Search

Health care costs comprise a substantial portion of total national expenditure. Although interest in cost-effectiveness analysis in neurosurgery has increased, there has been little cross-comparison of neurosurgical procedures. The aim of this study was to compare costs across elective neurosurgical procedures to understand whether drivers of cost differ. The Value Driven Outcomes database was used to evaluate treatment costs for resection of vestibular schwannoma, intracranial meningioma, gliomas, and pituitary adenoma; anterior cervical discectomy and fusion and lumbar spinal fusion; and aneurysm treatment. A total of 1997 patients (mean age 54.6 ± 14.5 years; 45.2% male) were evaluated. The mean length of stay (LOS) was 4.0 ± 4.4 days. For cases involving hardware implantation, including spine fusion or aneurysm treatment, supplies and implants (49.1%) accounted for the largest fraction of costs followed by facility costs (37.9%). For cases that did not involve hardware, including tumor cases, facility costs (63.9%) were the largest fraction, followed by supplies and implants (16.2%). Aneurysm treatment and lumbar fusion were 1.5–3 times more costly than cranial tumor resection and anterior cervical discectomy and fusion per patient. Multivariate linear regression demonstrated that LOS (β = 0.7, P = 0.0001) and patient treatment type (β = 0.2, P = 0.0001) had the greatest effect on costs. LOS correlated with cost differently depending on case type; its effect was largest for patients with meningioma and smallest for patients with vestibular schwannoma. Costs across time increased similarly for all case types. Costs for neurosurgical procedures vary widely depending on treatment type and correlated directly with LOS. Strategies to reduce cost may require different approaches depending on procedure type. [ABSTRACT FROM AUTHOR]

Rising mortality in the United States due to alcoholic liver disease (ALD) and the dearth of effective treatments for ALD have led to increased research in this area, particularly in alcoholic hepatitis. To understand the burden of illness and potential economic value of effective treatments, we conducted a health care claims analysis of over 15,000 commercially insured adults who were hospitalized with alcoholic hepatitis (AH) between 2006 and 2013 and followed for up to 5 years. Their average age was 54 years and 68% were male. Over 5 years, about two-thirds of these adults died (44% in the first year), and fewer than 500 received liver transplants. There were nearly 40,000 re-hospitalizations, with over 50% of the survivors re-hospitalized within a year and nearly 75% through the second year. The total costs were nearly $145,000 per patient, with costs decreasing over time from over $50,000 in the first year (including the index hospitalization) to about $10,000 per year in the later years. Total costs for the cohort over 5 years were $2.2 billion. Patients who received a liver transplant averaged about $300,000 in transplant-related costs and over $1,000,000 in total health care costs over 5 years. Average costs in years following the index hospitalization were similar to diabetes. AH has a high mortality and is a high-cost condition. [ABSTRACT FROM AUTHOR]

Background: In a previous single center study we found that a standardized drug treatment algorithm (ALGO) was more cost effective than treatment as usual (TAU) for inpatients with major depression. This report aimed to determine whether this promising initial finding could be replicated in a multicenter study.Methods: Treatment costs were calculated for two time periods: the study period (from enrolment to exit from study) and time in hospital (from enrolment to hospital discharge) based on daily hospital charges. Cost per remitted patient during the study period was considered as primary outcome.Results: 266 patients received ALGO and 84 received TAU. For the study period, ALGO costs were significantly lower than TAU (ALGO: 7 848 ± 6 065 €; TAU: 10 033 ± 7 696 €; p = 0.04). For time in hospital, costs were not different (ALGO: 14 734 ± 8 329 €; TAU: 14 244 ± 8 419 €; p = 0.617). Remission rates did not differ for the study period (ALGO: 57.9%, TAU: 50.0%; p=0.201). Remission rates were greater in ALGO (83.3%) than TAU (66.2%) for time in hospital (p = 0.002). Cost per remission was lower in ALGO (13 554 ± 10 476 €) than TAU (20 066 ± 15 391 €) for the study period (p < 0.001) and for time in hospital (ALGO: 17 582 ± 9 939 €; TAU: 21 516 ± 12 718 €; p = 0.036).Limitations: Indirect costs were not assessed. Different dropout rates in TAU and ALGO complicated interpretation.Conclusions: Treatment algorithms enhance the cost effectiveness of the care of depressed inpatients, which replicates our prior results in an independent sample. [ABSTRACT FROM AUTHOR]

Question Among people admitted for inpatient rehabilitation, is usual care plus standing balance circuit classes more cost-effective than usual care alone? Design Cost-effectiveness study embedded within a randomised controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis. Participants 162 rehabilitation inpatients from a metropolitan hospital in Sydney, Australia. Intervention The experimental group received a 1-hour standing balance circuit class, delivered three times a week for 2 weeks, in addition to usual therapy. The circuit classes were supervised by one physiotherapist and one physiotherapy assistant for up to eight patients. The control group received usual therapy alone. Outcome measures Costs were estimated from routinely collected hospital use data in the 3 months after randomisation. The functional outcome measure was mobility measured at 3 months using the Short Physical Performance Battery administered by a blinded assessor. An incremental analysis was conducted and the joint probability distribution of costs and outcomes was examined using bootstrapping. Results The median cost savings for the intervention group was AUD4,741 (95% CI 137 to 9,372) per participant; 94% of bootstraps showed that the intervention was both effective and cost saving. Conclusions Two weeks of additional standing balance circuit classes delivered in addition to usual therapy resulted in decreased healthcare costs at 3 months in hospital inpatients admitted for rehabilitation. There is a high probability that this intervention is both cost saving and effective. Registration ACTRN12611000412932. [Treacy D, Howard K, Hayes A, Hassett L, Schurr K, Sherrington C (2018) Two weeks of additional standing balance circuit classes during inpatient rehabilitation are cost saving and effective: an economic evaluation. Journal of Physiotherapy 64: 41–47] [ABSTRACT FROM AUTHOR]

Aims: The objective of this study was to evaluate diabetes-related healthcare resource use and associated costs in patients with type 2 diabetes (T2DM) treated with a sulfonylurea (SU), with and without hypoglycemia.Methods: In this retrospective cohort study, patients 18years or older receiving SU monotherapy or as add-on to metformin were identified from a US healthcare claims database (MarketScan®). Of 113,743 patients (56.8% male, average age 62.6years), 61.6% were on SU/metformin dual therapy and 38.4% were on SU monotherapy, and 5% had one or more episodes of hypoglycemia during the 12-month follow-up period.Results: Adjusted for baseline characteristics, patients with hypoglycemia were three times more likely than those without to use emergency room services (OR 3.04, 95% CI: 2.82, 3.25), almost four times more likely to have inpatient admissions (OR 3.84, 95% CI: 3.58, 4.12), and had more frequent physician office visits (4.3 vs 3.0 visits, p<0.01) in the 12-month follow-up period. The adjusted annual diabetes-related medical expenditure was three times higher in patients with hypoglycemia compared with those without ($6884 vs $2392, p<0.001).Conclusions: This study demonstrated the higher healthcare utilization and costs associated with hypoglycemia in patients with T2DM treated with an SU. [ABSTRACT FROM AUTHOR]

Introduction Preterm birth is the leading cause of U.S. infant morbidity and mortality; Medicaid enrollees disproportionately experience preterm deliveries. Data suggest that progesterone—an evidence-based therapy for preventing preterm birth—is not accessible to all eligible Medicaid beneficiaries. This study aimed to identify variation in progesterone coverage guidelines in a sample of state Medicaid managed care organizations (MMCOs). Material and Methods Using a cross-sectional design, participation in a web-based survey was offered to 20 MMCO members of the Medicaid Health Plans of America. The survey assessed coverage guidelines for progesterone and associated interventions to prevent preterm birth. MMCOs identified key barriers in providing progesterone. Descriptive analyses were performed. Results Analyses included data from 18 plans providing coverage in 31 of the 39 states with MMCOs (response rate, 90.0%). Responding MMCOs were diverse: 55.6% were multistate, 33.3% were nonprofit, and 31.2% covered more than 1,000,000 lives. Most respondents (87.5%) covered branded progesterone, and 81.3% covered compounded progesterone. Prior authorization was required by most plans for branded progesterone (86.7%) or compounded progesterone (75.0%). The MMCO gestational age restrictions for initiating progesterone varied from 22 to 37 weeks of gestation, even within the same state. MMCO-identified barriers to providing progesterone included cost, lack of clinician knowledge of indications and coverage, and variation in billing procedures. Discussion Marked variation in MMCO coverage policies and procedures for progesterone and related interventions to prevent preterm birth was noted. Implications for Practice and Policy Standardizing MMCO coverage policies may be one way to improve access to evidence-based interventions that prevent preterm birth. [ABSTRACT FROM AUTHOR]

Background: The Society of Surgical Oncology and American Society of Radiation Oncology consensus statement was the first professional guideline in breast oncology to declare "no ink on tumor" as a negative margin in patients with stages I/II breast cancer undergoing breast-conservation therapy. We sought to analyze the financial impact of this guideline at our institution using a historic cohort.Study Design: We identified women undergoing re-excision after breast-conserving surgery for invasive breast cancer from 2010 through 2013 using a prospectively maintained institutional database. Clinical and billing data were extracted from the medical record and from administrative resources using CPT codes. Descriptive statistics were used in data analysis.Results: Of 254 women in the study population, 238 (93.7%) had stage I/II disease and 182 (71.7%) had invasive disease with ductal carcinoma in situ. A subcohort of 83 patients (32.7%) who underwent breast-conservation therapy for stage I/II disease without neoadjuvant chemotherapy had negative margins after the index procedure, per the Society of Surgical Oncology and American Society of Radiation Oncology guideline. The majority had invasive ductal carcinoma (n = 70 [84.3%]) and had invasive disease (n = 45 [54.2%]), and/or ductal carcinoma in situ (n = 49 [59.0%]) within 1 mm of the specimen margin. Seventy-nine patients underwent 1 re-excision and 4 patients underwent 2 re-excisions, accounting for 81 hours of operative time. Considering facility fees and primary surgeon billing alone, the overall estimated cost reduction would have been $195,919, or $2,360 per affected patient, under the guideline recommendations.Conclusions: Implementation of the Society of Surgical Oncology and American Society of Radiation Oncology consensus guideline holds great potential to optimize resource use. Application of the guideline to a retrospective cohort at our institution would have decreased the overall re-excision rate by 5.6% and reduced costs by nearly $200,000. Additional analysis of patient outcomes and margin assessment methods is needed to define the long-term impact on surgical practice. [ABSTRACT FROM AUTHOR]

Objective We aimed to describe the management of a carbapenemase-producing Acinetobacter baumannii (CP-AB) outbreak using the Outbreak Reports and Intervention Studies of Nosocomial Infection (ORION) statement. We also aimed to evaluate the cost of the outbreak and simulate costs if a dedicated unit to manage such outbreak had been set-up. Methods We performed a prospective epidemiological study. Multiple interventions were implemented including cohorting measures and limitation of admissions. Cost estimation was performed using administrative local data. Results Five patients were colonized with CP-AB and hospitalized in the neurosurgery ward. The index case was a patient who had been previously hospitalized in Portugal. Four secondary colonized patients were further observed within the unit. The strains of A . baumannii were shown to belong to the same clone and all of them produced an OXA-23 carbapenemase. The closure of the ward associated with the discharge of the five patients in a cohorting area of the Infectious Diseases Unit with dedicated staff put a stop to the outbreak. The estimated cost of this 17-week outbreak was $474,474. If patients had been managed in a dedicated unit — including specific area for cohorting of patients and dedicated staff — at the beginning of the outbreak, the estimated cost would have been $189,046. Conclusion Controlling hospital outbreaks involving multidrug-resistant bacteria requires a rapid cohorting of patients. Using simulation, we highlighted cost gain when using a dedicated cohorting unit strategy for such an outbreak. [ABSTRACT FROM AUTHOR]

Aim Capecitabine and bevacizumab (CAP-B) maintenance therapy has shown to be more effective compared with observation in metastatic colorectal cancer patients achieving stable disease or better after six cycles of first-line capecitabine, oxaliplatin, bevacizumab treatment in terms of progression-free survival. We evaluated the cost-effectiveness of CAP-B maintenance treatment. Methods Decision analysis with Markov modelling to evaluate the cost-effectiveness of CAP-B maintenance compared with observation was performed based on CAIRO3 study results (n = 558). An additional analysis was performed in patients with complete or partial response. The primary outcomes were the incremental cost-effectiveness ratio (ICER) defined as the additional cost per life year (LY) and quality-adjusted life years (QALY) gained, calculated from EQ-5D questionnaires and literature and LYs gained. Univariable sensitivity analysis was performed to assess the influence of input parameters on the ICER, and a probabilistic sensitivity analysis represents uncertainty in model parameters. Results CAP-B maintenance compared with observation resulted in 0.21 QALYs (0.18LYs) gained at a mean cost increase of €36,845, yielding an ICER of €175,452 per QALY (€204,694 per LY). Varying the difference in health-related quality of life between CAP-B maintenance and observation influenced the ICER most. For patients achieving complete or partial response on capecitabine, oxaliplatin, bevacizumab induction treatment, an ICER of €149,300 per QALY was calculated. Conclusion CAP-B maintenance results in improved health outcomes measured in QALYs and LYs compared with observation, but also in a relevant increase in costs. Despite the fact that there is no consensus on cost-effectiveness thresholds in cancer treatment, CAP-B maintenance may not be considered cost-effective. [ABSTRACT FROM AUTHOR]

Background: Sustained efforts at preventing diabetic foot ulcers (DFUs) and subsequent leg amputations are sporadic in most health care systems despite the high costs associated with such complications. We sought to estimate effectiveness targets at which cost-savings (i.e. improved health outcomes at decreased total costs) might occur.Methods: A Markov model with probabilistic sensitivity analyses was used to simulate the five-year survival, incidence of foot complications, and total health care costs in a hypothetical population of 100,000 people with diabetes. Clinical event and cost estimates were obtained from previously-published trials and studies. A population without previous DFU but with 17% neuropathy and 11% peripheral artery disease (PAD) prevalence was assumed. Primary prevention (PP) was defined as reducing initial DFU incidence.Results: PP was more than 90% likely to provide cost-savings when annual prevention costs are less than $50/person and/or annual DFU incidence is reduced by at least 25%. Efforts directed at patients with diabetes who were at moderate or high risk for DFUs were very likely to provide cost-savings if DFU incidence was decreased by at least 10% and/or the cost was less than $150 per person per year.Conclusions: Low-cost DFU primary prevention efforts producing even small decreases in DFU incidence may provide the best opportunity for cost-savings, especially if focused on patients with neuropathy and/or PAD. Mobile phone-based reminders, self-identification of risk factors (ex. Ipswich touch test), and written brochures may be among such low-cost interventions that should be investigated for cost-savings potential. [ABSTRACT FROM AUTHOR]

Context: A recently updated Community Guide systematic review of the effectiveness of school sealant programs (SSPs) still found strong evidence that SSPs reduced dental caries among schoolchildren. This follow-up systematic review updates SSP cost and benefit information from the original 2002 review.Evidence Acquisition: Using Community Guide economic review methods, the authors searched the literature from January 2000 to November 20, 2014. The final body of evidence included 14 studies-ten from the current search and four with cost information from the 2002 review. Nine studies had information on SSP costs; six on sealant benefit (averted treatment costs and productivity losses); four on SSP net cost (cost minus benefit); and three on net cost to Medicaid of clinically delivered sealants. The authors imputed productivity losses and discounted costs/outcomes when this information was missing. The analysis, conducted in 2015, reported all values in 2014 U.S. dollars.Evidence Synthesis: The median one-time SSP cost per tooth sealed was $11.64. Labor accounted for two thirds of costs, and time to provide sealants was a major cost driver. The median annual economic benefit was $6.29, suggesting that over 4 years the SSP benefit ($23.37 at a 3% discount rate) would exceed costs by $11.73 per sealed tooth. In addition, two of four economic models and all three analyses of Medicaid claims data found that SSP benefit to society exceeded SSP cost.Conclusions: Recent evidence indicates the benefits of SSPs exceed their costs when SSPs target schools attended by a large number of high-risk children. [ABSTRACT FROM AUTHOR]

Medical linear accelerators (linacs) and cobalt-60 machines are both mature technologies for external beam radiotherapy. A comparison is made between these two technologies in terms of infrastructure and maintenance, dosimetry, shielding requirements, staffing, costs, security, patient throughput and clinical use. Infrastructure and maintenance are more demanding for linacs due to the complex electric componentry. In dosimetry, a higher beam energy, modulated dose rate and smaller focal spot size mean that it is easier to create an optimised treatment with a linac for conformal dose coverage of the tumour while sparing healthy organs at risk. In shielding, the requirements for a concrete bunker are similar for cobalt-60 machines and linacs but extra shielding and protection from neutrons are required for linacs. Staffing levels can be higher for linacs and more staff training is required for linacs. Life cycle costs are higher for linacs, especially multi-energy linacs. Security is more complex for cobalt-60 machines because of the high activity radioactive source. Patient throughput can be affected by source decay for cobalt-60 machines but poor maintenance and breakdowns can severely affect patient throughput for linacs. In clinical use, more complex treatment techniques are easier to achieve with linacs, and the availability of electron beams on high-energy linacs can be useful for certain treatments. In summary, there is no simple answer to the question of the choice of either cobalt-60 machines or linacs for radiotherapy in low- and middle-income countries. In fact a radiotherapy department with a combination of technologies, including orthovoltage X-ray units, may be an option. Local needs, conditions and resources will have to be factored into any decision on technology taking into account the characteristics of both forms of teletherapy, with the primary goal being the sustainability of the radiotherapy service over the useful lifetime of the equipment. [ABSTRACT FROM AUTHOR]

Aim: Diabetes mellitus (DM) patients are susceptible to foot injury or foot diseases such as diabetic foot and peripheral arterial disease. Although these conditions are considered important, few studies have investigated them in detail. Therefore, we investigated the epidemiology of diabetic foot complications (DFC) with respect to the effects on the public healthcare system.Methods: We evaluated the incidence, clinical characteristics, health service utilization frequency and medical expenses of DFC in type 2 DM patients in the Korea National Diabetes Program (KNDP), the largest multi-center, prospective cohort in Korea (n=4405). To determine precise outcomes, we used national representative databases, including claims data from the Health Insurance Review & Assessment Service of Korea.Results: During a median follow-up period of 3.30years, 528 patients (12.0%) were newly diagnosed with DFC at an incidence rate of 43.02 cases per 1000 person-years. The patients with DFC were significantly older than patients without DFC, but other clinical characteristics were similar between the two groups. The patients with DFC had more hospital visits (p<0.001), longer duration of hospitalization (p<0.001), and increased expenses (p<0.001) compared to patients without DFC. After multiple adjustments, the differences in number of hospital visits and medical expenses were consistent. In a before and after comparison within the DFC group, all three variables increased significantly after the onset of DFC (p<0.001).Conclusions: DFC were significantly associated with poor clinical outcomes and caused a substantial burden to the national healthcare system in Korea. Therefore, intervention to prevent DFC is important. [ABSTRACT FROM AUTHOR]

Background Minimally invasive transforaminal lumbar interbody fusion (TLIF) has undergone significant evolution since its conception as a fusion technique to treat lumbar spondylosis. Minimally invasive TLIF is commonly performed using intraoperative two-dimensional fluoroscopic x-rays. However, intraoperative computed tomography (CT)–based navigation during minimally invasive TLIF is gaining popularity for improvements in visualizing anatomy and reducing intraoperative radiation to surgeons and operating room staff. This is the first study to compare clinical outcomes and cost between these 2 imaging techniques during minimally invasive TILF. Methods For comparison, 28 patients who underwent single-level minimally invasive TLIF using fluoroscopy were matched to 28 patients undergoing single-level minimally invasive TLIF using CT navigation based on race, sex, age, smoking status, payer type, and medical comorbidities (Charlson Comorbidity Index). The minimum follow-up time was 6 months. The 2 groups were compared in regard to clinical outcomes and hospital reimbursement from the payer perspective. Results Average surgery time, anesthesia time, and hospital length of stay were similar for both groups, but average estimated blood loss was lower in the fluoroscopy group compared with the CT navigation group (154 mL vs. 262 mL; P = 0.016). Oswestry Disability Index, back visual analog scale, and leg visual analog scale scores similarly improved in both groups ( P > 0.05) at 6-month follow-up. Cost analysis showed that average hospital payments were similar in the fluoroscopy versus the CT navigation groups ($32,347 vs. $32,656; P = 0.925) as well as payments for the operating room ( P = 0.868). Conclusions Single minimally invasive TLIF performed with fluoroscopy versus CT navigation showed similar clinical outcomes and cost at 6 months. [ABSTRACT FROM AUTHOR]

Background: Long-acting beta agonists (LABA) and leukotriene receptor antagonists (LTRA) are the major add-on treatments in older adults with persistent asthma when inhaled corticosteroids (ICS) fail to achieve adequate asthma control.Objectives: To evaluate the cost-utility of ICS + LABA treatment compared with ICS + LTRA treatment in older adults with asthma.Methods: A Markov model was used to estimate the incremental costs and quality-adjusted life expectancy associated with ICS + LABA treatment versus ICS + LTRA treatment in older adults with asthma in the United States from the health system perspective. The HCUPnet 2010 national statistics were used to extract the costs associated with asthma and cardiovascular hospitalizations, and inpatient mortality associated with these events. Event probabilities were predicted using Medicare 2009-2010 claims for older adults with asthma. Treatment costs were estimated on the basis of average wholesale drug price listings, and utility estimates were extracted from the literature. To account for uncertainty, one-way sensitivity analysis and probabilistic sensitivity analysis were performed.Results: The model predicted that, compared with ICS + LTRA treatment, ICS + LABA treatment costs $5,823 more while gaining 0.03 quality-adjusted life-years (QALYs), resulting in an incremental cost-effectiveness ratio of $209,090 per QALY. Hospitalization probabilities and posthospitalization utilities were the most influential parameters in the one-way sensitivity analysis. Probabilistic uncertainty analysis using Monte-Carlo simulations showed that the probabilities that ICS + LTRA treatment is cost-effective compared with ICS + LABA treatment are 77% and 62% at $50,000 and $100,000 per QALY gained willingness-to-pay thresholds, respectively.Conclusions: The cost-effectiveness of ICS + LABA treatment is economically unfavorable in older adults when compared with LTRA as add-on treatment. [ABSTRACT FROM AUTHOR]

Background: In a randomized controlled trial of two policies for induction of labor (IOL) using Prostaglandin E2 (PGE2) vaginal gel, women who had an earlier amniotomy experienced a shorter IOL-to-birth time.Objective: To report the cost analysis of this trial and determine if there are differences in healthcare costs when an early amniotomy is performed as opposed to giving more PGE2 vaginal gel, for women undergoing IOL at term.Study Design: Following an evening dose of PGE2 vaginal gel, 245 women with live singleton pregnancies, ≥37+0 weeks, were randomized into an amniotomy or repeat-PGE2 group. Healthcare costs were a secondary outcome measure, sourced from hospital finance systems and included staff costs, equipment and consumables, pharmacy, pathology, hotel services and business overheads. A decision analytic model, specifically a Markov chain, was developed to further investigate costs, and a Monte Carlo simulation was performed to confirm the robustness of these findings. Mean and median costs and cost differences between the two groups are reported, from the hospital perspective.Results: The healthcare costs associated with IOL were available for all 245 trial participants. A 1000-patient cohort simulation demonstrated that performing an early amniotomy was associated with a cost-saving of $AUD289 ($AUD7094 vs $AUD7338) per woman induced, compared with administering more PGE2. Propagating the uncertainty through the model 10,000 times, early amniotomy was associated with a median cost savings of $AUD487 (IQR -$AUD573, +$AUD1498).Conclusions: After an initial dose of PGE2 vaginal gel, a policy of administering more PGE2 when the Modified Bishop's score is <7 was associated with increased healthcare costs compared with a policy of performing an amniotomy, if technically possible. Length of stay was the main driver of healthcare costs. [ABSTRACT FROM AUTHOR]

Background: Subcutaneous (s.c.) administration of bortezomib is the most widely used route of administration for the treatment of patients with multiple myeloma. No study has as yet prospectively evaluated home versus hospital administration of s.c. bortezomib with respect to patient preference and cost. Patients and methods: In this prospective trial, myeloma patients received the first administration of s.c. bortezomib of each cycle in the outpatient unit of the Department of Hematology. When possible, all subsequent doses of bortezomib within each cycle were provided at home. A cost analysis was carried out to compare the average cost of an injection of bortezomib in the outpatient unit and at home. In order to compare hospital and home administration of bortezomib for preference and satisfaction, patients had to complete 2 simple questionnaires analyzing 16 criteria, such as quality of life, well-being, social life, satisfaction, safety, quality of care, the reduction in personal transportation time, and personal anxiety. Each item was analyzed using a Likert scale. Results: Fifty patients were studied. Overall, a total of 1043 s.c. injections of bortezomib were carried out, 655 (62.8%) at home, and 388 (35.2%) in the outpatient unit. The cost analysis showed that the total cost of one s.c. injection of bortezomib in the outpatient unit was ∊1510.09 versus ∊1224.57 for the home administration, which represents a reduction of ∊285.52, i.e. 20% of the cost of the hospital administration. The evaluation of patient preference and satisfaction showed that home administration improved the quality of life in 84% of the patients, increased well-being in 78%, and improved the activities of daily living in 72% of the cases. Overall, 98% of the patients noted their preference for home administration over the hospital administration of bortezomib. Conclusion: Home administration of s.c. bortezomib is cost-effective and is preferred by myeloma patients compared with hospital administration. [ABSTRACT FROM AUTHOR]

Background: Patients with asthma and chronic obstructive pulmonary disease (COPD) overlap syndrome (ACOS) have more rapid disease progression and more exacerbations than do those with either condition alone. Little research has been performed, however, in these patients.Objective: The objective was to summarize the health care utilization, costs, and comorbidities of patients with uncontrolled asthma and patients with ACOS.Methods: This retrospective analysis used medical and pharmacy claims from large commercial health plans. The study included patients 6 years or older with a diagnosis of asthma and one or more asthma exacerbation (index event). Patients were classified as having asthma alone or ACOS, and the two groups were matched for age, sex, region, index year, index month, and health plan type. Outcomes included rates of comorbid disease, health care utilization, and costs during the 12 months before and after the index exacerbation.Results: Among the matched patients with asthma (6,505 ACOS; 26,060 without COPD), mean annual all-cause health care costs were twice as high as for patients with ACOS ($22,393 vs. $11,716; P < 0.0001). Asthma-related costs, representing 29% of total costs, were nearly twice as high among patients with ACOS ($6,319 vs. 3,356; P < 0.0001). Cost differences were driven by large differences in the proportions of patients with an inpatient hospitalization (34.0% vs. 14.6%; P < 0.0001) or emergency department visit (29.6% vs. 19.9%; P < 0.0001). Nearly all prespecified comorbid conditions were more prevalent in the ACOS group.Conclusions: Patients with asthma and COPD had nearly double the health care costs as did patients with asthma without COPD. The overall disease profile of patients with asthma should be considered when managing patients, rather than treating asthma as a solitary condition. [ABSTRACT FROM AUTHOR]

Purpose Evidence suggests that clinical outcomes for people with type 2 diabetes mellitus can be improved through multifactorial treatment. The key challenges in the successful treatment of type 2 diabetes include maintaining tight glycemic control, minimizing the risk of hypoglycemia, controlling cardiovascular risk factors, and reducing or controlling weight. The aim of the present analysis was to evaluate the cost per patient achieving a composite clinical end point (glycosylated hemoglobin <7%, with no weight gain and no hypoglycemic events) in patients with type 2 diabetes in Quebec, Quebec, Canada, receiving liraglutide 1.2 mg, liraglutide 1.8 mg, thiazolidinedione, sulfonylurea, insulin glargine, sitagliptin, or exenatide. Methods The proportion of patients achieving control was taken from a meta-analysis that was based on the Phase III trial program of liraglutide. Treatment costs, estimated from a health care payer perspective, were calculated on the basis of the trials included in the meta-analysis and captured the study drug, needles, self-monitoring of blood glucose (SMBG) test strips, SMBG lancets, and other antidiabetes medications received. Cost-effectiveness in terms of cost per patient achieving the composite end point (cost of control) was evaluated with an economic model developed in Microsoft Excel. No discounting was applied to cost or clinical outcomes because these were not projected beyond a 1-year time horizon. Sensitivity analyses were performed. Findings Liraglutide 1.8 mg was associated with the lowest number needed to treat, with 3 patients needing to be treated to bring 1 patient to the composite end point. Pioglitazone was associated with the highest number needed to treat, with 17 patients requiring treatment to bring 1 patient to the composite end point. Evaluation of only annual pharmacy costs indicated that liraglutide 1.8 mg was the most costly treatment at Can$2780 per patient per year. Pioglitazone and glimepiride were associated with the lowest direct annual costs. Combining the clinical efficacy data with the annual cost of medications produced cost of control values of Can$6070 (liraglutide 1.2 mg), Can$6949 (liraglutide 1.8 mg), Can$7237 (glimepiride), Can$7704 (exenatide), Can$8297 (insulin glargine), Can$8741 (pioglitazone), and Can$9270 (sitagliptin) per patient achieving the composite end point. Implications Liraglutide 1.2 mg and 1.8 mg were associated with the lowest cost of control values, driven by the high proportion of patients achieving the composite end point, which offset the higher medication costs. A relatively low cost of control value was achieved for glimepiride, driven by low acquisition costs, despite relatively few patients achieving the composite end point. [ABSTRACT FROM AUTHOR]

Background: The Dietary Approaches to Stop Hypertension (DASH) diet is a proven way to prevent and control hypertension and other chronic disease. Because the DASH diet emphasizes plant-based foods, including vegetables and grains, adhering to this diet might also bring about environmental benefits, including lower associated production of greenhouse gases (GHGs). Objective: The objective was to examine the interrelation between dietary accordance with the DASH diet and associated GHGs. A secondary aim was to examine the retail cost of diets by level of DASH accordance. Design: In this cross-sectional study of adults aged 39-79 y from the European Prospective Investigation into Cancer and Nutrition-Norfolk, United Kingdom cohort (n = 24,293), dietary intakes estimated from food-frequency questionnaires were analyzed for their accordance with the 8 DASH food and nutrient-based targets. Associations between DASH accordance, GHGs, and dietary costs were evaluated in regression analyses. Dietary GHGs were estimated with United Kingdom-specific data on carbon dioxide equivalents associated with commodities and foods. Dietary costs were estimated by using national food prices from a United Kingdom-based supermarket comparison website. Results: Greater accordance with the DASH dietary targets was associated with lower GHGs. Diets in the highest quintile of accordance had a GHG impact of 5.60 compared with 6.71 kg carbon dioxide equivalents/d for least-accordant diets (P < 0.0001). Among the DASH food groups, GHGs were most strongly and positively associated with meat consumption and negatively with whole-grain consumption. In addition, higher accordance with the DASH diet was associated with higher dietary costs, with the mean cost of diets in the top quintile of DASH scores 18% higher than that of diets in the lowest quintile (P < 0.0001). Conclusions: Promoting wider uptake of the DASH diet in the United Kingdom may improve population health and reduce diet-related GHGs. However, to make the DASH diet more accessible, food affordability, particularly for lower income groups, will have to be addressed. [ABSTRACT FROM AUTHOR]

Depression is a common disorder in later life that is associated with increased disability and costs, and negative health outcomes over time. Antidepressant treatments in the form of medications or psychotherapy are available, but a large proportion of those treated fail to respond fully, and relapse or recurrence of symptoms is frequent among those who recover. Hence, successful prevention would avoid these negative outcomes. This paper selectively reviews currently available observational and trial data on the prevention of depression. It initially reviews risk factors associated with depression, and then discusses strategies for primary (including universal, selective and indicated), secondary and tertiary prevention. Currently available evidence suggests that selective and indicated preventive interventions are feasible and initial results look promising. Existing trial data indicate that ongoing antidepressant treatments reduce the risk of relapse and recurrence of symptoms, but benefits may not extend beyond two or three years. At this point in time, no interventions have been shown to reduce the long term complications associated with depression. Mental health professionals will need to work collaboratively to develop primary, secondary and tertiary preventive interventions that are effective at targeting relevant risk factors systematically and that can be easily adopted into clinical practice. [ABSTRACT FROM AUTHOR]

Background: Differences in treatment patterns, health care resource use, and costs are expected among patients newly treated with quetiapine extended release (XR) or quetiapine immediate release (IR). Objective: To compare treatment patterns, health care resource use, and costs in patients with bipolar disorder newly treated with quetiapine XR or quetia- pine IR. Methods: This was an observational, retrospective cohort study that used HealthCore Integrated Research Database– Identified patients (age range, 18-64 years) with an International Classification of Disease, Ninth Revision diagnosis of bipolar disorder and Z1 pharmacy claim for quetiapine XR or quetiapine IR between October 2, 2008, and July 31, 2010. Outcomes were as follows: patient characteristics at the index date (first claim for quetiapine XR or quetiapine IR); 12-month preindex clinical character- istics, health care resource use, and costs; and 12-month postindex treatment patterns, health care resource use, and costs, assessed using generalized linear models (adjusted for index date and preindex patient demographic characteristics, clinical character- istics, health care resource use, and costs). Results: In total, 3049 patients with bipolar disorder were analyzed (651 in the quetiapine XR group and 2398 in the quetiapine IR group). Of patients initiating treatment with quetiapine XR, 8.8% had no change in or discontinuation of their index therapy compared with 5.7% of patients treated with quetiapine IR (adjusted odds ratio, 1.44; 95% confidence interval, 1.03-2.00; P = 0.0317). The average daily dose (adjusted mean) of quetiapine XR was higher than quetiapine IR (225 vs 175 mg/d, P < 0.0001). An average daily dose of 300 to 800 mg was reached sooner (15.6 vs 30.8 days, P = 0.0049) and in more patients (44.2% vs 27.2%, P < 0.0001) who were taking quetiapine XR compared with patients taking quetiapine IR. No differences in total health care costs were found between the cohorts; however, patients taking quetiapine XR were less likely to be hospitalized for mental health–related reasons (12.1% vs 18.3%, P = 0.0022) and incurred lower mental health–related costs (US $6686 vs US $7577, P = 0.0063) compared with patients taking quetiapine IR. Conclusions: Treatment patterns and dosing differ in patients with bipolar disorder treated with quetiapine XR compared with those treated with quetiapine IR. Mental health–related hospitalizations and costs may be reduced in the 12 months after patients initiating treatment with quetiapine XR compared with initiating treatment with quetiapine IR. [ABSTRACT FROM AUTHOR]

Abstract: Background: Pelvic and acetabular fractures are complex injuries requiring specialist treatment. Our institution is the National Centre for Treatment and Management of these injuries. Aim: To audit all referrals to our institution over a 6-month period and calculate the cost incurred by being the national referral centre. Methods: Retrospective review of database, and subsequent allocation of Casemix points to assess total cost of treatment for each patient referred to our institution. Results: 103 patients referred with pelvic or acetabular fracture for operative management. The furthest referral distance was 181miles. Over-all, the length of stay was 15.4 days. The average inclusive cost for a referral to our unit for operative management was €16,302. Conclusion: Pelvic and acetabular fractures are complex injuries that require specialist referral unit management. However for these units to remain sustainable money needs to “follow the patient”. [Copyright &y& Elsevier]

Abstract: Objective: Display the cost savings of minimal sterile covers and preparatory time while still maintaining optimal outcomes for sinus procedures. In-office non-sterile endoscopic sinus procedures have not shown a difference in infections and complications. Institutions continue to employ more “traditional” sterile preparation with similar procedures in the operating room. Multiple studies have also shown no significant difference in postoperative course when preoperative antibiotics are administered for sinus procedures. Methods: Endoscopic sinus procedures were selected (58 patients) to analyze itemized sterile costs. Drapes, gloves, gowns, and antibiotics were then tallied and compared to the same items for cochlear implants (14 procedures). The “sterile-prep” time was also analyzed and compared between the two procedures. Cost difference was analyzed. Results: Comparing the supplies used for sinus procedures (56) and cochlear implants, our average sinus cost was $10.19, compared to $34.64, with a difference of $24.45. This equated to a savings of $1418.00 in sinus procedure supplies that year. The difference in draping and scrubbing time showed a difference of 20min between groups, equaling a value of $1760 difference/case. This calculated to a savings of $10,2080 for sinus operating room time. There was no difference in patient outcomes with this surgical preparatory approach. Conclusion: Our analysis showed a large cost savings over a fiscal year in operative time and supplies. This did not compromise any patient outcomes given the already non-sterile nature of endoscopic sinus surgery. This practice can be adopted to greatly enhance efficiency without sacrificing surgical results. [Copyright &y& Elsevier]

Background: Biologic therapies have been used in patients with psoriatic arthritis (PsA) who have been inadequately treated with conventional disease-modifying anti-rheumatic drugs (DMARDs) Objective: Examine treatment patterns and health care costs among patients with PsAs who initiated biologic therapy either as monotherapy or adjunc-tively with traditional DMARDs. Methods: The MarketScan® database was used to identify adults with PsA who initiated therapy with a biologic (with first use identified as index date). Patients were required to have a 6-month pre-period with no biologic use and 1 year insurance eligibility pre- and post-index date. Cohorts of patients initiating biologic therapy either as monotherapy or adjunc-tively with traditional DMARDs were created. Med-ication use patterns including discontinuation, switching, and restarting were identified during the 1-year follow-up period. Cox proportional hazards models were conducted to compare time to discontin-uation of index biologic, and logistic models were used to compare the rate of discontinuation and biologic switching between the 2 cohorts. All-cause and PsA-related costs were compared between the 2 cohorts using propensity score-adjusted bootstrapping methods. All comparisons were made after adjusting for age, sex, Charlson comorbidity index, and PsA-related total cost over 1-year pre-index date. Results: Among the 3164 PsA patients identified, 67.7% initiated biologics as monotherapy and 32.3% initiated biologics adjunctively with traditional DMARDs. The number of patients on pain medica-tions, topical medications, and traditional DMARDs was significantly lower post index date compared to pre-index date (P < 0.01), while use of antihypertensives, antidiabetics, and statins increased after patients initiated biologic therapy. In 1-year post-period, approximately half of the patients (50.9%) who initiated a biologic continued their index biologic with an average time to discontinuation of 279.8 days for all patients. Rates of discontinuation, switching, and restart were 33.1%, 9.9%, and 6.1%, respectively, for all patients. Rates of switching and restart were similar between the 2 cohorts, but a significantly lower rate of discontinuation was ob-served in the biologic plus traditional DMARDs cohort than the biologic monotherapy cohort. Phar-macy expenditures were higher for the biologic + DMARD cohort than the biologic-monotherapy cohort ($14,486 vs $14,062; P = 0.0348). No statisti-cally significant differences for either all-cause or PsA-specific costs were observed across the treatment cohorts. Conclusions: Traditional DMARDs used in combi-nation with biologic therapy appear to reduce rates of biologic therapy discontinuation. [ABSTRACT FROM AUTHOR]

Background: Two previous retrospective database analyses compared early combination therapy with an ɑ-blocker (AB) and 5-ɑ reductase inhibitor (5-ARI) to delayed combination therapy and found that patients receiving the delayed combination therapy were more likely to have clinical progression, acute urinary retention (AUR), and surgery. Although these studies indicate the clinical benefits of early treatment, both studies failed to take into account important baseline clinical measures, such as prostate-specific antigen (PSA) values. Objective: This study was designed to compare clinical and cost differences in men with benign prostatic hyperplasia (BPH) who initiated early versus delayed combination therapy with a 5-ARI + an AB, factoring in baseline PSA values. Methods: This retrospective claims data analysis assessed data from >14 million US men with linked medical data, pharmacy data, laboratory results, and enrollment information from January 1, 2000, to December 31, 2009. Men aged 50 or older and treated for BPH with a 5-ARI + an AB were identified. Patients were required to be eligible for services at least 6 months before and 12 months after the index medication date. Patients were assigned to 1 of 2 treatment groups based on therapy (early or delayed) and 3 cohorts based on availability of PSA laboratory values (patients with a PSA value, patients with a PSA value >1.5 and <10, and all patients). Using a logistic model, the likelihood of clinical progression (defined as the occurrence of AUR or prostate surgery) during the 12 months after the date of first prescription fill was compared between BPH patients receiving early versus delayed combination therapy. BPH-related medical costs (excluding pharmacy costs) were assessed using generalized linear models. Results: Among the 13,551 patients identified for study inclusion, the highest risks for clinical progression, AUR, and prostate-related surgery were consistently demonstrated in patients with a PSA >1.5 and <10. Across all 3 cohorts, the delayed combination-treatment group was more likely to have clinical progression, AUR, and prostate-related surgeries versus the early combination- treatment group. The incremental difference in BPH-related costs between the delayed and early combination- treatment groups was $190 per patient overall; the greatest incremental difference ($397) was observed in patients with PSA >1.5 and <10. Conclusions: The results suggest that early initiation of combination therapy with 5-ARI + an AB, compared with delayed initiation, can reduce the risks for clinical progression, AUR, and prostate-related surgeries, as well as BPH-related medical costs, in patients with BPH. [ABSTRACT FROM AUTHOR]

Chronic kidney disease (CKD) is a worldwide public health threat and is still unrecognized by many low-income countries as a potentially devastating cause of morbidity and mortality in their population. Many other causes of morbidity and mortality compete for limited country resources both financially and for trained health personnel. Many low-income countries lack data about the rising burden of CKD. In a low-resource setting, where measures of serum creatinine may be unavailable, a simple CKD-screening program could include measures of proteinuria, but, can also include measures of CKD risk factors including blood glucose, blood pressure and body mass index. Screening programs can be coupled with both treatment and patient education programs where resources permit. Many low-income countries have no readily accessible and affordable renal replacement program so patients with ESKD die or must travel outside the country for treatment. Programs that focus both on educating nephrology health-care professionals and on prevention of CKD are necessary. Significant effort will be necessary to develop these resources and increased access to low-cost renal replacement therapy options will be important in the next decade. [ABSTRACT FROM AUTHOR]

Background: An orally disintegrating film (ODF) formulation of sildenafil was recently developed in Korea. This formulation is expected to enhance dosing convenience and increase patient compliance while yielding pharmacokinetics comparable to those of the conventional film-coated tablet (FCT) formulation. Objective: The goal of this study was to compare the pharmacokinetic profiles of a newly developed ODF formulation with those of a FCT formulation of sildenafil in healthy Korean male volunteers. Methods: This was a randomized, open-label, single- dose, 2-period crossover study conducted in 2 parts. Eligible subjects were between the ages of 20 and 50 years and within 20% of their ideal weight; subjects were equally divided into parts 1 and 2. Each subject received a single dose of the ODF and FCT formulations of sildenafil orally in a fasted state (part 1, 50 mg; part 2, 100 mg), with a 7-day washout period between the formulations. Blood samples were collected up to 24 hours postdosing. Pharmacokinetic parameters were determined for sildenafil and its active metabolite (N-desmethyl sildenafil). Adverse events (AEs) were evaluated based on subject interviews and physical examinations. Results: Among the 120 enrolled subjects (60 subjects for each part), 110 completed the study (part 1, n = 53; part 2, n = 57). In both parts, all the primary pharmacokinetic parameters were included in the range for assumed bioequivalence in sildenafil, yielding 90% CI ratios of 91.07% to 120.67% for AUC0-last and 86.68% to 122.93% for Cmax in part 1, and 101.68% to 114.78% for AUC0-last and 93.76% to 109.76% for Cmax in part 2. In part 1, headache was the most frequently noted AE, occurring in 3 subjects with both the test and the reference formulations. All other AEs occurred in <3 subjects. In part 2, nasal congestion was the most frequently observed AE (7 with the test formulation and 1 with the reference formulation), followed by abnormal vision (4 with the test formulation and 4 with the reference formulation), headache (4 with the test formulation and 4 with the reference formulation), and rhinorrhea (5 with the test formulation). All other AEs occurred in <3 subjects. Conclusions: The study findings suggest that the pharmacokinetics of the ODF formulation of sildenafil do not differ significantly from those of the conventional FCT formulation (50 and 100 mg) in these healthy Korean male subjects. The 2 formulations were well tolerated in both parts of the study, with no serious AEs observed. ClinicalTrials.gov identifier: NCT01769638 [ABSTRACT FROM AUTHOR]

Objective: The goal of this study was to examine the cost-effectiveness of fulvestrant 500 mg for the treatment of first progression or recurrence of advanced breast cancer in postmenopausal patients compared with generic nonsteroidal aromatase inhibitors (anastrozole and letrozole) in the United Kingdom. Methods: A cost-utility model based on a time-instate approach was used. Clinical effectiveness estimates used in the model were derived from a network meta-analysis for overall survival and serious adverse events. Overall survival was extrapolated by using a Weibull distribution, and progression-free survival (PFS) estimates were derived from a simultaneous network meta-analysis and extrapolation of PFS curves by using the log-normal distribution. Data on resource use, costs, and utilities were based on various sources, including expert opinion and published data. To explore uncertainty, 1-way and probability sensitivity analyses were conducted. The study was conducted from the perspective of the UK National Health Service, and costs are reported in 2010/2011 British pounds. Results: The base case incremental cost-effectiveness ratio (ICER) for fulvestrant 500 mg versus letrozole was £34,528, with incremental costs of £14,383 and an incremental quality-adjusted life-year (QALY) of 0.417. Extended dominance occurred for anastrozole because the ICER for anastrozole versus letrozole was higher than the ICER for fulvestrant 500 mg versus anastrozole. Based on the probability sensitivity analyses, the probability that fulvestrant 500 mg was the most cost-effective treatment option was 3%, 20%, and 53% at a willingness-to-pay threshold of £20,000, £30,000, and £40,000 per QALY, respectively. According to the 1-way sensitivity analyses, the PFS estimates were the key drivers of the model results. Conclusions: Although fulvestrant 500 mg was found not to be a cost-effective option at a standard UK threshold of £20,000 to £30,000 per QALY, it may be relevant to apply a higher threshold due to the poor prognosis of patients with advanced breast cancer and the limited number of hormonal treatment options available for this stage of treatment. Certain subgroups may also benefit from fulvestrant as a treatment option; however, limited data are currently available to identify these subgroups. [ABSTRACT FROM AUTHOR]

Abstract: Background: The clinical benefits of dual antiplatelet treatment (aspirin + clopidogrel) in the management of acute coronary syndromes (ACS) are well established. However, clopidogrel is a prodrug that requires hepatic activation. Concerns regarding its delayed onset of action, variability in antiplatelet effects, and prolonged recovery of platelet function after discontinuation have prompted the development of P2Y12 receptor antagonists. Ticagrelor is the most recently developed P2Y12 receptor antagonist available in the United States. Ticagrelor is a nonthienopyridine antiplatelet agent and is the first reversible oral antagonist of the P2Y12 receptors. Objective: This article reviews the pharmacology, clinical efficacy, and tolerability of ticagrelor use in management of ACS. Methods: Peer-reviewed clinical trials, review articles, and relevant treatment guidelines published from 1966 to March 15, 2012, were identified from the MEDLINE and Current Content databases using the search terms ticagrelor, ACS, pharmacokinetics, pharmacodynamics, pharmacoeconomics, and cost-effectiveness. Citations from available articles were also reviewed for additional references. Results: Nine pharmacokinetics/pharmacodynamics studies in humans and 1 clinical study were identified. In addition, the findings from 6 subanalyses based on the clinical study were included. Compared with clopidogrel, ticagrelor was associated with a significantly reduced composite rate of death from cardiovascular causes, myocardial infarction, or stroke (ticagrelor, 9.8%; clopidogrel, 11.7%; hazard ratio [HR] = 0.84; 95% CI, 0.77–0.92; P < 0.001). The difference in the rates of major bleeding was not significant (ticagrelor, 11.6%; clopidogrel, 11.2%). Ticagrelor was associated with a higher rate of non–coronary artery bypass graft surgery related major bleeding (4.5% vs 3.8%; P = 0.03), including fatal intracranial bleeding (0.1% vs 0.01%; P = 0.02), and fewer cases of other types of fatal bleeding (0.1% vs 0.3%; P = 0.03). Other adverse events reported with ticagrelor use included dyspnea (13.8%), headache (6.5%), and bradyarrhythmia (5.8%). The effects of ticagrelor have not been compared to those of other antiplatelet agents, including prasugrel. Conclusions: Based on the findings from the present review, ticagrelor provides reversible inhibition of adenosine diphosphate–induced platelet aggregation, with a faster onset of action than clopidogrel, and is effective in the treatment of patients with ACS. More data are required to definitively position ticagrelor with respect to other antiplatelet agents, including prasugrel. [Copyright &y& Elsevier]

The article offers recommendations for the treatment of adults suffering with minimal change disease (MCD). Topics discussed include use of drugs corticosteroids for treatment of nephrotic syndrome, cyclophosphamide in frequently relapsing MCD and maintaining initial high dose of corticosteroids. It suggests treating MCD patients who have acute kidney injury (AKI) with renal replacement therapy.

Abstract: Background: Fidaxomicin, a macrolide antibiotic, was the first medication for the management of Clostridium difficile infections (CDI) to be approved by the US Food and Drug Administration in more than 20 years. Objective: This article reviews published literature on fidaxomicin for management of CDI, including its chemistry, spectrum of activity, pharmacokinetic properties, pharmacodynamics, therapeutic efficacy, adverse events, dosing, administration, and pharmacoeconomic considerations. Methods: Pertinent English-language literature was reviewed through searches of MEDLINE, EMBASE, and BIOSIS from 1975 through September 2011. Reference lists of identified publications and published abstracts from the Interscience Conference on Antimicrobial Agents and Chemotherapy meetings were also reviewed. Search terms included, but were not limited to, fidaxomicin, difimicin, lipiarmycin, tiacumicin B, OPT-80, Clostridium spp, and diarrhea. Results: A total of 79 publications were identified and 10 were excluded; 6 review articles and 4 abstracts that were later published as articles. Fidaxomicin''s in vitro profile is favorable compared with oral metronidazole and vancomycin, with minimum inhibitory concentrations against C difficile that are 2 dilutions lower. From the 2 published Phase III trials, fidaxomicin was deemed to be noninferior in the treatment of mild to moderate CDI compared with oral vancomycin. Recurrence rates for all strains of CDI were lower with fidaxomicin than vancomycin. Adverse events associated with fidaxomicin were similar to placebo, with nausea and vomiting being the most common. Although no pharmacoeconomic studies have compared fidaxomicin with metronidazole or vancomycin, the current price exceeds $2500 (US) per treatment course. Conclusions: Reports suggest that fidaxomicin is noninferior to oral vancomycin in the treatment of mild or moderate CDI, although no published comparisons with metronidazole exist to date. Additionally, fidaxomicin improved outcomes compared with oral vancomycin in terms of rates of relapse and recurrent CDI, and in patients who might require concomitant antibiotics. Prospective, randomized studies comparing fidaxomicin with metronidazole in the treatment of mild or moderate CDI, as well as against vancomycin for severe CDI, should be undertaken to clarify the exact role of fidaxomicin in clinical practice. [Copyright &y& Elsevier]

Abstract: A total of 24 well-defined PKB/Akt1 inhibitors were used to generate pharmacophore models applying Catalyst/HypoGen program. The best ranked model (Hypo_1) was then validated by cost analysis, prediction capability, Cat-Scramble and receiver operating characteristic (ROC) studies. Then, pharmacophore-based virtual screening combined with docking study was performed to search an in-house compound database. Nine preferable hits 75–80, HTS-02143, BTB-14740 and HTS-08006 were prepared and biologically evaluated. Several compounds were identified as good PKB/Akt1 inhibitors, suggesting that Hypo_1 would be reliable and useful in virtual screening. Flow cytometric and western blotting analysis on compounds 79 and 80 further demonstrated that the inhibition of phosphorylation of PKB/Akt1 and its substrates (such as GSK3β) was responsible for their cytotoxic activities. [Copyright &y& Elsevier]

Abstract: Introduction: The provision of a complex lower-limb trauma service has significant resource implications. This financial burden is not recognised by the current fixed price tariff system (Payment by Results). The aim of this study was to compare the actual costs of treatment with reimbursement. Methods: We conducted a prospective study in two large regional plastic surgery centres in the UK, Salisbury Foundation Trust (SFT) and the Frenchay Hospital, Bristol (FH). The total cost of treatment for consecutive patients with complex lower limb trauma requiring free tissue transfer was calculated and compared with the Health Resource Group (HRG) tariff. Results: A cost analysis was performed on 20 patients (10 Salisbury, 10 Frenchay) with open tibial fractures (all grade IIIb Gustillo & Anderson) requiring free-flap reconstruction (15 anterolateral thigh (ALT) flaps, one serratus, one latissimus dorsi (LD), one scapular and two gracilis). The mean treatment cost of performing a free flap was £12792±£970 SEM (SFT) and £10953±£650 (FH). In both centres, the cost was more than double the HRG tariff (£4220 SFT, £4892 FH, p <0.05). Conclusions: Our study highlights the considerable disparity between the cost of managing patients with severe lower-limb trauma and the remuneration by Primary Care Trusts (PCTs). Accurate cost analysis of these cases will allow hospital trusts to negotiate appropriate tariffs with PCTs and develop services, which are cost neutral. [Copyright &y& Elsevier]

Objective: To examine resource use (costs) by women presenting for infertility evaluation and treatment over 18 months, regardless of treatment pursued.Design: Prospective cohort study in which women were followed for 18 months.Setting: Eight infertility practices.Patient(s): Three hundred ninety-eight women recruited from infertility practices.Intervention(s): Women completed interviews and questionnaires at baseline and after 4, 10, and 18 months of follow-up. Medical records were abstracted after 18 months to obtain details of services used.Main Outcome Measure(s): Per-person and per-successful-outcome costs.Result(s): Treatment groups were defined as highest intensity treatment use. Twenty percent of women did not pursue cycle-based treatment; approximately half pursued IVF. Median per-person costs ranged from $1,182 for medications only to $24,373 and $38,015 for IVF and IVF-donor egg groups, respectively. Estimates of costs of successful outcomes (delivery or ongoing pregnancy by 18 months) were higher--$61,377 for IVF, for example--reflecting treatment success rates. Within the time frame of the study, costs were not significantly different for women whose outcomes were successful and women whose outcomes were not.Conclusion(s): Although individual patient costs vary, these cost estimates developed from actual patient treatment experiences may provide patients with realistic estimates to consider when initiating infertility treatment. [ABSTRACT FROM AUTHOR]

Background: Emergency treatment of bleeding esophageal varices (BEV) in cirrhotic patients is of prime importance because of the high mortality rate surrounding the episode of acute bleeding. Nevertheless, there is a paucity of randomized controlled trials of emergency surgical therapy and no reports of the costs of any of the widely used forms of emergency treatment. The important issue of direct costs of care was examined in a randomized controlled trial that compared endoscopic sclerotherapy (EST) to emergency portacaval shunt (EPCS).Methods: Two hundred eleven unselected consecutive patients with ultimately biopsy-proven cirrhosis and endoscopically proven acute BEV were randomized to EST (n = 106) or EPCS (n = 105). Diagnostic workup was completed, and EST or EPCS was initiated within 8 h. Criteria for failure of EST or EPCS were clearly defined, and crossover rescue treatment was applied, when primary therapy failed. Ninety-six percent of patients underwent more than 10 years follow-up, or until death. Complete charges for all aspects of care were obtained continuously for more than 10 years.Results: Direct charges for all aspects of care were significantly lower in patients treated by EPCS than in patients treated by emergency EST followed by long-term repetitive sclerotherapy. Charges per patient, per year of treatment, and per year in each child's risk class were significantly lower in patients randomized to EPCS. Charges in patients who failed endoscopic sclerotherapy and underwent a rescue portacaval shunt were significantly higher than the charges in both the unshunted sclerotherapy patients and the patients randomized to EPCS. This result was particularly noteworthy given the widespread practice of using surgical portacaval shunt as rescue treatment only when all other forms of therapy have failed.Conclusions: In this randomized controlled trial of emergency treatment of acute BEV, EPCS was significantly superior to EST with regard to direct costs of care as reflected in charges for care as well as in survival rate, control of bleeding, and incidence of portal-systemic encephalopathy. These results provide support for the use of EPCS as a first line of emergency treatment of BEV in cirrhosis. [ABSTRACT FROM AUTHOR]

Abstract: There is little written on the financial cost of burns care. This project examined three major paediatric burns of 30–40% total body surface area (%TBSA) admitted to the South West Paediatric Burns Service in Bristol, and calculated the cost per patient of acute inpatient treatment. A list of costs was established for theatre time, bed time, medications and fluids, dressings, invasive procedures, therapy services and investigations. The time period was the initial inpatient stay, from admission to the burns service, to first discharge. Staff in the relevant managerial and purchasing departments provided additional information about charging. We calculated a mean cost per patient of £63,157.22 (range £55,354.79–£74,494.24). Our results suggest that current income achieved for a major paediatric burn underestimates the actual financial burden of treatment. The North Bristol NHS Trust tariff cost for a “major burn, third degree of more than 19% TBSA, or affecting multiple body regions with significant graft” is £17,797 (2009). The fact that our costs are almost certainly an underestimate in themselves serves to reinforce this view. We hope that the data presented here can provide some guidance and understanding in the funding of burns care, a complex and difficult area to cost. [Copyright &y& Elsevier]

Healthcare providers continue to seek improved methods for preventing, detecting and treating diseases that affect human survival and quality of life. At the same time, there will always be financial constraints because of limited societal resources. Many of the discussions on how to provide economically sound solutions to this challenge have not fully engaged the input of clinicians in the field. The purpose of this review is to increase economic knowledge for clinicians. We cover healthcare cost elements and methods used to assign value to a health outcome. We outline the challenges in conducting economic studies in the field of infectious diseases. Finally, we discuss the meaning of efficiency from multiple perspectives, and how the concept of economic externalities applies to infectious diseases. [ABSTRACT FROM AUTHOR]

Abstract: Background: The aim of this study was to calculate and analyze the cost of treatment for stage IV pressure ulcers. Methods: A retrospective chart analysis of patients with stage IV pressure ulcers was conducted. Hospital records and treatment outcomes of these patients were followed up for a maximum of 29 months and analyzed. Costs directly related to the treatment of pressure ulcers and their associated complications were calculated. Results: Nineteen patients with stage IV pressure ulcers (11 hospital-acquired and 8 community-acquired) were identified and their charts were reviewed. The average hospital treatment cost associated with stage IV pressure ulcers and related complications was $129,248 for hospital-acquired ulcers during 1 admission, and $124,327 for community-acquired ulcers over an average of 4 admissions. Conclusions: The costs incurred from stage IV pressure ulcers are much greater than previously estimated. Halting the progression of early stage pressure ulcers has the potential to eradicate enormous pain and suffering, save thousands of lives, and reduce health care expenditures by millions of dollars. [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]

Abstract: Background: Cytokine therapy is currently used as first-line treatment of metastatic renal cell carcinoma (mRCC). Until recently, treatments with proven efficacy after the failure of first-line cytokine therapy were not available. In recent clinical trials, sunitinib has been associated with good response rates in patients with mRCC. Objective: The aim of this study was to analyze the cost-effectiveness of sunitinib as second-line therapy for cytokine-refractory mRCC compared with current routine clinical practice in Finland (ie, best supportive care [BSC], including palliative biochemotherapy). Methods: A probabilistic decision-analytic model was developed to estimate the cost-effectiveness of sunitinib. Data were gathered from clinical trials, literature sources, and expert opinions, as well as from a local sample (n = 39) from 2 university hospitals in Finland. Clinical experts treating patients with mRCC in Finland provided the information on care practices of prescribing sunitinib. The analysis was conducted from the perspective of the health care payer in Finland. Results: According to estimated incremental cost-effectiveness ratios (ICERs), 1 progression-free month gained cost €4802 (2005 Euros); 1 life-year gained cost €30,831; and 1 quality-adjusted life-year (QALY) gained cost €43,698, compared with BSC, in the treatment of mRCC. The expected mean cost in BSC was €5543. When parameter uncertainty was considered, the probability of sunitinib being the more cost-effective choice of treatment was ~70% at the willingness-to-pay level of €45,000/QALY gained. Conclusions: Based on the results of this cost-effectiveness analysis, sunitinib is potentially cost-effective as a second-line treatment of mRCC compared with the treatment currently practiced in Finnish hospitals. The ICER (€/QALY gained) obtained in the present study was less than the value considered suitable for novel oncology treatments. [Copyright &y& Elsevier]

Abstract: Objective: The aim of this study was to compare the cost per unit of effectiveness (successful treatment episode) of 2 highly active antiretroviral therapy combinations–emtricitabine/tenofovir DF + efavirenz (TVD + EFV) and lamivudine/zidovudine + efavirenz (COMB + EFV)–in antiretroviral-naive, HIV-1-infected patients from the perspective of costs to society. Methods: This cost-effectiveness analysis was modeled using a decision tree that considered the therapeutic response (successful treatment episode, ie, HIV-1 RNA <400 copies/mL using data obtained directly from a clinical trial) and the switch to rescue therapy in nonresponders. The time horizon was 24 months of treatment. Cost was defined as direct medical costs (drugs, diagnostic and/or laboratory tests, treatment of adverse effects) and indirect medical costs (productivity losses). All data are presented as €(2005). Sensitivity analysis was 1-factor threshold, adjustment of ex-factory cost, only direct costs, and applying discount rate in the study. The results are presented as incremental costs, success rates, and cost per patient with undetectable viral load or additional success. Results: The expected 48-week cost of the regimen that includes TVD + EFV was €46,464, and for the regimen that included COMB + EFV, €56,198. Therefore, savings of €9734 were achieved for each patient treated with TVD + EFV, as well as a gain of 13% of patients with undetectable viral load after 24 months of treatment. Consequently, treatment with TVD + EFV combination would be dominant in therapy for antiretroviral-naive, HIV-1-infected patients. Sensitivity tests supported the stability of the base-case analysis. The cost-effectiveness ratios were €619.52 for the TVD + EFV regimen versus €906.41 for the COMB + EFV regimen. Conclusion: Based on the results of this analysis, patients who started treatment of HIV-1 infection with combination TVD + EFV had significantly lower health care resource utilization and overall treatment costs compared with the COMB + EFV combination. [Copyright &y& Elsevier]

Abstract: Objective: Medical expulsive therapy (MET) has recently emerged as an efficacious and safe option for the initial management of ureteral stones. The objective of this study was to assess the cost-effectiveness of MET compared with conservative therapy for the treatment of ureteral stones using international cost data from the United States and four European countries. Material and methods: A decision analysis model was built with the use of TreeAge Pro 2004 software with linear success rate assumptions. The likelihood of spontaneous passage of ureteral stones according to their size and location was estimated with the use of data derived from a published meta-analysis. The estimated cost of ureteroscopy (URS) in the United States ($4973) was based on the mean cost of 121 consecutive cases performed at a large metropolitan hospital. URS costs for other countries were obtained from a published international survey. The cost of tamsulosin ($2.08 per day), currently the most commonly used medical expulsive agent, was estimated as a mean of the costs obtained from two national pharmacy chains. MET and conservative therapies were compared with the use of one-way and two-way sensitivity analyses. Results: In the United States, MET using tamsulosin resulted in a $1132 cost advantage over observation. MET maintained its cost advantage even in countries where the cost of URS is much lower than in the United States. Two-way sensitivity analysis showed that MET remained cost-effective even with very low rates of spontaneous passage, minimal benefit of MET, or low cost of URS. Conclusion: MET is a cost-effective strategy for the management of distal ureteral stones—even those with a low rate of spontaneous passage—providing another incentive for initial “facilitated observation” before embarking on surgical intervention. [Copyright &y& Elsevier]

Abstract: Objective: The objective of the study was to analyze the methods to reduce cost in interventional radiology departments by reorganizing procurement. Materials and methods: All products used in the Department of Interventional Radiology were inventoried. An ABC-analysis was completed and A-products (high-value and high turnover products) underwent a XYZ-analysis which predicted demand on the basis of ordering frequency. Then criteria for a procurement strategy for the different material categories were fixed. The net working capital (NWC) was calculated using an interest rate of 8%/year. Results: Total annual material turnover was 353,000€. The value of all A-products determined by the inventory was 260,000€. Changes in the A-product procurement strategy tapped a cost reduction potential of 14,500/year€. The resulting total saving was 17,200€. Improved stores management added another 37,500€. The total cost cut of 52,000€ is equivalent to 14.7% of annual expenses. Conclusion: A flexible procurement strategy helps to reduce the storage and capital tie-up costs of A-products in interventional radiology without affecting the quality of service provided to patients. [Copyright &y& Elsevier]