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Increasingly, medical writers are being asked to work with health economics and outcomes research (HEOR) information. HEOR uses data from both economic and clinical research to assess the clinical and economic value of new treatments. Many medical writers have the underlying skills required to incorporate HEOR concepts into their work but need more background to do this comfortably. This article provides an introduction to health economics study design, key terms, and commonly used outcomes research approaches. It also describes how health economics writing resembles and differs from traditional medical writing. It briefly explores the present and future role of HEOR in US health policy. [ABSTRACT FROM AUTHOR]

Background: Prolonged postoperative ileus (POI) is the predominant cause of extended hospitalization after bowel resection surgery. Alvimopan accelerates gastrointestinal recovery, potentially reducing health care costs. We examined the value of alvimopan in reducing prolonged POI and length of stay for patients undergoing abdominal surgery using different definitions of POI.Study Design: We developed a decision analytic model to examine costs and outcomes associated with postoperative treatment with either an accelerated care pathway (ACP) only or alvimopan+ACP. To represent an overall perspective for alvimopan, data from four phase 3 bowel resection trials and one phase 4 radical cystectomy trial were used to populate the model with 3 different definitions of POI. The period analyzed included start of surgery to 7 days post discharge. Costs were obtained from standard US costing sources and are reported in 2015 US dollars. Due to variations in published definitions of POI, alternative definitions based on adverse event reports, NG tube insertion, and time to food toleration were examined.Results: The combined clinical trial data included 1,003 ACP and 1,013 alvimopan+ACP patients. When POI was reported as an adverse event, the incidence of POI was significantly lower with alvimopan+ACP (n = 70 [7%]) vs ACP alone (n = 148 [15%]; p < 0.0001). Time to discharge order written was shorter for patients with POI who were treated with alvimopan+ACP than with ACP (202 ± 115 hours vs 266 ± 138 hours; p < 0.0001). As a result, costs were $731 lower with alvimopan+ACP ($17,835) vs ACP ($18,566). Alternative definitions of POI produced similar results.Conclusions: The addition of alvimopan to existing treatment pathways for patients undergoing abdominal surgery can reduce overall hospital costs. [ABSTRACT FROM AUTHOR]

Recent developments in healthcare reform legislation and in the private-payer marketplace have increased impetus toward clinical integration. Industry changes require that healthcare delivery institutions confront fundamental scope and scale structural issues that may lead to increased vertical integration. To accomplish integration, firms must decide the organizational form of integration (alliance or merger/acquisition). One form of integration, accountable care organizations (ACOs), has featured prominently in recent legislation. Clinical integration and ACOs present significant shared-governance challenges that must be understood by hospital boards. The author outlines these governance issues using a case study of Silver Cross Hospital's governance structure for its ACO. [ABSTRACT FROM AUTHOR]

Objectives: Infants born to mothers who are hepatitis B surface antigen (HBsAg) positive are at risk for perinatal hepatitis B infection. As prevention, these infants receive a series of 3 or 4 doses of hepatitis B vaccine starting at birth and postvaccination serologic testing. Infants with antibody levels <10 mIU/mL are considered vaccine nonresponders and should be revaccinated. The objective of this cost analysis was to assess a single-dose revaccination strategy among infant nonresponders. Methods: We used a decision analytic tree to compare the costs of a single-dose revaccination strategy with the costs of a 3-dose revaccination strategy. The analysis consisted of 3 epidemiologic scenarios that varied levels of previous protection among infants indicated for revaccination. We assumed health outcomes in each strategy were the same, and we evaluated costs from the societal perspective using 2016 US dollars. We conducted sensitivity analyses on key variables, including the minimum required efficacy of a single revaccination dose. Results: In all analyses, the single-dose revaccination strategy was a lower-cost option than the 3-dose revaccination strategy. Under the assumption that all revaccination visits were previously unscheduled, single-dose revaccination reduced the cost per infant by $119.81 to $155.72 (depending on the scenario). Across all scenarios, the most conservative estimate for the threshold efficacy (the minimum efficacy required to result in a lower-cost option) value of single-dose revaccination was 67%. Conclusions: For infants who were born to HBsAg-positive mothers and who were not responding to the initial vaccine series, a single-dose revaccination strategy, compared with a 3-dose revaccination strategy, reduced costs across several scenarios. These results helped inform the Advisory Committee on Immunization Practices' vote in February 2017 to recommend single-dose revaccination. [ABSTRACT FROM AUTHOR]

Purpose. The results of a pharmacoeconomic study of the cost-effectiveness of posaconazole versus fluconazole in preventing invasive fungal infections (IFIs) in patients with graft-versus-host disease (GVHD) are reported. Methods. The results of a randomized clinical trial suggested that posaconazole may be as effective as fluconazole for the prevention of IFIs in recipients of allogeneic cell transplants who develop severe GVHD and that posaconazole may be superior to fluconazole in reducing IFI-related deaths. Using published data from that trial and data from secondary sources, an economic model was developed to estimate the costs, IFIs avoided, and life-years saved with posaconazole versus fluconazole therapy. The results of the modeled 112-day treatment simulation were extrapolated to a lifetime horizon. Results. In the modeled simulation, posaconazole therapy was associated with a lower probability of IFI development (0.05 versus 0.09), increased discounted life-years (7.87 life-years versus 7.66 life-years), and higher discounted costs per patient ($8,860 versus $5,710 in 2006 U.S. dollars) relative to fluconazole therapy. The estimated incremental cost-effectiveness of posaconazole versus fluconazole for IFI prophylaxis was $85,300 per IFI avoided and $15,300 per life-year saved. A sensitivity analysis indicated a 90% probability that the use of posaconazole for this purpose would be cost-effective at a threshold of $50,000 per life-year saved. Conclusion. Posaconazole is in the range of currently accepted criteria for cost-effectiveness relative to fluconazole for the prevention of IFIs among patients with GVHD. [ABSTRACT FROM AUTHOR]

Abstract: Investments in power generation, pollution controls, and electricity end use equipment are made in the face of uncertainty. Unanticipated events can cause regret—commitments that in retrospect were the wrong choices. We analyze how three uncertainties—electricity demand growth, natural gas prices, and power sector greenhouse gas regulations—could affect electric power sector investment decisions and costs in the U.S. over the next four decades. The effect of multi-pollutant regulations such as the Clean Air Interstate Rule (CAIR) upon these decisions and costs is also considered. We use decision trees to structure the problem, defining multiple futures for each uncertainty and then simulating how the U.S. energy market responds to them. A two-stage stochastic version of the energy-economy model MARKAL simulates the market. Relative importance of the uncertainties is assessed using two indices: expected cost of ignoring uncertainty (ECIU) and expected value of perfect information (EVPI). We also calculate the value of policy coordination (VPC), the cost saved by avoiding surprise changes in policy. An example shows how a stochastic program can be used to compute these indices. The analysis shows that the possibility of greenhouse gas regulation is the most important uncertainty by these measures. [ABSTRACT FROM AUTHOR]

Overactive bladder is a common condition, with recent findings estimating the prevalence in adults at about 15%. Symptoms, including urinary urgency, high voiding frequency and urge incontinence, have been shown to decrease patients' quality of life. Given its high prevalence, the economic burden of overactive bladder is also substantial, with a recent estimate placing the annual cost in the US at 9.1 billion US dollars (year 2000 values). The objective of this review is to provide a critical appraisal of published economic evaluations of pharmacological and non-pharmacological treatments for overactive bladder. Published economic evaluations of treatments for overactive bladder have focused entirely on pharmacological treatments -- mainly on the two most commonly used drugs, oxybutynin and tolterodine, each of which is available in immediate- and extended-release formulations. Ten economic evaluations (more than half are cost-effectiveness studies) have been published. Modelling with decision trees or Markov models has been the predominant method. Evaluations comparing drug therapy with no treatment have concluded that drug therapy is cost effective. Analyses comparing the formulations of oxybutynin and tolterodine have produced highly inconsistent results, largely due to the sources of data employed for effectiveness and treatment discontinuation rates. There are no evaluations of drugs relative to non-pharmacological treatment, and there are other significant gaps in the economic evaluations of treatment to date. These include gaps resulting from a lack of reliable data on the performance of these drugs in real-world settings, particularly data on long-term persistence with treatment. A more definitive pharmacoeconomic comparison of oxybutynin and tolterodine formulations, incorporating all available clinical data, and other treatment options would help direct treatment. [ABSTRACT FROM AUTHOR]

Objectives: A key criticism of applying the friction cost approach (FCA) to productivity cost estimation is its focus on a single friction period. A more accurate estimate of the friction cost of worker absence requires consideration of the chain of secondary vacancies arising from the opening of a new primary vacancy. Currently, empirical evidence on this is almost absent. We suggest an original approach to empirically estimate productivity costs that include a chain of secondary vacancies.Methods: The vacancy multiplier is based on labor market flows and transition probabilities between states of employment, unemployment, and economic inactivity. It is a summed infinite geometric series using a common ratio et - the probability of an employed person filling a new job vacancy in a given year. We report vacancy multipliers for 30 European countries for 2011-2019.Results: The average multiplier across Europe is 2.21 (standard deviation [SD] = 0.40) in 2019, meaning that every new primary vacancy created a chain of secondary vacancies that increased the primary friction cost by a factor of 2.21. The equivalent multiplier is 1.99 (SD = 0.37) between 2011 and 2019. Romania had the lowest country-specific multiplier (1.11 in 2011), and Greece the highest (4.51 in 2011).Conclusions: Our results highlight the extent of underestimation of current FCA costs, comprise a resource for future researchers, and provide an implementable formula to compute the multiplier for other countries. [ABSTRACT FROM AUTHOR]

Objective: To estimate the effect of 20-week abortion bans on maternal and consequent neonatal health outcomes and costs in the setting of fetal congenital diaphragmatic hernia.Methods: A decision-analytic model was built using TreeAge software to evaluate the effect of a 20-week ban on abortion in a theoretical cohort of 921 women diagnosed with fetal congenital diaphragmatic hernia. Probabilities, utilities, and costs were derived from the literature. The cohort size was based on the annual rate of prenatal diagnoses of congenital diaphragmatic hernia and live births among the 20 states with bans. The threshold for cost-effectiveness was set at $100,000 per quality-adjusted life-year. Analysis was completed from the maternal perspective. Clinical outcomes included mode of delivery, maternal death, intrauterine fetal death, neonatal death, neurodevelopmental disability, and use of extracorporeal membrane oxygenation. One-way sensitivity analysis was used on all variables and Monte Carlo simulation was performed.Results: A policy restricting termination was associated with higher costs, at an additional $158,419,623, with decreased quality of life and 674 fewer quality-adjusted life-years. With 20-week bans in place, 60 women would travel out of state to obtain abortions. There would be 158 more live births affected by congenital diaphragmatic hernia. Of these births, 45 neonates would die before 28 days after birth and an additional 37 would have long-term neurodevelopmental disability.Conclusion: In this model, bans that limit abortions beyond 20 weeks of gestation were associated with worse health outcomes and increased costs for women with pregnancies complicated by congenital diaphragmatic hernia. The restriction of health care access should be considered in terms of the long-term outcomes and economic effect on individuals and society. [ABSTRACT FROM AUTHOR]

Objectives: Obstructive sleep apnea (OSA) may contribute to impaired performance among otherwise healthy active duty military personnel. We used decision analysis to evaluate three approaches to identifying and treating OSA in low-risk populations, which may differ from current standard practice for high-risk populations.Methods: We developed a decision tree to compare two simple strategies for diagnosis and management of sleep apnea in a low-risk population. In one strategy, a simple screening inventory was followed by conventional laboratory polysomnography (split-night), whereas the alternative strategy involved performing home testing in all individuals. This allowed us to weigh the costs associated with large-scale diagnostic approaches against the costs of untreated OSA in a small fraction of the population.Results: We found that the home testing approach was less expensive than the screen-then-test approach across a broad range of other important parameters, including the annual performance cost associated with untreated OSA, the prevalence of OSA, and the duration of active duty.Conclusions: Assuming even modest annual performance costs associated with untreated OSA, a population strategy involving large-scale home testing is less expensive than a screening inventory approach. These results may inform either targeted or large-scale investigation of undiagnosed OSA in low-risk populations such as active duty military. [ABSTRACT FROM AUTHOR]

West Nile virus (WNV) was first detected in the Western Hemisphere in 1999 in New York City. From 1999 through 2004, >16,600 cases of WNV-related illnesses were reported in the United States, of which >7,000 were neuroinvasive disease and >600 were fatal. Several approaches are under way to develop a human vaccine. Through simulations and sensitivity analysis that incorporated uncertainties regarding future transmission patterns of WNV and costs of health outcomes, we estimated that the range of values for the cost per case of WNV illness prevented by vaccination was US 20,000 dollars-59,000 dollars(mean 36,000 dollars). Cost-effectiveness was most sensitive to changes in the risk for infection, probability of symptomatic illness, and vaccination cost. Analysis indicated that universal vaccination against WNV disease would be unlikely to result in societal monetary savings unless disease incidence increases substantially over what has been seen in the past 6 years. [ABSTRACT FROM AUTHOR]

Urinary tract infection (UTI) is an infection anywhere in the urinary tract, most commonly due to bacteria. If infection involves the kidney, the UTI is termed acute pyelonephritis (APN). An estimated 10-30% of all patients with APN are hospitalised for treatment; in the US, the incidence of hospitalisation is 11.7 per 10,000 for women and 2.4 per 10,000 for men. Perhaps because of the generally good prognosis of APN when treated with current antibacterial therapies, there have been relatively few studies of patient management and therapeutic options for the disease, or of its epidemiology and risk factors. The most cost-effective outpatient management strategy (immediate discharge, observation followed by discharge, etc.) is currently unknown. Appropriate antimicrobial selection is clearly important, as treatment failures will increase the cost of care and result in additional morbidity for patients. The direct and indirect costs of APN are significant: an estimated 2.14 billion US dollars (year 2000 values). Cost estimates are most sensitive to hospitalisation rates, which are unknown in the US. Additional studies are needed to better define when in-hospital treatment is required. As the pathogens causing APN are increasingly becoming resistant to current therapies, not only are clinical trials in order to test the effectiveness of alternative therapies, but epidemiological studies to identify risk factors for infection with a resistant isolate and effective prevention strategies are required, especially among those with previous episodes of APN. [ABSTRACT FROM AUTHOR]

The availability of long-acting risperidone injection may increase adherence and lead to improved clinical and economic outcomes for individuals with schizophrenia. The objective of this study was to assess the cost effectiveness of long-acting risperidone, oral risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and haloperidol depot in patients with schizophrenia over 1 year from a healthcare system perspective. Published medical literature, unpublished data from clinical trials and a consumer health database, and a clinical expert panel were utilized to populate a decision analytical model comparing the seven treatment alternatives. The model captured rates of patient compliance, the rates, frequency and duration of relapse, incidence of adverse events, and healthcare resource utilization and associated costs. Primary outcomes were expressed in terms of percentage of patients relapsing per year, number of relapse days per year (number and duration of relapses per patient per year), and total direct 2003 medical cost per patient per year. On the basis of model projections, the proportions of patients experiencing a relapse requiring hospitalization in 1 year were 66% for haloperidol depot, 41% for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 26% for long-acting risperidone, whereas the proportions of patients with an exacerbation not requiring hospitalization were 60% for haloperidol depot, 37% for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 24% for long-acting risperidone. The mean number of days of relapse requiring hospitalization per patient per year were 28 for haloperidol depot, 18 for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 11 for long-acting risperidone, whereas the mean number of days of exacerbation not requiring hospitalization were eight for haloperidol depot, five for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and three for long-acting risperidone. This would translate into direct medical cost savings with long-acting risperidone compared with oral risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and haloperidol depot of US dollars 161, 1425, 508, 259, 1068, and 8224, respectively. These findings were supported by sensitivity analyses. The utilization of long-acting risperidone is predicted to result in better clinical outcomes and lower total healthcare costs than its comparators, oral risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and haloperidol depot. Long-acting risperidone may therefore be a cost saving therapeutic option for patients with schizophrenia. [ABSTRACT FROM AUTHOR]

Objective: To develop a user-friendly tool for managing the transfer of economic evaluation results.Methods: Factors that may influence the transfer of health economic study results were systematically identified and the way they impact on transferability was investigated. A transferability decision chart was developed that includes: knock-out criteria; a checklist based on the transferability factors; and methods for improving transferability and for assessing the uncertainty of transferred results. This approach was tested on various international cost-effectiveness studies in the areas of interventional cardiology, vaccination and screening.Results: The transfer of study results is possible pending the outcomes of the transferability check and necessary adjustments. Transferability factors can be grouped into areas of methodological, healthcare system and population characteristics. Different levels of effort are required for analysis of factors, ranging from very low (e.g. discount rate) to very high (e.g. practice variation). The impact of differences of most transferability factors can be estimated via the key health economic determinants: capacity utilisation, effectiveness, productivity loss and returns to scale. Depending on the outcomes of the transferability check a correction of the study results for inflation and for differences related to currencies or purchasing power might be sufficient. Otherwise, modelling-based adjustments might be necessary, requiring the (re-)building and sometimes structural modification of the study model. For determination of the most essential adjustments, a univariate sensitivity analysis seems appropriate. If not all relevant study parameters can be substituted with country-specific ones, multivariate or probabilistic sensitivity analysis seems to be a promising way to quantify the uncertainty associated with a transfer. If study results cannot be transferred, the transfer of study models or designs should be investigated as this can significantly save time when conducting a new study.Conclusions: Our transferability decision chart is a transparent and user-friendly tool for assessing and improving the transferability of economic evaluation results. A state of the art description of the methodology in a study, providing detailed components for calculation, is not only essential for determining its transferability but also for improving it via modelling adjustments. [ABSTRACT FROM AUTHOR]

Background: Clinical diagnosis and empiric therapy have been strategies for treatment of suspected influenza in high-risk patients, but rapid tests for influenza have been introduced to help confirm cases. The aim of this study was to determine when rapid testing, empiric treatment, or no treatment is most cost-beneficial for high-risk adults with influenzalike respiratory tract illnesses.Methods: We performed a cost-benefit analysis evaluating the comparative advantage of the strategies of empiric therapy, no treatment, or test and treat patients whose tests are positive. The analysis focused on a hypothetical population of patients who are at a high-risk for complications of influenza. Our main outcome was the cost of care for an episode of influenza taken from the human capital perspective.Results: For older anti-influenza drugs (amantadine and rimantadine), rapid testing is not as cost-beneficial as empiric treatment, even when the prevalence of influenza is low. For the neuraminidase inhibitors, there is a narrow window of disease prevalence between 30% and 40% where testing is most cost-beneficial. When the disease likelihood is above this window, empiric treatment is preferred. Below this window, no treatment is more cost-beneficial. Even under the most favorable conditions, testing is preferred only for a small range of prevalence rates of influenza.Conclusion: When clinicians are planning to use the nonneuraminidase inhibitors to treat influenza, rapid testing is not the most cost-beneficial approach. Even when the more expensive neuraminidase inhibitors will be used, testing has a limited role in managing influenza in high-risk patients. [ABSTRACT FROM AUTHOR]

Background: The clinical manifestations of atherothrombotic disease include ischaemic heart disease (including myocardial infarction [MI]) and cerebrovascular disease (including ischaemic stroke [IS]). Although costs generated by the clinical manifestations of atherothrombotic disease represent an important economic burden for any healthcare system, very few economic comparative data are available.Objective: To: (i) assess management costs of the different practice patterns for acute and chronic phases for MI, IS and peripheral arterial disease (PAD) in eight European countries; and (ii) to simulate the cost of managing a patient with an atherothrombotic disease for 2 years in Europe.Study Perspective: Healthcare system.Methods: Firstly, the medical costs of managing MI and IS were analysed during the acute phase and subsequent 6-month periods over a total of 2 years. In each case, a decision tree was designed to indicate resource use. Assumptions concerning patient management and resource use were based on currently available local and international literature, official national statistics and local expert opinions (Delphi panel). Costs were assessed using diagnosis-related groups (Austria, Italy, Portugal and Sweden), or hospital databases and national tariffs (Belgium, France, Spain and Switzerland). Secondly, these costs were correlated to data from a large randomised clinical trial to estimate the overall cost per patient with atherothrombotic disease over a 2-year period.Results: For MI, there was a 2-fold difference in costs between the eight countries (euro9512-18 293), with 47-76% of costs devoted to acute management, 14-48% to follow-up management during the first year, and 4-17% to follow-up during the second year. For IS, there was a 10-fold difference (euro5607-56 370), with 18-75% devoted to follow-up for the years 1995-1997.Conclusions: There are differences in the overall costs and cost breakdown in the clinical management patterns of MI and IS in Europe. These differences seem to arise as a result of local treatment pattern specificities as well as the availability of specific and well-adapted structures for patients' rehabilitation. Further studies are necessary to fully explain these differences. The assessment of the total medical costs of managing an atherothrombotic patient over a 2-year period (MI, IS, established PAD) has to take into account the risk of ischaemic events in different vascular areas (MI, IS or major leg ischaemia). [ABSTRACT FROM AUTHOR]