Telehealth Strategies to Support Referral Management to Secondary Care in Brazil: A Cost-Effectiveness Analysis.

OBJECTIVES: This study aimed to assess the cost-effectiveness of a remotely operated referral management system (RORMS) compared with a conventional referral management system (CRMS) in Brazil. METHODS: This is a model-based cost-effectiveness analysis under the perspective of the Unified Healthcare System (Sistema Único de Saúde [SUS]) in Brazil. A Markov microsimulation model was developed to compare costs and referral outcomes of the RORMS and the CRMS. Model consisted of 4 states representative of sequential stepwise assessments of referral suitability, 3 states representative of referral outcomes, and 1 exit model state. Target population represented cases being referred from primary healthcare units to specialized care in SUS. Model inputs related to costs and effectiveness in the RORMS arm were obtained from the data set of a RORMS between July and December 2019. Model inputs for the CRMS model arm were obtained from administrative data sets of 2 Brazilian localities for the year 2019. Relative effect size of RORMS in comparison with CRMS in SUS was obtained from published studies. Effectiveness outcome was unnecessary referrals averted. The incremental cost-effectiveness ratio was calculated for the base case. Probabilistic sensitivity analysis was conducted. RESULTS: In the base-case analyses, RORMS dominated CRMS, with expected cost-savings from $50.42 to $80.62 per unnecessary referral averted. RORMS was the dominant strategy in 83.7% of 100 000 simulations in the probabilistic sensitivity analysis. In 16.2% of simulations, incremental cost-effectiveness ratio was between $0 and $222 per unnecessary referral averted. CONCLUSIONS: Model-based simulations indicate that the RORMS is likely to be cost saving in comparison with the CRMS.

Micro-Costing of a Remotely Operated Referral Management System to Secondary Care in the Unified Health System in Brazil.

Referral of cases from primary to secondary care in the Brazilian public healthcare system is one of the most important issues to be tackled. Telehealth strategies have been shown effective in avoiding unnecessary referrals. The objective of this study was to estimate cost per referred case by a remotely operated referral management system to further inform the decision making on the topic. Analysis of cost by applying time-driven activity-based costing. Cost analyses included comparisons between medical specialties, localities for which referrals were being conducted, and periods of time. Cost per referred case across localities ranged from R$ 5.70 to R$ 8.29. Cost per referred case across medical specialties ranged from R$ 1.85 to R$ 8.56. Strategies to optimize the management of referral cases to specialized care in public healthcare systems are still needed. Telehealth strategies may be advantageous, with cost estimates across localities ranging from R$ 5.70 to R$ 8.29, with additional observed variability related to the type of medical specialty.

Micro-Costing of a Remotely Operated Referral Management System to Secondary Care in the Unified Health System in Brazil / Microcusteio de um Sistema de Regulação Remoto para o Cuidado Especializado no Sistema Único de Saúde no Brasil

Abstract Referral of cases from primary to secondary care in the Brazilian public healthcare system is one of the most important issues to be tackled. Telehealth strategies have been shown effective in avoiding unnecessary referrals. The objective of this study was to estimate cost per referred case by a remotely operated referral management system to further inform the decision making on the topic. Analysis of cost by applying time-driven activity-based costing. Cost analyses included comparisons between medical specialties, localities for which referrals were being conducted, and periods of time. Cost per referred case across localities ranged from R$ 5.70 to R$ 8.29. Cost per referred case across medical specialties ranged from R$ 1.85 to R$ 8.56. Strategies to optimize the management of referral cases to specialized care in public healthcare systems are still needed. Telehealth strategies may be advantageous, with cost estimates across localities ranging from R$ 5.70 to R$ 8.29, with additional observed variability related to the type of medical specialty.

Resumo O encaminhamento de casos da atenção primária para a secundária no Sistema Único Brasileiro é uma das questões mais importantes a ser enfrentada. As estratégias de telessaúde têm se mostrado eficazes para evitar encaminhamentos desnecessários. O objetivo deste estudo foi estimar o custo por caso encaminhado por meio de um sistema de gerenciamento de referenciamentos operado remotamente para subsidiar a tomada de decisão sobre o tema. Análise de custo por meio da aplicação de custeio baseado em atividades orientado pelo tempo (time-driven activity-based costing ou TDABC). As análises de custo incluíram comparações entre especialidades médicas, localidades para as quais os encaminhamentos estavam sendo conduzidos e períodos de tempo. O custo por referenciamento em todas as localidades variou entre R$ 5,70 a R$ 8,29. O custo por referenciamento nas especialidades médicas variou entre R$ 1,85 a R$ 8,56. Estratégias para otimizar a gestão dos referenciamentos para a atenção especializada nos sistemas públicos de saúde ainda são necessárias. As estratégias de telessaúde podem ser vantajosas, com estimativas de custo entre as localidades variando entre R$ 5,70 a R$ 8,29, com variabilidade adicional observada relacionada ao tipo de especialidade médica.

Qualidade metodológica das avaliações econômicas de antineoplásicos submetidas à Agência Nacional de Saúde Suplementar (ANS) na atualização do rol 2020 ­ Estudo de avaliação crítica / Methodological quality of economic assessments of antineoplastics submitted to Supplementary Health Agency in the update of the 2020 list ­ Critical assessment study

Objetivo: Descrever e analisar criticamente as avaliações econômicas de medicamentos antineoplásicos submetidas à Agência Nacional de Saúde Suplementar (ANS) durante o processo de atualização do rol de procedimentos em saúde 2020. Métodos: Estudo transversal de análise crítica dos estudos de avaliação econômica integrantes da documentação submetida à ANS com o objetivo de incorporação no rol de procedimentos. A avaliação da qualidade metodológica foi realizada por meio da ferramenta Methodology Checklist 6: Economic Evaluations Version 3.0 da Scottish Intercollegiate Guidelines Network. Resultados: Foram incluídas 49 avaliações econômicas: 22 estudos de custo-efetividade, 10 estudos de custo-utilidade, três estudos de custo-minimização e 14 estudos de custo-efetividade e custo-utilidade. A qualidade metodológica foi considerada, na maior parte (88%), como aceitável ou de baixa qualidade. Conclusão: Estudos de avaliação econômica são fundamentais no processo decisório de incorporação de tecnologias na saúde suplementar. Esta análise crítica sugere que a qualidade dos estudos econômicos apresentados dentro das propostas de incorporação de antineoplásicos durante o processo de atualização do rol 2020 da ANS foi limitada. Inconsistências metodológicas e falta de um relato transparente reduzem a validade e a aplicabilidade dos achados na tomada de decisão.

Objective: To describe and critically appraise the economic evaluations of antineoplastic drugs submitted to the ANS during the process of updating its 2020' list of procedures. Methods: Cross-sectional study of critical analysis of the economic evaluation studies included in the documentation submitted to the ANS with the aim of incorporating them into the list of procedures. The methodological quality assessment was carried out using the Methodology Checklist 6: Economic Evaluations Version 3.0 of the Scottish Intercollegiate Guidelines Network. Results: Overall, 49 economic evaluations were included: 22 cost-effectiveness studies, 10 cost-utility studies, three cost-minimization studies and 14 mixed economic studies. Methodological quality was mostly considered as acceptable or low quality. Conclusion: Economic evaluation studies are fundamental in the decision-making process of incorporating technologies into supplementary health care. This critical appraisal suggests that the quality of the economic studies presented within the proposals to incorporate antineoplastics during the process of updating the ANS 2020 roll was limited. Methodological inconsistencies and lack of transparent reporting reduce the validity and applicability of findings for decision-making

Delays and Disruptions in Cancer Health Care Due to COVID-19 Pandemic: Systematic Review.

PURPOSE: There has been noteworthy concern about the impact of COVID-19 pandemic on health services including the management of cancer. In addition to being considered at higher risk for worse outcomes from COVID-19, people with cancer may also experience disruptions or delays in health services. This systematic review aimed to identify the delays and disruptions to cancer services globally. METHODS: This is a systematic review with a comprehensive search including specific and general databases. We considered any observational longitudinal and cross-sectional study design. The selection, data extraction, and methodological assessment were performed by two independent reviewers. The methodological quality of the studies was assessed by specific tools. The delays and disruptions identified were categorized, and their frequency was presented. RESULTS: Among the 62 studies identified, none exhibited high methodological quality. The most frequent determinants for disruptions were provider- or system-related, mainly because of the reduction in service availability. The studies identified 38 different categories of delays and disruptions with impact on treatment, diagnosis, or general health service. Delays or disruptions most investigated included reduction in routine activity of cancer services and number of cancer surgeries; delay in radiotherapy; and delay, reschedule, or cancellation of outpatient visits. Interruptions and disruptions largely affected facilities (up to 77.5%), supply chain (up to 79%), and personnel availability (up to 60%). CONCLUSION: The remarkable frequency of delays and disruptions in health care mostly related to the reduction of the COVID-19 burden unintentionally posed a major risk on cancer care worldwide. Strategies can be proposed not only to mitigate the main delays and disruptions but also to standardize their measurement and reporting. As a high number of publications continuously are being published, it is critical to harmonize the upcoming reports and constantly update this review.

Eficácia, segurança e aspectos regulatórios dos medicamentos órfãos para doenças raras: o caso Zolgensma® / Efficacy, safety and regulatory aspects of orphan drugs for rare diseases: Zolgensma®'s case study

Objetivo: discutir o processo regulatório de medicamentos para doenças raras no Brasil, com base no caso Zolgensma®, e avaliar criticamente as evidências disponíveis até o momento sobre a eficácia e a segurança do Zolgensma® no tratamento da atrofia muscular espinhal (AME). Metodologia: estudo descritivo realizado no Núcleo de Avaliação de Tecnologias em Saúde do Hospital Sírio-Libanês (NATS-HSL) em junho de 2019. Resultados: em abril de 2019, o uso do Zolgensma® para AME foi regulamentado nos Estados Unidos com base em dois estudos clínicos abertos (sem mascaramento), sem grupo comparador paralelo (e, portanto, não randomizados). Essas limitações metodológicas aumentam a incerteza nos resultados encontrados. A Agência Nacional de Vigilância Sanitária (Anvisa) aprovou estratégias para regulamentar o processo e os prazos de análise das submissões de registro de novos medicamentos para doenças raras, caso do Zolgensma®. Conclusão: faz-se necessário ampliar o debate em torno do processo de regulamentação e de incorporação de medicamentos órfãos para doenças raras no Brasil. O debate deve incluir as evidências relacionadas aos efeitos ­ benefícios e riscos ­ desses medicamentos, e maior clareza nos critérios para concessão de registro e recomendação de incorporação em sistemas de saúde. (AU).

Objective: to discuss the regulatory process of drugs for rare diseases in Brazil, based on the Zolgensma® case, and to critically evaluate the evidence so far available on the efficacy and safety of Zolgensma® for treating spinal muscular atrophy (SMA). Methods: descriptive study conducted at the Health Technology Assessment Center of the Sírio Libanês Hospital (NATS-HSL) in June 2019. Results: in April 2019, the use of Zolgensma® for SMA was regulated in the United States based on two open-lable (unmasked), non-comparative (and therefore non-randomized) studies. These methodological limitations increase the uncertainty related to study results. The National Agency of Sanitary Surveillance (Anvisa) has approved strategies to regulate the process and specific deadlines for completing the appraisal process of new medicines for rare diseases, such as Zolgensma®. Conclusion: it is necessary to broaden the debate about the process of regulation and incorporation of orphan drugs for rare diseases in Brazil. This debate should include evidence related to the effects (benefits and risks) of these drugs, and greater transparency of the criteria indispensable for granting registration and recommendation of incorporation into health systems. (AU).

Objetivo: analizar el proceso de fármacos reguladores para enfermedades raras en Brasil, con base en el caso Zolgensma, y para evaluar críticamente la evidencia disponible hasta el momento sobre la eficacia y seguridad de Zolgensma® nel tratamiento de atrofia muscular espinal (AME). Métodos: estudio descriptivo realizado en el Centro de Evaluación de Tecnología de Salud del Hospital Sírio-Libanês (NATS-HSL) en junio de 2019. Resultados: en abril de 2019, el uso de Zolgensma® para la AME se reguló en los Estados Unidos basado en dos estudios abiertos (no enmascarados), no comparativos (y por lo tanto no aleatorios). Estas limitaciones metodológicas aumentan la incertidumbre en los resultados encontrados. La Agencia Nacional de Vigilancia Sanitaria en Brasil (Anvisa) ha aprobado estrategias para regular el proceso y los plazos de análisis de las solicitudes de registro de nuevos fármacos para enfermedades raras, el caso de Zolgensma. Conclusión: es necesario ampliar el debate sobre el proceso de regulación e incorporación de medicamentos huérfanos para enfermedades raras en Brasil. Este debate debe incluir evidencia relacionada con los efectos (beneficios y riesgos) de estos medicamentos y una mayor transparencia en los criterios para otorgar el registro y la recomendación de incorporación a los sistemas de salud. (AU).

Electronic Version of the EQ-5D Quality-of-Life Questionnaire: Adaptation to a Brazilian Population Sample.

OBJECTIVES: To assess the measurement equivalence of the original paper version of an adapted tablet version of the EuroQol five-dimensional questionnaire (EQ-5D). METHODS: A randomly selected sample of 509 individuals aged 18 to 64 years from the general population responded to the EQ-5D at two time points separated by a minimum interval of 24 hours and were allocated to one of the following groups: test-retest group (tablet-tablet) or crossover group (paper-tablet and tablet-paper). Agreement between methods was determined using the intraclass correlation coefficient (ICC) and the κ coefficient. RESULTS: In the crossover group, the following ICC values were obtained: 0.76 (confidence interval [CI] 0.58-0.89) for EQ-5D scores and 0.77 (CI 0.68-0.84) for visual analogue scale in subjects responding first to the tablet version; 0.83 (CI 0.75-0.89) for EQ-5D scores and 0.75 (CI 0.67-0.85) for visual analogue scale in subjects responding first to the paper version. In the test-retest group, the ICC was 0.85 (CI 0.73-0.91) for EQ-5D scores and 0.79 (CI 0.66-0.87) for visual analogue scale. The κ values were higher than 0.69 in this group. The internal consistencies of the paper and tablet methods were similar. CONCLUSIONS: The paper and tablet versions of the EQ-5D are equivalent. Test-retest and crossover agreement was high and the acceptability of the methods was similar among individuals.