Introduction: Managed Entry Agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high-and middle-income countries. Methods: An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was 'What are the health technology MEAs that have been applied around the world?' This review was supplemented with studies not retrieved in the search known to the senior level co-authors including key South American markets. Afterall, involved senior level decision makers and advisers providing guidance on potential advantages and disadvantages of MEAs and ways forward. Results: 25 studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%), and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. Conclusion: We are likely to see a growth in MEAs with the continual launch of new high priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome based MEAs could be an important tool to improve access to new innovative medicines there are critical issues to address. Comparing knowledge, experiences and practices across countries is crucial to guide high-and middle-income countries when designing their future MEAs.

Background Relapsing-remitting multiple sclerosis (RRMM) is a chronic, progressive, inflammatory and immune-mediated disease that affects the central nervous system and is characterized by episodes of neurological dysfunction followed by a period of remission. The pharmacological strategy aims to delay the progression of the disease and prevent relapse. Interferon beta and glatiramer are commonly used in the Brazilian public health system and are available to patients who meet the guideline criteria. The scenario of multiple treatments available and in development brings the need for discussion and evaluation of the technologies already available before the incorporation of new drugs. This study analyses the effectiveness of first-line treatment of RRMS measured by real-world evidence data, from the Brazilian National Health System (SUS). Methods and findings We conducted a non-concurrent national cohort between 2000 and 2015. The study population consisted of 22,722 patients with RRMS using one of the following first-line drugs of interest: glatiramer or one of three presentations of interferon beta. Kaplan-Meier analysis was used to estimate the time to treatment failure. A univariate and multivariate Cox proportional hazard model was used to evaluate factors associated with treatment failure. In addition, patients were propensity score-matched (1:1) in six groups of comparative first-line treatments to evaluate the effectiveness among them. The analysis indicated a higher risk of treatment failure in female patients (HR = 1.

Objective: To assess health-related quality of life and associated factors in patients treated with atypical antipsychotics, as well as to determine utility values using the EuroQol-5D-3L instrument. Methods: A cross-sectional study was conducted at a state-run pharmacy in the Brazilian National Health System. Individuals were included if they were using a single atypical antipsychotic and completed the EuroQol-5D-3L. Sociodemographic, behavioral, and clinical data were collected. The dependent variable was the EuroQol-5D-3L utility score. Associations between the independent variables and the dependent variable were analyzed in a multiple linear regression model. Results: A total of 394 patients were included, and their mean utility score was 0.664±0.232. Patients treated with clozapine had the highest mean score (0.762 [0.202]), followed by olanzapine (0.687 [0.230]), risperidone (0.630 [0.252]), ziprasidone (0.622 [0.234]), and quetiapine (0.620 [0.243]). The following variables were related to higher utility scores: income, employment, clozapine use, no illicit psychoactive substance use, no suicide attempts, and no comorbidities. Conclusion: Evaluating health-related quality of life differences in the available atypical antipsychotics can facilitate the choice of treatment, improve health outcomes, and ensure rational prescriptions.

Background: There is a need to evaluate the health equity of atypical antipsychotics users who obtain their medicines from the Brazilian National Health System (SUS) through the identification of key factors that influence their health status due to concerns with equity of care. Research design and methods:Cross-sectional study among patients attending state pharmacies in Brazil. Individuals were included if they used atypical antipsychotics, aged ≥18 years, and answered the EQ-5D-3L questionnaire. Sociodemographic, behavioral, and clinical data were collected. The dependent variable was health status. Associations between the independent variables and the dependent variable were analyzed by adjusting a linear regression model. Results: Overall, 388 individuals met the eligibility criteria and were included in the analysis. The final multiple linear regression model demonstrated a statistically significant association between VAS and suicide attempts, private care, current antipsychotics, comorbidities, and perceived family support. Conclusions: The study identified several factors both individual and collective that correlate with the health status of atypical antipsychotic users, and confirmed the importance of providing medicines for treating psychotic disorders. However, other factors are involved including social support. Our results suggest additional activities and policies are necessary including strategies to address the differences in private and public health care.

Objetiva-se avaliar as evidências acerca do perfil de segurança para idosos dos medicamentos utili-zados no tratamentodo Diabetes Mellitus tipo 2, que são considerados medicamentos potencialmen-te inadequados pelo critério de Beers epela ferramenta STOPP: glibenclamida e clorpropamida. Realizou-se uma revisão integrativa da literatura realizada a partirda base de dados PubMed. Foram utilizados os descritores do banco Medical Subject Headings (MeSH) “chlorpropamide”,“glyburide” e “sulfonylureas” combinados ao descritor “aged”. Foram incluídos artigos que avaliaram o perfil de segurança douso de clorpropamida e/ou glibenclamida por idosos. Sete artigos foram selecionados. Não foi encontrado nenhum estudoque avaliasse a clorpropamida. Dois estudos avaliaram a segu-rança cardiovascular e o risco de morte com glibenclamida,mas não foram apontadas diferenças entre o uso deste medicamento e de outros da classe das sulfonilureias. Os demaistrabalhos eviden-ciaram uma associação entre o uso de glibenclamida e hipoglicemia, apesar de apresentarem resultados conflitantes quanto à relação da ocorrência deste evento com a função renal dos pacientes ido-sos. Concluí-se quea literatura aponta a necessidade de reavaliação da prescrição de glibenclamida, dada sua comprovada relação com odesenvolvimento de hipoglicemia em pacientes idosos.Palavras-chave: Diabetes Mellitus; Idoso; Glibenclamida; Clorpropamida; Efeitos Adversos. ABSTRACTThe aim is to evaluate scientific evidences about the safety profile among older patients of drugs used to treat type2 Diabetes that are considered potentially inappropriate medications by the Beers criteria and STOPP: glyburideand chlorpropamide. An integrative review was performed on Pub-Med database using Medical Subject Headings(MeSH), using the descriptors: “chlorpropamide”, “glyburide”, “sulfonylureas” and “aged”. Articles that evaluated thesafety profile of chlorpropamide and/or glyburide for older patients were included. Seven articles were selected,none of which as-sessed the safety profile of chlorpropamide. Two studies evaluated the cardiovascular safety andthe risk of death with glyburide, but no difference between this product and other drugs from the sul-fonylureasclass was identified. The other studies showed an association between the use of gly-buride and hypoglycemia,despite showing conflicting results regarding the relationship between this event and renal function of olderpatients. It concludes that the scientific literature showed the needing for reassessment of glyburide prescriptionamong older patients, given its proven relation-ship with the occurrence of hypoglycemia.Keywords: Diabetes Mellitus; Aged; Glyburide; Chlorpropamide; Adverse Effects.

Introduction: Eculizumab is currently the only treatment available for paroxysmal nocturnal hemoglobinuria (PNH). It was recently incorporated by Conitec and listed in the specialized component of SUS, making it necessary to develop a Clinical Protocol and Therapeutic Guidelines (PCDT), so that the medicine can be distributed to the population within 180 days. In this context, the challenge arises of rapidly developing a robust, evidence-based and society-validated PCDT for a rare disease with major financial impact on SUS. Conclusion: The HPN PCDT was elaborated and validated with agility, in approximately 60 days, with good acceptance by society.

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BackgroundChronic obstructive pulmonary disease (COPD) has an appreciable socioeconomical impact in low- and middle-income countries, but most epidemiological data originate from high-income countries. For this reason, it is especially important to understand survival and factors associated with survival in COPD patients in these countries.ObjectiveTo assess survival of COPD patients in Brazil, to identify risk factors associated with overall survival, including treatment options funded by the Brazilian National Health System (SUS).MethodologyWe built a retrospective cohort study of patients dispensed COPD treatment in SUS, from 2003 to 2015 using a National Database created from the record linkage of administrative databases. We further matched patients 1:1 based on sex, age and year of entry to assess the effect of the medicines on patient survival. We used the Kaplan-Meier method to estimate overall survival of patients, and Cox's model of proportional risks to assess risk factors.ResultThirty seven thousand and nine hundred and thirty eight patients were included. Patient's survival rates at 1 and 10 years were 97.6% (CI 95% 97.4–97.8) and 83.1% (CI 95% 81.9–84.3), respectively. The multivariate analysis showed that male patients, over 65 years old and underweight had an increased risk of death. Therapeutic regimens containing a bronchodilator in a free dose along with a fixed-dose combination of corticosteroid and bronchodilator seem to be a protective factor when compared to other regimens.ConclusionOur findings contribute to the knowledge of COPD patients' profile, survival rate and related risk factors, providing new evidence that supports the debate about pharmacological therapy and healthcare of these patients.