The impact of patients with generalized anxiety disorder in the Brazilian Private Healthcare System: a claim database study with expert's perspective / O impacto de pacientes com transtorno de ansiedade generalizada no Sistema Único de Saúde: um estudo de base de sinistros com a perspectiva de especialistas

This study describes the healthcare resource use and costs associated with anxiety assessing claim database outcomes and expert opinion from the perspective of the Brazilian Private Healthcare System. A retrospective analysis of the Orizon database was conducted, containing claims data of anxiety patients reported in Private Healthcare Systems (2015-2017) according to the ICD-10 code (F40 or F41 and their subtypes). Further, a 3-hour online meeting brought together five anxiety and Health Insurance Companies experts to discuss their perspectives. The total cost of the 18,069 patients identified in the database was BRL 490 million: related to medical appointments (2%), exams (16%), emergency room (5%), and others (77%). The mean number of appointments was 5.1 in a 4-year period, performed by 61% of the patients. Approximately 2,595 visits were made to psychiatrists by 923 patients, and 95% underwent at least one examination (100.6 examinations per patient, on average). The identification of anxiety patients and their corresponding burden is challenging to estimate. The higher impact is related to the frequency of healthcare use before the diagnosis than the treatment itself. These outcomes may help plan and implement adequate healthcare programs for patients with anxiety.

Este estudo descreve o uso de recursos de saúde e os custos relacionados à ansiedade associando resultados de uma base de dados administrativa e opinião de especialistas na perspectiva do Sistema Privado de Saúde Brasileiro. Foi realizada uma análise retrospectiva da base de dados da Orizon de pacientes com ansiedade em atendimento hospitalizar ou ambulatorial no Sistema Privado de Saúde (2015 - 2017) com o código CID-10 (F40 ou F41 e os seus subtipos), adicionalmente promovemos uma reunião online de 3 horas com cinco especialistas em ansiedade e em seguros de saúde para discutir as suas perspectivas. O custo total dos 18.069 pacientes identificados no banco de dados foi de R$ 490 milhões, relacionados a consultas médicas (2%), exames (16%), pronto-socorro (5%) e outros (77%). A média de consultas foi de 5,1 em um período de 4 anos, realizadas por 61% dos pacientes. Aproximadamente 2.595 visitas foram feitas a psiquiatras por 923 pacientes, e 95% realizaram pelo menos um exame (média de 100,6 exames por paciente. É desafiador identificar e estimar o impacto da doença no Sistema Privado de Saúde Brasileiro. O impacto maior está relacionado à frequência de uso de serviços de saúde antes do diagnóstico, em comparação com o próprio tratamento. Esses resultados podem ajudar a planejar e implementar programas de saúde adequados para pacientes com ansiedade.

The impact of depression in the Brazilian private healthcare system: patient journey and economic burden study associating claim database and expert's opinion approach / O impacto da depressão no sistema de saúde privado brasileiro: estudo da jornada do paciente e da carga econômica associando banco de dados de sinistros e abordagem de opinião de especialistas

Objective: The study aimed to describe the profile and economic burden of patients with depression from the perspective of the Brazilian Private Healthcare System (PHS). Methods: A two-step methodological quantitative-qualitative research design was performed: retrospective descriptive analysis of the Orizon database of patients with at least one claim of depression (F33, F38, or F39) in PHS (2013-2019) and experienced physicians perspective from an expert meeting. Results: 1,802 patients fulfilling the eligibility criteria counted BRL 74,978 million across the 4-year period. Over this period, nearly 60% of patients had a medical appointment (6.6 appointments per patient, on average), 61% had a psychologist, 9.8% had a psychiatrist appointment, and an average of 115.2 exams and 8.7 emergency visits per patient were performed. According to the experts, the economic impact of depression is more significant when considering the indirect costs related to productivity loss and impairment in occupational and interpersonal functioning. Conclusion: Identifying and diagnosing patients with depression and their real burden is challenging; even with significant costs identified in the claim database analyses in the Brazilian PHS, the real impact must be higher if indirect costs are considered. The depressive disorder should be prioritized in the Brazilian PHS to establish more adequate health policies.

Objetivo: O estudo teve como objetivo descrever o perfil e a carga econômica de pacientes com depressão na perspectiva do Sistema Único de Saúde (SUS). Métodos: Foi realizado um projeto de pesquisa quantitativo-qualitativo metodológico em duas etapas: análise descritiva retrospectiva do banco de dados Orizon de pacientes com pelo menos uma alegação de depressão (F33, F38 ou F39) no PHS (2013- 2019) e perspectiva de médicos experientes de uma reunião de especialistas. Resultados: 1.802 pacientes que preencheram os critérios de elegibilidade totalizaram R$ 74,978 milhões no período de 4 anos. Nesse período, cerca de 60% dos pacientes tiveram consulta médica (6,6 consultas por paciente, em média), 61% tiveram psicólogo, 9,8% consulta com psiquiatra e foram realizados em média 115,2 exames e 8,7 atendimentos de emergência por paciente . Segundo os especialistas, o impacto econômico da depressão é mais significativo quando considerados os custos indiretos relacionados à perda de produtividade e prejuízo no funcionamento ocupacional e interpessoal. Conclusão: Identificar e diagnosticar pacientes com depressão e sua real carga é desafiador; mesmo com custos significativos identificados nas análises da base de sinistros do SUS brasileiro, o impacto real deve ser maior se considerados os custos indiretos. O transtorno depressivo deve ser priorizado na APS brasileira para o estabelecimento de políticas de saúde mais adequadas.

Framework for Adoption of Next-Generation Sequencing (NGS) Globally in the Oncology Area.

Radical new possibilities of improved treatment of cancer are on offer from an advanced medical technology already demonstrating its significance: next-generation sequencing (NGS). This refined testing provides unprecedentedly precise diagnoses and permits the use of focused and highly personalized treatments. However, across regions globally, many cancer patients will continue to be denied the benefits of NGS as long as some of the yawning gaps in its implementation remain unattended. The challenges at the regional and national levels are linked because putting the solutions into effect is highly dependent on cooperation between regional- and national-level cooperation, which could be hindered by shortfalls in interpretation or understanding. The aim of the paper was to define and explore the necessary conditions for NGS and make recommendations for effective implementation based on extensive exchanges with policy makers and stakeholders. As a result, the European Alliance for Personalised Medicine (EAPM) developed a maturity framework structured around demand-side and supply-side issues to enable interested stakeholders in different countries to self-evaluate according to a common matrix. A questionnaire was designed to identify the current status of NGS implementation, and it was submitted to different experts in different institutions globally. This revealed significant variability in the different aspects of NGS uptake. Within different regions globally, to ensure those conditions are right, this can be improved by linking efforts made at the national level, where patients have needs and where care is delivered, and at the global level, where major policy initiatives in the health field are underway or in preparation, many of which offer direct or indirect pathways for building those conditions. In addition, in a period when consensus is still incomplete and catching up is needed at a political level to ensure rational allocation of resources-even within individual countries-to enable the best ways to make the necessary provisions for NGS, a key recommendation is to examine where closer links between national and regional actions could complement, support, and mutually reinforce efforts to improve the situation for patients.

Empowering quality data - the Gordian knot of bringing real innovation into healthcare system.

OBJECTIVES: The introduction of Personalised Medicine (PM) into healthcare systems could benefit from a clearer understanding of the distinct national and regional frameworks around the world. Recent engagement by international regulators on maximising the use of real-world evidence (RWE) has highlighted the scope for improving the exploitation of the treasure-trove of health data that is currently largely neglected in many countries. The European Alliance for Personalised Medicine (EAPM) led an international study aimed at identifying the current status of conditions. METHODS: A literature review examined how far such frameworks exist, with a view to identifying conducive factors - and crucial gaps. This extensive review of key factors across 22 countries and 5 regions revealed a wide variety of attitudes, approaches, provisions and conditions, and permitted the construction of a comprehensive overview of the current status of PM. Based on seven key pillars identified from the literature review and expert panels, the data was quantified, and on the basis of further analysis, an index was developed to allow comparison country by country and region by region. RESULTS: The results show that United States of America is leading according to overall outcome whereas Kenya scored the least in the overall outcome. CONCLUSIONS: Still, common approaches exist that could help accelerate take-up of opportunities even in the less prosperous parts of the world.

Fighting Cancer around the World: A Framework for Action.

Tackling cancer is a major challenge right on the global level. Europe is only the tip of an iceberg of cancer around the world. Prosperous developed countries share the same problems besetting Europe-and the countries and regions with fewer resources and less propitious conditions are in many cases struggling often heroically against a growing tide of disease. This paper offers a view on these geographically wider, but essentially similar, challenges, and on the prospects for and barriers to better results in this ceaseless battle. A series of panels have been organized by the European Alliance for Personalised Medicine (EAPM) to identify different aspects of cancer care around the globe. There is significant diversity in key issues such as NGS, RWE, molecular diagnostics, and reimbursement in different regions. In all, it leads to disparities in access and diagnostics, patients' engagement, and efforts for a better understanding of cancer.

Chronic pain patients in the Brazilian private healthcare system: a claim database study with the experts' perspective / Pacientes com dor crônica no sistema de saúde suplementar brasileiro: um estudo de banco de dados com a perspectiva dos especialistas

Objective: This study aimed to describe the demands and costs from chronic pain patients over the private Brazilian healthcare system. Methods: This was a retrospective claim database study to assess the resource utilization of pain patients in the private setting. We used a four-year follow-up period to assess inpatient, outpatient, and procedures reported. Further, we promoted a forum of discussion with five pain experts and healthcare managers to address the management of chronic pain and assistance models.Results: We identified 79,689 patients with chronic pain. The orthopedist was the main medical specialist consulted with a total number of 38,879 visits performed. The ophthalmologist, cardiologist, gynecologist, and general practitioner were also frequently consulted (rheumatologist was seldom consulted). Among non-medical specialists, the physical therapist was consulted 87,574 times by 12,342 patients (15% of the entire cohort), Among chronic pain patients, 96% performed at least one exam and 86% of the patients presented at least one ER visit during the follow-up period. In 4 years, we estimate that pain patients costed more than 3 billion reais to the private health care system. According to the experts' opinions, a fragmented healthcare system and the lack of patient centered interdisciplinary approaches contributes to a high ineffective pain management leading to a high use of resources. Conclusion: There is an urgent need to change the chronic pain care model in the Brazilian private setting. Qualification in pain management, a multidisciplinary patient centered care, integrated approaches, pain centers, and patients' education may help changing this scenario.

Objetivo: O objetivo do estudo foi descrever as demandas e custos dos pacientes com dor crônica no sistema privado de saúde brasileiro. Métodos: Neste estudo retrospectivo do banco de dados administrativo, avaliamos a utilização de recursos de pacientes com dor no ambiente privado. Em um período de quatro anos, avaliamos internações, visitas ambulatoriais e procedimentos. Adicionalmente, promovemos um fórum de discussão com cinco especialistas em dor e gerentes de saúde para abordar o manejo da dor e os modelos de assistência. Resultados: Identificamos 79.689 pacientes com dor crônica. O ortopedista foi o principal especialista médico consultado, com 38.879 visitas realizadas. O oftalmologista, o cardiologista, o ginecologista e o clínico geral também foram consultados com frequência (o reumatologista foi raramente consultado). Entre os especialistas não médicos, o fisioterapeuta foi consultado 87.574 vezes por 12.342 pacientes (15% de toda a coorte). Entre os pacientes, 96% realizaram pelo menos um exame e 86% apresentaram pelo menos uma consulta de emergência durante o período. Em 4 anos, estimamos um custo de mais de 3 bilhões de reais para o sistema privado de saúde. De acordo com as opiniões dos especialistas, um sistema de saúde fragmentado e a falta de abordagens centradas no paciente contribuem para um manejo ineficaz da dor, resultando em um alto uso de recursos. Conclusão: Há necessidade de mudar o modelo de manejo da dor crônica no sistema privado brasileiro. Qualificação dos profissionais, atendimento multidisciplinar centrado no paciente, abordagens integradas, centros de dor e educação dos pacientes podem ajudar a mudar esse cenário.

Delivering precision oncology to patients with cancer.

With the increasing use of genomic profiling for diagnosis and therapy guidance in many tumor types, precision oncology is rapidly reshaping cancer care. However, the current trajectory of drug development in oncology results in a paradox: if patients cannot access advanced diagnostics, we may be developing drugs that will reach few patients. In this Perspective, we outline the major challenges to the implementation of precision oncology and discuss critical steps toward resolving these, including facilitation of equal access to genomics tests, ensuring that clinical studies provide robust evidence for new drugs and technologies, enabling physicians to interpret genomics data, and empowering patients toward shared decision-making. A multi-stakeholder approach to evidence generation, value assessment, and healthcare delivery is necessary to translate advances in precision oncology into benefits for patients with cancer globally.

BRAF Testing in Melanoma and Colorectal Cancer in Latin America: Challenges and Opportunities.

The incidence of colorectal cancer in Argentina and Brazil has reached levels comparable to those in higher-income countries. Similarly, the incidence of melanoma in Latin America has increased during the past decades. BRAFmutation is seen frequently in melanomas and colorectal cancer. Discovering the expression of this specific biomarker in both cancers has unleashed the potential for targeted molecular therapies.In patients with BRAF-mutated melanoma, adopting a combined targeted treatment approach has shown a dramatic increase in overall survival. However, several barriers impede the development of early BRAF testing in Latin America, jeopardizing the potential for personalized therapies and care. To address this, the Americas Health Foundation convened a virtual meeting of Latin American oncologists to address the barriers to BRAF testing in melanoma and colorectal cancer. During a three-day conference, expert oncologists used literature reviews and personal experience to detail the barriers to early BRAF testing in their region. They proposed actionable steps to overcome the barriers identified, which included deficiencies in knowledge, treatment options, equitable distribution, timely results, and local data on BRAF mutations. Oncologists proposed several actions to overcome barriers, including raising public and healthcare awareness about the importance of BRAF testing, expanding treatment options in clinics across the region, developing centers in underserved areas, and increasing affordable treatment options for patients who test positive for BRAF mutations.

Correction: BRAF Testing in Melanoma and Colorectal Cancer in Latin America: Challenges and Opportunities.

[This corrects the article DOI: 10.7759/cureus.31972.].

Cancer control in Latin America and the Caribbean: recent advances and opportunities to move forward.

The increasing burden of cancer represents a substantial problem for Latin America and the Caribbean. Two Lancet Oncology Commissions in 2013 and 2015 highlighted potential interventions that could advance cancer care in the region by overcoming existing challenges. Areas requiring improvement included insufficient investment in cancer control, non-universal health coverage, fragmented health systems, inequitable concentration of cancer services, inadequate registries, delays in diagnosis or treatment initiation, and insufficient palliative services. Progress has been made in key areas but remains uneven across the region. An unforeseen challenge, the COVID-19 pandemic, strained all resources, and its negative effect on cancer control is expected to continue for years. In this Series paper, we summarise progress in several aspects of cancer control since 2015, and identify persistent barriers requiring commitment of additional resources to reduce the cancer burden in Latin America and the Caribbean.

Cost-effectiveness of ribociclib plus letrozole versus palbociclib plus letrozole or letrozole as monotherapy in first-line treatment of postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer: a Brazilian private payer perspective.

BACKGROUND: The global burden of breast cancer (BC) is high, especially in advanced stages. CDK 4/6 inhibitors represent a paradigm shift in the treatment of advanced BC HR+/HER2-, given the clinically and statistically significant gain in overall survival associated with this new class of medications. Nevertheless, as an innovation, the incorporation of these drugs impacts healthcare budgets, requiring cost-effectiveness analyses for decision-making. The aim of this study was to evaluate the cost-effectiveness of ribociclib plus letrozole compared with palbociclib plus letrozole or letrozole as monotherapy for first-line treatment of postmenopausal women with HR+/HER2- locally advanced or metastatic BC (aBC) from a Brazilian private healthcare system perspective. METHODS: A model including progression-free survival (PFS), progressed disease, and death health states was used to simulate lifetime costs and outcomes. PFS and overall survival were derived from the MONALEESA-2 trial (lifetime horizon). Healthcare costs included drug acquisition and monitoring, subsequent therapies, adverse events, and end-of-life costs. Effectiveness was measured in quality-adjusted life-years (QALYs). Deterministic and probabilistic sensitivity analyses were performed. RESULTS: The total cost of treatment with ribociclib plus letrozole was USD 72,091.82 versus USD 92,749.64 for palbociclib plus letrozole. Total QALYs were 3.30 and 3.16, respectively. Base-case analysis showed ribociclib as dominant over palbociclib in first-line treatment of women with HR+/HER2- aBC, associated with cost savings and QALY gains. The total cost of treatment with ribociclib plus letrozole was USD 83,058.73 versus USD 29,215.10 for letrozole. Total QALYs were 3.84 and 2.61, respectively. Compared with letrozole, ribociclib plus letrozole was associated with an incremental cost of USD 53,843.64 and an incremental QALY gain of 1.23, with incremental cost-effectiveness ratio of USD 43,826.91 per QALY gained. CONCLUSIONS: As demonstrated by the cost-effectiveness dominance over palbociclib, ribociclib results in savings when used as first-line treatment in postmenopausal women with HR+/HER2- aBC, warranting incorporation in the private healthcare system.

Cost of chronic red blood cell transfusion in the Brazilian private healthcare sector from a payer perspective / Custo de transfusão crônica de concentrado de hemácias na perspectiva do sistema de saúde suplementar brasileiro

Objective: In the private healthcare sector in Brazil, the dearth of information regarding transfusion cost may compromise the management of conditions requiring long-term transfusion. Therefore, the present study aimed to estimate the cost of chronic red blood cell (RBC) transfusion in this context. Methods: A payer perspective was chosen for the analysis. A survey performed by an expert advisory board gathered information on the amounts reimbursed by health plans to blood centers per outpatient transfusion of a single RBC bag in multitransfused patients. Survey results were contrasted to RBC transfusion cost calculated using Brazilian Hierarchical Classification of Medical Procedures (CBHPM) parameters from 2018 and 2010, the latter suggested by the advisory board as more accurately reflecting market prices. Results: Six blood centers in the South and Southeast of Brazil were surveyed. The median amount reimbursed per RBC unit was R$ 1,066.44 (interquartile range: R$ 665.00-1,252.00). The mean amount reimbursed was R$ 959.54 ± R$ 337.14 (minimum: R$ 295.00 ­ maximum: R$ 1,980.00). Using 2018 CBHPM parameters, the cost of transfusing one RBC unit was calculated as R$ 1,905.18. Using 2010 CBHPM parameters, the cost was R$ 1,119.69 per RBC unit. Conclusions: Analyses using 2018 CBHPM parameters may lead to overestimation of transfusion cost. The best estimate for outpatient transfusion of one RBC bag in the private health care sector in Brazil lies between the observed reimbursed values and 2010 CBHPM cost. The present results provide valuable information for future cost-effectiveness analyses focusing on disorders whose treatment involves routine RBC transfusion.

A carência de informações sobre custo de transfusão sanguínea na saúde suplementar brasileira pode comprometer análises econômicas e eventuais decisões relacionadas a esse procedimento no longo prazo. O objetivo deste estudo foi estimar o custo de transfusão crônica de concentrado de hemácias (CH) nesse contexto. Métodos: Foi escolhida a perspectiva do pagador. Uma pesquisa foi realizada com especialistas para levantamento de valores reembolsados para transfusão de uma bolsa de CH em pacientes politransfundidos. Os resultados da pesquisa foram comparados ao custo de transfusão de CH calculado utilizando a Classificação Brasileira Hierarquizada de Procedimentos Médicos (CBHPM), edições de 2018 e 2010, sendo a edição mais antiga sugerida pelos especialistas como estando mais de acordo com a realidade de mercado. Resultados: Seis hemocentros localizados no Sul e Sudeste do Brasil foram incluídos. Os valores mediano e médio reembolsados aos hemocentros foram R$ 1.066,44 (amplitude interquartil: R$ 665,00-1.252,00) e R$ 959,54 ± R$ 337,14 (mínimo: R$ 295,00 ­ máximo: R$ 1.980,00), respectivamente. Com base nos parâmetros da CBHPM 2018 e 2010, os custos de transfusão calculados para uma bolsa de CH foram R$ 1.905,18 e R$ 1.119,69, respectivamente. Conclusões: Análises utilizando parâmetros da CBHPM 2018 podem superestimar os custos de transfusão de CH. Na perspectiva do sistema de saúde suplementar brasileiro, a melhor estimativa de custo de transfusão por bolsa de CH está entre o valor reembolsado e o valor calculado utilizando a CBHPM 2010. O presente estudo apresenta informações importantes para futuras análises de custo-efetividade de patologias que envolvem tratamentos à base de politransfusão de CH.

Custo-efetividade e impacto orçamentário da introdução do cabozantinibe no tratamento de carcinoma de células renais avançado no sistema de saúde suplementar no Brasil / Cost-effectiveness and budgetary impact of introducing cabozantinib in the treatment of advanced renal cell carcinoma in the supplementary health system in Brazil

Objetivo: Este trabalho teve por objetivo determinar o custo-efetividade e o impacto orçamentário do cabozantinibe para o sistema de saúde suplementar no Brasil, no tratamento de carcinoma de células renais (RCC) avançado ou metastático, após falha de tratamento com inibidor do fator de crescimento endotelial vascular (VEGF), quando comparado ao atual tratamento aprovado: nivolumabe. Métodos: Foram utilizados custos referentes ao uso de recursos, tratamento médico, eventos adversos e qualidade de vida, calculados por estado de saúde. Foi considerado o tempo horizonte de 20 anos para análise de custo-efetividade e 5 anos para impacto orçamentário, e foi realizado um cenário alternativo comparando o cabozantinibe ao nivolumabe e axitinibe. Resultados: O cabozantinibe apresentou eficácia superior quando comparado ao nivolumabe e ao axitinibe e representa uma redução de custos comparado ao nivolumabe. Em relação aos eventos adversos, o cabozantinibe apresenta redução dos gastos quando comparado ao nivolumabe. Conclusão: Esses resultados mostram um potencial de economia ao sistema de saúde suplementar com a adoção do cabozantinibe no tratamento para RCC avançado ou metastático em segunda linha no Brasil.

Objective: This study aimed to determine the cost-effectiveness and budgetary impact of cabozantinib for the supplementary health system in Brazil, in the treatment of advanced or metastatic renal cell carcinoma (RCC) after treatment failure with vascular endothelial growth factor (VEGF) inhibitor, when compared current approved treatment: nivolumab. Methods: Costs related to the use of resources, medical treatment, adverse events and quality of life were used, calculated by health status. The horizon time of 20 years was considered for cost-effectiveness analysis and 5 years for budgetary impact, and an alternative scenario was carried out comparing cabozantinib to nivolumab and axitinib. Results: Cabozantinib showed superior efficacy when compared to nivolumab and axitinib and represents a cost reduction compared to nivolumab. In relation to adverse events, cabozantinib shows a reduction in costs when compared to nivolumab. Conclusion: These results show a potential savings for the supplementary health system with the adoption of cabozantinib in the treatment for advanced or metastatic second-line RCC in Brazil.

Access to pain management for cancer patients treated under the Brazilian private healthcare system / Acesso ao tratamento da dor de pacientes com câncer atendidos no sistema de saúde privado brasileiro

Objective: To reflect about current pain management in cancer patients treated under the Brazilian Private Healthcare System, considering legal boundaries, access to essential drugs and involved ethical issues. Panelists aimed to reach a consensus about recommendations to increase access to proper analgesia for patients with cancer secondary pain. Methods: Four Brazilian specialists, being a radiation oncologist (and bioethicist), an oncologist, a pain specialist and a CEO of a private healthcare plan, met after the 2019 American Society of Clinical Oncology (ASCO) meeting, held in Chicago, and discussed the aforementioned subjects. A consensus was reached and is described below. Results: Cancer pain is prevailing in our country, probably undertreated, and may be a prevalent cause of medical services overuse, which may increase healthcare costs. Thus, there may be an opportunity to improve patient's quality of life, with a positive budget impact for private healthcare plans, if this treatment becomes mandatorily reimbursed. There are several studies in the literature showing similar results, but this should be prospectively studied, preferable using real word evidence, at the Brazilian scenario. Cancer pain treatment protocols, designed by specialists, should be designed in agreement with all stakeholders. Conclusion: Panelists agreed that pain treatment, which must be considered a human right, is a clear priority in Brazil. All stakeholders should collaborate in designing protocols to improve patient's quality of life, consequently improving health insurance's budgets. If so, this would have clear consequences in access to innovative cancer treatments, as those discussed during the 2019 ASCO meeting.

Objetivo: Refletir sobre o manejo atual da dor em pacientes com câncer atendidos no sistema de saúde privado brasileiro, considerando limites legais, acesso a medicamentos essenciais e questões éticas envolvidas. Os participantes do painel procuraram chegar a um consenso sobre recomendações para aumentar o acesso à analgesia adequada para pacientes com dor secundária ao diagnóstico de câncer. Métodos: Quatro especialistas brasileiros reuniram-se após a reunião da Sociedade Americana de Oncologia Clínica (ASCO) de 2019, realizada em Chicago, e discutiram os mencionados assuntos. Um consenso foi alcançado e é descrito abaixo. Resultados: A dor oncológica prevalece em nosso país, provavelmente subtratada, e pode ser uma causa predominante de uso excessivo de serviços médicos, o que pode aumentar os custos com saúde. Assim, pode haver uma oportunidade de melhorar a qualidade de vida do paciente, com um impacto orçamentário positivo para planos de saúde privados, se esse tratamento for obrigatoriamente reembolsado. Existem vários estudos na literatura que mostram resultados semelhantes, mas isso deve ser estudado prospectivamente, preferencialmente usando evidências provenientes de dados de mundo real, no cenário brasileiro. Os protocolos de tratamento da dor do câncer, preparados por especialistas, devem ser elaborados de acordo com todas as partes interessadas. Conclusão: Os participantes do painel concordaram que o tratamento da dor, que deve ser considerado um direito humano, é uma clara prioridade no Brasil. Todas as partes interessadas devem colaborar na elaboração de protocolos para melhorar a qualidade de vida do paciente, consequentemente melhorando os orçamentos do seguro de saúde. Nesse caso, isso teria consequências claras no acesso a tratamentos inovadores contra o câncer, como os discutidos durante a reunião da ASCO em 2019.

New Challenges in Oncology for the Brazilian Private Health Sector: Specialists' Concerns After the ISPOR International Congress in Boston, Massachusetts, 2017.

The congress of the International Society for Pharmacoeconomics and Outcomes Research is one of the main worldwide forums for the dissemination of research and knowledge on healthcare economics. Brazil is the largest country in Latin America, with a per-capita gross domestic product of $15 200 in 2017 and healthcare expenditure of the order of $1 318 per inhabitant. Brazilian specialists participated actively in the society's latest congress, which took place in Boston, Massachusetts, from May 20 to 24, 2017. They met to discuss the main topics dealt with at the congress and their applicability to Brazilian realities. The topics chosen were precision medicine, new challenges for economic modeling within oncology and immuno-oncology, data to aid in managerial decision making (ie, data from real-world studies), and, lastly, strategies for accessing high-cost medications in Brazil. This opinion article sought to report the main conclusions and consensus reached by this group of specialists on the occasion of this discussion.

The Value of Biomarkers in Optimizing the Use of Immuno-oncologic Therapy.

The development of therapies that restore or activate the host immune response - the socalled "immuno-oncologic" therapy - has improved the survival of some cancer patients harboring specific tumor types. These drugs, however, are very expensive which has greatly limited their use and consequently reduced the number of patients who could likely benefit. Not to mention, the proportion of patients who display a clinical benefit from therapy is limited. Thus, from a clinical and health economics perspective, there is a pressing need to identify and treat those patients for whom a given immuno- oncologic therapy is most likely to be beneficial. At this end, the identification, validation and use of biomarkers emerge as an important therapeutic tool. Here, we briefly review the state of immunologic biomarker development and utilization and make suggestions for interested clinicians, health policy makers and other stakeholders to prepare for the broader use of biomarkers associated with immuno-oncologic therapy in routine practice. The biomarker field is clearly in its earliest stages and there is no doubt that continued research will identify new biomarkers with valuable clinical indications. Of course, the clinical utility of a biomarker must consider patient preferences and perspectives. In addition, health economic analyses are crucial to better define the value of immunotherapy based on precision medicine strategies and promote value-based pricing.

Cost-effectiveness and budgetary impact of lipegfilgrastim for the reduction of chemotherapy-induced neutropenia in Brazil / Custo-benefício e impacto orçamentário do lipegfilgrastim para a redução de neutropenia induzida por quimioterapia no Brasil

Background: Granulocyte-colony stimulating factors (G-CSFs) reduce the risk of chemotherapy-induced neutropenia. Lipegfilgrastim is a long-acting, once-per-cycle G-CSF, while Brazil's standard of care is short-acting filgrastim. A cost-effectiveness and budget impact analysis of lipegfilgrastim was conducted with filgrastim and once-per-cycle pegfilgrastim for adults at risk of neutropenia in Brazil. Methods: The decision model used national and clinical data to evaluate the costs and outcomes of each treatment. Costs included drug and medical expenses, outpatient and inpatient neutropenia treatments, and adverse events. Health outcomes included incidence of neutropenia-related events. For the budget impact analysis, health outcomes and costs for the pre/post-lipegfilgrastim scenarios were combined to identify expenditure with lipegfilgrastim's introduction. Results: Total cost per patient during a course of four chemotherapy cycles was estimated at R$12,920 for lipegfilgrastim, R$15,168 for filgrastim, and R$13,232 for pegfilgrastim. Based on better outcomes and lower total costs with lipegfilgrastim compared with filgrastim as well as pegfilgrastim, lipegfilgrastim was the dominant treatment strategy over both filgrastim and pegfilgrastim during the duration of chemotherapy treatment. Over 5 years, the uptake of lipegfilgrastim led to savings of R$61,532,403 in overall medical costs. Neutropenic events decreased by 17,141 and deaths linked to febrile neutropenia decreased by 239. Conclusion: Due to better outcomes and lower overall cost, lipegfilgrastim was a cost-saving strategy compared with filgrastim and pegfilgrastim in the Brazilian healthcare system. Furthermore, the budget impact analysis estimated a reduction in overall medical costs and improved health outcomes over 5 years following the introduction of lipegfilgrastim.

Introdução: Fatores estimuladores de colônias de granulócitos (G-CSFs) reduzem risco de neutropenia induzida por quimioterapia. Lipegfilgrastim é um G-CSF de longa ação, de "um por ciclo", enquanto o padrão de cuidado no Brasil é filgrastim de curta ação. Realizou-se uma análise de custo/ benefício e impacto orçamentário (IO) no Brasil do lipegfilgrastim um por ciclo com filgrastim e pegfilgrastim para adultos sob risco de neutropenia. Métodos: O modelo de decisão usou dados nacionais e clínicos para avaliar resultados e custos dos tratamentos que incluíam medicamentos, médicos, tratamentos ambulatoriais e hospitalares para a neutropenia, e eventos adversos. Resultados de saúde incluíam a incidência de eventos relacionados à neutropenia. Para a análise do IO, os custos e resultados de antes/depois do lipegfilgrastim foram combinados para identificar gastos com o lipegfilgrastim. Resultados: O custo total por paciente em quatro ciclos foi estimado em R$ 12.920 para lipegfilgrastim, R$ 15.168 para filgrastim e R$ 13.232 para pegfilgrastim. Com base em melhores resultados e custos totais menores, o lipegfilgrastim, comparado ao filgrastim e ao pegfilgrastim, representou a estratégia de tratamento predominante. Em 5 anos, o lipegfilgrastim gerou uma economia de R$ 61.532.403 em custos médicos gerais. Houve 17.141 menos eventos neutropênicos e as mortes relacionadas à neutropenia febril reduziram em 239. Conclusão: Devido a melhores resultados e menores custos, lipegfilgrastim, comparado ao filgrastim e ao pegfilgrastim, foi uma estratégia econômica no sistema brasileiro. A análise de IO estimou uma redução nos custos médicos e melhorou os resultados em 5 anos após a introdução do lipegfilgrastim.