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Objective: To investigate the impact of Medicaid expansion on state expenditures through the end of 2022., Data Sources: We used data from the National Association of State Budget Officers (NASBO)'s State Expenditure Report, Kaiser Family Foundation (KFF)'s Medicaid expansion tracker, US Bureau of Labor Statistics data (BLS), US Bureau of Economic Analysis data (BEA), and Pandemic Response Accountability Committee Oversight (PRAC)., Study Design: We investigated spending per capita (by state population) across seven budget categories, including Medicaid spending, and four spending sources. We performed a difference-in-differences (DiD) analysis that compared within-state changes in spending over time in expansion and nonexpansion states to estimate the effect of Medicaid expansion on state budgets. We adjusted for annual state unemployment rate, annual state per capita personal income, and state spending of Coronavirus Relief Funds (CRF) from 2020 to 2022 and included state and year fixed effects., Data Collection/extraction Methods: We linked annual state-level data on state-reported fiscal year expenditures from NASBO with state-level characteristics from BLS and BEA data and with CRF state spending from PRAC., Principal Findings: Medicaid expansion was associated with an average increase of 21% (95% confidence interval [CI]: 16%-25%) in per capita Medicaid spending after Medicaid expansion among states that expanded prior to 2020. After inclusion of an interaction term to separate between the coronavirus disease (COVID) era (2020-2022) and the prior period following expansion (2015-2019), we found that although Medicaid expansion led to an average increase of 33% (95% CI: 21%-45%) in federal funding of state expenditures in the post-COVID years, it was not significantly associated with increased state spending., Conclusions: There was no evidence of crowding out of other state expenditure categories or a substantial impact on total state spending, even in the COVID-19 era. Increased federal expenditures may have shielded states from substantial budgetary impacts., (© 2024 Health Research and Educational Trust.)

Aim: In 2022, in Italy, general practitioners (GPs) have been allowed to prescribe SGLT2i in Type 2 Diabetes (T2D) under National Health Service (NHS) reimbursement. In the pivotal clinical trial named DECLARE-TIMI 58, dapagliflozin reduced the risk of hospitalization for heart failure, CV death and kidney disease progression compared to placebo in a population of T2D patients. This study evaluated the health and economic impact of dapagliflozin for T2D patients who had or were at risk for atherosclerotic cardiovascular disease in the Italian GPs setting., Methods: A budget impact model was developed to assess the health and economic impact of introducing dapagliflozin in GPs setting. The analysis was conducted by adopting the Italian NHS perspective and a 3-year time horizon. The model estimated and compared the health outcomes and direct medical costs associated with a scenario with dapagliflozin and other antidiabetic therapies available for GPs prescription (scenario B) and a scenario where only other antidiabetic therapies are available (scenario A). Rates of occurrence of cardiovascular and renal complications as well as adverse events were captured from DECLARE-TIMI 58 trial and the literature, while cost data were retrieved from the Italian tariff and the literature. One-way sensitivity analyses were conducted to test the impact of model parameters on the budget impact., Results: The model estimated around 442.000 patients eligible for the treatment with dapagliflozin in the GPs setting for each simulated year. The scenario B compared to scenario A was associated with a reduction in the occurrence of cardiovascular and renal complication (-1.83%) over the 3 years simulated. Furthermore, the scenario A allowed for an overall cost saving of 102,692,305€: 14,521,464€ in the first year, 33,007,064€ in the second and 55,163,777€ in the third. The cost of cost of drug acquisition, the probability of cardiovascular events and the percentage of patients potentially eligible to the treatment were the factor with largest impact on the results., Conclusions: The use of dapagliflozin in GPs setting reduce the number of CVD events, kidney disease progression and healthcare costs in Italy. These data should be considered to optimize the value produced for the T2D patients who had or were at risk for atherosclerotic cardiovascular disease., (© 2024. The Author(s).)

Objectives: In many countries, the healthcare sector is dealing with important challenges such as increased demand for healthcare services, capacity problems in hospitals and rising healthcare costs. Therefore, one of the aims of the Dutch government is to move care from in-hospital to out-of-hospital care settings. An example of an innovation where care is moved from a more specialised setting to a less specialised setting is the performance of an antenatal cardiotocography (aCTG) in primary midwife-led care. The aim of this study was to assess the budget impact of implementing aCTG for healthy pregnant women in midwife-led care compared with usual obstetrician-led care in the Netherlands., Methods: A budget impact analysis was conducted to estimate the actual costs and reimbursement of aCTG performed in midwife-led care and obstetrician-led care (ie, base-case analysis) from the Dutch healthcare perspective. Epidemiological and healthcare utilisation data describing both care pathways were obtained from a prospective cohort, survey and national databases. Different implementation rates of aCTG in midwife-led care were explored. A probabilistic sensitivity analysis was conducted to estimate the uncertainty surrounding the budget impact estimates., Results: Shifting aCTG from obstetrician-led care to midwife-led-care would increase actual costs with €311 763 (97.5% CI €188 574 to €426 072) and €1 247 052 (97.5% CI €754 296 to €1 704 290) for implementation rates of 25% and 100%, respectively, while it would decrease reimbursement with -€7 538 335 (97.5% CI -€10 302 306 to -€4 559 661) and -€30 153 342 (97.5% CI -€41 209 225 to -€18 238 645) for implementation rates of 25% and 100%, respectively. The sensitivity analysis results were consistent with those of the main analysis., Conclusions: From the Dutch healthcare perspective, we estimated that implementing aCTG in midwife-led care may increase the associated actual costs. At the same time, it might lower the healthcare reimbursement., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Low-dose rivaroxaban reduced major adverse cardiac and limb events among patients with stable atherosclerotic vascular disease (ASCVD) in the COMPASS trial. The objective of our study was to evaluate the eligibility and budgetary impact of the COMPASS trial in a real-world population., Methods: The VA administrative and clinical databases were utilized to conduct a cross-sectional study to identify patients eligible for low-dose rivaroxaban receiving care at all 141 facilities between October 1, 2014 and September 30, 2015. Proportion of patients with stable ASCVD eligible for low-dose rivaroxaban and prevalence of multiple risk enrichment criteria among eligible patients. Pharmaceutical budgetary impact using VA pharmacy pricing. Chi-squared and Student's t tests were used to compare patients eligible versus ineligible patients., Results: From an initial cohort of 1,248,214 patients with ASCVD, 488,495 patients (39.1%) met trial eligibility criteria. Eligible patients were older (74.2 vs 64.5 years) with higher proportion of hypertension (84.1% vs 82.1%) and diabetes (46.2% vs 32.9) compared with ineligible patients (p < 0.001 for all comparisons). A median of 38.7% (IQR 4.6%) of total ASCVD patients per facility were rivaroxaban eligible. Estimated annual VA pharmacy budgetary impact would range from $0.47 billion to $1.88 billion for 25% to 100% treatment penetration. Annual facility level pharmaceutical budgetary impact would be a median of $12.3 million (IQR $8.0-$16.3 million) for treatment of all eligible patients. Among eligible patients, age greater than 65 years was the most common risk enrichment factor (86.9%). Prevalence of eligible patients with multiple enrichment factors varied from 34.2% (one factor) to 6.2% (four or more)., Conclusion: Over one third of patients with stable ASCVD may qualify for low-dose rivaroxaban within the VA. Additional studies are needed to understand eligibility in other populations and a formal cost-effectiveness analysis is warranted.

Maryland implemented the all-payer, rater-setting Global Budget Revenue (GBR) payment model in 2014 to reduce cost and improve quality. This study assessed the effect of GBR on total knee arthroplasty (TKA) outcomes by sex. Specifically, the authors assessed (1) demographics and (2) outcomes of males and females undergoing TKA before and after GBR implementation. The Maryland State Inpatient Database was queried from 2011 to 2016. There were 71,066 TKAs (male, n=25,413; female, n=45,634). For continuous and categorical variables, t testing and chi-square analyses were used, respectively. Difference-in-difference analyses using multiple regression compared changes in sex from the pre-GBR period (2011-2013) with the post-GBR period (2014-2016). The female proportion decreased (-1.9%; P =.040). Proportionally more TKA patients were Hispanic and Asian, from high-income areas, using Medicare and Medicaid, and morbidly obese (all P <.001). The mean length of stay (LOS), charges, and costs were decreased after GBR implementation (all P <.001). More patients were discharged routine and had fewer readmissions (both P <.001). There were fewer complications, including deep venous thromboses/pulmonary emboli, urinary tract infections, and blood transfusions (all P <.001). The difference-in-difference analyses suggested more females were discharged with home health care and had longer LOS than did males (both P <.001). The GBR appears to meet its main objective of cost reduction and improvements in quality of care. However, the proportion of females receiving TKA decreased, and their LOS did not improve as much as that of males. As other states consider global budgets, more research is needed to ensure this all-payer, rate-setting, capitated system does not cause decreased access to care. [ Orthopedics . 2021;44(2):e266-e273.].

Objectives: Various strategies to address healthcare spending and medical costs continue to be debated and implemented in the United States. To date, these efforts have failed to adequately contain the growth of healthcare cost. An alternative strategy that has elicited rising interest among policymakers is budget caps. As budget caps become more prevalent, it is important to identify which features are needed to ensure success, both in terms of cost reduction and health improvement., Methods: We explored the impacts of different features of budget caps by comparing hypothetical service level and global budget caps across 3 annual budget cap growth strategies over a 10-year timeframe in 2005-2015 for 8 of the most commonly occurring conditions in the United States. Health was assessed by a measure of disease burden (disability-adjusted life years)., Results: The results indicate that budget caps have the potential for creating savings but can also result in patient harm if not designed well. As a result of these findings, 5 principles were developed for designing budget caps and should guide the use of budget caps to address medical spending., Conclusions: As public discussion grows about the use of budget caps to constrain health spending, it is critical to recognize that the budget cap design and the resulting healthcare provider behavior will determine whether there is potential harm to public health. Budget cap design should consider variability at the condition level, including patient population, improvements in health, treatment costs, and the innovations available, to both create savings and maximize patient health. In assessing the impact of healthcare spending caps on costs and disease burden, we demonstrate that budget cap design determines potential harm to public health., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

BACKGROUND: Darolutamide, a structurally distinct androgen receptor inhibitor approved for the treatment of men with nonmetastatic castration-resistant prostate cancer (nmCRPC), has been shown to increase metastasis-free survival among men with nmCRPC compared with placebo. This treatment has a novel chemical structure that may also have safety, tolerability, and efficacy advantages for men with nmCRPC. OBJECTIVE: To estimate the projected budget impact of including darolutamide on a U.S. payer formulary as a treatment option for men with nmCRPC. METHODS: A budget impact model was developed to evaluate darolutamide for nmCRPC for a hypothetical 1-million-member plan over a 5-year period. Costs (drug acquisition, drug administration, and treatment-related adverse events [AEs]) were estimated for 2 scenarios: with and without darolutamide treatment for nmCRPC. The budget impact of darolutamide was calculated as the difference in costs for these 2 scenarios. An analysis for high-risk nmCRPC also was conducted. The model included treatments recommended by the National Comprehensive Cancer Network (e.g., apalutamide and enzalutamide) and potential comparators that are used but are not specifically indicated for nmCRPC. All treatments were assumed to be administered in combination with a weighted average androgen deprivation therapy comparator (consisting of luteinizing hormone-releasing hormone [LHRH] agonists, LHRH antagonists, and first-generation antiandrogens). Market share estimates were derived from interviews with physicians treating men with nmCRPC. The model includes grade 3-4 AEs, and the rates were obtained from clinical trial data. Costs were taken from publicly available sources and varied in a one-way sensitivity analysis. RESULTS: For a plan with 1 million lives, there were approximately 90 incident cases of nmCRPC (46 high risk) each year, with 332 (109 high risk) treatment-eligible cases by year 5. Darolutamide's market share increased from 3.6% in year 1 to 18% in year 5. Given the utilization of other agents, introducing darolutamide along with other targeted therapies was predicted to increase the total budget by $158,640 ($0.0132 per member per month [PMPM]) in year 1, which decreased over time to a cost savings of $149,240 ($0.0124 PMPM) by year 5. The scenario with darolutamide showed reduced AE costs each year. Similar results were observed for the high-risk nmCRPC population. CONCLUSIONS: Adding darolutamide to a U.S. payer formulary for the treatment of nmCRPC can result in a manageable increase in the budget that is partly offset by AE costs in the first 4 years, followed by a cost savings by year 5. DISCLOSURES: This study was conducted by RTI Health Solutions under the direction of Bayer U.S. and was funded by Bayer U.S., which was involved in the design of the study; collection, analysis, and interpretation of the data; writing of the report; and the decision to submit the report for publication. Miles and Purser (and/or their institutions) are employees of RTI Health Solutions and received research funding from Bayer U.S. to develop the budget impact model. Appukkuttan and Farej are employees of Bayer U.S. Wen was an employee of Bayer U.S. at the time of the study. This study was presented as a poster at the AMCP Virtual Learning Event, April 20-24, 2020.

Objectives: There are challenges in conducting a budget impact analysis (BIA) for rare disorders. Through this case study, we present some challenges and limitations of a BIA of managing patients affected with alpha-1 antitrypsin deficiency (AATD). We explored a conceptual basis and barriers for health services researchers interested in quantifying budget impacts of rare disease management program (DMP)., Methods: We developed a static budget impact cost calculator model in Microsoft Excel, obtaining the clinical impact of a DMP from the literature and translating it into costs using OLDW. Cost inputs and resource use was obtained from 2010 to 2015 claims data using the OLDW. Insurers' payments were calculated and categorized into the following cost buckets: physician visits, emergency room visits, inpatients stays, augmentation therapy, other prescription drugs costs, and other costs., Results: Data were based on 6832 patients with alpha-1 antitrypsin deficiency identified among over 21 million OLDW enrollees observed between January 1, 2010, and December 31, 2015. The introduction of a DMP was estimated to decrease costs of the management of patients with alpha-1 antitrypsin deficiency by $13.5 million over 5 years. The savings attributed to the program over the 5-year time horizon are due to 2555 exacerbations, 5180 emergency room visits, 9342 specialist visits, and 105 358 general practitioner visits avoided., Conclusions: A comprehensive DMP for a rare condition might provide cost savings to a health plan. BIAs for rare disease may be more informative if they focus on DMPs rather than on individual drugs., (Copyright © 2020 ISPOR--The professional society for health economics and outcomes research. Published by Elsevier Inc. All rights reserved.)

Background: Medical overuse is a leading contributor to the high cost of the US health care system and is a definitive misuse of resources. Elimination of overuse could improve health care efficiency. In 2014, the State of Maryland placed the majority of its hospitals under an all-payer, annual, global budget for inpatient and outpatient hospital services. This program aims to control hospital use and spending., Objective: To assess whether the Maryland global budget program was associated with a reduction in the broad overuse of health care services., Methods: We conducted a retrospective analysis of deidentified claims for 18-64 year old adults from the IBM MarketScan® Commercial Claims and Encounters Database. We matched 2 Maryland Metropolitan Statistical Areas (MSAs) to 6 out-of-state comparison MSAs. In a difference-in-differences analysis, we compared changes in systemic overuse in Maryland vs the comparison MSAs before (2011-2013) and after implementation (2014-2015) of the global budget program. Systemic overuse was measured using a semiannual Johns Hopkins Overuse Index., Results: Global budgets were not associated with a reduction in systemic overuse. Over the first 1.5 years of the program, we estimated a nonsignificant differential change of -0.002 points (95%CI, -0.372 to 0.369; p = 0.993) relative to the comparison group. This result was robust to multiple model assumptions and sensitivity analyses., Conclusions: We did not find evidence that Maryland hospitals met their revenue targets by reducing systemic overuse. Global budgets alone may be too blunt of an instrument to selectively reduce low-value care., (Published by Elsevier Inc.)

Purpose. Health economic evaluations that include the expected value of sample information support implementation decisions as well as decisions about further research. However, just as decision makers must consider portfolios of implementation spending, they must also identify the optimal portfolio of research investments. Methods. Under a fixed research budget, a decision maker determines which studies to fund; additional budget allocated to one study to increase the study sample size implies less budget available to collect information to reduce decision uncertainty in other implementation decisions. We employ a budget-constrained portfolio optimization framework in which the decisions are whether to invest in a study and at what sample size. The objective is to maximize the sum of the studies' population expected net benefit of sampling (ENBS). We show how to determine the optimal research portfolio and study-specific levels of investment. We demonstrate our framework with a stylized example to illustrate solution features and a real-world application using 6 published cost-effectiveness analyses. Results. Among the studies selected for nonzero investment, the optimal sample size occurs at the point at which the marginal population ENBS divided by the marginal cost of additional sampling is the same for all studies. Compared with standard ENBS optimization without a research budget constraint, optimal budget-constrained sample sizes are typically smaller but allow more studies to be funded. Conclusions. The budget constraint for research studies directly implies that the optimal sample size for additional research is not the point at which the ENBS is maximized for individual studies. A portfolio optimization approach can yield higher total ENBS. Ultimately, there is a maximum willingness to pay for incremental information that determines optimal sample sizes.

Aims: To estimate the budgetary impact of providing additional reimbursement for long acting injections for schizophrenia patients in psychiatric hospital settings in Japan to improve patient outcomes in schizophrenia. Methods: Budget impact analysis of change in reimbursement policy using a prevalence-based model over a five-year time horizon. The results are reported as net change in expenditure and consequent cost/savings in Japanese yen at the time of analysis. Results: The budget impact analysis shows that an increase in reimbursement for LAIs could lead to cumulative savings of an estimated 36.6 billion JPY over five years. These savings result from a decrease in hospitalization costs and an increased usage of LAI (assumed to be 10%). Based on the sensitivity analysis, the saving estimates are most sensitive to change in market share of generic and branded oral antipsychotics. Limitations: Historical data were used to estimate the future costs of drug and hospitalization; however, it is not the best predictor of future, hence a source of potential bias. A good level of treatment adherence with oral antipsychotics was assumed, which is generally not the case; therefore, we might have overestimated the effectiveness of oral atypical antipsychotics. Additionally, the drug cost due to reimbursement might have also been overestimated because in clinical setting, the increase of LAI use may not have reached 10% of the market share. Lastly, patients' behavior was derived from models, which may have loosely approximated the reality. Conclusions: An additional reimbursement for the use of LAI in schizophrenia patients is likely to be cost neutral/cost saving and should be considered as a policy option to improve patient outcomes and budget sustainability.

Background: High budget impact (BI) estimates of new drugs have led to decision-making challenges potentially resulting in restrictions in patient access. However, current BI predictions are rather inaccurate and short term. We therefore developed a new approach for BI prediction. Here, we describe the validation of our BI prediction approach using oncology drugs as a case study., Methods: We used Dutch population-level data to estimate BI where BI is defined as list price multiplied by volume. We included drugs in the antineoplastic agents ATC category which the European Medicines Agency (EMA) considered a New Active Substance and received EMA marketing authorization (MA) between 2000 and 2017. A mixed-effects model was used for prediction and included tumor site, orphan, first in class or conditional approval designation as covariates. Data from 2000 to 2012 were the training set. BI was predicted monthly from 0 to 45 months after MA. Cross-validation was performed using a rolling forecasting origin with e^|Ln(observed BI/predicted BI)| as outcome., Results: The training set and validation set included 25 and 44 products, respectively. Mean error, composed of all validation outcomes, was 2.94 (median 1.57). Errors are higher with less available data and at more future predictions. Highest errors occur without any prior data. From 10 months onward, error remains constant., Conclusions: The validation shows that the method can relatively accurately predict BI. For payers or policymakers, this approach can yield a valuable addition to current BI predictions due to its ease of use, independence of indications and ability to update predictions to the most recent data.

Objectives: To elicit citizen preferences for national budget resource allocation in Uganda, examine respondents' preferences for health vis-à-vis other sectors, and compare these preferences with actual government budget allocations., Methods: We surveyed 432 households in urban and rural areas of Mukono district in central Uganda.We elicited citizens' preferences for resource allocation across all sectors using a best-worst scaling (BWS) survey. The BWS survey consisted of 16 sectors corresponding to the Uganda national budget line items. Respondents chose, from a subset of four sectors across 16 choice tasks, which sectors they thought were most and least important to allocate resources to. We utilized the relative best-minus-worst score method and a conditional logistic regression to obtain ranked preferences for resource allocation across sectors. We then compared the respondents' preferences with actual government budget allocations., Results: The health sector was the top ranked sector where 82% of respondents selected health as the most important sector for the government to fund, but it was ranked sixth in national budget allocation, encompassing 6.4% of the total budget. Beyond health, water and environment, agriculture, and social development sectors were largely underfunded compared to respondents' preferences. Works and transport, education, security, and justice, law and order received a larger share of the national budget compared to respondents' preferences., Conclusions: Among respondents from Mukono district in Uganda, we found that citizens' preferences for resource allocation across sectors, including for the health sector, were fundamentally misaligned with current government budget allocations. Evidence of respondents' strong preferences for allocating resources to the health sector could help stakeholders make the case for increased health sector allocations. Greater investment in health is not only essential to satisfy citizens' needs and preferences, but also to meet the government's health goals to improve health, strengthen health systems, and achieve universal health coverage., Competing Interests: The authors have declared that no competing interests exist.

Background: Despite the large investments in donor-related health activities in areas of the globe prone to tension and conflict, few studies have examined in detail the role of these donor investments in human resources for health (HRH)., Methods: We used a mixed-methods research methodology comprising both quantitative and qualitative analyses to analyze the Enhanced Financial Reporting System of the Global Fund to Fight AIDS, Tuberculosis and Malaria budget and expenditure data from 2003 to 2017 for 13 countries in the Eastern Mediterranean Region (EMR). We analyzed additional detailed budgetary data over the period 2015-2017 for a sub-set of these countries. Two country-case studies were conducted in Afghanistan and Sudan for a more in-depth understanding of the HRH-related activities that occurred as a result of Global Fund grants., Results: The results show that US$2.2 billion Global Fund dollars had been budgeted and US$1.6 billion were expended over the period 2003-2017 in 13 Eastern Mediterranean countries. The average expenditures for human resources for health (training and human resources) as a percentage of total expenditure are 28%. Additional detailed budgetary data analysis shows a more conservative investment in HRH with 13% of total budgets allocated to "direct" HRH activities such as salaries, training costs, and technical assistance. HRH-related activities supported by the Global Fund in Afghanistan and Sudan were similar, including pre-service and in-services training, hiring of program coordinators and staff, and top-ups for clinical staff., Conclusions: HRH remains a key issue in strengthening the health systems of low- and middle-income countries. While this study suggests that Global Fund's HRH investments in the EMR are not lagging behind the global average, there appears to be a need to further scale up these investments considering this region's unique HRH challenges.

The objective of this analysis was to evaluate and report on the economic impact of implementing an integrated, quality, and operational improvement program on chronic obstructive pulmonary disease (COPD) care from acute through post-acute care settings. This initiative was established in a cohort of 12 hospitals in Alabama and sought to address COPD readmission through improved workflows pertaining to early diagnosis, efficient care transitions, and patient visibility across the entire care episode. Implementation of the initiative was influenced by lean principles, particularly cross-functional agreement of workflows to improve COPD care delivery and outcomes. A budget impact model was developed to calculate cost savings directly from objective data collected during this initiative. The model estimated payer annual savings over 5 years. Patients were classified for analysis based on whether or not they received noninvasive ventilation. Scenario analyses calculated savings for payers covering different COPD cohort sizes. The base case revealed annual per patient savings of $11,263 for patients treated through the quality improvement program versus traditional care. The model projected cumulative savings of $52 million over a 5-year period. Clinical incorporation of non-invasive ventilation (NIV) resulted in $20,535 annual savings per patient and projected $91 million over 5 years. We conclude that an integrated management program for COPD patients across the care continuum is associated with substantial cost savings and significantly reduced hospital readmissions., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: DDR and FWP received consulting fees for model development and manuscript preparation. They confirm that neither data analysis nor findings reported in this article were influenced by the supporting organization. DT and AB are employed by the funding organization. TLC is employed by and owns stock in the funding organization. They confirm that the funding organization had no influence on the data analysis nor findings reported in this article.

Aim: Given that rheumatoid arthritis (RA) patients with high anti-citrullinated protein antibodies (ACPA) titer values respond well to abatacept, the aim of this study was to estimate the annual budget impact of anti-cyclic citrullinated peptide (anti-CCP) testing and treatment selection based on anti-CCP test results. Materials and methods: Budget impact analysis was conducted for patients with moderate-to-severe RA on biologic or Janus kinase inhibitor (JAKi) treatment from a hypothetical US commercial payer perspective. The following market scenarios were compared: (1) 90% of target patients receive anti-CCP testing and the results of anti-CCP testing do not impact the treatment selection; (2) 100% of target patients receive anti-CCP testing and the results of anti-CCP testing have an impact on treatment selection such that an increased proportion of patients with high titer of ACPA receive abatacept. A hypothetical assumption was made that the use of abatacept would be increased by 2% in Scenario 2 versus 1. Scenario analyses were conducted by varying the target population and rebate rates. Results: In a hypothetical health plan with one million insured adults, 2,181 patients would be on a biologic or JAKi treatment for moderate-to-severe RA. In Scenario 1, the anti-CCP test cost was $186,155 and annual treatment cost was $101,854,295, totaling to $102,040,450. In Scenario 2, the anti-CCP test cost increased by $20,684 and treatment cost increased by $160,467, totaling an overall budget increase of $181,151. This was equivalent to a per member per month (PMPM) increase of $0.015. The budget impact results were consistently negligible across the scenario analyses. Limitations: The analysis only considered testing and medication costs. Some parameters used in the analysis, such as the rebate rates, are not generalizable and health plan-specific. Conclusions: Testing RA patients to learn their ACPA status and increasing use of abatacept among high-titer ACPA patients result in a small increase in the total budget (<2 cents PMPM).

Introduction: Ethiopian households' out-of-pocket healthcare payments constitute one-third of the national healthcare budget and are higher than the global and low-income countries average, and even the global target. Such out-of-pocket payments pose severe financial risks, can be catastrophic, impoverishing, and one of the causal barriers for low utilisation of healthcare services in Ethiopia. This study aimed to assess the financial risk of seeking maternal and neonatal healthcare in southern Ethiopia., Methods: A population-based cohort study was conducted among 794 pregnant women, 784 postpartum women, and their 772 neonates from 794 households in rural kebeles of the Wonago district, southern Ethiopia. The financial risk was estimated using the incidence of catastrophic healthcare expenditure, impoverishment, and depth of poverty. Annual catastrophic healthcare expenditure was determined if out-of-pocket payments exceeding 10% of total household or 40% of non-food expenditure. Impoverishment was analysed based on total household expenditure and the international poverty line of ≈ $1.9 per capita per day., Results: Approximately 93% (735) of pregnant women, 31% (244) of postpartum women, and 48% (369) of their neonates experienced illness. However, only 56 households utilised healthcare services. The median total household expenditure was $527 per year (IQR = 390: 370,760). The median out-of-pocket healthcare payment was $46 per year (IQR = 46: 46, 92) with two episodes per household, and shared 19% of the household's budget. The poorer households paid more than did the richer for healthcare, during pregnancy-related and neonatal illness. However, the richer paid more than did the poorer during postpartum illness. Forty-six percent of households faced catastrophic healthcare expenditure at the threshold of 10% of total household expenditure, or 74% at a 40% non-food expenditure, and associated with neonatal illness (aRR: 2.56, 95%CI: 1.02, 6.44). Moreover, 92% of households were pushed further into extreme poverty and the poverty gap among households was 45 Ethiopian Birr per day. The average household size among study households was 4.7 persons per household., Conclusions: This study demonstrated that health inequity in the household's budget share of total OOP healthcare payments in southern Ethiopia was high. Besides, utilisation of maternal and neonatal healthcare services is very low and seeking such healthcare poses a substantial financial risk during illness among rural households. Therefore, the issue of health inequity should be considered when setting priorities to address the lack of fairness in maternal and neonatal health.

Background: Prostate cancer is the most common cancer and second-leading cause of cancer death among men in the United States. Prostate cancer poses a large economic burden, which increases with progression from localized to metastatic disease. Newly approved treatments for non-metastatic castration-resistant prostate cancer (nmCRPC) delay disease progression and reduce the risk of metastatic disease. Quantifying the potential budget impact of these new treatments is of interest to health care decision makers., Objective: To estimate the budget impact of enzalutamide for the treatment of patients with nmCRPC in the United States over a 3-year time horizon., Methods: An Excel-based model was developed to estimate the budget impact to a U.S. health plan of enzalutamide, a second-generation antiandrogen, as an add-on to androgen deprivation therapy (ADT) for the treatment of high-risk nmCRPC patients (prostate-specific antigen doubling time of ≤ 10 months). Comparators include apalutamide + ADT, bicalutamide + ADT, and ADT only. The analysis includes treatment costs for nmCRPC and for treatment after progression to metastatic castration-resistant prostate cancer (mCRPC). The treated population size was estimated from epidemiological data and literature. Dosing, duration of therapy, and adverse event rates were based on package inserts and pivotal studies. RED BOOK, Centers for Medicare & Medicaid Services fee schedules, and literature were used to obtain costs of drugs, adverse events, and health care visits. Market shares were estimated for each comparator before and after enzalutamide adoption. A 1-way sensitivity analysis was performed to quantify the impact of parameter uncertainty., Results: In a hypothetical 1-million-member plan with 3% annual growth, it was estimated that there would be approximately 19 eligible incident nmCRPC patients in year 1, increasing to 20 eligible incident patients in year 3. With an assumed market share of approximately 6% for enzalutamide in year 1, the budget impact would be $106,074 ($0.009 per member per month [PMPM]). With a 26% enzalutamide share in year 3, the budget impact would be $632,729 ($0.048 PMPM). Cumulative budget impact to the health plan over 3 years is estimated to be $1,082,095 ($0.028 PMPM). The increased cost of the treatment regimen is partly offset by reduced postprogression costs., Conclusions: Treatment of nmCRPC patients with enzalutamide has a modest budget impact that is partly offset by delaying progression to mCRPC., Disclosures: This research was sponsored by Astellas Pharma and Pfizer, the codevelopers of enzalutamide. All authors contributed to the development of the manuscript and maintained control over the final content. Schultz is employed by Astellas Pharma and owns stock in Gilead Sciences and Shire. O'Day and Sugarman are employees of Xcenda, which received consultancy fees from Astellas Pharma. Ramaswamy is employed by Pfizer. A synopsis of the current study was presented in poster format at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2019, in San Diego, CA, on March 25-28, 2019.

Background: Medication-refractory gastroesophageal reflux disease (GERD) is sometimes treated with laparoscopic Nissen fundoplication (LNF); however, this is a non-reversible procedure associated with important side effects and the need for repeat surgery. Removable magnetic sphincter augmentation (MSA) devices are an alternative, effective, and safe treatment option for such patients who have some lower esophageal sphincter function. The objective of this study was to assess the economic impact of introducing MSA technology (i.e., LINX Reflux Management System) into current practice from a US-payer perspective., Methods: An economic budget impact model was developed over a 1-year time horizon that compared current treatment of GERD patients who are medically managed (but refractory) or receiving LNF to future treatment of GERD patients that included a mix of patients treated with medical management only, LNF, or MSA. Resources included within the analyses were index procedures (inpatient and outpatient use), reoperations (revisions and removals), readmissions, healthcare visits, diagnostic tests, procedures, and medications. Medicare payment rates were typically used to inform unit costs., Results: Assuming a hypothetical commercial insurance population of 1 million members, the base-case analysis estimated a net cost savings of $111,367 with introduction of the MSA. This translates to a savings of $0.01 per member per month. Results were largely driven by avoided inpatient procedures with use of the MSA device. Alternative analyses exploring the potential impact of increasing surgical volumes predicted that results would remain cost saving if the proportion of MSA market share taken from LNF was ≥ 90%., Conclusions: This study predicts that the introduction of the MSA device would lead to favorable budget impact results for the treatment of medication-refractory mechanical GERD for commercial payers. Future analyses will benefit from inclusion of middle-ground treatments as well as longer time horizons.

Introduction: The clinical and economic impact of cervical cancer consistently become a serious burden for all countries, including Indonesia. The implementation of HPV vaccination policy for a big country such as Indonesia requires a strong commitment from several decision-makers. The aim of this study was to provide a comprehensive description on cost-effectiveness and the budget-impact of HPV vaccination policy in Indonesia., Method: A cohort Markov model was used to evaluate the cost and the clinical impact of HPV vaccination for 10 years old girls in Indonesia. The researchers consider two doses of all three available HPV vaccines adjusted with the HPV infection profilewith 95% vaccination coverage to estimate the national cervical cancer incidence and mortality. The Budget impact analysis explores three different scenarios covering (1) Two districts per year expansion, (2) oneprovince per year expansion and (3) achieving the National Immunization Program in 2024., Results: Upon fully vaccinating almost 2.3 million 10-year-old girls, 34,723; 43,414; and 51,522 cervical cancer cases were prevented by Quadrivalent, Bivalent and Nonavalent vaccines, consecutively. Furthermore, the highest (591 cases) and lowest (399 cases) mortality were prevented by Nonavalent and Quadrivalent vaccines, respectively. Most of the vaccines were considerably cost-effective and only the Bivalent vaccine with the GAVI/UNICEF price which will be considered a cost-saving strategy.To provide national coverage of HPV vaccination in Indonesia, the government has to provide an annual budget of about US$49 million and US$22 million using the government contract price and GAVI/UNICEF price, respectively., Conclusion: HPV vaccination shows a cost-effective strategy and the budget required to provide this policy is considerably affordable for Indonesia., Competing Interests: The authors have declared that no competing interests exist.

Soft budget constraints (SBCs) undermine reforms to increase hospital service efficiency when hospital management can count on being bailed out by (subnational) governments in case of deficits. Using cost accounting data on publicly financed, non-profit hospitals in Austria from 2002 to 2015, we analyse the association between SBCs and hospital efficiency change in a setting with negligible risk of hospital closure in a two-stage study design based on bias-corrected non-radial input-oriented data envelopment analysis and ordinary least squares regression. We find that the European debt crisis altered the pattern of hospital efficiency development: after the economic crisis, hospitals in low-debt states had a 1.1 percentage point lower annual efficiency change compared to hospitals in high-debt states. No such systematic difference is found before the economic crisis. The results suggest that sudden exogenous shocks to public finances can increase the budgetary pressure on publicly financed institutions, thereby counteracting a pre-existing SBC., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Before the approval of dabrafenib and trametinib in combination, there were no approved therapies in the adjuvant setting that target the RAS/RAF/MEK/ERK pathway., Objective: To evaluate the budget impact of dabrafenib and trametinib in combination for adjuvant treatment of patients with BRAF V600 mutation-positive resected Stage IIIA, IIIB, or IIIC melanoma from a U.S. commercial payer perspective using data from the COMBI-AD trial, as well as other sources., Methods: The budget impact of dabrafenib and trametinib in combination for patients with BRAF V600E/K mutation-positive, resected Stage IIIA, IIIB, or IIIC melanoma was evaluated from the perspective of a hypothetical population of 1 million members with demographic characteristics consistent with those of a commercially insured U.S. insurance plan (i.e., adults aged less than 65 years) using an economic model developed in Microsoft Excel. The model compared melanoma-related health care costs over a 3-year projection period under 2 scenarios: (1) a reference scenario in which dabrafenib and trametinib are assumed to be unavailable for adjuvant therapy and (2) a new scenario in which the combination is assumed to be available. Treatments potentially displaced by dabrafenib and trametinib were assumed to include observation, high-dose interferon alpha-2b, ipilimumab, and nivolumab. Costs considered in the model include those of adjuvant therapies and treatment of locoregional and distant recurrences. The numbers of patients eligible for treatment with dabrafenib and trametinib were based on data from cancer registries, published sources, and assumptions. Treatment mixes under the reference and new scenarios were based on market research data, clinical expert opinion, and assumptions. Probabilities of recurrence and death were based on data from the COMBI-AD trial and an indirect treatment comparison. Medication costs were based on wholesale acquisition cost prices. Costs of distant recurrence were from a health insurance claims study., Results: In a hypothetical population of 1 million commercially insured members, 48 patients were estimated to become eligible for treatment with dabrafenib and trametinib in combination over the 3-year projection period; in the new scenario, 10 patients were projected to receive such treatment. Cumulative costs of melanoma-related care were estimated to be $6.3 million in the reference scenario and $6.9 million in the new scenario. The budget impact of dabrafenib and trametinib in combination was an increase of $549 thousand overall and 1.5 cents per member per month., Conclusions: For a hypothetical U.S. commercial health plan of 1 million members, the budget impact of dabrafenib and trametinib in combination as adjuvant treatment for melanoma is likely to be relatively modest and within the range of published estimates for oncology therapies. These results may assist payers in making coverage decisions regarding the use of adjuvant dabrafenib and trametinib in melanoma., Disclosures: Funding for this research was provided to Policy Analysis Inc. (PAI) by Novartis Pharmaceuticals. Stellato, Moynahan, and Delea are employed by PAI. Ndife, Koruth, Mishra, and Gunda are employed by Novartis. Ghate was employed by Novartis at the time of this study and is shareholder in Novartis, Provectus Biopharmaceuticals, and Mannkind Corporation. Gerbasi was employed by PAI at the time of this study and is currently an employee, and stockholder, of Sage Therapeutics. Delea reports grant funding from Merck and research funding from Amgen, Novartis, Sanofi, Seattle Genetics, Takeda, Jazz, EMD Serono, and 21st Century Oncology, unrelated to this work.

The relationship between resource allocation decisions within medical laboratory cost centers and overall hospital financial performance is empirically investigated using a panel of critical access hospitals in Washington State (2014-2016). In order to increase accessibility to hospital managers and health policy makers, a managerial finance perspective (defining performance using simple financial accounting ratios) is adopted. Results indicate that resource allocation decisions within the medical laboratory cost center have a significant impact on the financial performance of the hospital as a whole. However, the nature of the impact depends on the type of financial metric utilized. For instance, the proportion of the typical medical laboratory's budget that is allocated to rent is negatively and significantly related to the hospital's return on assets. Concomitantly, medical laboratory cost centers that have a larger footprint in the hospital (as measured by square footage) exhibit a significant, positive association with the hospital's current ratio. Thus, physically larger medical laboratories may allow the hospital to better manage its liquid assets.

We employ data from the Adolescent Health and Development in Context Study-a representative sample of urban youth ages 11-17 in and around the Columbus, OH area-to investigate the feasibility and validity of smartphone-based geographically explicit ecological momentary assessment (GEMA). Age, race, household income, familiarity with smartphones, and self-control were associated with missing global positioning systems (GPS) coverage, whereas school day was associated with discordance between percent of time at home based on GPS-only versus recall-aided space-time budget data. Fatigue from protocol compliance increases missing GPS across the week, which results in more discordance. Although some systematic differences were observed, these findings offer evidence that smartphone-based GEMA is a viable method for the collection of activity space data on urban youth., (© 2018 Society for Research on Adolescence.)

Background: Chemotherapy-induced nausea and vomiting (CINV) are among the most common and debilitating side-effects patients experience during chemotherapy, and are associated with considerable acute care use and healthcare cost. It is estimated that 70-80% of CINV could be prevented through appropriate use of CINV prophylaxis; however, suboptimal CINV compliance and control remains an issue in clinical practice. Netupitant/palonosetron (NEPA) is a fixed combination of serotonin-3 (5-HT 3 ) and neurokinin-1 (NK 1 ) receptor antagonists (RAs), respectively, indicated for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC). Phase 3 clinical trials showed a significantly higher complete response rate in both acute and delayed CINV in chemotherapy-naïve patients receiving NEPA compared to patients receiving palonosetron. Objective: The objective of this study was to estimate the budgetary impact of adding NEPA to a US payer or practice formulary for CINV prophylaxis. Methods: A model was developed to estimate the impact of adding NEPA to the formulary of a hypothetical US payer with 1.15 million members, including 150,000 (13%) Medicare beneficiaries. The model compared the annual total costs of CINV-related events and CINV prophylaxis in two scenarios: base year (no NEPA) and comparator year (10% and 5% NEPA usage in HEC and MEC patients, respectively). A univariate sensitivity analysis was conducted to explore the effect of variability in model parameters on the budget impact. Results: A total of 2,021 patients were eligible to receive CINV prophylaxis. With NEPA, CINV prophylaxis costs increased by 0.7% ($3,493,630 vs $3,518,760) while medical costs associated with CINV events decreased by 3.9% ($15,118,639 vs $14,532,442), resulting in a net cost saving of $561,067 (3.0%) for the health plan ($18,612,269 vs $18,051,202), or $0.04 per member per month. This was equivalent to saving $5,011 per patient moved to NEPA. Among all 5-HT 3 RA + NK 1 RA regimens, NEPA was associated with the lowest CINV-related costs, leading to the lowest total cost of care. Conclusions: Adding NEPA to a payer or practice formulary results in a net decrease in the total budget due to a substantial reduction in CINV event-related resource utilization and medical costs, and an increase in pharmacy costs <1%, saving over $5,000 per patient.

Background: As the economic burden of treating cancer patients has been soaring in European countries, performing a budget impact analysis is becoming one of the requirements for payers' application dossiers., Objective: The objective of this study was to estimate the budgetary impact of introducing the biosimilar trastuzumab (CT-P6) from the payer's perspective and to determine the number of additional patients who could be treated with resulting savings in 28 European countries., Methods: A budget impact model was developed to analyze the financial impact of switching from originator trastuzumab to biosimilar CT-P6 in the treatment of early and metastatic breast cancer and metastatic gastric cancer with a time horizon of 1-5 years. Budgetary savings and the number of patients potentially affected were measured based on epidemiological and sales volume data. The base-case analysis assumed that the price of CT-P6 is 70% of the originator price, the switching rate of originator to CT-P6 in the first year is 20%, and the annual growth in the switching rate for each subsequent year is 5%., Results: For analyses using the base-case scenario following CT-P6 introduction, the total estimated budgetary savings over a 5-year period (depending on the scenario) ranged from €1.13 billion to €2.27 billion based on epidemiological data, or from €0.91 billion to €1.82 billion based on sales volume data. In the first year only, the projected budgetary savings ranged from €58 million to €136 million, and the number of additional patients who could be treated using the savings ranged from 3503 to 7078 by sensitivity analysis., Conclusions: The conducted budget impact analysis assessing a switch from originator trastuzumab to biosimilar CT-P6 in 28 European countries indicates that budget savings could be between €0.91 billion and €2.27 billion over the next 5 years. These savings could be used to help improve patient access to local biologics in their respective countries while simultaneously strengthening the overall public health landscape across the European Union.

Background: In 1988, the Australian government introduced a single nominal rate of tax on all beer products calculated on alcohol content. However, in 2000/01, varying nominal rates of tax were introduced for beer products according to three alcohol content levels (low-/mid-/high-strength) and container type (on-/off-premises). Little is known about the effect of the different tax policies on alcohol consumption and government revenue., Methods: We undertake time series analysis over 1989-2016 to examine the effect of beer tax policies in two sub-periods (before/after 2000/01) on category-level beer consumption per capita and government revenue. We also test if the policy changes in 2000/01 had immediate or long-term effects on total (all beer category) consumption over 1989-2016. Data includes monthly domestic beer sales volumes by category (in litres of alcohol), monthly government revenue from beer tax (AUD$), and inflation-adjusted tax rates (AUD$ per litre of alcohol)., Results: Before 2000/01, the single nominal tax rate had a significant positive effect on revenue, but no significant effect on consumption. After 2000/01, the relatively higher nominal tax rates for two beer categories (mid- and high-strength off-premises) had a significant negative effect on their consumption, and a significant negative effect on revenue in one category (mid-strength off-premises). However, across the full period examined (1989-2016), the level and slope of total beer consumption was not significantly affected by the tax policy changes in 2000/01., Conclusion: Raising alcohol taxes has the potential to reduce consumption and increase government revenue, but has been underutilised for these public health and public finance objectives in Australia., (Copyright © 2019 Elsevier B.V. All rights reserved.)

To advance in order to overcome the challenge of enabling greater autonomy in the use of financial resources in the Unified Health System (SUS), system managers agreed that transfers from the Union to other federated entities will be carried out through a financial investment account and a costing account. Over the past few years, states and municipalities managed more than 34,000 bank accounts dedicated to the Union's on-lendings, in which balance exceeded R$8 billion. However, from 2018, Ordinance 3,992/2017 unequivocally separated the budget flow from the financial flow, and the fund-to-fund transfers started to be carried out in only 11,190 bank accounts. Since then, managers have had financial autonomy in the management of financial resources received from the Union, if in accordance with the parameters established in their respective budget items at the end of each fiscal year.

Objective: To analyze the regional allocation of the resources from the Brazilian Popular Pharmacy Program, taking into account the relative availability of the program and the potential needs of the region., Methods: Data from the National Health Survey of the Annual Report of Social Information and the administrative database of the program were used to create a non-parametric indicator of coverage using multiple data envelopment analysis technique. This indicator considers the relative availability of the program, taking into account equal access to equal needs (equity based on regional needs). The analysis of this indicator shows if the regions that most need pharmaceutical assistance are those that receive more resources from the Brazilian Popular Pharmacy Program., Results: The states belonging to the richest regions of the country, Southeast and South, present wider relative coverage of the Brazilian Popular Pharmacy Program compared to poorer localities. In addition, the inequalities observed between locations are better explained by inefficiency in the transfer of resources to the basic component of pharmaceutical care than by the Brazilian Popular Pharmacy Program itself. According to the model, a 43.76% increase in the transfer to the basic component of pharmaceutical care would be required in order to improve equity, whereas the increase required by the Brazilian Popular Pharmacy Program is equivalent to 22.71%., Conclusions: Although the Brazilian Popular Pharmacy Program seeks to reduce the socioeconomic inequalities observed in access to pharmaceutical care, which integrates health care services, regional disparities in access to medicine persist. These regional differences are attributed mostly to allocation failures and problems in managing the conventional pharmaceutical care cycle provided through SUS pharmacies.

Collective financing, in the form of either public domestic revenues or pooled donor funding, at the country level is necessary to finance common goods for health, which are population-based functions or interventions that contribute to health and have the characteristics of public goods. Financing of common goods for health is an important part of policy efforts to move towards Universal Health Coverage (UHC). This paper builds from country experiences and budget documents to provide an evidence-based argument about how government and donor financing can be reorganized to enable more efficient delivery of common goods for health. Issues related to fragmentation of financing-within the health sector, across sectors, and across levels of government-emerge as key constraints. Effectively addressing fragmentation issues requires: (i) pooling funding and consolidating governance structures to repackage functions across programs; (ii) aligning budgets with efficient delivery strategies to enable intersectoral approaches and related accountability structures; and (iii) coordinating and incentivizing investments across levels of government. This policy response is both technical in nature and also highly political as it requires realigning budgets and organizational structures.

Objective: To analyze the allocation of financial resources in the Brazilian Unified Health System (SUS) in the state of São Paulo by level of care, health region, source of funds and level of government., Methods: This is an exploratory study based on 2014 data extracted from the Public Health Budget Database, presented in absolute terms, relative terms and per capita ., Results: In 2014, R$52.1 bi were spent on public health, 58.0% having corresponded to the expenditures of the municipalities and 42.0% to those of the state government. Regional per capita spending varied from R$561.75 to R$824.85. As for the per capita spending on primary health care, which represented 37.5% of the municipalities' total expenditure, the lowest value was found in the city of São Paulo and the highest, in Araçatuba. Campinas had the highest per capita expenditure on medium and high complexity care, while Presidente Prudente had the lowest. The highest regional percentage of the current net revenue spent on health was verified in Registro, and the lowest, in the city of São Paulo., Conclusions: The paradigm of the health sector's financing in São Paulo revealed that the expenditure on primary health care, level elected by health policy as strategic because it depends on coordination and integral health care in the attention networks, was not considered a priority in relation to the expenditure with the medium and high complexity, exposing the iniquities in the state's regions.

Background : To determine the relative impact of each of the 3 state-level tobacco control policies (cigarette taxation, tobacco control spending, and smoke-free air [SFA] laws) on adult smoking rate overall and separately for adult subgroups in the United States. Methods : A difference-in-differences analysis was conducted with generalized propensity scores. State-level policies were merged with the individual-level Behavioral Risk Factor Surveillance System in 1995-2009. Results : State cigarette taxation was the only policy that significantly impacted smoking among the general adult population, with a 1-standard deviation increase in taxes (i.e., $0.68 in constant 2014 dollars) lowering the adult smoking rate by about a quarter of a percentage point. The taxation impact was consistent, regardless of the presence of, or interactions with, other policies. Taxation was also the only policy that significantly reduced smoking for some adult subgroups, including females, non-Hispanic whites, adults aged 51 or older, and adults with more than a high school education. However, other adult subgroups responded to the other 2 types of policies, either by mediating the taxation effect or by reducing smoking independently. Specifically, tobacco control spending reduced smoking among young adults (ages 18-25 years) and Hispanics. SFA laws affected smoking among men, young adults, non-Hispanic blacks, and Hispanics. Conclusions : State cigarette taxation is the single most important policy for reducing smoking among the general adult population. However, adult subgroups' reactions to taxes are diverse and mediated by tobacco control spending and SFA laws.

The aim of this article is to present the development of cross-country comparable food reference budgets in 26 European countries, and to discuss their usefulness as an addition to food-based dietary guidelines (FBDG) for tackling food insecurity in low-income groups. Reference budgets are illustrative priced baskets containing the minimum goods and services necessary for well-described types of families to have an adequate social participation. This study was conducted starting from national FBDG, which were translated into monthly food baskets. Next, these baskets were validated in terms of their acceptability and feasibility through focus group discussions, and finally they were priced. Along the paper, we show how that food reference budgets hold interesting contributions to the promotion of healthy eating and prevention of food insecurity in low-income contexts in at least four ways: (1) they show how a healthy diet can be achieved with limited economic resources, (2) they bring closer to the citizen a detailed example of how to put FBDG recommendations into practice, (3) they ensure that food security is achieved in an integral way, by comprising the biological but also psychological and social functions of food, and (4) providing routes for further (comparative) research into food insecurity.

Maryland implemented one of the most aggressive payment innovations the nation has seen in several decades when it introduced global budgets in all its acute care hospitals in 2014. Prior to this, a pilot program, total patient revenue (TPR), was established for 8 rural hospitals in 2010. Using financial hospital report data from the Health Services Cost Review Commission from 2007 to 2013, we examined the hospitals' financial results including revenue, costs, and profit/loss margins to explore the impact of the adoption of the TPR pilot global budget program relative to the remaining hospitals in the state. We analyze financial results for both regulated (included in the global budget and subject to rate-setting) and unregulated services in order to capture a holistic image of the hospitals' actual revenue, cost and margin structures. Common size and difference-in-differences analyses of the data suggest that regulated profit ratios for treatment hospitals increased (from 5% in 2007 to 8% in 2013) and regulated expense-to-gross patient revenue ratios decreased (75% in 2007 and 68% in 2013) relative to the controls. Simultaneously, the profit margins for treatment hospitals' unregulated services decreased (- 12% in 2007 and - 17% in 2013), which reduced the overall margin significantly. This analysis therefore indicates cost shifting and less profit gain from the program than identified by solely focusing on the regulated margins.

Aims: To assess the budget impact to a US commercial health plan of providing access to the Flexitouch (FLX) advanced pneumatic compression device (Tactile Medical) to lymphedema (LE) patients with either comorbid chronic venous insufficiency (CVI) or frequent infections., Methods: Budget impact was calculated over 2 years for a hypothetical US payer with 10-million commercial members. Model inputs were derived from published sources and from a case-matched analysis of Blue Health Intelligence (BHI) claims data for the years 2012-2016. To calculate the budget impact, the Status Quo budget (i.e. total cost for LE and sequelae-related medical treatment) was compared to the budget under each of three Alternate Payer Policy scenarios which assumed that a sub-set of patients was redistributed from their initial treatment groups to a group that received FLX. Model outputs included cumulative payer costs, net budget impact, and breakeven point. Sensitivity analyses were performed to assess the impact of model inputs on results., Results: Increasing access to FLX yielded a favorable budget impact in every scenario. For LE patients with comorbid CVI, the three alternate scenarios resulted in cumulative 2-year budget impacts of -$52,841, -$173,317, and -$375,601, respectively. For LE patients with comorbid frequent infections, the three alternate scenarios resulted in cumulative 2-year budget impacts of -$192,729, -$259,339, and -$613,179, respectively., Limitations: Use of claims data assumes accurate coding and does not allow one to control for disease severity or treatment adherence. Also, the distribution of patients between treatment arms was determined using claims data from a specific payer organization, and could differ for health plans with different coverage policies., Conclusions: While previous studies have illustrated cost savings with adoption of FLX, US commercial health plans may also achieve tangible cost savings by expanding access to FLX for LE patients with comorbid CVI and multiple infections.

Aim: Acute pancreatitis is associated with significant morbidity and mortality. In the United States, more than 3,00,000 patients are admitted and about 20,000 die from acute pancreatitis per year. In Taiwan, the incidence rate of acute pancreatitis is 0.03% and the mortality rate among severe acute pancreatitis is 16.3%. The aim of the study was to evaluate the impact of the global budgeting system on health service utilization, health care expenditures, and quality of care among patients with acute pancreatitis in Taiwan., Materials and Methods: The National Health Insurance Research Database (NHIRD) was used for analysis. Data on patients with acute pancreatitis diagnosed during the period 2000 and 2001 were used as baseline data, and data from 2004 and 2005 were used as post-intervention data. The length of stay (LOS), diagnostic costs, drug cost, therapy costs, total costs, risk of readmission within 14 days, and risk of revisiting the emergency department (ED) within 3 days of discharge before and after implementation of the global budgeting system were compared and analyzed., Results: Data on 2810 patients with acute pancreatitis were analyzed in this study. There was a significant difference in mean LOS before and after introduction of the global budget system (7.34 ± 0.22 days and 7.82 ± 0.22 days, respectively; P < .001)). The mean total costs before and after implementation of the global budget system were Taiwan dollars (NT$) 28,290.66 ± 1576.32 and NT$ 42,341.83 ± 2285.23, respectively. The mean rate of revisiting the ED within 3 days decreased from 9.9 ± 0.9% before adoption of global budgeting to 7.2 ± 0.6% after implementation of the system. The mean 14-day re-admission rates before and after introduction of global budgeting were 11.6 ± 1.0% and 7.9 ± 0.7%, respectively., Conclusion: The global budget system was associated with significantly longer length of stay, higher health care expenditures, and better quality of care in patients treated for acute pancreatitis.

Aim: To estimate budget impact of adopting lesinurad as add-on to allopurinol for urate-lowering therapy in gout. Methods: A budget impact model was developed for a US payer perspective, using a Markov model to estimate costs, survival and discontinuation in a one-million-member health plan. The population included patients failing first-line gout therapy, followed for 5 years. Results: Incremental costs of adding lesinurad versus no lesinurad were US$241,907 and US$1,098,220 in first and fifth years, respectively. Cumulative 5-year incremental cost was US$3,633,440. Estimated incremental mean cost per treated patient with gout per year was US$112. The mean per-member per-month cost increased by US$0.06. Conclusion: Initiating lesinurad would result in an incremental per-member per-month cost of US$0.06 over 5 years.

The study aimed to investigate inequalities in the commitment of family income to private expenditures on dental care in Brazil. Data were analyzed from 55,970 Brazilian households that participated in the nationwide Family Budgets Survey in 2008-2009. The commitment of family income to private spending on dental care was calculated by dividing the mean annual per capita household spending on dental care by the mean annual per capita income, classified in four categories: > 0%, ≥ 5%, ≥ 10%, and ≥ 20%. Analysis of income commitment only included households with positive spending. Only 2,961 households (7%) reported positive spending on dental care. Mean annual per capita spending was BRL 42.19 (USD 12.78) overall and BRL 602.47 (USD 182.57) among those with positive spending. Households with the highest absolute expenditures on dental care were those from urban areas and the wealthiest quintile. Meanwhile, households with the highest proportional income commitment were from rural areas and the poorest quintile. Among those that reported positive spending, 55% of the households in the poorest quintile committed ≥ 20% of their income to dental care. The proportion was only 6% in the wealthiest quintile of the population. The poorest households in the wealthiest regions of Brazil (Central, South, and Southeast) showed the highest income commitments. There were striking socioeconomic inequalities in spending and income commitment to dental care. The evaluation of these inequalities is relevant for the evaluation and orientation of public health policies.

As the second largest item in the budget of every US state, Medicaid budget stability and financial transparency have significance for every state. This study is the first to test whether managed care enrollment reduces the variance of Medicaid spending, in contrast to the focus of the existing literature on spending levels. This variance bears directly on whether budget constrained states whether budget constrained states benefit from managed care in the form of stabilized spending, leading to improved budget predictability. Capitated payments stabilize spending at the margin, but the effects may be unobservable in aggregate due to variation in enrollment, which is directly measured in the analysis, or selection bias, which is unobserved. Although the majority of Medicaid enrollees are in managed care, the study shows that managed care use has been concentrated among the enrollees with the most stable spending, resulting in only small gains to budget predictability. This finding is robust to the exclusion of the claims expenditures that exhibit the most variance.

Background: Necitumumab (Neci) was the first biologic approved by the FDA for use in combination with gemcitabine and cisplatin (Neci + GCis) in first-line treatment of metastatic squamous non-small cell lung cancer (msqNSCLC). The potential financial impact on a health plan of adding Neci + GCis to drug formularies may be important to value-based decision makers in the United States, given ever-tightening budget constraints., Objective: To estimate the budget impact of introducing Neci + GCis for first-line treatment of msqNSCLC from U.S. commercial and Medicare payer perspectives., Methods: The budget impact model estimates the costs of msqNSCLC before and after adoption of Neci + GCis in hypothetical U.S. commercial and Medicare health plans over a 3-year time horizon. The eligible patient population was estimated from U.S. epidemiology statistics. Clinical data were obtained from randomized clinical trials, U.S. prescribing information, and clinical guidelines. Market share projections were based on market research data. Cost data were obtained from online sources and published literature. The incremental aggregate annual health plan, per-patient-per-year (PPPY), and per-member-per-month (PMPM) costs were estimated in 2015 U.S. dollars. One-way sensitivity analyses were conducted to assess the effect of model parameters on results., Results: In a hypothetical 1,000,000-member commercial health plan with an estimated population of 30 msqNSCLC patients receiving first-line chemotherapy, the introduction of Neci + GCis at an initial market share of approximately 5% had an overall year 1 incremental budget impact of $88,394 ($3,177 PPPY, $0.007 PMPM), representing a 2.9% cost increase and reaching $304,079 ($10,397 PPPY, $0.025 PMPM) or a 7.4% cost increase at a market share of 14.7% in year 3. This increase in total costs was largely attributable to Neci drug costs and, in part, due to longer survival and treatment duration for patients treated with Neci+GCis. Overall, treatment costs increased by $81,812 (13.5%), and disease costs increased by $7,951 (0.4%), whereas adverse event costs decreased by $1,368 (0.5%) in year 1. From the Medicare perspective, the overall year 1 incremental budget impact was $438,056 ($0.037 PMPM, $3,112 PPPY), representing a 3.0% cost increase. The higher incremental budget in Medicare, compared with commercial plans, was due to higher msqNSCLC incidence in the older Medicare patients (154 vs. 30 patients, respectively). Results were most sensitive to Neci drug costs., Conclusions: Based on projected market shares, coverage for first-line therapy with Neci + GCis appeared to modestly affect overall U.S. health care budgets for msqNSCLC-related care. Given the small eligible patient population, the PMPM budgetary impact on a commercial health plan of reimbursing Neci + GCis in the first year was less than $0.01, rising with increased use of Neci + GCis to $0.025 in the third year. The real-world effect of Neci + GCis needs to be evaluated to validate this analysis; however, these findings may help policymakers in making coverage decisions for Neci + GCis., Disclosures: This study was funded by Eli Lilly and Company. Molife, Brown, Tawney, and Cuyun Carter are equity holders and employees of Eli Lilly and Company. Bly, Cinfio, and Klein are employees of Medical Decision Modeling, which received funding from Eli Lilly and Company to conduct this research and prepare this manuscript.

Introduction: Brodalumab is a new biologic approved by the US Food and Drug Administration in 2017 for the treatment of moderate-severe psoriasis. This study evaluated the impact of the introduction of brodalumab on the pharmacy budget on US commercial health plans., Methods: An Excel-based health economic decision analytic model with a US health plan perspective was developed. The model incorporated published moderate-to-severe psoriasis prevalence data; market shares of common biologic drugs, including adalimumab, ustekinumab, secukinumab, ixekizumab, and etanercept, used for the treatment of moderate-severe psoriasis; 2017-year Wholesale Acquisition Costs for the biologic drugs; drug dispensing fee; patient co-pay; and drug contracting discount. Total annual health plan costs for the biologic drugs were estimated. Scenarios with different proportions of patients treated with brodalumab were compared to a control scenario when no brodalumab was used., Results: In a hypothetical commercial health plan covering two million members, 7,038 moderate-to-severe psoriasis patients were estimated to be eligible for treatment with brodalumab. Prior to brodalumab approval, the proportions of patients treated by other biologics were estimated at 50.8% for adalimumab, 13.5% for ustekinumab, 14.1% for secukinumab, 4.4% for ixekizumab, and 17.2% for etanercept. With a 20% drug price discount applied to all biologics, the annual health plan costs for brodalumab, adalimumab, ustekinumab, secukinumab, ixekizumab, and etanercept were estimated at $37,224, $49,166, $55,084, $56,061, $64,396, and $57,170, respectively. When no brodalumab is used, the total annual pharmacy budget for the biologics used among these patients was estimated at $414,362,647. Among scenarios where the proportions of brodalumab usage were 3%, 8%, 16%, and 30%, the total annual pharmacy cost was estimated to be reduced by $3,698,129, $9,861,677, $19,723,355, and $36,981,290, respectively., Conclusion: Based on the economic model, brodalumab has the potential to substantially reduce pharmacy expenditures for the treatment of patients with moderate-to-severe plaque psoriasis in the US.

Objective: To determine the net economic impact of switching from low-osmolar contrast media (LOCM) to iso-osmolar contrast media (IOCM; iodixanol) in patients undergoing inpatient coronary or peripheral angioplasty in the United States (US)., Methods: A budget impact model (BIM) was developed from a hospital perspective. Nationally representative procedural and contrast media prevalence rates, along with MARCE (major adverse renal cardiovascular event) incidence and episode-related cost data were derived from Premier Hospital Data (October 2014 to September 2015). A previously estimated relative risk reduction in MARCE associated with IOCM usage (9.3%) was applied. The higher cost of IOCM was included when calculating the net impact estimates at the aggregate, hospital type, and per hospital levels. One-way (±25%) and probabilistic sensitivity analyses identified the model's most important inputs., Results: Based on weighted analysis, 513,882 US inpatient angioplasties and 35,610 MARCE cases were estimated annually. Switching to an "IOCM only" strategy from a "LOCM only" strategy increases contrast media cost, but prevents 2,900 MARCE events. The annual budget impact was an estimated saving of $30.71 million, aggregated across all US hospitals, $6,316 per hospital, or $60 per procedure. Net savings were maintained across all univariate sensitivity analyses. While MARCE/event-free cost differential was the most important factor driving total net savings for hospitals in the Northeast and West, procedural volume was important in the Midwest and rural locations., Conclusions: Switching to an "IOCM only" strategy from a "LOCM only" approach yields substantial net global savings to hospitals, both at the national level and within hospital sub-groups. Hospital administrators should maintain awareness of the factors that are likely to be more influential for their hospital and recognize that purchasing on the basis of lower contrast media cost may result in higher overall costs for patients undergoing inpatient angioplasty.

Objective: To examine the impact of provider competition under global budgeting on the use of cesarean delivery in Taiwan., Data Sources/study Setting: (1) Quarterly inpatient claims data of all clinics and hospitals with birth-related expenses from 2000 to 2008; (2) file of health facilities' basic characteristics; and (3) regional quarterly point values (price conversion index) for clinics and hospitals, respectively, from the fourth quarter in 1999 to the third quarter in 2008, from the Statistics of the National Health Insurance Administration., Study Design: Panel data of quarterly facility-level cesarean delivery rates with provider characteristics, birth volumes, and regional point values are analyzed with the fractional response model to examine the effect of external price changes on provider behavior in birth delivery services., Principal Findings: The decline in de facto prices of health services as a result of noncooperative competition under global budgeting is associated with an increase in cesarean delivery rates, with a high degree of response heterogeneity across different types of provider facilities., Conclusions: While global budgeting is an effective cost containment tool, intensified financial pressures may lead to unintended consequences of compromised quality due to a shift in provider practice in pursuit of financial rewards., (© Health Research and Educational Trust.)