedema after breast cancer treatment: 10 years of follow-up.

PURPOSE: To evaluate the incidence and risk factors of lymphedema 10 years after surgical treatment for breast cancer. METHODS: Prospective observational hospital-based cohort of women undergoing axillary lymph node dissection. Lymphedema was assessed by indirect volume, measured by circumference, and diagnosed if there was a difference of 200 mL between the arms or if the patient was treated for it. Independent variables were patient, tumour and treatment characteristics. Descriptive statistics were conducted as survival analysis using the Kaplan-Meier estimate. Cox regression was performed, considering a 95% confidence interval (95%CI). RESULTS: The study evaluated 964 women. The cumulative incidence of lymphedema observed was 13.5% at two years of follow-up, 30.2% at five years and 41.1% at 10 years. Final model showed an increased risk for lymphedema among women that underwent radiotherapy (HR = 2.19; 95%CI 1.63-2.94), were obese (HR = 1.52; 95%CI 1.20-1.92), had seroma formation after surgery (HR = 1.46; 95%CI 1.14-1.87), underwent chemotherapy infusion in the affected limb (HR = 1.45; 95%CI 1.12-1.87) or advanced disease staging (HR = 1.41; 95%CI 1.11-1.80). CONCLUSIONS: Cumulative incidence of lymphedema was 41.1%. Women undergoing axillary radiotherapy, obese, who developed seroma, underwent chemotherapy infusion in the affected limb and with advanced disease had a higher risk of lymphedema.

Differences in utility scores obtained through Brazilian and UK value sets: a cross-sectional study.

BACKGROUND: Multiple sclerosis (MS) is a chronic disease associated with several impacts; especially regarding patients' health-related quality of life (HRQL). EuroQol 5 Dimensions questionnaire (EQ-5D) provides self-reported analysis of HRQL and utility scores. Although the British algorithm to convert EQ-5D responses into utility is the most used in the literature, national settings is more appropriate for health policy decision makers. A Brazilian algorithm is available, but not used in MS patients yet. Primarily, this study aimed to address potential differences in utility scores obtained through Brazilian and British value sets. Secondary objective was to determine the role of disability, fatigue and patients socio-demographic and clinical characteristics relevant to MS on the utility scores reported by Brazilian patients. METHODS: Cross-sectional study with MS patients treated in 8 Brazilian sites. Patients were interviewed about socio-demographic and clinical characteristics, self-reported disability level, HRQL and impact of fatigue on daily living. Disability level, HRQL and impact of fatigue were assessed using the Expanded Disability Status Scale (EDSS) and the Brazilian versions of EQ-5D-3 L and Modified Fatigue Impact Scale (MFIS-BR), respectively. Patients were classified in subgroups according to EDSS (mild: 0-3; moderate: 4-6.5; severe: >7) and the self-perceived impact of fatigue (absent: ≤ 38 points; low: 39-58; high: ≥ 59). EQ-5D-3 L data was converted into a utility index using an algorithm developed by a Brazilian research group (QALY Brazil) and also the UK algorithm. Differences between utility scores were analysed through Wilcoxon test. RESULTS: Two hundred and ten patients were included in the study. Utility index mean scores of 0.59 (SD = 0.22) and 0.56 (SD = 0.32) for the Brazilian and UK algorithms were observed, respectively, without statistically significant difference for the distribution of data (p = 0.586). However, when utility scores were lower than 0.5, Brazilian algorithm provided higher estimates than UK with a better agreement between the scores found closer to 1. The same trend was observed when data was stratified for EDSS and impact of fatigue, with statistically significant difference between scores in categories of mild/severe disabilities and absent/high impact of fatigue. CONCLUSIONS: Results suggest that Brazilian value set provided higher utility scores than the UK, particularly for measures below 0.5.