Real-world impact of empagliflozin on total cost of care in adults with type 2 diabetes: Results from an outcomes-based agreement.

BACKGROUND: Value-based health care is expanding through payment models such as outcomes-based agreements between manufacturers and payers. OBJECTIVE: To describe the total-cost-of-care outcomes of an outcomes-based agreement evaluating the real-world impact of empagliflozin vs other type 2 diabetes mellitus (T2DM) drugs among all patients with T2DM, with and without cardiovascular disease (within and beyond the requirement of the agreement). METHODS: In this prospective real-world analysis, members from the health plan of an integrated health care delivery system from the commercial and Medicare Advantage lines of business, who qualify under the confines of the contract, were included for analysis. Thus, members aged 18 years and older who were continuously enrolled in the identification (January 1, 2018, to December 31, 2018) and measurement periods (≤1 year post-index) with a T2DM diagnosis were retained. Patients using empagliflozin and empagliflozin-combination drugs constituted the empagliflozin group; those using all other antihyperglycemics, the nonempagliflozin group. Patients with type 1 diabetes, or those using metformin or insulin monotherapy, at index were excluded. Eligible members were followed for up to the earliest occurrence of disenrollment date, discontinuation (60-day medication fill gap allowed) of empagliflozin (or nonempagliflozin containing) medication, or the end of the measurement period. We compared, using Student's t-test and summary statistics (for reporting the outcomes agreement) and a propensity-matched difference-in-difference model (for the followup evaluation beyond the requirement of the agreement), the mean all-cause total cost of care (pharmacy plus medical) per patient per month (PPPM) between the 2 groups, including a subgroup of members with a baseline cardiovascular disease diagnosis. RESULTS: There were 4,577 (3,069 and 1,508 in the commercial and Medicare) and 33,712 (15,571 and 18,141 in the commercial and Medicare) in the empagliflozin and nonempagliflozin groups, respectively. The difference in mean total cost PPPM was $75 lower for empagliflozin vs nonempagliflozin groups, driven mainly by lower medical costs in the empagliflozin group (-$465 PPPM). However, the difference was not statistically significant in the propensity score-matched model. CONCLUSIONS: Although empagliflozin had higher pharmacy costs, the total cost of care for patients with T2DM and with established cardiovascular disease were comparable to the group of patients with all other T2DM, driven mainly by lower medical costs. DISCLOSURES: The authors report no conflicts of interest beyond being employees of the 2 organizations involved in this outcomes-based agreement. Ms. Palli is a former employee of Boehringer Ingelheim Pharmaceuticals, Inc., who was affiliated at the time of study conduct.

Estimation of the cost-effectiveness of apixaban versus vitamin K antagonists in the management of atrial fibrillation in Argentina.

Apixaban, a novel oral anticoagulant which has been approved for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation, reduces both ischemic and haemorrhagic stroke and produces fewer bleedings than vitamin K antagonist warfarin. These clinical results lead to a decrease in health care resource utilization and, therefore, have a positive impact on health economics of atrial fibrillation. The cost-effectiveness of apixaban has been assessed in a variety of clinical settings and countries. However, data from emergent markets, as is the case of Argentina, are still scarce.We performed a cost-effectiveness analysis of apixaban versus warfarin in non-valvular atrial fibrillation (NVAF) in patients suitable for oral anticoagulation in Argentina. A Markov-based model including both costs and effects were used to simulate a cohort of patients with NVAF. Local epidemiological, resource utilization and cost data were used and all inputs were validated by a Delphi Panel of local experts. We adopted the payer's perspective with costs expressed in 2012 US Dollars.The study revealed that apixaban is cost-effective compared with warfarin using a willingness to pay threshold ranging from 1 to 3 per capita Gross Domestic Product (11558 - 34664 USD) with an incremental cost-effectiveness ratio of 786.08 USD per QALY gained. The benefit is primarily a result of the reduction in stroke and bleeding events.The study demonstrates that apixaban is a cost-effective alternative to warfarin in Argentina.

Estimated hospitalizations attributable to diabetes mellitus within the public healthcare system in Brazil from 2008 to 2010: study DIAPS 79.

OBJECTIVE: To estimate the number of hospitalizations attributable to diabetes mellitus (DM) and its complications within the public healthcare system in Brazil (SUS) and the mean cost paid per hospitalization. METHODS: The official database from the Hospital Information System of the Unified Health System (SIH/SUS) was consulted from 2008 to 2010. The proportion of hospitalizations attributable to DM was estimated using attributable risk methodology. The mean cost per hospitalization corresponds to direct medical costs in nursing and intensive care, from the perspective of the SUS. RESULTS: The proportion of hospitalizations attributable to DM accounted for 8.1% to 12.2% of total admissions in the period, varying according to use of maximum (self-reported with correction factor) or minimal (self-reported) DM prevalence. The hospitalization rate was 47 to 70.8 per 10.000 inhabitants per year. The mean cost per hospitalization varied from 1.302 Brazilian Reais (BRL) to 1,315 BRL. Assuming the maximum prevalence, hospitalizations were distributed as 10.3% as DM itself, 36.6% as chronic DM-associated complications and 53.1% as general medical conditions. Advancing age was accompanied by an increase in hospitalization rates and corresponding costs, and more pronounced in male patients. CONCLUSION: The results express the importance of DM in terms of the use of health care resources and demonstrate that studies of hospitalizations with DM as a primary diagnosis are not sufficient to assess the magnitude of the impact of this disease.

Estimated hospitalizations attributable to Diabetes Mellitus within the public healthcare system in Brazil from 2008 to 2010: study DIAPS 79 / Hospitalizações atribuíveis ao diabete melito no sistema de saúde público do Brasil (2008 a 2010): estudo DIAPS 79

Objective: to estimate the number of hospitalizations attributable to diabetes mellitus (DM) and its complications within the public healthcare system in Brazil (SUS) and the mean cost paid per hospitalization. Methods: the official database from the Hospital Information System of the Unified Health System (SIH/SUS) was consulted from 2008 to 2010. The proportion of hospitalizations attributable to DM was estimated using attributable risk methodology. The mean cost per hospitalization corresponds to direct medical costs in nursing and intensive care, from the perspective of the SUS. Results: the proportion of hospitalizations attributable to DM accounted for 8.1% to 12.2% of total admissions in the period, varying according to use of maximum (self-reported with correction factor) or minimal (self-reported) DM prevalence. The hospitalization rate was 47 to 70.8 per 10.000 inhabitants per year. The mean cost per hospitalization varied from 1.302 Brazilian Reais (BRL) to 1,315 BRL. Assuming the maximum prevalence, hospitalizations were distributed as 10.3% as DM itself, 36.6% as chronic DM-associated complications and 53.1% as general medical conditions. Advancing age was accompanied by an increase in hospitalization rates and corresponding costs, and more pronounced in male patients. Conclusion: the results express the importance of DM in terms of the use of health care resources and demonstrate that studies of hospitalizations with DM as a primary diagnosis are not sufficient to assess the magnitude of the impact of this disease. .

Objetivo: estimar o número de hospitalizações atribuíveis ao diabete melito (DM) e suas complicações no Sistema Único de Saúde (SUS) brasileiro e avaliar o valor médio pago por hospitalização. Métodos: foram consultados bancos de dados do Sistema de Informações Hospitalares do Sistema Único de Saúde (SIH/SUS), no período de 2008 a 2010. As proporções de hospitalizações atribuíveis ao DM foram estimadas por meio da metodologia do risco atribuível. O custo médio por hospitalização correspondeu aos custos diretos médicos em enfermaria e tratamento intensivo, sob a perspectiva do SUS. Resultados: hospitalizações atribuíveis ao DM corresponderam a 8,1 a 12,2% do total de internações no período, variando de acordo com a utilização de prevalência máxima (autorreferida com fator de correção) ou mínima (autorreferida) para DM. A taxa de hospitalização foi de 47 a 70,8 por 10 mil habitantes por ano. O custo médio por hospitalização variou de R$ 1.302 a R$ 1.315. Assumindo-se a prevalência máxima, as hospitalizações se (*) Fractions attributable to chronic complications and general medical conditions calculated based on the self-reported prevalence from the VIGITEL survey (**) Fractions attributable to chronic complications and general medical conditions calculated based on the self-reported data expended to include the undiagnosed distribuíram em 10,3% como DM propriamente dito, 36,6% associadas às complicações crônicas do DM e 53,1% atribuídas a condições médicas gerais. O avanço da idade foi acompanhado pelo aumento nas taxas de hospitalizações e nos custos médios correspondentes, sendo mais acentuado nos pacientes do gênero ...

The epidemiologic burden of hepatitis C virus infection in Latin America .

Chronic infection with hepatitis C virus (HCV) is a major and growing public health concern worldwide, including in Latin America. With more efficacious therapies becoming available, decision-makers will require accurate estimates of disease prevalence to assess the potential impact of new treatments. However, few estimates of the epidemiologic burden, either overall or by country, are available for Latin America; and the potential impact of currently-available treatments on the epidemiologic burden of HCV in Latin America has not been assessed. To address this, we systematically reviewed twenty-five articles presenting population-based estimates of HCV prevalence from general population or blood donor samples, and supplemen- ted those with publically-available data, to estimate the total number of persons infected with HCV in Latin America at 7.8 million (2010). Of these, over 4.6 million would be expected to have genotype 1 chronic HCV, based on published data on the risk of progression to chronic disease and the HCV genotype distribution of Latin America. Finally, we calculated that between 1.6 and 2.3 million persons with genotype 1 chronic HCV would potentially benefit from current treatments, based on published estimates of genotype-specific treatment responsiveness. In conclusion, these estimates demonstrate the substantial present epidemiologic burden of HCV, and quantify the impending societal and clinical burden from untreated HCV in Latin America.

Cost-effectiveness and budget impact of saxagliptine as additional therapy to metformin for the treatment of diabetes mellitus type 2 in the Brazilian private health system.

OBJECTIVES: To compare costs and clinical benefits of three additional therapies to metformin (MF) for patients with diabetes mellitus type 2 (DM2). METHODS: A discrete event simulation model was built to estimate the cost-utility ratio (cost per quality-adjusted life years [QALY]) of saxagliptine as an additional therapy to MF when compared to rosiglitazone or pioglitazone. A budget impact model (BIM) was built to simulate the economic impact of saxagliptine use in the context of the Brazilian private health system. RESULTS: The acquiring medication costs for the hypothetical patient group analyzed in a time frame of three years, were R$ 10,850,185, R$ 14,836,265 and R$ 14,679,099 for saxagliptine, pioglitazone and rosiglitazone, respectively. Saxagliptine showed lower costs and greater effectiveness in both comparisons, with projected savings for the first three years of R$ 3,874 and R$ 3,996, respectively. The BIM estimated cumulative savings of R$ 417,958 with the repayment of saxagliptine in three years from the perspective of a health plan with 1,000,000 covered individuals. CONCLUSION: From the perspective of private paying source, the projection is that adding saxagliptine with MF save costs when compared with the addition of rosiglitazone or pioglitazone in patients with DM2 that have not reached the HbA1c goal with metformin monotherapy. The BIM of including saxagliptine in the reimbursement lists of health plans indicated significant savings on the three-year horizon.

Custo-efetividade e impacto orçamentário da saxagliptina como terapia adicional à metformina para o tratamento do diabetes mellitus tipo 2 no sistema de saúde suplementar do Brasil / Cost-effectiveness and budget impact of saxagliptine as additional therapy to metformin for the treatment of diabetes mellitus type 2 in the brazilian private health system

OBJETIVOS: Comparar custos e benefícios clínicos de três terapias adicionais à metformina (MF) para pacientes com diabetes mellitus tipo 2 (DMT2). MÉTODOS: Um modelo de simulação de eventos discretos foi construído para estimar a relação custo-utilidade (custo por QALY) da saxagliptina como uma terapia adicional à MF comparada à rosiglitazona ou pioglitazona. Um modelo de impacto orçamentário (BIM - Budget Impact Model) foi construído para simular o impacto econômico da adoção de saxagliptina no contexto do Sistema Suplementar de Saúde brasileiro. RESULTADOS: O custo de aquisição da medicação para o grupo de pacientes hipotéticos analisados, para o horizonte temporal de três anos, foi de R$ 10.850.185,00, R$ 14.836.265,00 e R$ 14.679.099,00 para saxagliptina, pioglitazona e rosiglitazona, respectivamente. Saxagliptina exibiu menores custos e maior efetividade em ambas as comparações, com economias projetadas para os três primeiros anos de -R$ 3.874,00 e -R$ 3.996,00, respectivamente. O BIM estimou uma economia cumulativa de R$ 417.958,00 com o reembolso da saxagliptina em três anos a partir da perspectiva de uma operadora de plano de saúde com 1 milhão de vidas cobertas. CONCLUSÃO: Da perspectiva da fonte pagadora privada, a projeção é de que o acréscimo de saxagliptina à MF poupe custos quando comparado ao acréscimo de rosiglitazona ou pioglitazona em pacientes com DMT2 que não atingiram a meta de hemoglobina glicada (HbA1c) com metformina em monoterapia. O BIM, para a inclusão de saxagliptina nas listas de reembolso das operadoras de planos de saúde, indicou uma economia significativa para o horizonte de 3 anos.

OBJECTIVES: To compare costs and clinical benefits of three additional therapies to metformin (MF) for patients with diabetes mellitus type 2 (DM2). METHODS: A discrete event simulation model was built to estimate the cost-utility ratio (cost per quality-adjusted life years [QALY]) of saxagliptine as an additional therapy to MF when compared to rosiglitazone or pioglitazone. A budget impact model (BIM) was built to simulate the economic impact of saxagliptine use in the context of the Brazilian private health system. RESULTS: The acquiring medication costs for the hypothetical patient group analyzed in a time frame of three years, were R$ 10,850,185, R$ 14,836,265 and R$ 14,679,099 for saxagliptine, pioglitazone and rosiglitazone, respectively. Saxagliptine showed lower costs and greater effectiveness in both comparisons, with projected savings for the first three years of R$ 3,874 and R$ 3,996, respectively. The BIM estimated cumulative savings of R$ 417,958 with the repayment of saxagliptine in three years from the perspective of a health plan with 1,000,000 covered individuals. CONCLUSION: From the perspective of private paying source, the projection is that adding saxagliptine with MF save costs when compared with the addition of rosiglitazone or pioglitazone in patients with DM2 that have not reached the HbA1c goal with metformin monotherapy. The BIM of including saxagliptine in the reimbursement lists of health plans indicated significant savings on the three-year horizon.

Status Update of the Reimbursement Review Environment in the Public Sector across Four Latin American Countries.

In Latin America, social security and public sectors represent the largest financiers and providers of health care. Many countries in the region have compulsory packages of basic health care benefits. As part of an effort to improve quality of care and access, several health technology assessment agencies, both governmental and academia, among a number of Latin American countries have been formally established in the past few years. Several Latin American countries have recently developed and published methodological guidelines in economic evaluation, indicating that there is a growing interest in evaluating health-related products, drugs, and technologies used by the population. Presentations on the health care system and the role of health technology assessment, pharmacoeconomics, and risk sharing policies, from the public sector perspective, in the Latin American countries Argentina, Brazil, Colombia, and Mexico were made at the 3rd Latin American ISPOR Conference held in Mexico City in 2011 and are discussed in this article. In conclusion, there is a clear need for Latin American countries to evaluate the value of new technologies that are being incorporated into their health care system. In addition, health technology assessment guidelines are important for their local needs in terms of regulation along with common country unions. In the future, the Latin American region needs to increase drug access along with implementing cost-containment measures to improve quality and health outcomes.

[Treatment patterns in advanced breast cancer with anthracycline and taxanes and their costs in three public hospitals of Mexico]. / Patrones de tratamiento y costo de atención del cáncer de mama avanzado con falla a antraciclinas y taxanos en 3 hospitales públicos de México.

OBJECTIVES: In Mexico, breast cancer is the second leading cause of cancer mortality among females. For patients with advanced breast cancer (ABC) resistant to anthracyclines and taxanes (AT), there are limited treatment options. There is a scarcity of data regarding clinical management of this population and treatment costs at this stage of the disease. The objective of this study was to describe the treatment patterns of care for metastatic breast cancer after AT and the associated cost from the point-of-view of the Mexican Public Health Care Sector. METHODS: Between January 1, 2004 and December 31, 2007, a retrospective cohort of adult female ABC patients resistant to AT was developed by reviewing and extracting key data from medical charts. We conducted a retrospective, transversal and descriptive analysis of the patient data. Target population data files were obtained from 414 patients from 3 public hospitals in México. RESULTS: Capecitabine, vinorelbine and cyclophosphamide were the most commonly prescribed agents, however clinical drug therapy management of the disease was different within and among the three hospitals included in the study. This difference translated into a disparity of prescription costs, ranging from an average of $122.22 pesos/patient/month (cyclophosphamide, IC 95% $94.43-$150.01) to $37,835.53 pesos/patient/month (capecitabine+trastuzumab IC 95% $34,953.18-$40,717.88) for the first treatment after AT. CONCLUSIONS: The results highlight a lack of standardized care for patients and suggest that differences in treatment patterns are not only a reflection of scarcity of scientific data and diversity of prescription preferences among physicians but also of economic restrictions. Ultimately, there is a clear unmet medical need to be addressed through evidence-based medicine alternatives that support efficacy and cost effectiveness treatments.