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Introduction: tuberculosis (TB) is a frequent complication in patients receiving tumor necrosis factor-alpha (TNF-a) blockers. It occurs upon the reactivation of a latent infection or the progression of a recent infection.Objective: to learn about the incidence of TB in a population receiving tumor necrosis factor-alpha (TNF-a) blockers, to analyze the presentation of this condition and to conduct a latent infection research prior to the initiation of therapy.Method: retrospective cohort study. Patients receiving tumor necrosis factor-alpha (TNF-a) blockers between 2010 and 2016 were included in the study. Data were obtained from the IT systems of the National Resources Fund and the National Tuberculosis Program. The incidence of TB was calculated and the cases developing TB were described.Results: 991 treatments were included for 980 patients in total. 9 cases of TB were reported. Global incidence was 419.9 (IC 95% 191.9-591.2) out of 100,000 people per year. Cases of TB were only seen in patients treated with adalimumab. Screening for LTBI upon initiation of the drug was heterogeneous and the disseminated forms of TB prevailed (6/9) over isolated pulmonary affectation (3/9). In all cases anti- TNFa was suspended when TB was diagnosed, and it was not reinitiated.Conclusions: the incidence of TB in patients receiving tumor necrosis factor-alpha (TNF-a) blockers was 16.5 times greater than in the general population. Disseminated forms of TB prevailed, and some cases occurred in individuals who had received LTBI therapy prior to the initiation of the drug, suggesting the risk persists as long as there is exposure to the drug.

Background:Diabetes mellitus rates continue to rise, which coupled with increasing costs of associated complications has appreciably increased global expenditure in recent years. The risk of complications are enhanced by poor glycaemic control including hypoglycaemia. Long-acting insulin analogues were developed to reduce hypoglycaemia and improve adherence. Their considerably higher costs though have impacted their funding and use. Biosimilars can help reduce medicine costs. However, their introduction has been affected by a number of factors. These include the originator company dropping its price as well as promoting patented higher strength 300 IU/ml insulin glargine. There can also be concerns with different devices between the manufacturers.Objective:To assess current utilisation rates for insulins, especially long-acting insulin analogues, and the rationale for patterns seen, across multiple countries to inform strategies to enhance future utilisation of long-acting insulin analogue biosimilars to benefit all key stakeholders.Our approach:Multiple approaches including assessing the utilisation, expenditure and prices of insulins, including biosimilar insulin glargine, across multiple continents and countries.Results:There was considerable variation in the use of long-acting insulin analogues as a percentage of all insulins prescribed and dispensed across countries and continents. This ranged from limited use of long-acting insulin analogues among African countries compared to routine funding and use across Europe in view of their perceived benefits. Increasing use was also seen among Asian countries including Bangladesh and India for similar reasons. However, concerns with costs and value limited their use across Africa, Brazil and Pakistan. There was though limited use of biosimilar insulin glargine 100 IU/ml compared with other recent biosimilars especially among European countries and Korea. This was principally driven by small price differences in reality between the originator and biosimilars coupled with increasing use of the patented 300 IU/ml formulation. A number of activities were identified to enhance future biosimilar use. These included only reimbursing biosimilar long-acting insulin analogues, introducing prescribing targets and increasing competition among manufacturers including stimulating local production.Conclusions:There are concerns with the availability and use of insulin glargine biosimilars despite lower costs. This can be addressed by multiple activities.

Refereed/Peer-reviewed Background and Objective 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 of this article 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. It also involved senior-level decision makers and advisers providing guidance on the potential advantages and disadvantages of MEAs and ways forward. Results Twenty-five 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. Conclusions 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: Emergency sanitary measures imposed to contain spread and infection of SARS-CoV-2 may have collateral effects on care for cardiovascular disease. Global country data regarding incidence of acute myocardial infarction (STEMI) during the pandemia is critical for future health care policy. Our objective was to determine whether emergency sanitary measures imposed in Uruguay during the pandemia for SARS-CoV-2 had a direct impact on the quality of care for STEMI. Methods: We performed a whole country population based retrospective study to determine the incidence for STEMI reperfusion (fibrinolytics and percutaneous) (FBL and PCI respectively) during the emergency sanitary period. Incidence rate of STEMI reperfusion, time to reperfusion and mortality associated with reperfusion was collected from the National Resources Fund (unique governmental based organization in charge of STEMI reperfusion in Uruguay). This same data was retrieved for 2019, 2018 and 2017. Data was Findings: Number of treated patients for STEMI (PCI and FBL) in Uruguay was lower in 2020 (136 patients) compared to 2019 (180 patients), 2018 (182 patients) and 2017 (174 patients). FBL was performed as unique treatment in 5.1%, 7.2%, 7.7% and 12.1% respectively. Incidence rate for STEMI in Uruguay during the studied period in 2020 was lower with a reduced IRR (0.74, 95%CI: 0.59, 0.91) compared with previous years. Median time to reperfusion was similar (4.10h; range 0.67 – 23.50h) compared to 2019 (3.50h; range 0.50 – 23.50h), 2018 (3.60h; range 0.80 – 22.75h) and 2017 (3.70h; range 0.25 – 23.00h) (p=0.4). Mortality after 15 days was similar in 2017 (8%), 2018 (6%), 2019 (11%) and 2020 (8%). Interpretation: Emergency sanitary measures were associated with a decrease in the incidence for STEMI reperfusion without affecting its time to reperfusion and mortality. Funding Statement: No funding was received. Declaration of Interests: The authors declare not to have any interest conflicts. Ethics Approval Statement: The study was approved by the NRF review board and informed consent was collected from all patients before any reperfusion procedure was performed.

Resumen Introduccion El Fondo Nacional de Recursos financia los procedimientos de revascularizacion miocardica en Uruguay. Las evaluaciones posteriores a la revascularizacion mostraron un inadecuado control de los factores de riesgo. Objetivos Describir el control de los factores de riesgo y el uso de farmacos cardioprotectores en los pacientes ingresados en un programa de prevencion secundaria asi como analizar el impacto de dicho programa en la mortalidad y en la realizacion de nuevos procedimientos cardiologicos invasivos. Metodologia Se estudio una cohorte de pacientes del programa y se comparo la mortalidad y la realizacion de nuevos procedimientos a los 28 meses con una cohorte historica de control. Resultados Ingresaron al programa 900 pacientes; en 487 se analizo el alcance de los objetivos terapeuticos a los 6 y 12 meses. Al ano se alcanzo el objetivo en el 40,5% para presion arterial ( Conclusiones La implementacion del programa mejoro el control de los factores de riesgo, optimizo el uso de farmacos cardioprotectores y probablemente contribuyo a una disminucion de la mortalidad.