An empirical investigation of time-varying cost-effectiveness across the product life cycle.

Cost-effectiveness is traditionally treated as a static estimate driven by clinical trial efficacy and drug price at launch. Prior studies suggest that cost-effectiveness varies over the drug's lifetime. We examined the impact of "learning by doing," one of the least studied drivers of changes in cost-effectiveness across the product life cycle. We combined time-series trends in effectiveness over time by cancer regimen using the Surveillance, Epidemiology, and End Results-Medicare database. We estimated the time-varying effects of treatments in colorectal and pancreatic cancer over their life cycle, including FOLFOX (leucovorin, 5-fluorouracil, and oxaliplatin) and gemcitabine, on survival of patients. Mean prices over time by strength and dosage form were calculated using historical wholesale acquisition costs. We found consistent downward trends in the mortality hazard ratios, which suggest that effectiveness improves over time. In the case of first-line FOLFOX for colorectal cancer, the implied incremental cost-effectiveness ratio based on the observational data fell from $610,000 per life year gained in 2004 to $27,000 per life year gained in 2011. Cost-effectiveness estimated at launch is unlikely to be representative of cost-effectiveness over the drug's lifetime. In the drugs studied, the impact of time-varying clinical effectiveness dominated the impact of changing prices overtime.

Amazon plant diversity revealed by a taxonomically verified species list.

Recent debates on the number of plant species in the vast lowland rain forests of the Amazon have been based largely on model estimates, neglecting published checklists based on verified voucher data. Here we collate taxonomically verified checklists to present a list of seed plant species from lowland Amazon rain forests. Our list comprises 14,003 species, of which 6,727 are trees. These figures are similar to estimates derived from nonparametric ecological models, but they contrast strongly with predictions of much higher tree diversity derived from parametric models. Based on the known proportion of tree species in neotropical lowland rain forest communities as measured in complete plot censuses, and on overall estimates of seed plant diversity in Brazil and in the neotropics in general, it is more likely that tree diversity in the Amazon is closer to the lower estimates derived from nonparametric models. Much remains unknown about Amazonian plant diversity, but this taxonomically verified dataset provides a valid starting point for macroecological and evolutionary studies aimed at understanding the origin, evolution, and ecology of the exceptional biodiversity of Amazonian forests.

Maternal and Infant Adverse Outcomes Associated with Mild and Severe Preeclampsia during the First Year after Delivery in the United States.

OBJECTIVE: The burden of preeclampsia severity on the health of mothers and infants during the first year after delivery is unclear, given the lack of population-based longitudinal studies in the United States. STUDY DESIGN: We assessed maternal and infant adverse outcomes during the first year after delivery using population-based hospital discharge information merged with vital statistics and birth certificates of 2,021,013 linked maternal-infant births in California. We calculated sampling weights using the National Center for Health Statistics data to adjust for observed differences in maternal characteristics between California and the rest of the United States. Separately, we estimated the association between preeclampsia and gestational age and examined collider bias in models of preeclampsia and maternal and infant adverse outcomes. RESULTS: Compared with women without preeclampsia, women with mild and severe preeclampsia delivered 0.66 weeks (95% confidence interval [CI]: 0.64, 0.68) and 2.74 weeks (95% CI: 2.72, 2.77) earlier, respectively. Mild preeclampsia was associated with an increased risk of having any maternal adverse outcome (relative risk [RR] = 1.95; 95% CI: 1.93, 1.97), as was severe preeclampsia (RR = 2.80; 95% CI: 2.78, 2.82). The risk of an infant adverse outcome was increased for severe preeclampsia (RR = 2.15; 95% CI: 2.14, 2.17) but only marginally for mild preeclampsia (RR = 0.99; 95% CI: 0.98, 1). Collider bias produced an inverse association for mild preeclampsia and attenuated the association for severe preeclampsia in models for any infant adverse outcome. CONCLUSION: Using multiple datasets, we estimated that severe preeclampsia is associated with a higher risk of maternal and infant adverse outcomes compared with mild preeclampsia, including an earlier preterm delivery.

An empirical tool for estimating the share of unmet need due to healthcare inefficiencies, suboptimal access, and lack of effective technologies.

BACKGROUND: Although there has been growing attention to the measurement of unmet need, which is the overall epidemiological burden of disease, current measures ignore the burden that could be eliminated from technological advances or more effective use of current technologies. METHODS: We developed a conceptual framework and empirical tool that separates unmet need from met need and subcategorizes the causes of unmet need into suboptimal access to and ineffective use of current technologies and lack of current technologies. Statistical models were used to model the relationship between health-related quality of life (HR-QOL) and treatment utilization using data from the National Health and Wellness Survey (NHWS). Predicted HR-QOL was combined with prevalence data from the Global Burden of Disease Study (GBD) to estimate met need and the causes of unmet need due to morbidity in the US and EU5 for five diseases: rheumatoid arthritis, breast cancer, Parkinson's disease, hepatitis C, and chronic obstructive pulmonary disease (COPD). RESULTS: HR-QOL was positively correlated with adherence to medication and patient-perceived quality and negatively correlated with financial barriers. Met need was substantial across all disease and regions, although significant unmet need remains. While the majority of unmet need was driven by lack of technologies rather than ineffective use of current technologies, there was considerable variation across diseases and regions. Overall unmet need was largest for COPD, which had the highest prevalence of all diseases in this study. CONCLUSION: We developed a methodology that can inform decisions about which diseases to invest in and whether those investments should focus on improving access to currently available technologies or inventing new technologies.

The Economic and Social Burden of the 2014 Ebola Outbreak in West Africa.

Background: The 2014 Ebola virus disease (EVD) outbreak in West Africa was more devastating than all previous EVD outbreaks combined; however, many estimates of its economic burden did not capture its significant social costs. This study aimed to review all currently available estimates, identify social components missed by these estimates, and generate a comprehensive cost of the 2014 EVD outbreak. Methods: We conducted a systematic review of the grey (reports produced by nonprofit or nongovernmental organizations, government, or industry) and published literature to identify current estimates of the burden of the outbreak. Based on the findings of this review, we identified 6 key areas absent or underestimated from previous estimates and calculated the underestimated social costs using estimates from the literature and extrapolation. Results: Current estimates of the economic burden of the outbreak range from $2.8 to $32.6 billion in lost gross domestic product. We estimated the comprehensive economic and social burden from the 2014 EVD outbreak to be $53.19 billion (2014 USD). The most significant component, $18.8 billion, was deaths from non-Ebola causes. Conclusions: A more complete understanding of the burden of the 2014 EVD outbreak underscores the value of interventions that can mitigate or reduce the severity of future outbreaks.

Short-term costs of preeclampsia to the United States health care system.

BACKGROUND: Preeclampsia is a leading cause of maternal morbidity and mortality and adverse neonatal outcomes. Little is known about the extent of the health and cost burden of preeclampsia in the United States. OBJECTIVE: This study sought to quantify the annual epidemiological and health care cost burden of preeclampsia to both mothers and infants in the United States in 2012. STUDY DESIGN: We used epidemiological and econometric methods to assess the annual cost of preeclampsia in the United States using a combination of population-based and administrative data sets: the National Center for Health Statistics Vital Statistics on Births, the California Perinatal Quality Care Collaborative Databases, the US Health Care Cost and Utilization Project database, and a commercial claims data set. RESULTS: Preeclampsia increased the probability of an adverse event from 4.6% to 10.1% for mothers and from 7.8% to 15.4% for infants while lowering gestational age by 1.7 weeks (P < .001). Overall, the total cost burden of preeclampsia during the first 12 months after birth was $1.03 billion for mothers and $1.15 billion for infants. The cost burden per infant is dependent on gestational age, ranging from $150,000 at 26 weeks gestational age to $1311 at 36 weeks gestational age. CONCLUSION: In 2012, the cost of preeclampsia within the first 12 months of delivery was $2.18 billion in the United States ($1.03 billion for mothers and $1.15 billion for infants), and was disproportionately borne by births of low gestational age.

Estimating the future burden of cardiovascular disease and the value of lipid and blood pressure control therapies in China.

BACKGROUND: Lifestyle and dietary changes reflect an ongoing epidemiological transition in China, with cardiovascular disease (CVD) playing an ever-increasing role in China's disease burden. This study assessed the burden of CVD and the potential value of lipid and blood pressure control strategies in China. METHODS: We estimated the likely burden of CVD between 2016 and 2030 and how expanded use of lipid lowering and blood pressure control medication would impact that burden in the next 15 years. Accounting for the costs of drug use, we assessed the net social value of a policy that expands the utilization of lipid and blood pressure lowering therapies in China. RESULTS: Rises in prevalence of CVD risk and population aging would likely increase the incidence of acute myocardial infarctions (AMIs) by 75 million and strokes by 118 million, while the number of CVD deaths would rise by 39 million in total between 2016 and 2030. Universal treatment of hypertension and dyslipidemia patients with lipid and blood pressure lowering therapies could avert between 10 and 20 million AMIs, between 8 and 30 million strokes, and between 3 and 10 million CVD deaths during the 2016-2030 period, producing a positive social value net of health care costs as high as $932 billion. CONCLUSIONS: In light of its aging population and epidemiological transition, China faces near-certain increases in CVD morbidity and mortality. Preventative measures such as effective lipid and blood pressure management may reduce CVD burden substantially and provide large social value. While the Chinese government is implementing more systematic approaches to health care delivery, prevention of CVD should be high on the agenda.

The Rising Burden of Preeclampsia in the United States Impacts Both Maternal and Child Health.

OBJECTIVE: Preeclampsia is one of the top six causes of maternal mortality in the United States (US) and is associated with considerable perinatal morbidity and mortality. Evidence suggests the US incidence of preeclampsia has increased dramatically over the past two decades. This study aims to compile, summarize, and critique the literature on the health and economic burden of preeclampsia and early-onset preeclampsia. STUDY DESIGN: We reviewed the literature for estimates of burden of preeclampsia and early-onset preeclampsia to both mother and child, summarized the evidence on economic and social burden, and highlighted current gaps in the literature. RESULTS: No recent studies comprehensively assess the costs and health consequences of preeclampsia or early-onset preeclampsia for both mother and child. Where it exists, the literature suggests preeclampsia and early-onset preeclampsia cause numerous adverse health consequences, but these conditions currently lack effective treatment. The need for preterm delivery from early-onset preeclampsia suggests its costs are substantial: very (28-31 weeks) and extremely (<28 weeks) preterm birth cost approximately 40 and 100 times a term pregnancy, respectively. CONCLUSION: Given the severity of outcomes from preeclampsia, further research on its health and economic consequences is essential to inform policy and resource allocation decisions in health care.

Turning evidence into practice under payment reform: the new frontier of translational science.

Momentum is building to replace the current fee-for-service payment system with value-based reimbursement models that aim to deliver high quality care at lower costs. Although the goals of payment and delivery system reforms to improve quality and reduce costs are clear, the actual path by which provider groups can achieve these goals is not well understood, in large part because the role of identifying and discouraging the use of low-value, high-cost services and encouraging the use of high-value, low-cost services has traditionally fallen to health plans, not provider groups. The shifting focus towards provider accountability for costs and quality promises to expand the role of provider organizations from mainly delivering care to both delivering and prioritizing it based on costs and quality. We discuss how progress on two important but challenging fronts will be needed for provider groups to successfully translate evidence into value. First, robust evidence on the costs and benefits of treatments will need to be developed and made easily accessible to provider groups. Second, provider groups will need to translate that evidence into systems that support cost-effective clinical decisions.

Advances in Addressing Patient Heterogeneity in Economic Evaluation: A Review of the Methods Literature.

Cost-effectiveness analyses commonly use population or sample averages, which can mask key differences across subgroups and may lead to suboptimal resource allocation. Despite there being several new methods developed over the last decade, there is no recent summary of what methods are available to researchers. This review sought to identify advances in methods for addressing patient heterogeneity in economic evaluations and to provide an overview of these methods. A literature search was conducted using the Econlit, Embase and MEDLINE databases to identify studies published after 2011 (date of a previous review on this topic). Eligible studies needed to have an explicit methodological focus, related to how patient heterogeneity can be accounted for within a full economic evaluation. Sixteen studies were included in the review. Methodologies were varied and included regression techniques, model design and value of information analysis. Recent publications have applied methodologies more commonly used in other fields, such as machine learning and causal forests. Commonly noted challenges associated with considering patient heterogeneity included data availability (e.g., sample size), statistical issues (e.g., risk of false positives) and practical factors (e.g., computation time). A range of methods are available to address patient heterogeneity in economic evaluation, with relevant methods differing according to research question, scope of the economic evaluation and data availability. Researchers need to be aware of the challenges associated with addressing patient heterogeneity (e.g., data availability) to ensure findings are meaningful and robust. Future research is needed to assess whether and how methods are being applied in practice.

Modeling health impact of global health programs implemented by Population Services International.

BACKGROUND: Global health implementing organizations benefit most from health impact estimation models that isolate the individual effects of distributed products and services - a feature not typically found in intervention impact models, but which allow comparisons across interventions and intervention settings. Population Services International (PSI), a social marketing organization, has developed a set of impact models covering seven health program areas, which translate product/service distribution data into impact estimates. Each model's primary output is the number of disability-adjusted life-years (DALYs) averted by an intervention within a specific country and population context. This paper aims to describe the structure and inputs for two types of DALYs averted models, considering the benefits and limitations of this methodology. METHODS: PSI employs two modeling approaches for estimating health impact: a macro approach for most interventions and a micro approach for HIV, tuberculosis (TB), and behavior change communication (BCC) interventions. Within each intervention country context, the macro approach determines the coverage that one product/service unit provides a population in person-years, whereas the micro approach estimates an individual's risk of infection with and without the product/service unit. The models use these estimations to generate per unit DALYs averted coefficients for each intervention. When multiplied by program output data, these coefficients predict the total number of DALYs averted by an intervention in a country. RESULTS: Model outputs are presented by country for two examples: Water Chlorination DALYs Averted Model, a macro model, and the HIV Condom DALYs Averted Model for heterosexual transmission, a micro model. Health impact estimates measured in DALYs averted for PSI interventions on a global level are also presented. CONCLUSIONS: The DALYs averted models offer implementing organizations practical measurement solutions for understanding an intervention's contribution to improving health. These models calculate health impact estimates that reflect the scale and diversity of program operations and intervention settings, and that enable comparisons across health areas and countries. Challenges remain in accounting for intervention synergies, attributing impact to a single organization, and sourcing and updating model inputs. Nevertheless, these models demonstrate how DALYs averted can be viably used by the global health community as a metric for predicting intervention impact using standard program output data.

Risk Prediction Using Bayesian Networks: An Immunotherapy Case Study in Patients With Metastatic Renal Cell Carcinoma.

PURPOSE: To address the need for more accurate risk stratification models for cancer immuno-oncology, this study aimed to develop a machine-learned Bayesian network model (BNM) for predicting outcomes in patients with metastatic renal cell carcinoma (mRCC) being treated with immunotherapy. METHODS: Patient-level data from the randomized, phase III CheckMate 025 clinical trial comparing nivolumab with everolimus for second-line treatment in patients with mRCC were used to develop the BNM. Outcomes of interest were overall survival (OS), all-cause adverse events, and treatment-related adverse events (TRAE) over 36 months after treatment initiation. External validation of the model's predictions for OS was conducted using data from select centers from the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). RESULTS: Areas under the receiver operating characteristic curve (AUCs) for BNM-based classification of OS using baseline data were 0.74, 0.71, and 0.68 over months 12, 24, and 36, respectively. AUC for OS at 12 months increased to 0.86 when treatment response and progression status in year 1 were included as predictors; progression and response at 12 months were highly prognostic of all outcomes over the 36-month period. AUCs for adverse events and treatment-related adverse events were approximately 0.6 at 12 months but increased to approximately 0.7 by 36 months. Sensitivity analysis comparing the BNM with machine learning classifiers showed comparable performance. Test AUC on IMDC data for 12-month OS was 0.71 despite several variable imbalances. Notably, the BNM outperformed the IMDC risk score alone. CONCLUSION: The validated BNM performed well at prediction using baseline data, particularly with the inclusion of response and progression at 12 months. Additionally, the results suggest that 12 months of follow-up data alone may be sufficient to inform long-term survival projections in patients with mRCC.

Epidemiological and economic burden of metabolic syndrome and its consequences in patients with hypertension in Germany, Spain and Italy; a prevalence-based model.

BACKGROUND: The presence of metabolic syndrome in patients with hypertension significantly increases the risk of cardiovascular disease, type 2 diabetes and mortality. Our aim is to estimate the epidemiological and economic burden to the health service of metabolic syndrome in patients with hypertension in three European countries in 2008 and 2020. METHODS: An age, sex and risk group structured prevalence based cost of illness model was developed using the United States Adult Treatment Panel III of the National Cholesterol Education Program criteria to define metabolic syndrome. Data sources included published information and public use databases on disease prevalence, incidence of cardiovascular events, prevalence of type 2 diabetes, treatment patterns and cost of management in Germany, Spain and Italy. RESULTS: The prevalence of hypertension with metabolic syndrome in the general population of Germany, Spain and Italy was 36%, 11% and 10% respectively. In subjects with hypertension 61%, 22% and 21% also had metabolic syndrome. Incident cardiovascular events and attributable mortality were around two fold higher in subjects with metabolic syndrome and prevalence of type 2 diabetes was around six-fold higher. The economic burden to the health service of metabolic syndrome in patients with hypertension was been estimated at €24,427, €1,900 and €4,877 million in Germany, Spain and Italy and forecast to rise by 59%, 179% and 157% respectively by 2020. The largest components of costs included the management of prevalent type 2 diabetes and incident cardiovascular events. Mean annual costs per hypertensive patient were around three-fold higher in subjects with metabolic syndrome compared to those without and rose incrementally with the additional number of metabolic syndrome components present. CONCLUSION: The presence of metabolic syndrome in patients with hypertension significantly inflates economic burden and costs are likely to increase in the future due to an aging population and an increase in the prevalence of components of metabolic syndrome.

Access to health care and mortality of children under 5 years of age in the Gambia: a case-control study.

OBJECTIVE: To assess whether traditional measures of access to health care (distance and travel time to a facility) and non-traditional measures (social and financial support indicators) are associated with mortality among children under 5 years of age in the Gambia. METHODS: We conducted a case-control study in a population under demographic surveillance. Cases (n = 140) were children under 5 years of age who died between 31 December 2003 and 30 April 2006. Each case was matched in age and sex to five controls (n = 700). Information was gathered by interviewing primary caregivers. The data were analysed using conditional logistic regression. FINDINGS: Of traditional measures of access, only rural versus urban/periurban residence was important: children from rural areas were more likely to die (OR: 4.9; 95% confidence interval, CI: 1.2-20.2). For non-traditional measures, children were more likely to die if their primary caregivers lacked help with meal preparation (OR: 2.3; 95% CI: 1.2-4.1), had no one to relax with (OR: 1.8; 95% CI: 1.1-2.9), had no one who could offer good advice (OR: 23.1; 95% CI: 4.3-123.4), had little say over how earned money was spent (OR: 12.7; 95% CI: 1.3-127.6), were unable to cut spending for health care (OR: 2.5; 95% CI: 1.5-4.2) or had to carry out odd jobs to pay for the care (OR: 3.4; 95% CI: 2.1-5.5). A protective effect was observed when the caregiver had other children to care for (OR: 0.2; 95% CI: 0.1-0.5). CONCLUSION: Improving access to health-care for children in the Gambia and similar settings is not simply a matter of reducing travel time and distance to a health facility, but requires improvements in caregivers' support networks and their access to the financial resources they need.

Meeting oxygen needs in Africa: an options analysis from the Gambia.

OBJECTIVE: To compare oxygen supply options for health facilities in the Gambia and develop a decision-making algorithm for choosing oxygen delivery systems in Africa and the rest of the developing world. METHODS: Oxygen cylinders and concentrators were compared in terms of functionality and cost. Interviews with key informants using locally developed and adapted WHO instruments, operational assessments, cost-modelling and cost measurements were undertaken to determine whether oxygen cylinders or concentrators were the better choice. An algorithm and a software tool to guide the choice of oxygen delivery system were constructed. FINDINGS: In the Gambia, oxygen concentrators have significant advantages compared to cylinders where power is reliable; in other settings, cylinders are preferable as long as transporting them is feasible. Cylinder costs are greatly influenced by leakage, which is common, whereas concentrator costs are affected by the cost of power far more than by capital costs. Only two of 12 facilities in the Gambia were found suitable for concentrators; at the remaining 10 facilities, cylinders were the better option. CONCLUSION: Neither concentrators nor cylinders are well suited to every situation, but a simple options assessment can determine which is better in each setting. Nationally this would result in improved supply and lower costs by comparison with conventional cylinders alone, although ensuring a reliable supply would remain a challenge. The decision algorithm and software tool designed for the Gambia could be applied in other developing countries.

One size does not always fit all in value assessment.

Laying a clear path for incorporating reliable evidence on heterogeneity in value assessments could improve their applicability for healthcare decision making.

Costs and consequences of large-scale vector control for malaria.

BACKGROUND: Five large insecticide-treated net (ITN) programmes and two indoor residual spraying (IRS) programmes were compared using a standardized costing methodology. METHODS: Costs were measured locally or derived from existing studies and focused on the provider perspective, but included the direct costs of net purchases by users, and are reported in 2005 USD. Effectiveness was estimated by combining programme outputs with standard impact indicators. FINDINGS: Conventional ITNs: The cost per treated net-year of protection ranged from USD 1.21 in Eritrea to USD 6.05 in Senegal. The cost per child death averted ranged from USD 438 to USD 2,199 when targeting to children was successful.Long-lasting insecticidal nets (LLIN) of five years duration: The cost per treated-net year of protection ranged from USD 1.38 in Eritrea to USD 1.90 in Togo. The cost per child death averted ranged from USD 502 to USD 692.IRS: The costs per person-year of protection for all ages were USD 3.27 in KwaZulu Natal and USD 3.90 in Mozambique. If only children under five years of age were included in the denominator the cost per person-year of protection was higher: USD 23.96 and USD 21.63. As a result, the cost per child death averted was higher than for ITNs: USD 3,933-4,357. CONCLUSION: Both ITNs and IRS are highly cost-effective vector control strategies. Integrated ITN free distribution campaigns appeared to be the most efficient way to rapidly increase ITN coverage. Other approaches were as or more cost-effective, and appeared better suited to "keep-up" coverage levels. ITNs are more cost-effective than IRS for highly endemic settings, especially if high ITN coverage can be achieved with some demographic targeting.

Determinants of provider choice for malaria treatment: experiences from The Gambia.

Malaria is responsible for an estimated one million deaths per year, the vast majority in sub-Saharan Africa. Many of these deaths are attributed to delays in seeking treatment and poor adherence to drug regimes. While there are a growing number of studies describing the factors influencing treatment seeking for malaria, far less is known about the relative weight given to these factors in different settings. This study estimates two models of demand for malaria treatment in the Farafenni region of The Gambia. The first examines the determinants of seeking malaria treatment outside the home versus no treatment or self-care while the second identifies the determinants of provider choice conditional on having decided to seek malaria treatment outside the home. Providers included hospital; health centre; and 'other' which included pharmacies, kiosks; petty traders; neighbours; and traditional healers. Results show that older people were more likely to opt for self-care, or no treatment. The longer the time spent ill or the more severe the fever, the more likely a treatment was sought outside the home. Time of the year and availability of community infrastructure played a key role in both models. Poorer households and those from the Fula ethnic group were much more likely to visit an 'other' provider than a hospital. The policy and methodological implications of these findings are discussed.

Assessing Variation in the Cost of Palivizumab for Respiratory Syncytial Virus Prevention in Preterm Infants.

BACKGROUND: The variability in cost of palivizumab treatment, indicated for prevention of respiratory syncytial virus (RSV) infections in high-risk infants, has not been robustly estimated in prior studies. This study aimed to determine the cost variations of palivizumab from a US payer perspective for otherwise healthy preterm infants born 29-35 weeks gestational age (wGA) using infant characteristics and applied dosing regimens. METHODS: Fenton Growth Charts were merged with World Health Organization Child Growth Standards to estimate preterm infant growth patterns. The merged growth chart was applied to infants who received palivizumab from a prospective, observational registry to determine future body weight using each infant's wGA and birth weight. Using quarter 3 (Q3) 2016-Q2 2017 vial cost, treatment costs at monthly dosing intervals were estimated using expected weights and averaged by age to derive expected mean 2016-2017 RSV seasonal costs per infant under various dosing scenarios. RESULTS: Given different dosing scenarios (two to five doses), birth month, and growth patterns for preterm infants 29-35 wGA, the estimated average 2016-2017 seasonal cost of palivizumab treatment ranged from $3221 to $12,568. Outpatient-only cost (excluding first dose at hospital discharge) ranged from $1733 to $11,862. The main drivers of costs were dosing regimen (74% of variance), dosing interacted with birth month (17%), and wGA (6%). CONCLUSION: The considerable variability in the average cost of palivizumab treatment for preterm infants is driven by choice of dosing regimen, wGA, and birth month. Therefore, when estimating the cost of palivizumab, it is important to consider both infant characteristics at each dose and potential dosing regimens.

The Lifetime Health Burden of Delayed Graft Function in Kidney Transplant Recipients in the United States.

Background. Although delayed graft function (DGF) is associated with an increased risk of acute rejection and decreased graft survival, there are no estimates of the long-term or lifetime health burden of DGF. Objectives. To estimate the long-term and lifetime health burden of DGF, defined as the need for at least one dialysis session within the first week after transplantation, for a cohort representative of patients who had their first kidney transplant in 2014. Methods. Data from the United States Renal Data System (USRDS; 2001-2014) were used to estimate a semi-Markov parametric multi-state model with three disease states. Maximum length of follow-up was 13.7 years, and a microsimulation model was used to extrapolate results over a lifetime. The impact of DGF was assessed by simulating the model for each patient in the cohort with and without DGF. Results. At the end of 13.7 years of follow-up, DGF reduces the probability of having a functioning graft from 52% to 32%, increases the probability of being on dialysis from 10% to 19%, and increases the probability of death from 38% to 50% relative to transplant recipients who do not experience DGF. A typical transplant recipient with DGF (median age = 53) is observed to lose 0.87 quality-adjusted life-years (QALYs). Extrapolated over a lifetime, the same 53-year-old DGF patient is projected to lose 3.01 (95% confidence interval: 2.33, 3.70) QALYs relative to a transplant recipient with the same characteristics who does not experience DGF. Conclusions. The lifetime health burden of DGF is substantial. Understanding these consequences will help health care providers weigh kidney transplant decisions and inform policies for patients in the context of varying risks of DGF.