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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]

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]

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]

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: 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]