Unmet need for and impact of adopting immunobiological drugs for moderate to severe plaque psoriasis in a pediatric population

ABSTRACT Objective Therefore, this study aimed to evaluate the impact of secukinumab and ustekinumab against moderate-to-severe plaque psoriasis in a Brazilian pediatric population with access to public healthcare. Methods A survey of immunobiological treatments registered for use against pediatric psoriasis at the National Health Surveillance Agency was conducted. These treatments were compared to the list available in the same treatment category in the public health system through the Clinical Protocol and Therapeutic Guidelines for psoriasis. A quantitative analysis of the data of patients treated with immunobiological drugs the previous year in accordance with the Clinical Protocol and Therapeutic Guidelines was performed using data available in the DATASUS portal. Results The public budget impact scenarios analyzed were comparable to the investment already planned for acquiring the only available drug option. Conclusion The incorporation of two therapeutic options in the Clinical Protocol and Therapeutic Guidelines list for moderate-to-severe pediatric psoriasis was feasible in a horizon of 5 years compared to the investment into the single option available to pediatric patients. These findings can facilitate the local analysis of budgetary impact and discussions on the feasibility of this therapeutic incorporation at the state level.

Epidemiological and Clinical Patterns of Newly Diagnosed Hepatocellular Carcinoma in Brazil: the Need for Liver Disease Screening Programs Based on Real-World Data.

PURPOSE: Describe sociodemographic and clinical characteristics of patients with hepatocellular carcinoma (HCC) and establish their history in the Brazilian public health system. METHODS: Retrospective observational study was conducted using the database from the Department of Informatics of the Unified Health System (DataSUS). Patients with at least one claim of HCC between July/2011 and June/2016 were included. A record linkage methodology was performed to obtain longitudinal data across different databases. Demographic and clinical data were evaluated, including the time elapsed between diagnosis of HCC risk-factors and the cancer development. Data was analyzed using descriptive statistics. RESULTS: A total of 28,822 HCC cases were identified between July/2011 and June/2016. Mean age was 59.7 years (SD = 14.7), and most patients were men (55.9%). The highest relative number of HCC cases was detected in the south of Brazil (> 20 cases/100,000 inhabitants). About 86.5% of the patients had diagnosis of HCC without previous liver diseases. Only 8% had diagnosis of chronic viral hepatitis and 3.5% cirrhosis. About 76% were diagnosed at an advanced stage, and only 11% of the patients had early stage HCC. Approximately 58% of patients with previous underlying liver diseases were diagnosed at early stages, compared with only 24% of patients without prior record of underlying diseases. CONCLUSION: The diagnosis of HCC in the Brazilian public health is usually made in patients with no previous diagnosis of liver disease and in advanced stages, when no curative treatment is available and survival rates are low. Public health policies are key for the screening and monitoring liver disease and, consequently, HCC.

Dados de mundo real no processo de tomada de decisão: uma análise sob a perspectiva do sistema brasileiro de saúde suplementar / Real-world evidence in decision-making process: analysis from the Brazilian private healthcare system perspective

O debate sobre a necessidade de melhoria da utilização de recursos em saúde fez aumentar o interesse em evidências do mundo real (EMR) nos últimos anos. No sétimo congresso Latino-Americano da Sociedade Internacional de Farmacoeconomia e Pesquisa de Desfechos, diferentes palestrantes exploraram como o manejo desses dados pode auxiliar no processo de tomada de decisão. Quatro membros representando diferentes segmentos do Sistema de Saúde Suplementar (SSS) brasileiro foram convidados a participar de um painel de especialistas, a fim de entender suas percepções sobre o assunto. O nível de confiança na informação atualmente disponível variou entre 70% e 90% e os dados são utilizados na rotina de tomada de decisão. Considerando a utilização de evidências para prever decisões, os especialistas relatam não existir uma matriz institucional, mas que as informações existentes são utilizadas na construção de modelos preditivos por meio da criação de pacotes de serviços. A priorização da tomada de decisão é hoje essencialmente baseada em estimativas de custos. Apesar disso, são observadas diferentes situações em que dados de mundo real podem balizar esse processo. Existiu consenso de que uma mudança de paradigmas está ocorrendo e que esses processos representam um futuro plausível. O uso de EMR é de grande importância no processo de tomada de decisão na perspectiva do SSS e, acima de tudo, no suporte de modelos de saúde baseados em valor, sendo recomendado pela Agência Nacional de Saúde Suplementar como um pilar estratégico para a sustentabilidade do sistema.

The debate about the needs for healthcare resource utilization improvement has been soaring during the last years. As a result, discussions on enhancements of the decision-making process through the leverage of real-world evidence (RWE) has also been fostered. In the 7th Latin American congress of the International Society for Pharmacoeconomics and Outcomes Research, different speakers explored how the management of these data support real-life healthcare decisions. Four members representing different segments from the Brazilian Supplementary Healthcare System (SHS) were invited to participate on an expert panel in order to understand their perceptions on this subject. The confidence level on available data ranges from 70% to 90% and information is used on decision-making routine. When the use of real-world evidence to predict decision was considered, panelists reported the absence of an institutional decision matrix, but that existing information is used to build predictive models through the creation of service packages. The prioritization of decision-making today is essentially based on the estimation of costs. However, different situations in which real-world data can guide this process are observed. There was a consensus on a paradigm shift ongoing and that these processes represent a plausible future. The use of RWE is of great importance on decision-making process from the SHS perspective and, above all, in a support of value-based healthcare model which is recommended by Brazilian private agency (ANS) as the strategic pillar to system sustainability