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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]

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]

Introduction: Low molecular weight heparins are effective and have a good tolerability profile as first-line prophylaxis for venous thromboembolism (VTE) in major orthopaedic surgery. However, pharmacological inequivalence within the class could lead to differences in cost-effectiveness ratios.Objective: To quantify the potential economic impact of subcutaneous bemiparin sodium 3500 IU/day compared with enoxaparin sodium 40 mg/day as prophylaxis for VTE in patients undergoing total knee replacement (TKR) surgery, considering both in-hospital and post-discharge outcomes and costs during 6 weeks of postoperative follow-up.Methods: A cost-effectiveness analysis was performed using a decision modelling approach. The results were expressed in terms of costs and incremental cost effectiveness in Euro (2002 values). The treatment costs (hospital stay, physician services, drug administration) and costs incurred due to complications such as pulmonary embolism and/or proximal deep vein thrombosis, bleeding events, wound haematoma and thrombocytopenia were considered for this analysis. The target population comprised all adult patients undergoing TKR surgery included in a previous clinical trial (n = 381). The study was conducted in the setting of the Spanish National Health System. The time horizon chosen was 6 weeks.Results: Bemiparin provided cost savings of Euro144.48 per patient compared with enoxaparin when costs derived from treatment and complications during the 6-week postoperative period were considered (Euro4675.01 vs Euro4819.49). Pharmacy costs per patient were lower for bemiparin during hospital stay (Euro43.34 vs Euro50.20; difference, Euro-6.86) and for post-discharge prophylaxis (Euro68.63 vs Euro87.78; difference Euro-19.15). Bemiparin was calculated to avoid 42 additional VTE events per 1000 patients treated at 6 weeks. The incremental cost-effectiveness analysis indicated that bemiparin was dominant over enoxaparin, producing better outcomes and cost savings. The sensitivity analysis supported the cost effectiveness of bemiparin in all the ranges tested for complications and costs.Conclusions: Our model suggests, based on its underlying assumptions and data, that bemiparin may be more cost effective than enoxaparin for thromboprophylaxis in total knee replacement surgery in the Spanish healthcare setting. [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]

Initial reports on HemoQuant, a new quantitative test for occult gastrointestinal bleeding, suggest it is more sensitive than Hemoccult. Increased detection of upper gastrointestinal tract bleeding and dietary hemoglobin may reduce HemoQuant's specificity in the screening setting. The authors performed a cost effectiveness analysis comparing Hemoccult and HemoQuant for colorectal cancer screening using assumptions based on probabilities and costs in the current literature, varying the specificity of HemoQuant. The analysis showed the marginal cost effectiveness of Hemoccult versus no test to be $43,000, and HemoQuant versus Hemoccult to be $296,000 if HemoQuant specificity is 0.95. The marginal cost effectiveness ratio increased to $601,000 if three HemoQuant tests were used. Survival benefit was small and highly dependent on Hemoccult sensitivity and mortality from colonoscopy if HemoQuant specificity was less than 0.9. The authors conclude that unless the high sensitivity reported for HemoQuant is accompanied by a specificity comparable to that of Hemoccult, HemoQuant may not be an acceptable alternative for colorectal cancer screening. [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: The majority of serious thromboembolic events occurring in assisted reproductive technologies (ART) are in women with ovarian hyperstimulation syndrome (OHSS).Objectives: The purpose of this study was to present a thorough review and cost analysis regarding the use of venous thromboembolism (VTE) prophylaxis in OHSS to inform clinical management.Data Sources: Databases used were Pubmed and Embase, in addition to checking reference lists of retrieved articles (inception to November 2017).Methods: The systematic search strategy identified 365 titles and abstracts. Articles included in the qualitative synthesis had identified venous thrombosis incidence rates or ratios. A separate search for the cost model was conducted recognizing all associated complications of VTE. The decision tree was modeled to best fit the patient population and a sensitivity analysis was performed over a range of variables.Results: The cost of VTE event per OHSS patient not on prophylaxis was €5940 (range €3405 to €38,727), versus €4134 (€2705 to €23,192) per event per patient on prophylaxis, amounting to a saving of (€19 to €23,192) per VTE per patient. Sensitivity analysis found VTE prophyaxis to be cost effective if the incidence of VTE in the OHSS population was greater than 2.79%. Prophylactic therapy was cost effective through 16 weeks of treatment.Limitations: OHSS is infrequent and hence, the incidence of VTE in patients with OHSS is low; therefore, the data used to inform the incidence of VTE in OHSS in the model carry some uncertainty. Further, low molecular weight heparin (LMWH) has side effects therefore individualization of care must be considered.Conclusions: With the increasing incidence of infertility and requirement for ART, thromboembolism in OHSS poses a major health threat for patients. VTE prophylaxis using enoxaparin was cost effective in patients with severe OHSS over a wide range of costs and incidences. Prophylaxis was also cost effective through the completion of the first trimester of pregnancy. [ABSTRACT FROM AUTHOR]

Background: Multiple techniques have been suggested for the treatment of isolated knee articular cartilage injuries. For smaller lesions (<2-5 cm2), microfracture and osteochondral autograft transplantation (OAT) are commonly used options. With an increasing focus on health care efficiency, analyzing the cost-effectiveness of treatment modalities has become increasingly important. Purpose/Hypothesis: The purpose of this study was to analyze the costs and outcomes of microfracture and OAT to compare their cost-effectiveness. The hypothesis was that microfracture would be more cost-effective. Study Design: Economic and decision analysis; Level of evidence, 2. Methods: A literature search was performed to identify studies comparing microfracture and OAT for the treatment of articular cartilage lesions of the distal femur in an adult population. Data from these studies including surgical time, failure rates, revision surgeries, outcome scores, and return to athletics were then incorporated into a constructed cost model using standard accounting methodology. The model was based on actual 2013 cost figures (in US dollars) for all procedure, operating room, and instrumentation costs. Results: Three studies, with a mean follow-up of 8.7 years, met the inclusion criteria of having evidence level 1 or 2 comparing microfracture and OAT. There was a cumulative 28.6% reoperation rate among patients undergoing microfracture compared with 12.5% among patients undergoing OAT. While both groups demonstrated significant improvements compared with preoperative levels, the only significant differences in any outcome score reported between the 2 procedures were the International Cartilage Repair Society (ICRS) score and patient-reported return to their previous sports activity level. While microfracture had a lower initial cost ($3100), these savings lessened over 1 year ($1843) and 10 years ($996). Microfracture was more cost-effective when comparing Lysholm and Hospital for Special Surgery scores, whereas OAT was more cost-effective when comparing Tegner and ICRS scores. There was a significantly lower cost for return to play in athletes after OAT versus microfracture at 1 year ($11,428 vs $16,953, respectively), 3 years ($12,856 vs $38,000, respectively), and 10 years ($32,141 vs $60,799, respectively). Conclusion: Published level 1 and 2 clinical studies with a 10-year follow-up demonstrated that the net cost and cost-effectiveness of microfracture and OAT are comparable for the treatment of isolated articular cartilage lesions of the distal femur. Clinical Relevance: Given similar clinical outcomes, microfracture and OAT are both viable, cost-effective first-line treatment options for these injuries. [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]

Introduction: Excellent treatment outcomes with long-term durability and few adverse effects are expectations of treatments for chronic conditions. The long-term cost effectiveness of newer treatments for benign prostatic hyperplasia (BPH), including high-energy transurethral microwave thermotherapy (TUMT) and combination pharmaceutical therapy, has not been sufficiently studied against existing alternatives. The objective of this study was to estimate the incremental cost effectiveness of BPH treatment alternatives.Methods: We employed a Markov model over a 20-year time horizon and the payer's perspective to evaluate the cost effectiveness of watchful waiting (WW), pharmaceuticals (alpha-adrenoceptor antagonists [alpha-blockers], 5-alpha-reductase inhibitors [5-ARIs], combination therapy), TUMT and transurethral resection of the prostate (TURP) in treating BPH. Markov states included improvement in symptoms, no improvement in symptoms, adverse effects and death. We used data from the published literature for outcomes, including systematic reviews whenever possible. Costs were estimated using a managed-care claims database and Medicare fee schedules, and were reported in Dollars US, 2004 values. Costs and effectiveness outcomes were discounted at a rate of 3% per year. Men (aged > or =45 years) with moderate to severe lower urinary tract symptoms and uncomplicated BPH were included in the analysis, and results were stratified by age and BPH symptom levels. Outcomes included costs, QALYs, incremental cost-utility ratios and cost-effectiveness acceptability curves. Sensitivity analysis was performed on important parameters, with an emphasis on probabilistic sensitivity analysis.Results: alpha-Blockers and TUMT were cost effective for treating moderate symptoms using the threshold of Dollars US 50,000 per QALY. For example, at 65 years of age, the cost per QALY was Dollars US 16,018 for alpha-blockers compared with WW and Dollars US 30,204 for TUMT versus alpha-blockers. TURP was the most cost-effective treatment for severe symptoms (Dollars US 5824 per QALY ) versus WW. Model results were robust to changes in costs and sensitive to the assumed probabilities, utility weights, extent of improvement and life expectancy. Nevertheless, acceptability curves consistently demonstrated the same alternatives as most likely to be cost effective.Conclusions: Our model suggests that alpha-blockers and TURP appear to be the most cost-effective alternatives, from a US payer perspective, for BPH patients with moderate and severe symptoms, respectively. TUMT was promising for patients with moderate symptoms and the oldest patients with severe symptoms, but otherwise was dominated. Value of information analysis could be used to determine the net benefit of additional research. [ABSTRACT FROM AUTHOR]

The aim of this paper was to conduct a critical systematic review of the available literature on the clinical and economic burden of bladder cancer in developed countries, with a focus on the cost effectiveness of interventions aimed at reducing that burden. Forty-four economic studies were included in the review. Because of long- term survival and the need for lifelong routine monitoring and treatment, the cost per patient of bladder cancer from diagnosis to death is the highest of all cancers, ranging from $US96 000–187 000 (2001 values) in the US. Overall, bladder cancer is the fifth most expensive cancer in terms of total medical care expenditures, accounting for almost $US3.7 billion (2001 values) in direct costs in the US. Screening for bladder cancer in the general population is currently not recommended. The economic value of relatively new and less expensive urine assays and molecular urinary tumour markers has not been assessed. However, the literature suggests that screening patients suspected of having bladder cancer and using less invasive diagnostic procedures is cost effective. Very few cost-effectiveness studies have evaluated intravesical therapies such as bacillus Calmette-Guérin and mitomycin in the management of superficial disease and no robust recommendations can be drawn. Economic analyses suggest that non-surgical treatment strategies for the management of invasive disease aiming at bladder preservation may not be cost effective, because they have not consistently demonstrated survival benefits and do not eliminate the need for subsequent radical cystectomy. The literature suggests that the current conventional frequent follow-up and monitoring of patients can be cost effectively replaced by less frequent and less invasive monitoring, and should rely more heavily on intravesical chemotherapy to reduce the need for cystoscopies. Bladder cancer is a fairly common and costly malignancy. Nevertheless, the existing literature only contributes marginally to our knowledge concerning the burden of bladder cancer and the economic value of various interventions. The limited value of the literature in this area may be attributed to (i) being published as abstracts rather than full peer-reviewed evaluations; (ii) employing questionable methodologies; and (iii) being in many cases nearly obsolete, rendering them less relevant to, if not in conflict with, current clinical practice. Consequently, opportunities exist to conduct meaningful economic research in all areas of the management of bladder cancer, including screening, diagnosis, follow-up and treatment, especially with respect to new and innovative pharmaceutical and other technologies. [ABSTRACT FROM AUTHOR]