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Osteoporosis (OP) is a major public health concern, but still OP care does not meet guidelines. Interventions have been developed to improve appropriate OP management. The objective of the present study was to systematically review the current literature to ascertain the efficacy of interventions to improve OP care and characterize interventions taking into account elements related to their potential cost and feasibility. Studies published from 2003 to 2018 were retrieved from PubMed/MEDLINE, Science Direct, Web of Science, Cochrane, and Wiley Online Library databases. Screening of references and quality assessment were independently performed by two reviewers. We classified interventions into three types according to the target of the intervention: health system (structural interventions), healthcare professional (HCP), and patient. Meta-analysis was performed by type of intervention and their effect on two outcomes: prescription of BMD measurement and prescription of OP therapy. A total of 4268 records were screened; 32 studies were included in the qualitative analysis and 29 studies in the quantitative analysis. Structural interventions strongly and significantly improved prescription of BMD measurement (OR = 9.99, 95% CI 2.05; 48.59) and treatment prescription (OR = 3.82, 95% CI 2.16; 6.75). The impact of HCP-centered interventions on BMD measurement prescription did not reach statistical significance (OR = 2.19, 95% CI 0.84; 5.73) but significantly improved treatment prescription (OR = 3.82, 95% CI 2.16; 6.75). Interventions involving patients significantly improved the prescription of BMD measurement (OR = 2.16, 95% CI 1.62; 2.89) and treatment prescription (OR = 1.70, 95% CI 1.35; 2.14). Interventions to improve OP management had a significant positive impact on prescription of BMD measurement but a more limited impact on treatment prescription. [ABSTRACT FROM AUTHOR]

Background: Previous studies have not evaluated the impact of illness severity and postrupture procedures in the cost of care for intracranial aneurysms. We hypothesize that the severity of aneurysm rupture and the aggressiveness of postrupture interventions play a role in cost. Methods: The Value Driven Outcomes database was used to assess direct patient cost during the treatment of ruptured intracranial aneurysm with clipping, coiling, and Pipeline flow diverters. Results: One hundred ninety-eight patients (mean age 52.8 ± 14.1 years; 40.0% male) underwent craniotomy (64.6%), coiling (26.7%), or flow diversion (8.6%). Coiling was 1.4× more expensive than clipping (p =.005) and flow diversion was 1.7× more expensive than clipping (p <.001). More severe illness as measured by American Society of Anesthesia, Hunt/Hess, and Fisher scales incurred higher costs than less severe illness (p <.05). Use of a lumbar drain protocol to reduce subarachnoid hemorrhage and use of an external ventricular drain to manage intracranial pressure were associated with reduced (p =.05) and increased (p <.001) total costs, respectively. Patients with severe vasospasm (p <.005), those that received shunts (p <.001), and those who had complications (p <.001) had higher costs. Multivariate analysis showed that procedure type, length of stay, number of angiograms, vasospasm severity, disposition, and year of treatment were independent predictors of cost. Conclusions: These results show for the first time that disease and vasospasm severity and intensity of treatment directly impact the cost of care for patients with aneurysms in the USA. Strategies to alter these variables may prove important for cost reduction. [ABSTRACT FROM AUTHOR]

Background Clinicians prescribe high-cost medicines for rare diseases and nonapproved indications when conventional therapies have failed. Objective To examine the use of non-formulary high-cost medicines at an Australian public hospital. Methods Retrospective audit of individual patient use applications for nonformulary medicines costing more than $5000 AUD per year at a large tertiary referral hospital in Adelaide, South Australia over a 12-month study period from January 2015 to December 2015. Main outcome measures Total cost of non-formulary high-cost medicines, medication class, indications for use, level of supporting evidence and proposed monitoring outcomes. Results Eighty-seven individual patient use applications were examined. All except one were approved, at a total cost of $1,339,203 AUD. The most common drug classes were anti-CD20 (n = 33, 38%), combined antiretrovirals (n = 10, 11%) and TNF-alpha antagonists (n = 10, 11%). There were 56 indications for these medicines with the majority being inflammatory conditions (n = 52, 60%), followed by infections (n = 14, 16%) and malignancies (n = 14, 16%). Of the first-time individual patient use applications (n = 63), there were 25 applications (40%) that provided a case series as supporting evidence. Approximately half of new individual patient use applications (n = 32) proposed an objective monitoring outcome, but few (n = 13, 21%) contained sufficient information to allow a third party to determine efficacy of the medication. Conclusions Non-formulary high-cost medicines are being used for a broad range of indications based largely on low levels of evidence. Prospective definition of an adequate response to treatment and reporting of these outcomes is required to improve the evidence-base and to aid decision-making for subsequent treatment courses. [ABSTRACT FROM AUTHOR]

Introduction: Cost efficiency is important for hospitals in order to provide high-quality health care for all patients. As hemihepatectomies are increasingly being performed laparoscopically, the aims of this study were to evaluate the costs of laparoscopic hemihepatectomy and to compare them to conventional open techniques. Patients and methods: This is a retrospective analysis of clinical outcomes and financial calculations of all patients who underwent hemihepatectomy between January 2015 and December 2016 at the Department of Surgery, Campus Charité Mitte and Campus Charité Virchow-Klinikum, Berlin, Germany, being allocated to the DRG (diagnosis-related group) H01A (complex operations of the liver and pancreas with complex intensive care treatment) or H01B (operations of the liver and pancreas without complex intensive care treatment). To overcome selection bias, a 1:1 propensity score matching (PSM) analysis was performed. Results: After PSM, a total of 64 patients were identified; 32 patients underwent laparoscopic hemihepatectomy (LH); and 32 patients received open hemihepatectomy (OH). After PSM, no significant differences were observed in clinical baseline characteristics. The duration of surgery was significantly longer for patients undergoing LH compared to OH (LH, 334 min, 186–655 min; OH, 274 min, 176–454 min; p = 0.005). Patients in the LH group had a significantly shortened median hospital stay of 5 d, when compared to OH (LH, 9.5 d, 3–35 d; OH, 14.5 d, 7–37d; p = 0.005). We observed a significant higher rate of postoperative complication in the OH group (p = 0.022). Cost analysis showed median overall costs of 17,369.85€ in the LH group and 16,103.64€ in the OH group (p = 0.390). Conclusion: Our data suggest that higher intraoperative costs of laparoscopic liver surgery, e.g., for surgical devices and due to longer operation times, are compensated by fewer postoperative complications and consecutive shorter length of stay when compared with OH. [ABSTRACT FROM AUTHOR]

Purpose: A cost minimisation analysis compares the costs of different interventions' to ascertain the least expensive over time. We compared different prostate targeted drug treatments with TURP to identify the optimal cost saving duration of a medical therapy for symptomatic benign prostatic enlargement (BPE). Methods: The Evolution registry is a prospective, multicentre registry, conducted by the European Association of Urology Research Foundation (EAUrf) for 24 months in 5 European countries. Evolution was designed to register the management of symptomatic BPE in clinical practice settings in 5 European countries. Direct cost evaluation associated with prostate targeted medical therapies and TURP was also recorded and analysed. Results: In total, 1838 men were enrolled with 1246 evaluable at 24 months. Medical therapies were more cost saving than TURP for treatment durations ranging from 2.9 to 70.4 years. Cost saving depended on both medication class and individual country assessed. Daily tamsulosin monotherapy was more cost saving than TURP for ≤ 13.9 years in Germany compared to ≤ 32.7 years in Italy. Daily finasteride monotherapy was more cost saving for ≤ 5.9 years in France compared to ≤ 36.9 years in Spain. Combination therapy was more cost saving for ≤ 5.9 years for Italian patients versus ≤ 13.8 years in Germany. Conclusions: BPE medical management was more cost saving than TURP for different specific treatment durations. Information from this study will allow clinicians to convey medical and surgical costs over time, to both patients and payors alike, when considering BPE treatment. [ABSTRACT FROM AUTHOR]

Hypoplastic left heart syndrome (HLHS) is a highly resource-intensive diagnosis. Geographic variation in cost and length of stay (LOS) in HLHS is not well described. Neonates diagnosed with HLHS between 2000 and 2012 were identified using the Kids’ Inpatient Database. Hospitalizations were stratified into two groups: (1) birth and (2) secondary. United States regional differences in hospital charges and LOS were compared using adjusted linear regression. Of 2431 birth hospitalizations, 449 neonates (18.5%) died while inpatient and mortality rates differed by region (p = 0.02). After birth, 40.5% (n = 985) of neonates were transferred; transfers were most common in the Midwest (p < 0.0001). Adjusted average LOS was shortest in the West and longest in the South (26.1 days; 95% CI 24.0, 35.1 vs. 34.9 days; 95% CI 31.8, 38.1). Average adjusted charges were lowest in the Northeast ($324,600; 95% CI $271,400, $377,900) and highest in the West ($400,500; 95% CI $346,700, $454,300, p = 0.05). Among 1895 secondary hospitalizations, 24.9% of neonates died as inpatients, and the average adjusted LOS was shortest in the West (26.8 days; 95% CI 23.9, 29.7) and longest in the South (38.5 days; 95% CI 34.4, 42.4). Average adjusted charges were lowest in the Northeast ($326,900; 95% CI $270,700, $383,100) and highest in the South ($505,900; 95% CI $450,200, $561,500, p < 0.0001). Significant geographic variations in mortality, LOS, and hospital charges exist in care of US HLHS neonates. Reducing variation in care should remain a priority in national quality efforts in congenital heart disease. [ABSTRACT FROM AUTHOR]

Introduction: It is hypothesized that using fluocinolone acetonide (FAc) implants such as Iluvien for the treatment of diabetic macular edema (DME) may reduce the total number of intravitreal injections and clinic visits, resulting in an overall treatment cost reduction. The primary aim of this study is to identify the real-world cost savings achievable in a tertiary National Health Service (NHS) hospital.Methods: A retrospective cost analysis study was conducted. The inclusion criteria were patients with refractory DME who were switched to Iluvien. The average yearly costs were calculated both before and after the switch to Iluvien. All costs including medicines, investigations, clinics, and management of raised intraocular pressure (IOP) were calculated. The cost differences over the 3 years’ worth of Iluvien treatment were calculated and analyzed. To ensure non-inferiority of this treatment intervention, the best corrected visual acuity (BCVA) and central retinal thickness (CRT) were also analyzed. Statistical analysis was conducted with a Student t test where appropriate and statistical significance is identified where p < 0.05.Results: Fourteen eyes of 13 patients met the inclusion criteria. Switching patients to Iluvien achieved on average a saving of £2606.17 per patient (p = 0.33) over the 3 years. However, seven cases (50%) had a rise in IOP after Iluvien that warranted medical treatment and two cases (14.3%) required glaucoma surgery. Incorporating the costs of glaucoma management reduced the overall savings over 3 years to £1064.66 per patient. The BCVA and CRT analysis showed a non-inferiority relationship between Iluvien and any previous treatment.Conclusions: The use of Iluvien in refractory DME patients represents a cost- and time-saving procedure, while showing non-inferiority in terms of efficacy. [ABSTRACT FROM AUTHOR]

Burkitt lymphoma is an aggressive B cell malignancy accounting for 1-2% of all adult lymphomas. Treatment with dose-intensive, multi-agent chemotherapy is effective but associated with considerable toxicity. In this observational study, we compared real-world efficacy, toxicity, and costs of four frequently employed treatment strategies for Burkitt lymphoma: the Lymphome Malins B (LMB), the Berlin-Frankfurt-Münster (BFM), the HOVON, and the CODOX-M/IVAC regimens. We collected data from 147 adult patients treated in eight referral centers. Following central pathology assessment, 105 of these cases were accepted as Burkitt lymphoma, resulting in the following treatment groups: LMB 36 patients, BFM 19 patients, HOVON 29 patients, and CODOX-M/IVAC 21 patients (median age 39 years, range 14-74; mean duration of follow-up 47 months). There was no significant difference between age, sex ratio, disease stage, or percentage HIV-positive patients between the treatment groups. Five-year progression-free survival (69%, p = 0.966) and 5-year overall survival (69%, p = 0.981) were comparable for all treatment groups. Treatment-related toxicity was also comparable with only hepatotoxicity seen more frequently in the CODOX/M-IVAC group (p = 0.004). Costs were determined by the number of rituximab gifts and the number of inpatients days. Overall, CODOX-M/IVAC had the most beneficial profile with regards to costs, treatment duration, and percentage of patients completing planned treatment. We conclude that the four treatment protocols for Burkitt lymphoma yield nearly identical results with regards to efficacy and safety but differ in treatment duration and costs. These differences may help guide future choice of treatment. [ABSTRACT FROM AUTHOR]

Costs of HSCT in the United States have been widely reported, but complete information on costs in developing countries is lacking. We performed an analysis designed to assess the real, detailed costs of HSCT in Mexico. Using the database of the Current Accounts Department at our Institution, we performed a micro-costing based analysis of patients from 2010 through 2015 to obtain the overall cost of HSCT during the in-patient procedure and 2-month follow-up. One hundred five transplantations (57% autologous) were performed. The most frequent indications for transplantation were lymphomas (32%), followed by acute leukemias (22%). The most frequently used conditioning regimen was reduced BUCY 2 (38%), followed by BEAM (28%). Among post-transplant complications, acute graft-versus-host-disease was not associated with higher costs (p = 0.8). The median costs (in-patient and 2-month outpatient follow-up) for auto and allo-HSCT were 12,155 and 18,260 USD, respectively. Advances in HSCT technology have improved outcomes and increased the availability of this technique; however, this procedure can also significantly influence the socioeconomic wellbeing of patients, especially in developing countries. Our study highlights the feasibility of performing HSCT in Mexico at lower costs than developed countries, while preserving quality of care. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the costs associated with induction of labour in intrauterine growth restriction fetuses comparing different procedures.Study Design: 150 pregnancies at term diagnosed with intrauterine growth restriction and indication for induction of labour were included. 24 were ripened with misoprostol 25 μg tablets, 24 with dinoprostone 10 mg vaginal insert, and 77 with Cook® cervical ripening balloon. To determine the costs of induction of labour, method of induction, intrapartum medication, epidural analgesia, type of delivery, and maternal and neonatal admissions were considered. Statistical analysis was performed using the G-Stat 2.0 free statistical software. ANOVA test was used for comparisons between quantitative parametric variables. Chi-squared test or Fisher test was used for qualitative variables. A value of p < 0.05 was considered statistically significant.Results: Up to 70.83% women in dinoprostone group gave birth within the first 24 h compared to 42.66% in misoprostol group and 36.36% in CG (p < 0.01). Misoprostol tablets were cheaper (9.45 ± 1.52 US dollars) than dinoprostone or Cook® balloon (41.67 ± 0 and 59.85 ± 0 54.45 ± 0 US dollars, respectively) (p < 0.01). Costs related to maternal admissions were higher in CG (475.13 ± 146.95$) than dinoprostone group (475.13 ± 146.95$) or MG (427.97 ± 112.65$) (p = 0.03). Total costs in misoprostol group (2765.18 ± 495.38$) were lower than in the dinoprostone group (3075.774 ± 896.14$) or Cook® balloon group (3228.02 ± 902.06$) groups.Conclusions: Misoprostol for induction of labour had lower related costs than dinoprostone or Cook® balloon, with similar obstetrical and perinatal outcomes. [ABSTRACT FROM AUTHOR]

Hypertonic saline with furosemide has been proposed for a long time as an effective therapeutic option for the treatment of acute decompensated heart failure (ADHF). We previously reported the efficacy of continuous infusion of 1.7 % hypertonic saline plus low-dose furosemide in treatment for ADHF. Although this therapeutic strategy can be a useful option for effective decongestion in treatment for ADHF, there is no study that assesses the effect and safety of saline supplementation compared with standard therapy in Japan. The aim of this study was to investigate the efficacy, safety, and cost-effectiveness of 1.7 % hypertonic saline plus low-dose furosemide infusion compared with carperitide. We compared clinical outcomes, adverse events, and cost for patients receiving carperitide (carperitide group) with those for patients receiving 1.7 % hypertonic saline plus low-dose furosemide (salt group) during the initial hospitalization for ADHF. The cost analysis was performed on the basis of the previous report about cost-effectiveness of acute heart failure. A total of 175 ADHF patients received either carperitide ( n = 111) or 1.7 % hypertonic saline plus low-dose furosemide infusion ( n = 64) as initial treatment. There were no differences in length of hospital stay (27 ± 19 vs. 25 ± 16 day, p = 0.170) and infusion period (7.2 ± 6.1 vs. 8.4 ± 7.5 day, p = 0.474) between the two groups. The incidence of rehospitalization did not differ at 1 month (7.6 vs. 6.6 %, p = 1.000) and 1 year (36.8 vs. 37.7 %, p = 0.907) between the two groups. The Kaplan-Meier curves revealed no significant difference for 1 year all-cause mortality between the two groups (log-rank, p = 0.724). The single hospitalization cost was 95,314 yen lower and the yearly hospitalization cost 125,628 yen lower in the salt group compared with the carperitide group. Thus, intravenous 1.7 % hypertonic saline plus low-dose furosemide infusion is as effective as carperitide in terms of clinical outcome and is a cost-effective therapeutic strategy for the treatment of ADHF. [ABSTRACT FROM AUTHOR]

Background: Motor neurone disease (MND) is a devastating condition which greatly diminishes patients' quality of life and limits life expectancy. Health technology appraisals of future interventions in MND need robust data on costs and utilities. Existing economic evaluations have been noted to be limited and fraught with challenges.Objective: The aim of this study was to identify and critique methodological aspects of all published economic evaluations, cost studies, and utility studies in MND.Methods: We systematically reviewed all relevant published studies in English from 1946 until January 2016, searching the databases of Medline, EMBASE, Econlit, NHS Economic Evaluation Database (NHS EED) and the Health Economics Evaluation Database (HEED). Key data were extracted and synthesised narratively.Results: A total of 1830 articles were identified, of which 15 economic evaluations, 23 cost and 3 utility studies were included. Most economic studies focused on riluzole (n = 9). Six studies modelled the progressive decline in motor function using a Markov design but did not include mutually exclusive health states. Cost estimates for a number of evaluations were based on expert opinion and were hampered by high variability and location-specific characteristics. Few cost studies reported disease-stage-specific costs (n = 3) or fully captured indirect costs. Utilities in three studies of MND patients used the EuroQol EQ-5D questionnaire or standard gamble, but included potentially unrepresentative cohorts and did not consider any health impacts on caregivers.Conclusion: Economic evaluations in MND suffer from significant methodological issues such as a lack of data, uncertainty with the disease course and use of inappropriate modelling framework. Limitations may be addressed through the collection of detailed and representative data from large cohorts of patients. [ABSTRACT FROM AUTHOR]

Background: Identifying patient-level and disease-specific predictors of healthcare utilization in inflammatory bowel disease (IBD) may allow targeted interventions to reduce costs and improve outcomes.Aim: To identify demographic and clinical predictors of healthcare utilization among veterans with IBD.Methods: We conducted a single-center cross-sectional study of veterans with IBD from 1998 to 2010. Demographics and disease characteristics were abstracted by manual chart review. Annual number of IBD-related visits was estimated by dividing total number of IBD-related inpatient and outpatient encounters by duration of IBD care. Associations between predictors of utilization were determined using stepwise multivariable linear regression.Results: Overall, 676 patients (56% ulcerative colitis (UC), 42% Crohn's disease (CD), and 2% IBD unclassified (IBDU)) had mean 3.08 IBD-related encounters annually. CD patients had 3.59 encounters compared to 2.73 in UC (p < 0.01). In the multivariable model, Hispanics had less visits compared to Caucasians and African-Americans (2.09 vs. 3.09 vs. 3.42), current smokers had more visits than never smokers (3.54 vs. 2.43, p = 0.05), and first IBD visit at age <40 had more visits than age >65 (3.84 vs. 1.75, p = 0.04). UC pancolitis was associated with more visits than proctitis (3.47 vs. 2.15, p = 0.04). CD penetrating phenotype was associated with more encounters than inflammatory type (4.68 vs. 4.15, p = 0.04).Conclusions: We found that current tobacco use, age <40 at first IBD visit, UC pancolitis, and CD fistuilizing phenotype in addition to Caucasian and African-American race were independent predictors of increased healthcare utilization. Interventions should be targeted at these groups to decrease healthcare utilization and costs. [ABSTRACT FROM AUTHOR]

Introduction: Robotic-assisted surgery is gaining popularity in general surgery. Our objective was to evaluate and compare operative outcomes and total costs for robotic cholecystectomy (RC) and laparoscopic cholecystectomy (LC).Methods and Procedures: A retrospective review was performed for all patients who underwent single-procedure RC and LC from January 2011 to July 2015 by a single surgeon at a large academic medical center. Demographics, diagnosis, perioperative variables, postoperative complications, 30-day readmissions, and operative and hospital costs were collected and analyzed between those patient groups.Results: A total of 237 patients underwent RC or LC, and comprised the study population. Ninety-seven patients (40.9 %) underwent LC, and 140 patients (50.1 %) underwent RC. Patients who underwent RC had a higher body mass index (p = 0.03), lower rates of coronary artery disease (p < 0.01), and higher rates of chronic cholecystitis (p < 0.01). There were lower rates of intraoperative cholangiography (p < 0.01) and conversion to an open procedure (p < 0.01), however longer operative times (p < 0.01) for patients in the RC group. There were no bile duct injuries in either group, no difference in bile leak rates (p = 0.65), or need for reoperation (p = 1.000). Cost analysis of outpatient-only procedures, excluding cases with conversion to open or use of intraoperative cholangiography, demonstrated higher total charges (p < 0.01) and cost (p < 0.01) and lower revenue (p < 0.01) for RC compared to LC, with no difference in total payments (p = 0.34).Conclusions: Robotic cholecystectomy appears to be safe although costlier in comparison with laparoscopic cholecystectomy. Further studies are needed to understand the long-term implications of robotic technology, the cost to the health care system, and its role in minimally invasive surgery. [ABSTRACT FROM AUTHOR]

Background: Diffuse large B-cell lymphoma (DLBCL) is the commonest non-Hodgkin lymphoma. Previous studies examining the cost of treating DLBCL have generally focused on a specific first-line therapy alone; meaning that their findings can neither be extrapolated to the general patient population nor to other points along the treatment pathway. Based on empirical data from a representative population-based patient cohort, the objective of this study was to develop a simulation model that could predict costs and life expectancy of treating DLBCL.Methods: All patients newly diagnosed with DLBCL in the UK's population-based Haematological Malignancy Research Network ( www.hmrn.org ) in 2007 were followed until 2013 (n = 271). Mapped treatment pathways, alongside cost information derived from the National Tariff 2013/14, were incorporated into a patient-level simulation model in order to reflect the heterogeneities of patient characteristics and treatment options. The NHS and social services perspective was adopted, and all outcomes were discounted at 3.5 % per annum.Results: Overall, the expected total medical costs were £22,122 for those treated with curative intent, and £2930 for those managed palliatively. For curative chemotherapy, the predicted medical costs were £14,966, £23,449 and £7376 for first-, second- and third-line treatments, respectively. The estimated annual cost for treating DLBCL across the UK was around £88-92 million.Conclusions: This is the first cost modelling study using empirical data to provide 'real world' evidence throughout the DLBCL treatment pathway. Future application of the model could include evaluation of new technologies/treatments to support healthcare decision makers, especially in the era of personalised medicine. [ABSTRACT FROM AUTHOR]

Background: Umbilical hernias are well described in the literature, but its impact on health care is less understood. The purpose of this study was to investigate the effect of non-operative management of umbilical hernias on cost, work absenteeism, and resource utilization.Methods: The Truven Health Database, consisting of 279 employers and over 3000 hospitals, was reviewed for all umbilical hernia patients, aged 18-64 who were enrolled in health plans for 12 months prior to surgery and 12 months after surgery. Patients were excluded if they had a recurrence or had been offered a "no surgery" approach within 1 year of the index date. The remaining patients were separated into surgery (open or laparoscopic repair) or no surgery (NS). Post-cost analysis at 90 and 365 days and estimated days off from work were reviewed for each group.Results: The non-surgery cohort had a higher proportion of females and comorbidity index. Adjusted analysis showed significantly higher 90 and 365 costs for the surgery group (p < 0.0001), though the cost difference did decrease over time. NS group had significantly higher estimated days of health-care utilization at both the 90 (1.99 vs. 3.58 p < 0.0001) and 365 (8.69 vs. 11.04 p < 0.0001) day post-index mark. A subgroup analysis demonstrated laparoscopic repair had higher costs compared to open primarily due to higher index procedure costs (p < 0.05).Conclusions: Though the financial costs were found to be higher in the surgery group, the majority of these were due to the surgery itself. Significantly higher days of health-care utilization and estimated days off work were experienced in the NS group. It is our belief that early operative intervention will lead to decreased costs and resource utilization. [ABSTRACT FROM AUTHOR]

Purpose: This paper aims to review the current evidence for autologous chondrocyte implantation (ACI) generations relative to other treatment modalities, different cell delivery methods and different cell source application.Methods: Literature search was performed to identify all level I and II studies reporting the clinical and structural outcome of any ACI generation in human knees using the following medical electronic databases: PubMed, EMBASE, Cochrane Library, CINAHL, SPORTDiscus and NICE healthcare database. The level of evidence, sample size calculation and risk of bias were determined for all included studies to enable quality assessment.Results: Twenty studies were included in the analysis, reporting on a total of 1094 patients. Of the 20 studies, 13 compared ACI with other treatment modalities, seven compared different ACI cell delivery methods, and one compared different cell source for implantation. Studies included were heterogeneous in baseline design, preventing meta-analysis. Data showed a trend towards similar outcomes when comparing ACI generations with other repair techniques and when comparing different cell delivery methods and cell source selection. Majority of the studies (80 %) were level II evidence, and overall the quality of studies can be rated as average to low, with the absence of power analysis in 65 % studies.Conclusion: At present, there are insufficient data to conclude any superiority of ACI techniques. Considering its two-stage operation and cost, it may be appropriate to reserve ACI for patients with larger defects or those who have had inadequate response to other repair procedures until hard evidence enables specific clinical recommendations be made.Level Of Evidence: II. [ABSTRACT FROM AUTHOR]

Introduction: Until recently, treatment options for damage to cartilage in the knee were limited to the use of microfracture or, occasionally, mosaicplasty. The developments of autologous and characterised chondrocyte implantation have provided new treatment options but have large upfront costs. The objective of this study was to estimate the cost effectiveness of characterised chondrocyte implantation in the UK National Health Service.Methods: An economic model was constructed in Microsoft Excel®, with patients undergoing either microfracture or chondrocyte implantation. Following treatment failure, patients can undergo a series of interventions, ultimately ending in knee replacement. Effectiveness and utility were modelled using clinical trial data, which were supplemented with synthesised registry data, and costs were taken from published sources. Results were expressed in clinical events, quality-adjusted life-years (QALYs) and British pounds. Both costs and outcomes were discounted at 3.5 % per year.Results: Chondrocyte implantation is estimated to reduce the lifetime probability of knee replacement by 50 % in comparison with microfracture, and to increase QALYs by 0.72 (16.57 vs. 15.85). Costs were estimated to be £23,307 for chondrocyte implantation, and £8008 for microfracture, with the incremental cost of £15,299 for chondrocyte implantation reflecting reduced resource use offsetting some of the procedure cost. These values gave a cost per QALY gained of £21,245.Conclusion: Chondrocyte implantation is estimated to provide substantial patient benefits over a lifetime horizon, with a considerable increase in QALYs. Despite the increase in costs, the procedure is cost effective at standard thresholds used in the UK. [ABSTRACT FROM AUTHOR]

Background: Despite widespread use of transjugular intrahepatic portosystemic shunt (TIPS) for treatment of portal hypertension, a paucity of nationwide data exists on predictors of the economic impact related to TIPS.Aims: Using the National Inpatient Sample (NIS) database from 2001 to 2012, we aimed to evaluate factors contributing to hospital cost of patients admitted to US hospitals for TIPS.Methods: Using the NIS, we identified a discharge-weighted national estimate of 61,004 TIPS procedures from 2001 to 2012. Through independent sample analysis, we determined profile factors related to increases in hospital costs.Results: Of all TIPS cases, the mean charge adjusted for inflation to the year 2012 is $125,044 ± $160,115. The mean hospital cost adjusted for inflation is $44,901 ± $54,565. Comparing pre- and post-2005, mean charges and cost have increased considerably ($98,154 vs. $142,652, p < 0.001 and $41,656 vs. $46,453, p < 0.001, respectively). Patients transferred from a different hospital, weekend admissions, Asian/Pacific Islander patients, and hospitals in the Northeastern and Western region had higher cost. Number of diagnoses and number of procedures show positive correlations with hospital cost, with number of procedures exhibiting stronger relationships (Pearson 0.613). Comorbidity measures with highest increases in cost were pulmonary circulation disorders ($32,157 increase, p < 0.001).Conclusion: The cost of the TIPS procedure is gradually rising for hospitals. Alongside recent healthcare reform through the Affordable Care Act, measures to reduce the economic burden of TIPS are of increasing importance. Data from this study are intended to aid physicians and hospitals in identifying improvements that could reduce hospital costs. [ABSTRACT FROM AUTHOR]

Background: Burn injury is an emergency medical condition that rapidly develops as a result of tissue exposure to electrical, chemical or thermal energy. Therefore, its treatment usually begins at the emergency department. In this study we aimed to perform an epidemiological analysis of burn injuries presenting to the emergency department of a tertiary burn center, and factors affecting the cost of their medical care. Methods: Patients who presented to Baskent University Ankara Hospital Adult Emergency Department with burn injuries between January 2012 and December 2014 were studied for age, sex, time of admission, type of burn injury, clinical prognosis, mortality rate, percent burn area, and total cost of care. A total of 264 patients were enrolled. Chi square test was used for the comparison of categorical variables. Non-parametric tests were used for the comparison of continuous variables. Results: This study included 179 (67.8 %) women and 85 (32.2 %) men. The most common types of burn injuries were hot water burns and scalding. Eleven point seven percent of the patients sustained burn injuries in occupational accidents. 95.1 % of the patients were discharged from the emergency and 4.5 % of them were hospitalized. Only 1 (0.4 %) patient died. There was no significant difference between patient outcomes (discharge vs. hospital admission) with respect to the cost of care ( p = 0.846) No significant difference was found between the cost of care of surgical and non-surgical management of burn injuries ( p = 0.206). No significant difference was found between the costs of care of different types of burn injuries ( p = 0.053). There was a significant difference between burn degrees with respect to the cost of care ( p = 0.038). A significant difference was found between the costs of care of patients with a percent burn area of less than 10 % and those with a percent burn area of more than 10 % ( p < 0.001), indicating that as percent burn area increased, a proportional increase occurred in the cost of care. Conclusions: Burn degree and percent burn area were the main determinants of the cost of care of burn injuries. In conclusion, burn injuries are preventable by taking occupational measures and raising public awareness about domestic accidents. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to compare the short-term surgical outcomes and cost-benefits following totally laparoscopic distal gastrectomy (TLDG) and laparoscopy-assisted distal gastrectomy (LADG) for the treatment of gastric cancer.Methods: Between April 2007 and December 2013, a total of 100 patients with gastric cancer underwent laparoscopic distal gastrectomy. The patients were classified into two groups according to whether intracorporeal anastomosis or extracorporeal anastomosis had been performed. The comparison between the groups was based on clinicopathological characteristics and surgical and economic outcomes.Results: There were 57 and 43 patients who underwent TLDG and LADG, respectively. The patients' demographics and tumor characteristics did not show any statistically significant differences with the exception for tumor location. In the LADG group, tumors were localized to relatively higher positions (p = 0.024) and received Roux-en-Y reconstruction more frequently (p < 0.001). There were no differences in the incidence of morbidity. Anastomotic leakage was not recorded in either group, although anastomotic stenosis occurred in one patient (1.8 %) after TLDG and in two patients (4.7 %) after LADG. Compared with the LADG group, the TLDG group was associated with significantly less operative blood loss (p < 0.001), a shorter time to oral intake (p = 0.012), and hospital stay (p = 0.018). The median operation costs were greater in the TLDG group than in the LADG group (¥982,000 in TLDG vs. ¥879,830 in LADG; p < 0.001), whereas the median total hospital costs were similar between the two groups (¥1302,665 in LADG vs. ¥1383,322 in TLDG: p = 0.119).Conclusion: This study suggests that TLDG is as technically feasible, safe, and effective as LADG for treating patients with gastric cancer. Furthermore, TLDG is associated with equivalent total hospital costs compared with LADG. The increased operation cost is offset by the decreased costs associated with longer periods of hospitalization. [ABSTRACT FROM AUTHOR]

Purpose: The standard practice in pediatric patients diagnosed with intussusception has been reduction via enema and admission for a period of nil per os and observation. Little data exists to support this practice. The objective of this study was to examine whether post-reduction admission to hospital is required.Methods: A retrospective chart review was performed on all patients aged 0-18 years old with intussusception over a span of 20 years. Study included children treated for intussusception on first encounter with enema and subsequently admitted for observation. Study excluded those readmitted for recurrence after 48 h, patients whose intussusception did not reduce on first try, those lost to follow-up, and those who went to the operating room. Early recurrence was defined as recurrence within 48 h post-reduction.Results: Out of 171 patients admitted, only one experienced an early recurrence (0.6 %). Median length of stay for all patients was 2 days. Average cost incurred per day for intussusception admission was $404.Conclusion: Intussusception in a child that is successfully reduced via enema has a low recurrence rate and is usually followed by prompt resolution of symptoms. An abbreviated period of observation in the emergency department post-reduction may result in healthcare savings. [ABSTRACT FROM AUTHOR]

Purpose: Inguinal hernia repair is frequently performed in premature infants. Evidence on optimal management and timing of repair, as well as related medical costs is still lacking. The objective of this study was to determine the direct medical costs of inguinal hernia, distinguishing between premature infants who had to undergo an emergency procedure and those who underwent elective inguinal hernia repair.Methods: This cohort study based on medical records concerned premature infants with inguinal hernia who underwent surgical repair within 3 months after birth in a tertiary academic children's hospital between January 2010 and December 2013. Two groups were distinguished: patients with incarcerated inguinal hernia requiring emergency repair and patients who underwent elective repair. Real medical costs were calculated by multiplying the volumes of healthcare use with corresponding unit prices. Nonparametric bootstrap techniques were used to derive a 95 % confidence interval (CI) for the difference in mean costs.Results: A total of 132 premature infants were included in the analysis. Emergency surgery was performed in 29 %. Costs of hospitalization comprised 65 % of all costs. The total direct medical costs amounted to €7418 per premature infant in the emergency repair group versus €4693 in the elective repair group. Multivariate analysis showed a difference in costs of €1183 (95 % CI -1196; 3044) in favor of elective repair after correction for potential risk factors.Conclusion: Emergency repair of inguinal hernia in premature infants is more expensive than elective repair, even after correction for multiple confounders. This deserves to be taken into account in the debate on timing of inguinal hernia repair in premature infants. [ABSTRACT FROM AUTHOR]

Purpose: This paper responds to the call for more research to fully understand out of pocket (OOP) costs for cancer patients by providing a detailed discussion of such costs for adult haematology patients from Queensland, Australia.Methods: The descriptive qualitative research was based on in-depth interviews with 45 (n = 45) haematology patients from regional, rural and remote areas.Results: The discussion itemises the OOP costs under four categories including the costs associated with travel and accommodation, the costs associated with family and friends during relocation, the costs associated with diagnosis and treatment, and the costs of parking.Conclusions: The paper provides evidence of the categories of financial burden experienced by haematology patients who have to relocate for specialist treatment by detailing the extensive range of OOP costs. The expectation is that the itemisation of OOP cost variables will contribute to future efforts of quantification. [ABSTRACT FROM AUTHOR]

Introduction: The objective of this study was to analyze medical costs and healthcare resource utilization (HRU) associated with everolimus-based therapy or chemotherapy among elderly women with hormone-receptor-positive, human-epidermal-growth-factor-receptor-2-negative (HR+/HER2-) metastatic breast cancer (mBC).Methods: Elderly women (≥65 years) with HR+/HER2- mBC who failed a non-steroidal-aromatase-inhibitor and subsequently began a new line of treatment with everolimus-based therapy or chemotherapy for mBC (index therapy) during July 20, 2012 to March 31, 2014 were identified from two large commercial claims databases. All-cause, BC-, and adverse event (AE)-related medical costs (2014 USD), and all-cause and AE-related HRU per patient per month (PPPM) were compared between patients treated with everolimus-based therapy and chemotherapy across their first four lines of therapy for mBC. Adjusted costs and HRU differences were estimated by pooling all lines and using multivariable models adjusted for differences in patient characteristics.Results: In total, 925 elderly patients (mean age approximately 73 years) with HR+/HER2- mBC met the inclusion criteria; 230 received everolimus-based therapy (240 lines) and 737 received chemotherapy (939 lines). Compared with chemotherapy, everolimus-based therapy was associated with significantly lower total all-cause PPPM medical services costs (adjusted mean difference: $4007), driven by lower inpatient ($1994) and outpatient ($1402) costs; lower BC-related medical services costs ($3129), driven by both BC-related inpatient ($1883) and outpatient costs ($913); and lower AE-related medical services costs ($1873; all P < 0.01). Additionally, compared to patients treated with chemotherapy, patients treated with everolimus-based therapy had fewer all-cause outpatient visits (adjusted incidence rate ratio = 0.69), BC-related outpatient visits (0.66), other-medical-service visits (0.65), and AE-related HRU (0.59), which was driven by significantly fewer AE-related outpatient visits (0.56; all P < 0.01). Subgroup analyses comparing medical costs of everolimus-based therapy with capecitabine monotherapy showed consistent results overall.Conclusion: This retrospective claims database analysis of elderly women with HR+/HER2- mBC in the United States showed that everolimus-based therapy was associated with significantly lower all-cause, BC-related, and AE-related medical services costs and less use of healthcare resources compared with chemotherapy.Funding: Novartis. [ABSTRACT FROM AUTHOR]

Antifungal prophylaxis/therapy (AP/AT) raises the cost of allogeneic haematopoietic cell transplantation (alloHCT). Its efficacy, different approaches for AP/AT, diagnostic measures and cost-effectiveness must still be evaluated. In 2010, we conducted a prospective study with 106 consecutive patients receiving an alloHCT analysing AP/AT, choice and costs of diagnostics applied including CT scans, galactomannan (Gal) and β-D-glucan (β-D) testing. Antifungal prophylaxis in 91 patients consisted of fluconazole (FLU) or L-AMB (AmBisome™ 1 or 3 mg/kg/day b.w.), and antifungal therapy had to be initiated in 38 % of the FLU/L-AMB-1-mg patients but in none with L-AMB 3 mg. Empirical AT consisted of L-AMB 1 mg/kg (n = 12) and preemptive AT of L-AMB 3 mg/kg (n = 17) and proved very efficacious with no further antifungal drug escalation in 89.6 %. Mean costs of diagnostic measures were 402 €/alloHCT; however, only 22 % of the CT scans, 4 % of β-D and 3 % of galactomannan testing were positive. We detected one proven, 17 probable and 14 possible fungal infections. Due to the German diagnosis-related group system with additional compensation, all our AP/AT strategies were adequately reimbursed. While clinical symptoms and CT scans are the most commonly used, inexpensive decision-making tools for starting AT, the expensive laboratory diagnostic procedures are ineffective; we have therefore discontinued regular GAL/β-D testing and changed our AP in patients at risk. [ABSTRACT FROM AUTHOR]

Purpose: The authors evaluated the ability of a fibrin sealant (TISSEEL™: Baxter Healthcare Corp, Deerfield, IL, USA) to reduce the incidence of post-operative seroma following abdominal wall hernia repair.Methods: We performed a 4-year retrospective review of patients undergoing abdominal wall hernia repair, with and without TISSEEL, by a single surgeon (FEE) at The Johns Hopkins Hospital. Demographics, surgical risk factors, operative data and 30-day outcomes, including wound complications and related interventions, were compared. The quantity and cost of Tisseel per case was reviewed.Results: A total of 250 patients were evaluated: 127 in the TISSEEL group and 123 in the non-TISSEEL control group. The average age for both groups was 56.6 years (P = 0.97). The majority of patients were female (TISSEEL 52.8%, non-TISSEEL 56.1%, P = 0.59) and ASA Class III (TISSEEL 56.7%, non-TISSEEL 58.5%, P = 0.40). There was no difference in the average defect size for both groups (TISSEEL 217 ± 187.6 cm(2), non-TISSEEL 161.3 ± 141.5 cm(2), P = 0.36). Surgical site occurrences occurred in 18.1% of the TISSEEL and 13% of the non-TISSEEL group (P = 0.27). There was a trend towards an increased incidence of seroma in the TISSEEL group (TISSEEL 11%, non-TISSEEL 4.9%, P = 0.07). A total of $124,472.50 was spent on TISSEEL, at an average cost of $995.78 per case.Conclusions: In the largest study to date, TISSEEL™ application offered no advantage for the reduction of post-operative seroma formation following complex abdominal hernia repair. Moreover, the use of this sealant was associated with significant costs. [ABSTRACT FROM AUTHOR]

Introduction: Health technology assessment is not required for regulatory submission or approval in either the United States (US) or Japan. This study was designed as a cross-country evaluation of cost analyses conducted in the US and Japan based on the PRONOUNCE phase III lung cancer trial, which compared pemetrexed plus carboplatin followed by pemetrexed (PemC) versus paclitaxel plus carboplatin plus bevacizumab followed by bevacizumab (PCB).Methods: Two cost analyses were conducted in accordance with International Society For Pharmacoeconomics and Outcomes Research good research practice standards. Costs were obtained based on local pricing structures; outcomes were considered equivalent based on the PRONOUNCE trial results. Other inputs were included from the trial data (e.g., toxicity rates) or from local practice sources (e.g., toxicity management). The models were compared across key input and transferability factors.Results: Despite differences in local input data, both models demonstrated a similar direction, with the cost of PemC being consistently lower than the cost of PCB. The variation in individual input parameters did affect some of the specific categories, such as toxicity, and impacted sensitivity analyses, with the cost differential between comparators being greater in Japan than in the US.Conclusion: When economic models are based on clinical trial data, many inputs and outcomes are held consistent. The alterable inputs were not in and of themselves large enough to significantly impact the results between countries, which were directionally consistent with greater variation seen in sensitivity analyses. The factors that vary across jurisdictions, even when minor, can have an impact on trial-based economic analyses.Funding: Eli Lilly and Company. [ABSTRACT FROM AUTHOR]

Summary: Scientific interest in vitamin D has greatly risen during the last 10 years. The analysis of the changes in vitamin D prescriptions and related costs in a regional prescription dataset has revealed a profound increase in the period 2006-2013. Further studies on cost-effectiveness of such increase in vitamin D supplementation are needed. Introduction: The aim of this study was to analyze the changes in population-based prescription patterns of vitamin D supplements in the general population in an Italian regional setting during an 8-year period (2006-2013). Methods: Data have been retrieved from the database of reimbursed prescriptions of the Region of Tuscany containing all of the medical reimbursements for the whole regional population (total of 3,619,872 and 3,692,828 inhabitants in 2006 and 2013, respectively). Data referring to adult population (age 20-90+ years) have been considered for this analysis (3,033,530 in 2006 and 3,066,741 in 2013). Two different flows (pharmaceutical distribution dataset and general data flow) were taken into account, using the ATC5 coding system for vitamin D supplements alone or in combination with calcium or alendronate. The number of boxes dispensed was retrieved, the number of patients receiving a specific treatment was calculated, and a cost analysis was performed. Results: An upsurge in the prescriptions of vitamin D compounds was disclosed, mainly sustained by a 75.3-fold increase in cholecalciferol, in all age groups and both sexes. This occurred in parallel to a 4.3-fold rise in prescriptions of oral alendronate in combination with cholecalciferol, a slight decrease in dispensed alendronate alone, and a modest increase in the prescription of the combination of calcium salts and cholecalciferol, and calcium alone. The total cost for reimbursement by the Regional Health System for vitamin D-related compounds rose from €3,242,100 euros in 2006 to €8,155,778 in 2013. Conclusion: The huge increase in vitamin D prescriptions and related costs in the last decade, as revealed by the analysis of a regional pharmaceutical dataset, reflects the increased awareness of the possible consequences of a poor vitamin D status. Further studies on cost-effectiveness of such increase in vitamin D supplementation are needed. [ABSTRACT FROM AUTHOR]

Purpose: This paper is to evaluate the efficacy and safety of transforaminal lumbar interbody fusion (TLIF) using unilateral pedicle screws along with contralateral translaminar facet joint screw (UPS+TFS) fixation in comparison with the method using bilateral pedicle screws fixation (BPS) in degenerative lumbar diseases.Methods: Forty patients with single-level lumbar diseases were divided into two groups randomly. One group was treated by TLIF with BPS fixation while the other group was treated by the new technique with UPS+TFS fixation. The preoperative and postoperative ODI, JOA, VAPS scores, mean operation time, mean operation blood loss, fusion rate and complications were collected for comparison under two surgical methods. In terms of complications, only two cases of superficial infection in the BPS group and one case of urinary tract infection in the other group was found.Results: The mean operation time and blood loss was significantly less in UPS+TFS group than in BPS group. The preoperation and postoperative ODI, JOA and VAPS at the intervals of 6 weeks, 3, 6 months and 1 year between the BPS and UPS+TFS group showed no significant disparities. Only one patient in UPS+TFS group was not fused with pseudoarthrosis formation.Conclusions: The clinical efficacy and safety of TLIF with UPS+TFS fixation were comparable to BPS fixation; however, the soft tissue injury and the corresponding operation cost were reduced with unilateral pedicle screw plus translaminar facet screw fixation. [ABSTRACT FROM AUTHOR]

Nebivolol is a highly selective β-adrenergic receptor antagonist with a pharmacologic profile that differs from those of other drugs in its class. In addition to cardioselectivity mediated via β receptor blockade, nebivolol induces nitric oxide-mediated vasodilation by stimulating endothelial nitric oxide synthase via β agonism. This vasodilatory mechanism is distinct from those of other vasodilatory β-blockers (carvedilol, labetalol), which are mediated via α-adrenergic receptor blockade. Nebivolol is approved for the treatment of hypertension in the US, and for hypertension and heart failure in Europe. While β-blockers are not recommended within the current US guidelines as first-line therapy for treatment of essential hypertension, nebivolol has shown comparable efficacy to currently recommended therapies in lowering peripheral blood pressure in adults with hypertension with a very low rate of side effects. Nebivolol also has beneficial effects on central blood pressure compared with other β-blockers. Clinical data also suggest that nebivolol may be useful in patients who have experienced erectile dysfunction while on other β-blockers. Here we review the pharmacological profile of nebivolol, the clinical evidence supporting its use in hypertension as monotherapy, add-on, and combination therapy, and the data demonstrating its positive effects on heart failure and endothelial dysfunction. [ABSTRACT FROM AUTHOR]

Objective: To assess the clinical success and costs of computed tomography (CT)-guided radiofrequency ablation (RFA) of osteoblastoma (OB) and spinal osteoid osteoma (OO). Materials and methods: Nineteen patients with OB and eight patients with spinal OO were treated with CT-guided RFA. The OBs were localized in the extremities ( n = 10), the vertebral column ( n = 2), and (juxta-)articular ( n = 7). Dedicated procedural techniques included three-dimensional CT-guided access planning in all cases, overlapping RFA needle positions (median, two positions; range, 1-6 RF-electrode positions) within the OB nidus (multiple ablation technique, n = 15), and thermal protection in case of adjacent neural structure in four spinal OO. The data of eight operated OB and ten operated spinal OO patients were used for comparison. Long-term success was assessed by clinical examination and using a questionnaire sent to all operated and RFA-treated patients including visual analogue scales (VAS) regarding the effect of RFA on severity of pain and limitations of daily activities (0-10, with 0 = no pain/limitation up to 10 = maximum or most imaginable pain/limitation). Results: All patients had a clear and persistent pain reduction until the end of follow-up. The mean VAS score for all spinal OO patients and all OB patients treated either with RFA or with surgical excision significantly decreased for severity of pain at night, severity of pain during the day, and both for limitations of daily and of sports activities. Conclusions: RFA is an efficient method for treating OB and spinal OO and should be regarded as the first-line therapy after interdisciplinary individual case discussion. [ABSTRACT FROM AUTHOR]

Background: Studies have shown that pharmaceutical care can result in favorable clinical outcomes in human immunodeficiency virus (HIV)-infected patients, however, few studies have assessed the economic impact. The objective of this study was to evaluate the clinical and economic impact of pharmaceutical care of HIV-infected patients. Methods: A controlled ambispective study was conducted in Brazil from January 2009 to June 2012. Patients were allocated to either intervention or control group. The control group was followed according to standard care while the intervention group was also followed by a pharmacist at each physician appointment for one year. Effectiveness outcomes included CD4+ count, viral load, absence of co-infections and optimal immune response, and economic outcomes included expenses of physician and pharmaceutical appointments, laboratory tests, procedures, and hospitalizations, at six months and one year. Results: Intervention and control groups included 51 patients each. We observed significant decreases in total pharmacotherapy problems during the study. At six months, the intervention group contained higher percentages of patients without co-infections and of patients with CD4+ >500 cells/mm³. None of the differences between intervention and control group considering clinical outcomes and costs were statistically significant. However, at one year, the intervention group showed higher percentage of better clinical outcomes and generated lower spending (not to procedures). An additional health care system daily investment of US$1.45, 1.09, 2.13, 4.35, 1.09, and 0.87 would be required for each additional outcome of viral load <50 copies/ml, absence of co-infection, CD4+ >200, 350, and 500 cells/mm3, and optimal immune response, respectively. Conclusion: This work demonstrated that pharmaceutical care of HIV-infected patients, for a one-year period, was able to decrease the number of pharmacotherapy problems. However, the clinical outcomes and the costs did not have statistical difference but showed higher percentage of better clinical outcomes and lower costs for some items. [ABSTRACT FROM AUTHOR]

Purpose: To calculate the costs to the US healthcare system of transition from single-row (SR) to double-row (DR) rotator cuff repair (RCR) and to calculate the decrease in re-operations for re-tear that DR RCR would need to accomplish in order to render the transition cost-neutral. Methods: Standard accounting methods were used to determine the cost of a single RCR, the annual cost to the US healthcare system of rotator cuff surgery, the cost of a single-revision RCR, and the decrease in revision for re-tear rate necessary to make DR or suture bridge (SB) methods cost-neutral in comparison with SR methods. We varied tear size, operating room cost, time required for implant placement, annual tear size distribution, and repair method. Results: The cost of RCR ranged from $7,572 (SR, <1 cm tear) to $12,979 (DR, >5 cm tear). Complete conversion from SR RCR to a DR technique without an associated decrease in revision surgeries would increase the annual US healthcare cost between $80 million and $262 million per year. To obtain cost neutrality, use of DR or SB methods would need to result in one fewer revision in every 17 primary repairs (for tears <1 cm) to one fewer in every four primary repairs (for tears >5 cm). Conclusions: Conversion from SR to DR or SB RCR techniques would result in considerable increases in healthcare expenditures. Since the large decreases in revision surgery rates necessary to justify DR or SB repairs purely on a cost basis may not be realistic or even possible, the use of these methods should be supported by evidence of improved structural healing rates and quality-adjusted life years in comparison with SR methods. Level of evidence: IV. [ABSTRACT FROM AUTHOR]

Subcutaneous liraglutide (Victoza), a glucagon-like peptide 1 receptor agonist, is approved for the treatment of adult patients with type 2 diabetes mellitus. Once-daily liraglutide, as monotherapy or add-on therapy to other antidiabetic agents (including basal insulin), was an effective and generally well tolerated treatment in adult patients with type 2 diabetes in several well-designed phase III trials and in the real world clinical practice setting. In addition to improving glycaemic control, liraglutide had beneficial effects on bodyweight, systolic blood pressure and surrogate measures of β-cell function in clinical trials, with these benefits maintained during long-term treatment (≤2 years). Liraglutide has a convenient once-daily administration regimen, a low potential for drug-drug interactions and low propensity to cause hypoglycaemia. Thus, liraglutide continues to be a useful option for the management of type 2 diabetes. This article reviews the therapeutic use of liraglutide in adult patients with type 2 diabetes and summarizes its pharmacological properties. [ABSTRACT FROM AUTHOR]

Sevelamer carbonate (Renvela), a buffered form of sevelamer hydrochloride (Renagel), is an orally administered non-absorbed phosphate-binding anion exchange resin used in the treatment of hyperphosphataemia in chronic kidney disease (CKD). In the EU, sevelamer carbonate is approved in adult CKD patients who require dialysis and in those who do not require dialysis with serum phosphate levels ≥1.78 mmol/L, whereas in the USA sevelamer carbonate is approved in adult CKD patients who require dialysis. Sevelamer carbonate and sevelamer hydrochloride achieved similar reductions in serum phosphate levels in randomized comparative trials in patients with CKD receiving haemodialysis; sevelamer carbonate also reduced serum phosphate levels in noncomparative studies in CKD patients not requiring dialysis. The most common adverse events with sevelamer carbonate are gastrointestinal in nature. Sevelamer has pleiotropic effects, such as improving the serum lipid profile and attenuating endothelial and cardiovascular risk factors in CKD. All formulations of sevelamer have markedly higher acquisition costs than calcium-based phosphate binders. Cost-effectiveness analyses focusing specifically on sevelamer carbonate have not been conducted, and those based on clinical trial data with sevelamer hydrochloride have provided both favourable and unfavourable results compared with calcium-based phosphate binders, reflecting heterogeneity between modelled analyses in terms of data sources, assumptions, comparators, geographical regions, type of costs included and other factors. Although well-designed studies evaluating the impact of phosphate binders on hard clinical endpoints appear to be warranted, sevelamer carbonate may be particularly useful for the treatment of patients at risk of metabolic acidosis (offering advantages over sevelamer hydrochloride in this regard) and for individuals requiring treatment with a phosphate binding agent that does not contain aluminium or calcium. [ABSTRACT FROM AUTHOR]

A combination of prolonged-release (PR) oxycodone with PR naloxone (Targin, Targiniq, Targinact) in one tablet with a fixed 2:1 ratio is available for the treatment of patients with severe pain, which can only be adequately managed with opioid analgesics. The aim of this formulation is to counteract opioid-induced constipation through the local antagonist effect of naloxone in the gut wall, while maintaining analgesia due to the low bioavailability of oral naloxone. Three large, 12-week, randomized, double-blind, phase III trials in patients with moderate to severe, chronic, non-malignant pain, plus a prospectively planned pooled analysis of two of these studies, demonstrated that oxycodone/naloxone PR improved bowel function, as measured by the bowel function index, compared with oxycodone PR. Additionally, oxycodone/naloxone PR relieved pain more effectively than placebo and no less effectively than oxycodone PR after 12 weeks. Phase II efficacy data in cancer patients are consistent with those observed in patients with non-malignant pain. Oxycodone/naloxone PR was generally well tolerated; the most frequently reported adverse events were of gastrointestinal origin, consistent with those known to occur with opioid therapy. Of note, numerically lower rates of constipation were observed in the oxycodone/naloxone PR group compared with the oxycodone PR group. A cost-utility analysis predicted that oxycodone/naloxone PR would be a cost-effective option compared with oxycodone PR in patients with non-malignant pain. Although more comparative data are needed, oxycodone/naloxone PR is an effective option for use in patients with severe chronic pain, particularly among those with opioid-induced constipation. [ABSTRACT FROM AUTHOR]

Rivaroxaban (Xarelto), an oral direct factor Xa inhibitor, is approved for the initial treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as the prevention of recurrent DVT and PE. It is administered at a fixed oral dose and does not require routine coagulation monitoring. In the EINSTEIN-DVT and EINSTEIN-PE trials, in over 8,000 patients with DVT and/or PE, a single-drug approach with rivaroxaban was shown to be noninferior to standard therapy consisting of subcutaneous enoxaparin sodium overlapping with and followed by an oral dose-adjusted vitamin K antagonist (enoxaparin-VKA) with regard to the incidence of symptomatic recurrent venous thromboembolism (VTE) after 3, 6 or 12 months of treatment. Rivaroxaban was generally well tolerated in patients with DVT or PE, with no significant between-group differences in clinically relevant bleeding between the rivaroxaban and enoxaparin-VKA groups. Notably, rivaroxaban was associated with a significantly lower rate of major bleeding compared with enoxaparin-VKA when EINSTEIN-DVT and EINSTEIN-PE data were pooled. Pharmacoeconomic analyses indicated that rivaroxaban may be a cost-effective alternative to enoxaparin-VKA for the treatment of DVT or PE and prevention of recurrent VTE. Extended prophylaxis with rivaroxaban reduced the incidence of symptomatic recurrent VTE to a greater extent than placebo in the EINSTEIN-Extension trial, but was associated with a non-significant increase in the risk of clinically relevant bleeding compared with placebo. In conclusion, rivaroxaban is a reasonable alternative to standard therapy for the treatment of DVT and PE, and as extended thromboprophylaxis. [ABSTRACT FROM AUTHOR]

Oral fidaxomicin (Dificid; Dificlir) is a first-in-class macrocyclic antibacterial that is approved in several countries for the treatment of adult patients with Clostridium difficile-associated diarrhoea. Fidaxomicin 200 mg twice daily for 10 days was an effective and generally well tolerated treatment in adult patients with a first episode or first recurrence of C. difficile infection. In two multinational phase III trials, fidaxomicin treatment was noninferior to vancomycin treatment with regard to clinical cure rates and was associated with statistically significantly lower C. difficile infection recurrence rates and statistically significantly higher global cure rates than vancomycin. The drug has a favourable pharmacological profile, including having a narrow spectrum of activity that targets relevant pathogens, minimal impact on normal faecal microflora, a convenient treatment regimen and attainment of very high faecal concentrations. Albeit further clinical experience is required to fully define the position of fidaxomicin, it is a valuable emerging option for the treatment of first episode and recurrent episodes of C. difficile-associated diarrhoea. [ABSTRACT FROM AUTHOR]

BACKGROUND: Recent clinical trials of male circumcision, oral pre-exposure prophylaxis (PrEP), and a vaginal microbicide gel have shown partial effectiveness at reducing HIV transmission, stimulating interest in implementing portfolios of biomedical prevention programs. OBJECTIVE: To evaluate the effectiveness and cost-effectiveness of combination biomedical HIV prevention and treatment scale-up in South Africa, given uncertainty in program effectiveness. DESIGN: Dynamic HIV transmission and disease progression model with Monte Carlo simulation and cost-effectiveness analysis. PARTICIPANTS: Men and women aged 15 to 49 years in South Africa. INTERVENTIONS: HIV screening and counseling, antiretroviral therapy (ART), male circumcision, PrEP, microbicide, and select combinations. MAIN MEASURES: HIV incidence, prevalence, discounted costs, discounted quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. KEY RESULTS: Providing half of all uninfected persons with PrEP averts 28 % of future HIV infections for $9,000/QALY gained, but the affordability of such a program is questionable. Given limited resources, annual HIV screening and ART utilization by 75 % of eligible infected persons could avert one-third of new HIV infections, for approximately $1,000/QALY gained. Male circumcision is more cost-effective, but disproportionately benefits men. A comprehensive portfolio of expanded screening, ART, male circumcision, microbicides, and PrEP could avert 62 % of new HIV infections, reducing HIV prevalence from a projected 14 % to 10 % after 10 years. This strategy doubles treatment initiation and adds 31 million QALYs to the population. Despite uncertainty in program effectiveness, a comprehensive portfolio costs less than $10,000/QALY gained in 33 % of simulation iterations and less than $30,000/QALY gained in 90 % of iterations, assuming an annual microbicide cost of $100. CONCLUSIONS: A portfolio of modestly-effective biomedical HIV prevention programs, including male circumcision, vaginal microbicides, and oral PrEP, could substantially reduce HIV incidence and prevalence in South Africa and be likely cost-effective. Given limited resources, PrEP is the least cost-effective intervention of those considered. [ABSTRACT FROM AUTHOR]

Purpose: To analyze the therapeutic indications for off-label use of rituximab, the available evidence for its use, the outcomes, and the cost. Methods: This was a retrospective analysis of patients treated with rituximab for off-label indications from January 2007 to December 2009 in two tertiary hospitals. Information on patient characteristics, medical conditions, and therapeutic responses was collected from medical records. Available evidence for the efficacy of rituximab in each condition was reviewed, and the cost of treatment was calculated. Results: A total of 101 cases of off-label rituximab use were analyzed. The median age of the patients involved was 53 [interquartile range (IQR) 37.5-68.0] years; 55.4 % were women. The indications for prescribing rituximab were primarily hematological diseases (46 %), systemic connective tissue disorders (27 %), and kidney diseases (20 %). Available evidence supporting rituximab treatment for these indications mainly came from individual cohort studies (53.5 % of cases) and case series (25.7 %). The short-term outcome (median 3 months, IQR 2-4 months) was a complete response in 38 % of cases and partial response in 32.6 %. The highest short-term responses were observed for systemic lupus erythematosus and membranous glomerulonephritis, and the lowest was for neuromyelitis optica, idiopathic thrombocytopenic purpura, and miscellaneous indications. Some response was maintained in long-term follow-up (median 23 months IQR 12-30 months) in 69.2 % of patients showing a short-term response. Median cost per patient was € 5,187.5 (IQR € 5,187.5-7,781.3). Conclusions: In our study, off-label rituximab was mainly used for the treatment of hematological, kidney, and systemic connective tissue disorders, and the response among our patient cohort was variable depending on the specific disease. The level of evidence supporting the use of rituximab for these indications was low and the cost was very high. We conclude that more clinical trials on the off-label use of rituximab are needed, although these may be difficult to conduct in some rare diseases. Data from observational studies may provide useful information to assist prescribing in clinical practice. [ABSTRACT FROM AUTHOR]

Purpose: Assessment of the cost utility (CU) of acute renal replacement therapy (RRT) from a societal perspective during a 5-year follow-up. Methods: This was a cross-sectional cohort study in a medical-surgical intensive care unit and an acute RRT unit of 410 consecutive patients treated with acute RRT in Helsinki University Hospital in 2000-2002. Five-year survival and health-related quality of life (HRQoL) were assessed and used to calculate quality-adjusted life years (QALYs) in two ways. They were first calculated for the 5-year follow-up period and, second, estimated for the expected lifetime. HRQoL was assessed by the EuroQol (EQ-5D) in 2003. The cost analysis included hospital costs during index hospitalization along with hospital and societal costs for the following 5 years. The CU ratio was determined as total costs divided by gained QALYs. Results: Median survival time for all patients was 0.20 years and the EQ-5D index score was 0.68, 0.18 lower than that of the age- and gender-matched general population. All RRT-treated patients gained 0.10 QALYs/patient and hospital survivors 2.54 QALYs in 5 years. Overall the CU ratio was poor [5 year median 271,116 (29,782-2,177,581) €/QALY]. However, it was acceptable (less than 50,000 €/QALY) in patients who survived for more than a year and did not need chronic RRT. Cost utility decreased with increasing age exceeding 1.0 million €/QALY in the older groups. Conclusions: In general, the CU ratio of acute RRT is poor. However, it is acceptable in patients with renal recovery who survive for more than 1 year. [ABSTRACT FROM AUTHOR]

The HIV pandemic continues to be one of our greatest contemporary public health threats. Policy makers in many middle- and low-income countries are in the process of scaling up HIV prevention, treatment and care services in the context of a reduction in international HIV funding due to the global economic downturn. In order to scale up services that are sustainable in the long term, policy makers and implementers need to have access to robust and contemporary strategic information, including financial information on expenditure and cost, in order to be able to plan, implement, monitor and evaluate HIV services. A major problem in middle- and low-income countries continues to be a lack of basic information on the use of services, their cost, outcome and impact, while those few costing studies that have been performed were often not done in a standardized fashion. Some researchers handle this by transposing information from one country to another, developing mathematical or statistical models that rest on assumptions or information that may not be applicable, or using top-down costing methods that only provide global financial costs rather than using bottom-up ingredients-based costing. [ABSTRACT FROM AUTHOR]

Nucleoside reverse transcriptase inhibitors (NRTIs) remain a critical component of therapy for HIV-infected patients. The drugs are effective, relatively inexpensive and an important component of antiretroviral therapy (ART), particularly in areas where the introduction of effective therapy has been delayed. They are an essential part of initial therapy for HIV and for prevention of mother-to-child transmission; however, toxicities and resistance may limit their use. The role for pre-exposure prophylaxis (PrEP) to reduce sexual transmission of HIV is still undefined, but this use may have a significant impact on NRTI resistance worldwide, most particularly in areas where subtype C predominates. With increasing prevalence of resistant HIV, the approval of new agents that are effective against resistant virus, and those that use novel cellular targets, are essential. Large studies are now in progress examining the safety and efficacy of NRTI-sparing regimens, but results are not currently available. NRTIs may lose relevance in the not distant future unless steps are put in place to reduce the development and spread of NRTI- resistant viruses, and new NRTIs with minimal toxicity are developed that have a novel resistance profile. This article describes the principal NRTIs, their mechanism of action, and resistance and selected toxicities of the class and of the individual drugs. [ABSTRACT FROM AUTHOR]

Background: Chronic kidney disease (CKD) is associated with significant economic burdens to both patients and the healthcare system, but pharmaceutical cost analyses are uncommon despite drug therapy being a cornerstone of CKD management. Methods: This observational, retrospective review of drug cost distribution at a single tertiary care pediatric nephrology program in Canada was conducted on prevalent patients with CKD aged 1 month to 20 years, between 1 January and 31 December 2009. Results: The time-adjusted annual pharmaceutical cost of our cohort ( n = 148) was just below US $250,000 with a cost per patient per year of $1,800. The highest costs were in the growth and nutrition category, followed by anemia, hypertension and bone metabolism. Total drug cost per patient increased as CKD stage advanced. Adherence was not demonstrated in any drug category, and the mean daily pill burden was nine (range 2-23). Conclusions: This study has shown that while the annual pharmaceutical costs on a per patient basis are similar between children and adults, the cost distribution is very different. An increase in awareness of the unique needs of the pediatric population should allow for more cost-effective financial planning in pediatric CKD clinics. [ABSTRACT FROM AUTHOR]

Orphan drugs are intended for diseases with a very low prevalence, and many countries have implemented legislation to support market access of orphan drugs. We argue that it is time to revisit the special market access status of orphan drugs. Indeed, evidence suggests that there is no societal preference for treating rare diseases. Although society appears to assign a greater value to severity of disease, this criterion is equally relevant to many common diseases. Furthermore, the criterion of equity in access to treatment, which underpins orphan drug legislation, puts more value on health improvement in rare diseases than in common diseases and implies that population health is not maximized. Finally, incentives for the development, pricing and reimbursement of orphan drugs have created market failures, including monopolistic prices and the artificial creation of rare diseases. We argue that, instead of awarding special market access status to orphan drugs, there is scope to optimize research and development (R&D) of orphan drugs and to control prices of orphan drugs by means of, for example, patent auctions, advance purchase commitments, pay-as-you-go schemes and dose-modification studies. Governments should consider carefully the right incentive strategy for R&D of orphan drugs in rare diseases. [ABSTRACT FROM AUTHOR]

Intraocular pressure (IOP) reduction is currently the only therapeutic approach demonstrated to preserve visual function in patients with glaucoma. The first line of glaucoma treatment consists of topical IOP-lowering medications, usually initiated as monotherapy. A significant proportion of patients require more than one medication to reach a target IOP at which optic nerve damage will not progress. As prostaglandin analogues (PGAs) are the most effective class for reducing IOP, one of the other commonly used classes (β-adrenoceptor antagonist [β-blocker], carbonic anhydrase inhibitor or α2-adrenoceptor agonist) is frequently combined with a PGA. In the last decade, the use of fixed combinations containing two medications in a single bottle has steadily increased. Fixed combinations have the potential to simplify the dosing regimen, increase patient adherence, avoid the washout effect of the second drop on the first medication instilled, decrease exposure to preservatives and, sometimes, reduce the cost of treatment. Clinical trials have evaluated PGA-based fixed combinations versus unfixed combinations (individual components administered concomitantly) or versus individual monotherapies; however, any advantage that the fixed combinations may have in terms of IOP-lowering efficacy is still debated. For these reasons, the PGA-based fixed combinations are not approved by regulatory authorities in some countries, such as the US. We review the published studies evaluating the efficacy and tolerability of the IOP-lowering unfixed and fixed combination therapies with PGAs. Regarding unfixed combinations, the review shows that α2-adrenergic agonists-PGA and carbonic anhydrase inhibitor-PGA combinations seem to be at least as effective at reducing IOP as the β-blocker-PGA combinations. As for the fixed combinations, the review shows that the three PGA-timolol fixed combinations are more effective than their component medications used separately as monotherapy and are better tolerated than the three respective prostaglandins. The three PGA-timolol fixed combinations are less effective at reducing IOP than the unfixed combinations but are better tolerated. The advantage of the fixed combinations in terms of patient adherence and persistence is supported by a very small number of studies and remains to be more accurately determined. Most studies, but not all, seem to show that PGA-timolol fixed combinations are more effective than other available β-blocker fixed combinations (dorzolamide-timolol fixed combinations) at reducing IOP and are similarly tolerated [ABSTRACT FROM AUTHOR]

Aim: The objective of the present analysis was to assess the effectiveness of national and international guidelines in the treatment of patients with allergic rhinitis as well as rhinitis and asthma. Subject and methods: The data of 121,593 patients collected during nine prospective observational studies carried out between 1998 and 2005 were examined using an individual patient data meta-analysis method. Results: A total of 76,981 patient data were included in the final analysis. In all, 14.8% of patients with allergic rhinitis were treated according to the recommendations. The effectiveness results show no statistical differences between the treatment suggested in the guideline and other therapies, in terms of reducing the nasal symptom score and improving the global health state. Patients receiving a non-conform therapeutic regime reported a mean improvement in nasal symptoms of 4.58 points of a possible 9. Applying the guidelines strictly, by supplementing additional treatment modalities according to the severity of the symptoms of rhinitis, did not result in any additional improvement (3.26 points out of 9). Conclusion: The authors' findings conflict with the results of previous studies that demonstrated the superiority of following guideline recommendations over an open choice of therapy. The analysis of confounding factors demonstrated that patient compliance is one of the important determinants for effective and efficient guideline implementation. [ABSTRACT FROM AUTHOR]

Study design:A prospective study.Objectives:To determine the cost of acute phase of injury (ASCI) among spinal cord-injured patients managed conservatively in Nigeria.Settings:Gwagwalada, Abuja.Methods:Over a 1-year period (1 January 2009 to 31 December 2009), the cost of ASCI of consecutive spinal cord-injured patients, gainfully employed preinjury, who paid the hospital bill directly from their purses and could estimate their daily income, and who were managed conservatively for 6 weeks before discharge to rehabilitation, was prospectively examined.Results:A total of 34 cases of spinal cord-injured patients with a mean age of 35.4±12.8 years were included in this study. The mean cost of ASCI over 6 weeks was $1598.29, an average of 6.4-232.8% of patients' annual income where >50% of the people live on less than a dollar a day. The mean cost of hospitalization was 14.9% of the total cost of ASCI in this study. It was significantly more expensive to treat tetraplegics compared with paraplegics.Conclusion:This study identified the cost of acute phase of spinal cord injury in Nigeria to assist clinicians in planning treatment that could reduce financial burden on the patients but optimize patients' care. [ABSTRACT FROM AUTHOR]

Purpose: In recent years, colorectal cancer surgery has benefitted from new techniques such as laparoscopy and robotic surgery. However, many treatment disparities exist among different centers for patients affected by the same kind of tumors. Methods: Forty-five (41%) open (OCO) vs. 30 (28%) laparoscopic (LCO) vs. 34 (31%) robotic-assisted (RCO) colectomies and 34 (40%) open (ORR) vs. 52 (60%) robotic (ROR) rectal resections performed during a 15-month period, in elective setting, were compared. Patients presenting contraindications for minimally invasive procedures were excluded from the study, so that all the enrolled patients were suitable for either of the surgical procedures. Results: Overall morbidity rates were similar among groups. Perioperative mortality was nil. No significant differences were noted as for total number of lymph nodes harvested between arms. Mean time (days) to first bowel movement to gas was 3.3 vs. 2.3 vs. 2.6 for OCO, LCO, and RCO, respectively ( p < 0.001), and 3.3 vs. 2.0 for ORR and ROR, respectively ( p = 0.003). Among several European Organization in Research and Treatment of Cancer QLQ-C30 functional scales considered only physical functioning was significantly better at 30 days for RCO vs. OCO (96.3 ± 10 RCO vs. 85.5 ± 12.6 OCO; p = 0.015). Robotic surgery was much more expensive in comparison to open as well as laparoscopic procedures. Conclusions: Laparoscopic and robotic surgeries for colorectal cancer present both the same advantages in comparison to open procedures in terms of faster recovery. However, our data do not seem to support the routine use of RCO as a cost-effective procedure. [ABSTRACT FROM AUTHOR]