Budget impact analysis of the freestyle libre flash continuous glucose monitoring system® in patients with diabetes mellitus type 1 in Chile.

OBJECTIVE: To estimate the budget impact of covering the FreeStyle Libre Flash Continuous Glucose Monitoring System (FSL) for type 1 Diabetes Mellitus patients (T1DM), compared to self-monitoring of blood glucose (SMBG), from the perspective of public and private third-party payers in Chile. METHODS: A budget impact model was developed to estimate the cost difference between SMBG and FSL over five years. Two FSL coverage schemes were assessed. Input parameters were retrieved from the literature review and complemented by expert opinion. Healthcare costs were estimated by a micro-costing approach and reported in USD. RESULTS: For a public sector third-party payer, incorporating FSL implied a cost increase up to USD 0.013 per member per month (PMPM) for the fifth year under the broad coverage scheme and a net saving of 0.0001 PMPM (all years) under the restricted coverage scheme. From a private sector third-party payer, incorporating FSL implied savings up to USD 0.028 PMPM (fifth year) for the broad coverage scheme and up to USD 0.012 PMPM (fifth year) for the restricted scheme. CONCLUSION: Incorporating the FSL for T1DM patients was associated with a marginal incremental cost for the public sector third-party payer and cost savings in Chile's private healthcare sector.

Economic Impact Analysis of Incorporation of Elecsys sFlt-1/PlGF Ratio Into Routine Practice for the Diagnosis and Follow-Up of Pregnant Women With Suspected Preeclampsia in Argentina.

OBJECTIVES: Preeclampsia (PE) is a hypertensive disorder of pregnancy that can cause severe complications and adverse fetal/maternal outcomes. We aimed to estimate the annual economic impact of incorporating Elecsys® sFlt-1/PlGF PE ratio, which measures soluble fms-like tyrosine kinase-1 and placental growth factor, into routine clinical practice in Argentina to aid diagnosis of PE and hemolysis, elevated liver enzymes, and low platelets syndrome from second trimester onward in pregnancies with clinical suspicion of PE. METHODS: A decision tree was used to estimate annual economic impact on the Argentine health system as a whole, including relevant costs associated with diagnosis, follow-up, and treatment from initial presentation of clinically suspected PE to delivery. Annual costs of a standard-of-care scenario and a scenario including PE ratio (reference year 2021) were analyzed. RESULTS: The economic model estimated that using the sFlt-1/PlGF ratio would enable the overall health system to save ∼$6987 million Argentine pesos annually (95% confidence interval $12 045-$2952 million), a 39.1% reduction in costs versus standard of care, mainly due to reduced hospitalizations of women with suspected PE. The economic impact calculation estimated net annual savings of approximately $80 504 Argentine pesos per patient with suspected PE. Based on the assumed uncertainty of the parameters, the likelihood the intervention would be cost saving was 100% for the considered scenarios. CONCLUSION: Our analysis suggests that the implementation of the sFlt-1/PlGF ratio in women with suspected PE in Argentina will enable the health system to achieve significant savings, contributing to more efficient clinical management through the likely reduction of unnecessary hospitalizations, depending on assumptions. Results rest on the payers' ability to recover savings generated by the intervention.

An analysis of African Swine Fever consequences on rural economies and smallholder swine producers in Haiti.

African Swine Fever (ASF) causes high mortality and often results in strict culling policies for affected pigs and international market restrictions. It took more than 25 years for swine inventories in Haiti and the Dominican Republic to recover from an ASF outbreak that took place from 1978 to 1984. The 2021 outbreaks in the Dominican Republic and Haiti pose threats to animal health, livestock markets, and producer livelihoods. A partial equilibrium Haitian pig sector model (HPM-2021) was developed to assess the economic impacts of a 2021 Haitian ASF outbreak of a similar size to the 1980s outbreak. The dynamic model examines ASF impacts from 2021 to 2024, through 100 iterations of stochastic supply shocks, and three specific demand shocks. Recovery alternatives are assessed through 2030, and outbreaks and recovery outcomes are compared to a baseline reflecting 2019 trends. The analysis includes economic effects on national pork and maize in Haiti, the Dominican Republic, the rest of the Caribbean, and the rest of the world. Findings demonstrate higher vulnerabilities of the traditional sector to ASF-related disruptions. The inflated prices generated by pork production shortfalls are an opportunity to accelerate income growth for remaining traditional pig producers. When there is no consumer avoidance, the production losses caused by ASF generate high prices and contribute to a minimum of 49% increase in traditional sector revenue, and a minimum of 2.22% revenue growth in the commercial sector from the 2019 base year. Nevertheless, the potential for consumer avoidance of pork cause prices to decrease and offset those gains by as much as 90% in the traditional sector and 44% in the commercial sector. Smaller commercial sector impacts derive from different elasticities. ASF-induced high prices also lead to increased consumer expenditure losses by up to 200% over the outbreak period. Nevertheless, consumer expenditures tend to recover instantaneously with ASF eradication. Due to persisting demand shocks, producers will earn up to 0.3% lower than baseline levels income from 2027 to 2030. Few models evaluate the economic impacts of health response policies in less developed countries like Haiti. HPM-2021 results highlight ASF impacts on prices, which can benefit certain producers and disincentivize on-farm disease reporting. Slow recovery and consumer avoidance of pork are detrimental to long-term swine industry survival, producer livelihoods, and the overall rural economy.

Impacto orçamentário da incorporação do rituximabe para o tratamento de leucemia linfocítica crônica no SUS / Budget impact of the incorporation of rituximab for the treatment of chronic lymphocytic leukemia in Brazil

Objetivo: O presente estudo objetiva desenvolver um modelo de análise de impacto orçamentário (AIO) relacionada à incorporação do rituximabe no tratamento de primeira linha da leucemia linfocítica crônica (LLC) no Sistema Único de Saúde (SUS). Métodos: A elaboração da AIO foi realizada de acordo com as recomendações metodológicas das diretrizes brasileiras, considerando a perspectiva do SUS, horizonte temporal de cinco anos, população a ser tratada, diferentes cenários de market share do rituximabe e custos diretos envolvidos no tratamento atual e no tratamento proposto, e também foi executada uma análise de sensibilidade para avaliar possíveis incertezas futuras. Resultados: A cada ano e ao final do horizonte temporal de cinco anos, a incorporação do rituximabe promoverá aumento dos custos, quando comparado com o valor de ressarcimento do SUS para o tratamento de primeira linha da LLC. No cenário de maior participação de mercado do rituximabe, os custos totais foram menores em relação ao cenário de menor market share. Dado que a estimativa da AIO é para gastos futuros, incertezas relacionadas como a possível elevação do custo do medicamento foi o fator que promoveu o cenário de maiores gastos. Conclusões: A projeção de custos estimados pela AIO demonstrou menores gastos financeiros no cenário de maior difusão do medicamento, o que pode ter correlação com o atraso da progressão da doença ao utilizar o rituximabe, e consequentemente menos pacientes irão requerer segunda linha de tratamento, que tem custo mais elevado.

Objective: This study aims to develop a budget impact analysis (BIA) model related to the incorporation of rituximab in the first-line treatment of chronic lymphocytic leukemia (CLL) in the Unified Health System (SUS). Methods: The preparation of the BIA was carried out in accordance with the methodological recommendations of the Brazilian guidelines, considering the perspective of the SUS, a time horizon of five years, population to be treated, different market share scenarios for rituximab and direct costs involved in the current treatment and treatment proposed, a sensitivity analysis was also performed to assess possible future uncertainties. Results: Each year and at the end of the five-year time horizon, the incorporation of rituximab will increase costs, when compared to the SUS reimbursement value for the first-line treatment of CLL. In the scenario of higher market share for rituximab, total costs were lower compared to the scenario of lower market share. Given that the BIA estimate is for future expenses, uncertainties related to the possible increase in the cost of the drug were the factor that promoted the scenario of higher expenses. Conclusions: The projection of costs estimated by the BIA showed lower financial expenses in the scenario of greater diffusion of the drug, which may be correlated with the delay in the progression of the disease when using rituximab and, consequently, fewer patients will require second-line treatment, which has a higher cost.

Qual a qualidade da análise de impacto regulatório elaborada por agências reguladoras do Brasil? / ¿Cuál es la calidad del análisis de impacto regulatorio elaborado por las agencias reguladoras brasileñas? / What is the quality of the regulatory impact analysis prepared by Brazilian regulatory agencies?

Resumo A análise de impacto regulatório (AIR) é uma ferramenta que busca identificar os impactos relevantes que uma política regulatória pode ter, com vistas a subsidiar a tomada de decisão. O seu uso tornou-se obrigatório no Brasil, mas não há estudos que tenham investigado se a qualidade da análise tem alcançado o nível desejado no país. Assim, o objetivo da presente pesquisa foi avaliar a qualidade das AIRs realizadas por agências reguladoras federais brasileiras. Para a condução deste trabalho, foi desenvolvido e aplicado um instrumento com 50 critérios para a verificação da qualidade de um conjunto de 21 AIRs. Os resultados indicaram boa qualidade das AIRs em alguns aspectos, como na definição de problemas e objetivos, mas apontaram fragilidades em outros, como na análise de impactos e na comparação de alternativas. Como agenda para pesquisas futuras, foi proposta investigação de hipóteses e fatores que podem explicar a ausência de um padrão de qualidade da AIR no país.

Resumen El análisis de impacto regulatorio (AIR) es una herramienta que busca identificar los impactos relevantes que puede tener una política regulatoria, con miras a apoyar la toma de decisiones. Su uso se ha vuelto obligatorio en Brasil, pero no hay estudios que hayan investigado si la calidad del análisis ha alcanzado el nivel deseado en el país. Así, el objetivo de la presente investigación fue evaluar la calidad de los AIR realizados por las agencias reguladoras federales brasileñas. Para realizar la investigación se elaboró y aplicó un instrumento con 50 criterios de evaluación de la calidad en un conjunto de 21 AIR. Los resultados indicaron buena calidad de los AIR en algunos aspectos, como en la definición de problemas y objetivos, pero señalaron debilidades en otros, como en el análisis de impactos y en la comparación de alternativas. Como agenda de estudios futuros, se propusieron investigaciones de hipótesis y factores que puedan explicar la ausencia de un estándar de calidad del AIR en el país.

Abstract The regulatory impact analysis - RIA is a tool that seeks to identify the regulatory policy's relevant impacts to support decision-making. Its use has become mandatory in Brazil, but no studies have investigated whether the quality of the analysis has reached the desired level in the country. Thus, the objective of this research was to evaluate the quality of RIAs carried out by Brazilian federal regulatory agencies. An instrument was developed and applied with 50 criteria for quality assessment in a set of 21 RIAs. The results indicated the good quality of the RIAs in some aspects, such as the definition of problems and objectives, but they pointed out weaknesses in others, such as the analysis of impacts and the comparison of alternatives. As an agenda for future studies, investigations of hypotheses and factors that may explain the absence of a quality standard for RIA in the country were proposed.

Economic assessment of incorporating the hexavalent vaccine as part of the National Immunization Program of Peru.

BACKGROUND: This study aimed to estimate the economic impact of replacing the current Peruvian primary immunization scheme for infants under 1 year old with an alternative scheme with similar efficacy, based on a hexavalent vaccine. METHODS: A cost-minimization analysis compared the costs associated with vaccine administration, adverse reactions medical treatment, logistical activities, and indirect social costs associated with time spent by parents in both schemes. A budgetary impact analysis assessed the financial impact of the alternative scheme on healthcare budget. RESULTS: Incorporating the hexavalent vaccine would result in a 15.5% net increase in healthcare budget expenditure ($48,281,706 vs $55,744,653). Vaccination costs would increase by 54.1%, whereas logistical and adverse reaction costs would be reduced by 59.8% and 33.1%, respectively. When including indirect social costs in the analysis, the budgetary impact was reduced to 8.7%. Furthermore, the alternative scheme would enable the liberation of 17.5% of national vaccines storage capacity. CONCLUSIONS: Despite of the significant reduction of logistical and adverse reaction costs, including the hexavalent vaccine into the National Immunization Program of Peru in place of the current vaccination scheme for infants under 1 year of age would increase the public financial budget of the government as it would represent larger vaccine acquisition costs. Incorporating the indirect costs would reduce the budgetary impact demonstrating the social value of the alternative scheme. This merits consideration by government bodies, and future studies investigating such benefits would be informative.

The environmental cost of broiler production and carbon sequestration potential of eucalyptus plantations around farms in Mato Grosso do Sul, Brazil.

The present study aimed to evaluate the environmental cost of the production process of broilers from the approach of emergy accounting and carbon sequestration potential for broiler farms. The study assessed a standard farm of the conventional system containing ten houses in 19 ha. We evaluated the following indices solar transformity (Tr), renewability (%R), emergy yield ratio (EYR), emergy investment ratio (EIR), environmental loading ratio (ELR), emergy sustainability index (ESI), and emergy exchange ratio (EER) and carbon sequestration potential of eucalyptus plantation. The total emergy input was 2.79E-06 seJ ha-1 y-1 for the broiler growth process. The highest investment in the production process was related to materials, which came from feeding and electricity. The renewability index indicated the low sustainability of the system with increased consumption of economical materials and equipment, with a low proportion of the emergy use of renewable resources. High investment in broilers production in the conventional system generates an environmental loading ratio that indicates high environmental degradation. Planting trees in the surrounding areas of the farm facilities can minimize the externalities of the production system with the plantation carbon sequestration potential.

The impact of tobacco tax reforms on poverty in Mexico.

This paper investigates the impact of increasing the tobacco taxes on the poverty rate in Mexico. Unlike most LMIC countries, the prevalence of smoking in Mexico is higher among the well-off than among the poor. Yet, tobacco tax rates in Mexico are lower than those in most LMIC countries. There is room, thus, to implement tax reforms and compensating policies to mitigate their impact on the poor. Our analysis is based on the stochastic dominance approach. More precisely, several tax reforms are analyzed through the so-called Consumption Dominance curves. In addition, the reforms are assumed to be revenue neutral and to give rise to compensating subsidies on specific goods. Our results show that if the Mexican government were to implement a WHO-type reform, poverty among households with at least one smoking member would increase by 2.6 % points. Yet, the deleterious effects are entirely mitigated by price subsidies on staple foods. SUPPLEMENTARY INFORMATION: The online version of this article (10.1007/s43546-021-00141-x) contains supplementary material, which is available to authorized users.

Cost-Effectiveness and Budget Impact Analysis of Primary Screening With Human Papillomavirus Test With Genotyping in Argentina.

OBJECTIVES: Cervical cancer (ICC) is the fourth leading cause of mortality in women in Argentina and primary screening with conventional cytology (Papanicolaou smear) is the most widely used strategy despite its limitations. Strategies based on human papillomavirus (HPV) testing have the potential to improve detection and reduce mortality. The objective of this study is to evaluate the cost-effectiveness and budgetary impact of a strategy based on HPV testing with genotyping. METHODS: We used a decision model to compare the ICC screening strategies. The population consisted of 30- to 65-year-old females suitable for screening in Argentina. Inputs comprised epidemiologic, diagnostic performance, and costs data. The clinical impact was represented by the number of ICC detected and ICC-related mortality. Incremental cost-effectiveness ratio, estimated in terms of Argentinean pesos per life-year gained, and the budgetary impact were calculated at 5, 10, and 20 years. Univariate and probabilistic sensitivity analyses were performed. RESULTS: Primary screening with HPV testing would prevent 1853 ICC deaths and reduce mortality by 13% at year 10 compared with Papanicolaou smear. With an incremental cost-effectiveness ratio of AR$329 042 in the base case, it would be cost-effective for a cost-effectiveness threshold of 1 gross domestic product per capita. It would imply an additional expense in the first 5 years and probably savings in the subsequent ones. Sensitivity analyses confirm the robustness of the findings. CONCLUSIONS: The primary screening strategy based on HPV testing with genotyping compared with conventional cytology is most likely a cost-effective strategy in Argentina.

A Framework to Assess the Citation Performance of Complex Innovation Systems.

Scientometric indicators are useful to evaluate the relevance of scientific research, to prepare rankings, and to evaluate and inform research policies. That is why the choice of appropriate indicators is a matter of primary concern. This article aims to introduce a framework to decide the appropriate type of indicator for assessing the citation-based performance of complex innovation systems. The framework is two-fold: First, it brings the methodology to decide when the use of standard average based indicators is granted, and when scale-invariant indicators are mandatory. Second, it provides the procedures to build scale-invariant indicators to assess the relative impact of complex innovation systems. The framework is validated empirically through the evaluation of the relative impact of the Chilean science system in 2017. The result suggests that the Chilean science system has characteristics of a complex innovation system such as the distribution of citations fits to a power law with an exponential cutoff - 2.77 ± 0.09 and a power-law correlation between the size of the system and its impact 1.29 ± 0.11 . Furthermore, the framework shows to be efficient to compare fields of vastly different sizes.

Budget impact analysis of surfactant therapy for bronchiolitis in critically ill infants: the Colombian National Health System perspective.

BACKGROUND: Severe bronchiolitis requiring mechanical ventilation was associated with an absence of surfactant activity and phosphatidylglycerol, causing airway obstruction in acute bronchiolitis. Exogen surfactant in mechanically ventilated infants decreased duration of stay in the intensive care unit and had favorable effects on oxygenation and carbon dioxide removal. This study aimed to evaluate the budget impact of surfactant therapy for bronchiolitis in critically ill infants in Colombia. METHODS: Budget impact analysis was performed to estimate the economic impact of surfactant therapy (ST) for the treatment of infants with a diagnosis of bronchiolitis, requiring mechanical ventilation. The analysis considered a 4-year time horizon and Colombian National Health System perspective. The model estimated drug costs associated with current scenario using humidified oxygen or adrenaline nebulization, and new scenario adding exogen surfactant. The size of the target population was calculated using epidemiological national data. Univariate one-way sensitivity analyses and scenario analyses were performed. RESULTS: In the base-case analysis the 4-year costs associated to ST and no-ST were estimated to be US$ 55,188,132 and US$ 55,972,082 respectively, indicating savings for Colombian National Health equal to US$ 783,950 if ST is adopted for the routine management of patients with bronchiolitis requiring mechanical ventilation. In the one-way sensitivity analysis, only increases in the cost of the surfactant drug and cost or length of stay in the pediatric intensive unit reduce the potential savings of ST. CONCLUSION: ST was cost-saving in emergency settings for treating infants with severe bronchiolitis requiring mechanical ventilation. This shift in treatment approach proved to be economically favorable in the Colombian context.

Budget Impact Analysis of Anticoagulation Clinics in Patients with Atrial Fibrillation under Chronic Therapy with Oral Anticoagulants.

OBJECTIVES: To assess budget impact of the implementation of an anticoagulation clinic (AC) compared to usual care (UC), in patients with non-valvular atrial fibrillation (NVAF). METHOD: A decision tree was designed to analyze the cost and events rates over a 1-year horizon. The patients were distributed according to treatment, 30% Direct Oral Anticoagulant (DOAC) regimens and the rest to warfarin. The thromboembolism and bleeding were derived from observational studies which demonstrated that ACs had important impact in reducing the frequency of these events compared with UC, due to higher adherence with DOACs and proportion of time in therapeutic range (TTR) with warfarin. Costs were derived from the transactional platform of Colombian government, healthcare authority reimbursement and published studies. The values were expressed in American dollars (USD). The exchanged rate used was COP $3.693 per dollar. RESULTS: During 1 year of follow-up, in a cohort of 228 patients there were estimated 48 bleedings, 6 thromboembolisms in AC group versus 84 bleedings, and 12 thromboembolisms events in patients receiving UC. Total costs related to AC were $126 522 compared with $141 514 in UC. The AC had an important reduction in the cost of clinical events versus UC ($52 085 vs $110 749) despite a higher cost of care facilities ($74 436 vs $30 765). A sensibility analysis suggested that in the 83% of estimations, the AC produced savings varied between $27 078 and $135 391. CONCLUSIONS: This study demonstrated that AC compared with UC, produced an important savings in the oral anticoagulation therapy for patients with NVAF.

The budgetary impact of alemtuzumab in multiple sclerosis in Quito, Ecuador. Payer's perspective.

Introduction: Multiple sclerosis is a neurological condition that causes disabilities and is most common in young adults. It imposes high financial costs affecting the quality of life of patients, families, and society. It is critical to measure the budgetary impact of new technologies to treat this disease. Objective: The aim of the article is to estimate the budgetary impact of introducing alemtuzumab as an escalation therapy in patients diagnosed with Recurrent Remitting Multiple Sclerosis and treated in Quito, Ecuador. Materials and methods: A cohort of 85 patients receiving treatment with disease-modifying therapies was used, within a 5-year timeframe, between 2021 and 2025. The baseline scenario, including the percentages of administration of the different drugs, is compared with the alternative scenario, including alemtuzumab. The cost assessment included only direct medical resources. To obtain local resources for management of the disease, a neurologist and clinical expert who treats most of the patients in Quito was consulted. Results: Considering a cohort of 85 patients with active Recurrent Remitting Multiple Sclerosis, the average global budget impact in 5 years would be USD 10,603,230.00 in the base case and USD 9,995,817.00 in the alemtuzumab scenario. Conclusion: The inclusion of alemtuzumab as escalation therapy represents budgetary savings over the next 5 years (2021-2025).

Budget impact analysis of pneumococcal conjugate vaccines in Colombia.

Objective: Pneumococcal diseases including invasive pneumococcal disease (IPD), pneumonia, and acute otitis media (AOM) impose a substantial public health burden. This study performed a budget impact analysis of the use of pneumococcal conjugate vaccines (PCVs) in the National Immunization Program (NIP) in Colombia.Methods: We compared the direct medical cost of the scenario without and with PCV vaccination using either pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) or 13-valent pneumococcal conjugate vaccine (PCV-13) over 5 years (2020-2024) from the health-care system perspective. Vaccine efficacy estimates were obtained from published sources and vaccine prices were taken from the Pan-American Health Organization Revolving Fund. Vaccine coverage was assumed to be 90% based on Colombia data.Results: Using PHiD-CV in the NIP in Colombia would reduce the estimated cost for treating pneumococcal disease by US$46.1 m over the 2020-2024 period (US$40.2 m using PCV-13), with a budget impact of US$100.1 m for PHiD-CV (US$121.4 m for PCV-13), and would cost US$3.1 m less per year on vaccine doses than using PCV-13.Conclusion: These findings are potentially valuable for the selection of vaccines for their national immunization programs under conditions of budgetary constraint.

Cladribina oral para o tratamento da esclerose múltipla remitente-recorrente altamente ativa: análise de impacto orçamentário sob a perspectiva do sistema brasileiro de saúde suplementar / Cladribine tablets for the treatment of highly active recurrent multiple sclerosis: budget impact analysis from the perspective of the Brazilian supplementary health system

Objetivo: Avaliar o impacto orçamentário da inclusão da cladribina oral no tratamento de esclerose múltipla remitente-recorrente em alta atividade da doença (EMRR HDA) no Sistema de Saúde Suplementar (SSS). Métodos: Foi conduzida uma análise de impacto orçamentário, sob a perspectiva do SSS, com horizonte temporal de quatro anos, considerando a abordagem de coorte aberta na qual o número de pacientes elegíveis para tratamento varia em cada ano com a introdução de novos pacientes diagnosticados de EMRR HDA e a retirada de indivíduos prevalentes devido a morte ou progressão secundária. Foram considerados custos médicos diretos, incluindo a aquisição e administração de medicamentos, monitoramento, eventos adversos e surtos. Os comparadores utilizados na análise foram: alentuzumabe, fingolimode, natalizumabe e ocrelizumabe. Os custos foram apresentados em real brasileiro (BRL). Resultados: O custo incremental da inclusão da cladribina oral para o SSS foi estimado em 463.265 BRL, 739.691 BRL, -1.414.963 BRL, -3.719.007 BRL, nos anos 1, 2, 3 e 4, respectivamente. Isso resultou em um custo incremental total de -3.931.015 BRL no período analisado, representando 1,5% da redução orçamentária total no tratamento de EMRR HDA. Conclusão: A inclusão da cladribina oral para o tratamento de pacientes com diagnóstico de EMRR HDA poderia gerar uma economia substancial para o sistema brasileiro de saúde suplementar, atingindo um valor de cerca de 3,9 milhões de BRL em um período de quatro anos

Objective: To evaluate the budget impact of adopting cladribine tablets as a treatment strategy for relapsing remitting multiple sclerosis with high disease activity (RRMS HDA), from the Brazilian private healthcare system perspective. Methods: A budget impact analysis, under private healthcare system perspective, with a 4-years time horizon was conducted, considering the open cohort approach in which the number of patients eligible for treatment varies each year with the introduction of newly diagnosed RRMS HDA patients and the drop out of prevalent individuals due to death or secondary progression. Direct medical costs, including acquisition, drug administration, monitoring, adverse events and relapses were considered. Comparators used in the analysis were: alentuzumab, fingolimod, natalizumab and ocrelizumab. Costs were presented in Brazilian real (BRL). Results: The incremental cost of incorporating cladribine tablets into the private healthcare system was estimated at 463,265BRL, 739,961BRL, -1,414,963 BRL, -3,716,007 BRL, in years 1, 2, 3 and 4, respectively. This resulted in a total incremental cost of -3,931,015 BRL over the period analyzed, representing 1.5% of the total budget reduction in the treatment of RRMS HDA. Conclusion: Incorporation of cladribine tablets for the management of RRMS HDA could generate substantial savings for the private healthcare system, reaching a value of approximately 3.9 million BRL in a 4-years period

Cost-Effectiveness Analysis and Budget Impact: Antimuscarinics and Mirabegron for the Treatment of Patients With Urge Urinary Incontinence: The Brazilian Public Health System Perspective.

OBJECTIVES: The Brazilian public health system does not cover pharmacotherapy for urge urinary incontinence (UUI). The aim of this study was to estimate the cost-effectiveness and budget impact of providing tolterodine, solifenacin, oxybutynin (OXY), darifenacin, and mirabegron for the treatment of UUI in Brazilian public health system. METHODS: A cost-effectiveness analysis with budget impact was performed. Six scenarios were assessed: in one scenario, all 5 therapeutic alternatives approved for coverage, and in the remaining 5 scenarios, only 1 alternative is approved for adoption for all patients. Clinical data were derived from a rapid systematic review conducted in several databases. One-way sensitivity analysis was also performed. The time horizon was 12 months. RESULTS: The cost-effectiveness analysis showed that patients treated with OXY had the lowest incremental cost-effectiveness ratio (ICER) per outcomes assessed (change in urinary incontinence episodes (UIE): R$1180.08; change in urge incontinence episodes: R$757.85 and change in micturition frequency: R$907.75), corresponding to a budget impact of R$17.9 billion over 5 years. The change in effectiveness measures was the parameter that most influenced the results of the ICER per patient-year. CONCLUSION: The results of the study have shown that OXY and solifenacin had the lowest ICER per patient-year and the lowest budget impact when compared with other drugs.

Treatment With Liposomal Amphotericin B for All Confirmed Cases of Human Visceral Leishmaniasis in Brazil: A Budget Impact Analysis.

OBJECTIVES: To estimate the budget impact of the expansion of liposomal amphotericin B use for all confirmed cases of visceral leishmaniasis (VL) in Brazil. Currently, the first-line medicine for VL treatment is meglumine antimoniate. Liposomal amphotericin B is indicated only for patients with a greater risk of severity by the disease. METHODS: The analysis was performed from the perspective of the Brazilian public healthcare system over 3 years, considering the following 2 scenarios: the reference scenario with the current recommendations for VL treatment and the alternative scenario based on the use of liposomal amphotericin B for all patients. A diffusion rate of 60% was used in the first year, 80% in the second year, and 100% in the third year. The epidemiological parameters used in the analysis came from the Notifiable Diseases Information System and from a clinical trial that evaluated the efficacy and safety of medicines for the treatment of VL in the country. The costs were related to the treatment of VL and to hospital and outpatient care. RESULTS: In the reference scenario, the total cost for treatment of the 3453 VL confirmed cases in 2014 was $1 447 611.75. The incremental budget impact with the use of liposomal amphotericin B for all the VL confirmed cases was $299 646.43 in the third year. CONCLUSIONS: The analysis presented will support the decision process for the use and expansion of liposomal amphotericin B for all VL confirmed cases in Brazil.

Nimotuzumab (CIMAher®) en pacientes cubanos con cáncer de cabeza y cuello estadios III/IV: Análisis de impacto presupuestario / Nimotuzumab (CIMAher®) in Cuban patients with head and neck cancer stage III/IV: Budget impact analysis

En Cuba, el cáncer es la segunda causa de muerte con 24.902 defunciones en el 2018; de ellas, 795 fueron por tumores de laringe y 826 por tumores de labio, cavidad bucal y faringe. El anticuerpo monoclonal nimotuzumab (CIMAher®) está registrado como tratamiento combinado con radioterapia o quimioterapia para el cáncer de células escamosas de cabeza y cuello estadios avanzados. Del mismo se conoce su efectividad y perfil de seguridad, no así el impacto económico que acarrearía la incorporación del mismo al Sistema Nacional de Salud (SNS) cubano; de forma tal de asignar y reajustar presupuestos en la esfera de medicamentos. Por tanto, se hizo necesario realizar un análisis de impacto presupuestario, con el objetivo de estimar el impacto financiero de la incorporación del nimotuzumab (CIMAher®) al paquete de beneficios del SNS cubano. Se tomaron los datos de prevalencia e incidencia de la enfermedad en los estadios III/IV. Se estableció un escenario actual con la terapia radio/quimioterapia secuencial y una tasa de penetración de 100%. El escenario futuro fue radio/quimioterapia secuencial + nimotuzumab (CIMAher®) con tasa anual de penetración 20, 40, 60, 80 y 100 por ciento. La perspectiva fue desde el SNS y un horizonte temporal de 5 años (2019-2023). El análisis de impacto presupuestal mostró que, desde perspectiva, horizonte y tasa de penetración establecidos, el SNS debe invertir aproximadamente de 10 a 65 millones de pesos cubanos (CUP); cifras menores al presupuesto destinado a salud pública(AU)

In Cuba, cancer is the second cause of death with 24,902 deaths in 2018; 795 were due to laryngeal tumors and 826 due to tumors of the lip, oral cavity and pharynx. The monoclonal antibody nimotuzumab (CIMAher®) is registered as a combined treatment with radiotherapy or chemotherapy for advanced squamous cell carcinoma of the head and neck. Its effectiveness and safety profile are known, but not their economic impact into the Cuban National Health System (NHS); in order to allocate and readjust budgets in the field of medicines. Therefore, it was necessary to perform a budget impact analysis in order to estimate the financial impact of the incorporation of nimotuzumab (CIMAher®) into the benefits package of the Cuban NHS. Data on prevalence and incidence of the disease in stages III / IV were taken into account. The current scenario was with the therapy radio/sequential chemotherapy and penetration rate of 100 percent. The future scenario was radio/sequential chemotherapy + nimotuzumab (CIMAher®) and annual penetration rate of 20, 40, 60, 80 and 100 percent. The perspective was from the NHS and a time horizon of five years (2019-2023). The budget impact analysis showed that from an established perspective, horizon and penetration rate, the NHS must invest 10-65 million Cuban pesos (CUP) approximately; lower values than the budget allocated to Public Health(AU)