Search

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]

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]

Background: As economic considerations become more important in healthcare reimbursement, decisions about the further development of medical innovations need to take into account not only medical need and potential clinical effectiveness, but also cost-effectiveness. Already early in the innovation process economic evaluations can support decisions on development in specific indications or patient groups by anticipating future reimbursement and implementation decisions. One potential concept for early assessment is value-based pricing.Methods: The objective is to assess the feasibility of value-based pricing and product design for a hypothetical vascular closure device in the pre-clinical stage which aims at decreasing bleeding events. A deterministic decision-analytic model was developed to estimate the cost-effectiveness of established vascular closure devices from the perspective of the Statutory Health Insurance system. To identify early benchmarks for pricing and product design, three strategies of determining the product's value are explored: 1) savings from complications avoided by the new device; 2) valuation of the avoided complications based on an assumed willingness-to-pay-threshold (the efficiency frontier approach); 3) value associated with modifying the care pathways within which the device would be applied.Results: Use of established vascular closure devices is dominated by manual compression. The hypothetical vascular closure device reduces overall complication rates at higher costs than manual compression. Maximum cost savings of only about €4 per catheterization could be realized by applying the hypothetical device. Extrapolation of an efficiency frontier is only possible for one subgroup where vascular closure devices are not a dominated strategy. Modifying care in terms of same-day discharge of patients treated with vascular closure devices could result in cost savings of €400-600 per catheterization.Conclusions: It was partially feasible to calculate value-based prices for the novel closure device which can be used to inform product design. However, modifying the care pathway may generate much more value from the payers' perspective than modifying the device per se. Manufacturers should thus explore the feasibility of combining reimbursement of their product with arrangements that make same-day discharge attractive also for hospitals. Due to the early nature of the product, the results are afflicted with substantial uncertainty. [ABSTRACT FROM AUTHOR]

Aim Neuraxial blockade (epidural or spinal anesthesia/analgesia) with external cephalic version increases the external cephalic version success rate. Hospitals and insurers may affect access to neuraxial blockade for external cephalic version, but the costs to these institutions remain largely unstudied. The objective of this study was to perform a cost analysis of neuraxial blockade use during external cephalic version from hospital and insurance payer perspectives. Secondarily, we estimated the effect of neuraxial blockade on cesarean delivery rates. Methods A decision-analysis model was developed using costs and probabilities occurring prenatally through the delivery hospital admission. Model inputs were derived from the literature, national databases, and local supply costs. Univariate and bivariate sensitivity analyses and Monte Carlo simulations were performed to assess model robustness. Results Neuraxial blockade was cost saving to both hospitals ($30 per delivery) and insurers ($539 per delivery) using baseline estimates. From both perspectives, however, the model was sensitive to multiple variables. Monte Carlo simulation indicated neuraxial blockade to be more costly in approximately 50% of scenarios. The model demonstrated that routine use of neuraxial blockade during external cephalic version, compared to no neuraxial blockade, prevented 17 cesarean deliveries for every 100 external cephalic versions attempted. Conclusions Neuraxial blockade is associated with minimal hospital and insurer cost changes in the setting of external cephalic version, while reducing the cesarean delivery rate. [ABSTRACT FROM AUTHOR]

Background Micafungin demonstrated non-inferiority to caspofungin as definitive therapy for candidaemia and invasive candidiasis ( IC) in a major randomised clinical trial. Aim The aim of this study was to investigate if micafungin is a cost-saving option compared with caspofungin for treating candidaemia and IC. Methods A decision analytical model was constructed to capture downstream consequences of using either agent as initial therapy for candidaemia and IC. The main outcomes were treatment success and treatment failure (i.e. death, mycological persistence, emergent infection, clinical failure but microbiological success). Outcome probabilities and treatment pathways were derived from the literature. Cost inputs were from the latest Australian resources, and resource use was estimated by expert panel. The analysis was from the Australian hospital perspective. Sensitivity analyses using Monte Carlo simulation were conducted. Results Micafungin ( AU$52 816) was associated with a lower total cost than caspofungin ( AU$52 976), with a net cost-saving of $160 per patient. This was primarily due to the lower cost associated with alternative antifungal treatment in the micafungin arm. Hospitalisation was the main cost-driver for both arms. The model outcome was most sensitive to the proportion of treatment success in the micafungin arm. Uncertainty analysis demonstrated that micafungin had a 58% chance of being cost-saving compared with caspofungin. Conclusions Micafungin was cost-equivalent to caspofungin in treating candidaemia and IC, with variation in drug acquisition cost the critical factor. [ABSTRACT FROM AUTHOR]

Objective: To compare the cost of two treatment regimens for moderate to severe ovarian hyperstimulation syndrome (OHSS): conservative inpatient versus outpatient management with paracentesis.Design: A decision-tree mathematical model comparing conservative inpatient versus outpatient management of moderate to severe OHSS was created. The common final pathway of either management was resolution of OHSS. Sensitivity analyses were performed over the range of variables.Main Outcome Measure(s): Total management cost of OHSS.Result(s): The cost of conservative therapy including first-tier complications was $10,099 (range $9,655-$15,044). The cost of outpatient management with paracentesis was $1954 (range $788-$12,041). This resulted in an estimated cost savings of $8145 with outpatient management with paracentesis. One-way sensitivity analyses were performed. Varying the probability of admission after outpatient treatment still indicated that outpatient treatment was the most cost-effective (probability = 1.0, cost = $6110). Varying the duration of hospitalization with primary inpatient treatment was equal to outpatient treatment costs only at a stay of 0.71 days or shorter.Conclusion(s): Our model suggests early outpatient paracentesis for moderate to severe OHSS is the most cost-effective management plan when compared with traditional conservative inpatient therapy. The cost savings for outpatient management persisted throughout a variety of outcome probabilities. [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]