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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]

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]

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]

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]

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]

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]

Background: Palivizumab is one of the most costly paediatric medications for Medicaid and other health plans. It is uncertain whether the costs of palivizumab administration are justified in specific risk groups. Ongoing investigations of palivizumab require identification of reliable data sources.Objective: To estimate the reliability between Medicaid paid claims data and medical records documentation in a cost analysis of palivizumab.Study Design: A cross-sectional study of data reliability was performed within a cost analysis study of palivizumab in a cohort of at-risk patients during the US 2002/3 respiratory syncytial virus season. Exposure classification (to palivizumab prophylaxis) was compared using Medicaid claims and medical records data.Methods: The study was performed in 28 widely dispersed paediatric medical practices serving North Carolina, USA Medicaid patients within the AccessCare/Community Care of North Carolina (CCNC) Program, an enhanced primary care case management programme. Patients were eligible if they were born between 1 March 2002 and 28 February 2003 at 32-35 weeks estimated gestational age, were enrolled in the North Carolina primary care case management Medicaid programme during the study period and were patients of the participating practices. Medicaid healthcare claims were obtained in December 2003 for services provided between October 2002 and May 2003. Medical records were abstracted by community-based case managers. Primary variables included frequency, dates and dose of palivizumab injections. The main outcomes measures were agreement in the number of palivizumab injections, dates of administration and doses of palivizumab between Medicaid paid claims and medical record data.Results: Injection frequencies matched between medical record and Medicaid claims data for only 46.2% of study participants. Congruence in injection service dates occurred between data sources for only 1% of injections. Doses were similar between data sources for 81.9% of injections.Conclusions: In Medicaid recipients receiving palivizumab injection, Medicaid claims data were inconsistent with medical records data. Use of multiple data sources and validation are recommended to identify temporal relationships between drug administration and endpoints of interest. [ABSTRACT FROM AUTHOR]

We investigated medical resource consumption, productivity loss and costs associated with patients treated with antidepressants for depression in primary care in Sweden. Patients on treatment for depression were followed naturalistically for six-months, and data on patients' characteristics, daily activity and resource-use were collected. The total cost per patient was estimated at euro 5,500 (95%CI euro 5,000-6,100) over six months in 2005 prices. Direct costs were estimated at euro 1,900 (euro 1,700-2,200), 35% of total costs, and indirect costs at euro 3,600 (euro 3,100-4,100), 65% of total costs. The cost for antidepressants represented only 4% of the total costs. We conclude that the burden of depression is high, both to the individual as well as to wider society, and there seems to be a particular need for therapies that have the potential to improve productivity in depressed patients. [ABSTRACT FROM AUTHOR]

The diffusion of protease inhibitors and non-nucleoside reverse transcriptase inhibitors in the US in 1996 and 1997 reduced the number of deaths attributable to HIV disease and changed the way we think about the illness. Today, HIV disease may be deemed a fairly expensive chronic condition rather than an intolerably expensive fatal illness. Although most studies have found that patients receiving new drug therapies are hospitalised less frequently than patients who received early drug therapies, it is unclear whether the diffusion of new drug therapies has increased or decreased the annual cost of care. However, it is evident that the diffusion of new drug therapies has increased the lifetime cost of care. Analysts rely on models to simulate the course and cost of HIV disease. This study reviews the evolution of these models, paying particular attention to how these models estimate the cost of care. The primary findings of this review are that the economic data used in these models are often too imprecise to accurately identify the cost of each disease stage and are almost always outdated. Moreover, it was found that estimates of drug costs in these models may not accurately reflect actual expenditures. [ABSTRACT FROM AUTHOR]

Aromatase inhibitors (AIs) have been evaluated clinically in a wide range of breast cancer treatment settings. Although these agents appear to have clinical superiority, they are more expensive than the therapies (primarily tamoxifen) they have been compared with, thus economic evaluation is required to consider their incremental value to the payer. This paper reviews published economic evaluations of AIs as first-line therapy for advanced cancer, and as adjuvant therapy for early breast cancer. The evaluations in the advanced setting demonstrate a range of different modelling techniques and consider the payer's perspective in three healthcare systems. There is broad similarity in the application of standard cohort Markov modelling techniques to evaluate AIs in the early breast cancer setting, covering four separate health system perspectives. AIs appear cost effective compared with current practice. An analysis in the advanced setting suggests that letrozole may be the more cost-effective AI. No direct comparisons of alternative AIs in the adjuvant setting are reported, although indirect comparisons may be feasible. Future evaluations of treatment strategies over the entire course of the disease may also be needed. [ABSTRACT FROM AUTHOR]

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

To determine the costs associated with the diagnostic work-up and percutaneous revascularization of renal artery stenosis from various perspectives. A prospective multicenter comparative study was conducted between 1998 and 2001. A total of 402 hypertensive patients with suspected renal artery stenosis were included. Costs were assessed of computed tomography angiography (CTA), magnetic resonance angiography (MRA), digital subtraction angiography (DSA), and percutaneous revascularization. From the societal perspective, DSA was the most costly (euro 1,721) and CTA the least costly diagnostic technique (euro 424). CTA was the least costly imaging procedure irrespective of the perspective used. The societal costs associated with percutaneous renal artery revascularization ranged from euro 2,680 to euro 6,172. Overall the radiology department incurred the largest proportion of the total societal costs. For the management of renal artery stenosis, performing the analysis from different perspectives leads to the same conclusion concerning the least costly diagnostic imaging and revascularization procedure. [ABSTRACT FROM AUTHOR]

Overactive bladder is a common condition, with recent findings estimating the prevalence in adults at about 15%. Symptoms, including urinary urgency, high voiding frequency and urge incontinence, have been shown to decrease patients' quality of life. Given its high prevalence, the economic burden of overactive bladder is also substantial, with a recent estimate placing the annual cost in the US at 9.1 billion US dollars (year 2000 values). The objective of this review is to provide a critical appraisal of published economic evaluations of pharmacological and non-pharmacological treatments for overactive bladder. Published economic evaluations of treatments for overactive bladder have focused entirely on pharmacological treatments -- mainly on the two most commonly used drugs, oxybutynin and tolterodine, each of which is available in immediate- and extended-release formulations. Ten economic evaluations (more than half are cost-effectiveness studies) have been published. Modelling with decision trees or Markov models has been the predominant method. Evaluations comparing drug therapy with no treatment have concluded that drug therapy is cost effective. Analyses comparing the formulations of oxybutynin and tolterodine have produced highly inconsistent results, largely due to the sources of data employed for effectiveness and treatment discontinuation rates. There are no evaluations of drugs relative to non-pharmacological treatment, and there are other significant gaps in the economic evaluations of treatment to date. These include gaps resulting from a lack of reliable data on the performance of these drugs in real-world settings, particularly data on long-term persistence with treatment. A more definitive pharmacoeconomic comparison of oxybutynin and tolterodine formulations, incorporating all available clinical data, and other treatment options would help direct treatment. [ABSTRACT FROM AUTHOR]

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

Objective: To evaluate the relationship between adherence to antidepressant therapy and economic outcomes. Design: Retrospective database analysis using pharmacy and medical claims from a pharmacy benefit and medical management company serving a large managed care organization (MCO) that provides healthcare coverage for approximately 3.5 million members. Participants: Patient selection was based on the following criteria: (i) newly started on antidepressant therapy between 1 April 1999 through 30 June 1999; (ii) titrated to a usual antidepressant dosage level within 6 months of the initiation of therapy; (iii) continuously enrolled in the health plan between 1 January 1999 through 31 December 1999; and (iv) >18 years of age. Outcome measures: Antidepressant adherence was calculated as a ratio of the total number of day’s supply during the 180-day follow-up period divided by 180 days. Patients were defined as adhering to treatment if they had a ratio of ≥0.70. The means of pharmacy ingredient costs, medical charges and total healthcare charges incurred during the follow-up period were compared. Adjusted means (least squares means) were calculated after adjusting for potential confounding factors that may have influenced relevant outcomes. Results: Of the total cohort (14 190 patients), 39.7% (n = 5638) of patients were deemed to be adhering (≥70.0% completion) to their treatment. Adherent patients were significantly more advanced in age (55.2 vs 54.3 years, p < 0.01) and had a higher mean Chronic Disease Score (3.80 vs 3.47, p < 0.0001). After adjusting for confounding factors, adherent patients incurred lower total healthcare charges ($US11 327 vs $US11 815, p = 0.433) significantly lower medical charges ($US9411 vs $US10 692, p = 0.039) and significantly higher pharmacy charges ($US1915 vs $US1123, p < 0.0001) than non-adherent patients during the initial 6 months of therapy (all 1999 values). Conclusion: In this MCO, patients who were adherent with antidepressant therapy possessed significantly lower medical charges. These findings indicate that patient adherence with antidepressant therapy significantly improved the economic outcomes. It is suggested that there is a need for raising awareness about the importance of patient adherence as well as to improve methods of detecting individuals with depression in order to gain the economic benefits associated with adherence. [ABSTRACT FROM AUTHOR]

The prevailing uncertainty about the pharmacoeconomic positioning of granulocyte colony-stimulating factor (G-CSF) in the prevention and treatment of chemotherapy-induced febrile neutropenia has resulted in a number of pharmacoeconomic evaluations published in the past 10 years. These studies vary considerably regarding the approaches used and the results presented. In order to contribute to a clearer pharmacoeconomic positioning of G-CSF, a systematic review of economic evaluations was carried out. The focus of the review was prophylaxis and therapy of chemotherapy-induced neutropenia in patients with cancer. A computerised bibliography search of several databases was conducted yielding 33 studies. The findings demonstrated the cost-saving potential of G-CSF in standard-dose chemotherapy to be limited, with lower costs often seen in the control group. The results of these studies were too heterogeneous to extract a clear recommendation from a cost-saving point of view. The administration of G-CSF after high-dose chemotherapy with stem cell support resulted more often in cost savings in the G-CSF group as compared with standard-dose chemotherapy, illustrating a possible cost-saving potential of G-CSF. In the treatment of established chemotherapy-induced febrile neutropenia, cost savings were found in all studies. This result is surprising but hampered by the small number of studies (n = 5) and remains to be confirmed by more rigourously designed prospective economic analyses. Despite the substantial research on this topic, the economic evaluation of G-CSF is far from being settled and needs further investigation. [ABSTRACT FROM AUTHOR]

Objective: To document the costs and outcomes of the various forms of the septic syndromes [systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis, septic shock), particularly those associated with infection acquired in an intensive care unit (ICU).Design: Prospective data collection for all septic patients admitted to a medical ICU during a 1-year period. Costs were computed from the viewpoint of the hospital.Results: Mean total hospital costs were Euro 26,256, Euro 35,185, and Euro 27,083 for patients with sepsis, severe sepsis, and septic shock, respectively. Total costs varied slightly according to the site of infection and the severity of sepsis but were influenced mostly by its mode of acquisition: patients having sepsis associated with ICU-acquired infection incurred total costs about three times those of patients presenting with infection and sepsis on ICU admission (from Euro 39,908 in patients with ICU acquired sepsis to Euro 44,851 in patients with ICU-acquired septic shock). Stratifying patients by the presence of ICU-acquired infection also showed that a first episode of infection complicated by ICU-acquired sepsis incurred at least 2.5 times more costs than a single episode of sepsis.Conclusions: In this series the medical costs of sepsis were not markedly influenced by its severity but by its mode of acquisition. Due to wide variations in ICU costs cost-effectiveness analyses of treatments for sepsis should document the case-mix of patients and the contribution to this of nosocomial infections. [ABSTRACT FROM AUTHOR]

Introduction: The objective of this study was to assess the cost effectiveness of a continuous combined oral preparation of norethisterone (norethindrone) acetate and ethinylestradiol (NA/EE) [FemHRT] as both a first-line and second-line therapy for menopausal women.Perspective: Third-party payer.Methods: The cost effectiveness of NA/EE was assessed as both a first- and second-line therapy in comparison with conjugated equine oestrogen 0.625mg and medroxyprogesterone acetate 2.5mg (CEE/MPA) and no therapy. Analysis was conducted within a Markov model with states relating to the presence and absence of vaginal bleeding, menopausal symptoms and hip fracture. Analysis forecasted life expectancy, QALYs and lifetime costs for a 50-year-old menopausal woman. Compliance was modelled related to menopausal symptoms and vaginal bleeding. For the base-case analysis, it was assumed that compliant women would take therapy for up to 5 years. Sensitivity analysis assumed therapy was taken only for 1 year.Results: Compared with both CEE/MPA and no therapy, NA/EE led to an increase in both costs and QALYs, both as a first- and second-line therapy. For first-line therapy, the incremental cost per QALY gained for NA/EE was $2200 Canadian dollars ($Can; 1999 values) [compared with no therapy] and was $Can20 300 (compared with CEE/MPA). For second-line therapy, the incremental cost per QALY gained for NA/EE was $Can900 (compared with no therapy) and was $Can16 400 (compared with CEE/MPA). Results were robust to most sensitivity analyses.Conclusions: NA/EE is a cost-effective therapy for women with menopausal symptoms both as a first-line and second-line therapy. [ABSTRACT FROM AUTHOR]

Background: Alzheimer's disease (AD) is a devastating illness that causes enormous emotional stress to affected families and is associated with substantial medical and nonmedical costs.Objective: To determine the effects of 28 weeks of memantine treatment for patients with AD on resource utilisation and costs.Study Design and Methods: Multicentre, prospective, double-blind, randomised, placebo-controlled clinical trial performed in the US. The Wilcoxon-Mann-Whitney test was used to examine the resource utilisation variables and logistic regression models were used for multivariate resource utilisation analyses. Analysis of covariance (ANCOVA) models (log and non-log) were computed to examine costs from a societal perspective. All costs were calculated in 1999 US dollars.Study Population: Outpatients with moderate to severe AD. Overall, 252 patients received randomised treatment, and 166 patients (placebo n = 76, memantine n = 90) formed the treated-per-protocol (TPP) subset for the health economic analyses, on which the main cost analysis was based.Main Outcome Measure: Resource Utilisation in Dementia (RUD) scale, measuring patient and caregiver resource utilisation, and various sources for cost calculations.Results: Controlling for baseline differences between the groups, significantly less caregiver time was needed for patients receiving memantine than for those receiving placebo (difference 51.5 hours per month; 95% CI -95.27, -7.17; p = 0.02). Analysis of residential status also favoured memantine: time to institutionalisation (p = 0.052) and institutionalisation at week 28 (p = 0.04 with the chi-square test). Total costs from a societal perspective were lower in the memantine group (difference dollars US 1089.74/month [non-overlapping 95% CI for treatment difference -1954.90, -224.58]; p = 0.01). The main differences between the groups were total caregiver costs (dollars US-823.77/month; p = 0.03) and direct nonmedical costs (dollars US-430.84/month; p = 0.07) favouring memantine treatment. Patient direct medical costs were higher in the memantine group (p < 0.01), mainly due to the cost of memantine.Conclusion: Resource utilisation and total health costs were lower in the memantine group than the placebo group. The results suggest that memantine treatment of patients with moderate to severe AD is cost saving from a societal perspective. [ABSTRACT FROM AUTHOR]

Introduction: Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances. When adhered to, they have been shown to have the potential to improve both the process of care and patient health outcomes. Economic issues can be incorporated into guidelines with respect to both recommendations (based on the criteria of cost effectiveness) and defining outcomes for assessing adherence with guidelines. Methods: We reviewed 217 Canadian clinical practice guidelines relating to prescription medications. The role of economics within existing practice guidelines was assessed using standardized abstracting techniques. Results: Costs or economics were considered in only 26% of the guidelines identified. The role of economic considerations within these guidelines varied considerably from a relatively minor to major role. Furthermore, only 4% of guidelines defined measurable outcomes, including economic outcomes, that could be monitored to assess adherence with recommendations. Conclusions: The inclusion of economic considerations in clinical guidelines in Canada is limited. The possible reasons for this lack of economic considerations need to be explored further. Without consideration of economic issues when developed, clinical practice guidelines may lead to a more inefficient healthcare system. [ABSTRACT FROM AUTHOR]

Galantamine is one of several orally administered cholinesterase inhibitors that improve cognition in patients with mild to moderate Alzheimer's disease. Compared with placebo, galantamine 16 or 24 mg/day improved cognition and activities of daily living, delayed emergence of behavioural symptoms and reduced caregiver burden in three pivotal randomised studies of 5 or 6 months' duration. Galantamine may reduce the considerable economic burden of Alzheimer's disease by delaying the need for full-time care (FTC) in patients with mild to moderate Alzheimer's disease. In pharmacoeconomic analyses with a time horizon of 10 years conducted in Canada, Sweden, The Netherlands and the US, data from the pivotal trials were incorporated into a model to examine economic implications associated with galantamine treatment. FTC was defined in the model as the consistent requirement for caregiving and supervision for the greater part of each day regardless of the location of care and the identity of caregiver. When the effect of galantamine 16 or 24 mg/day was analysed from the perspective of a comprehensive healthcare payer, treatment was associated with cost savings (inclusive of drug costs) relative to no treatment, regardless of country for which the model was customised. Cost savings resulted from the delay in the time until FTC was required in patients with mild to moderate disease. In sensitivity analyses, cost savings were most sensitive to the cost of institutional care. In the analyses that considered the effect of galantamine 24 mg/day solely on cognition, galantamine was predicted to reduce the time FTC was required by approximately 10% in patients with mild to moderate Alzheimer's disease compared with no pharmacological treatment. Greater reductions in the time that FTC was required were predicted when the effects of galantamine 16 or 24 mg/day on behavioural symptoms in addition to cognition were considered in the US analysis or in sensitivity analyses in studies in other countries. In conclusion, pharmacoeconomic analyses, which were based on modelling of data from pivotal clinical trials with galantamine and included drug costs, indicate that galantamine treatment may result in cost savings from a healthcare payer perspective. The effects of galantamine on cognition and behavioural symptoms in patients with mild to moderate Alzheimer's disease are predicted to delay the need for FTC, which may result in cost savings. From a societal perspective, the caregiver burden of caring for a patient with Alzheimer's disease in the community may be decreased and the time that patients have without severe disease may be prolonged. [ABSTRACT FROM AUTHOR]

Background: In the Balloon Angioplasty and Anticoagulation Study (BAAS), coumarins added to routine aspirin therapy before coronary angioplasty reduced cardiac events at the cost of a slightly higher risk of bleeding complications.Objective: To determine the cost effectiveness of coumarin treatment, based on the occurrence of both cardiac and bleeding events.Methods: Effectiveness was measured, applying two definitions, in terms of the number of events occurring at one year. In the first definition, the occurrence of death, myocardial infarction (MI), or stroke was assessed. The second definition also included revascularisations and major bleeding episodes as an event. Costs were limited to direct medical costs. Cost effectiveness was addressed by probability ellipses representing the point estimates and uncertainties surrounding both costs and effectiveness.Results: At 1 year, death, MI or stroke occurred 1.1% less often when treating with aspirin plus coumarins rather than aspirin therapy alone. When revascularisations and major bleeding events were also included, the difference was 5.0%. Overall, the additional costs in relation to coumarin treatment were compensated by a reduction in repeat interventions. When including all costs, the savings associated with coumarin treatment were estimated at Euros 235 per patient after 1 year. The probability that coumarins are cost saving was estimated at 0.85. The probability that coumarins combine additional effectiveness with cost savings was estimated at 0.70 when survival free of MI or stroke as an effectiveness measure was considered, and at 0.83 when survival free of MI, stroke, revascularisation or major bleeding was considered.Conclusion: Coumarin therapy added to routine aspirin therapy before coronary angioplasty, and continued during follow-up, may not only be considered more effective but also cost saving relative to aspirin therapy alone. [ABSTRACT FROM AUTHOR]

Objective: To determine whether the use of risperidone in a US managed-care environment is associated with a reduction in the use of mental healthcare services.Methods: Mental health service use and costs for patients with psychoses treated with risperidone versus those treated with conventional antipsychotic agents were compared by both between-group and within-group comparisons. The study controlled for differences between the groups. Only direct medical costs were considered. All costs were for the years 1994 to 1996.Perspective: US managed care plan.Results: Costs (excluding antipsychotic drug costs) per member per month (PMPM) were 180 US dollars lower with risperidone (p < 0.05); per member per year (PMPY) costs were 2160 US dollars lower. In patients who received both risperidone and conventional treatments, PMPM costs were 212 US dollars (2544 US dollars PMPY) lower during risperidone treatment. Total costs (including antipsychotic drug costs) were 624 US dollars PMPY lower with risperidone by between-group comparisons and 1008 US dollars PMPY lower by within-group comparisons.Conclusions: These results show that higher risperidone acquisition costs are offset by reductions in other mental healthcare costs, particularly inpatient hospitalisation costs. This indicates that risperidone may be a more economical choice than traditional antipsychotics for the treatment of psychoses. [ABSTRACT FROM AUTHOR]

Background and Objective: Glycoprotein (GP) IIb/IIIa receptor inhibitors enhance thrombolysis in patients with acute coronary syndromes. This analysis evaluates the economic impact of abciximab, a GP IIb/IIIa inhibitor, as an adjunct to urokinase in peripheral artery occlusions of less than 6 weeks duration.Study Design: A post-hoc economic analysis was performed using clinical data and inpatient resource utilisation derived from the prospective comparative phase II Platelet Receptor Antibodies in Order to Manage Peripheral Artery Thrombosis (PROMPT) pilot study. Study endpoints were amputation-free survival and survival without open surgery or major amputation after 90 days, and the rate of major complications at 30 days.Perspective: Third-party payer and the societal perspective.Patients and Methods: Seventy patients with lower extremity thrombi were randomised (2 : 5 ratio) to urokinase plus placebo or to urokinase plus abciximab. Economically relevant data were retrospectively derived from the clinical study database from a specific evaluation of patient records and from expert opinion.Results: From the viewpoint of the society, average total per-patient direct and indirect costs accruing over 3 months were more favourable for treatment with abciximab plus urokinase than for urokinase alone [9723 euros (EUR) vs EUR10 322; 2000 values], despite higher initial hospitalisation costs of the combination therapy. Abciximab plus urokinase was the dominant strategy at 3 months due to a clinically higher rate of survival without amputation or bypass surgery coupled with a lower average per-patient cost. From the perspective of the third-party payer, treatment with abciximab plus urokinase was economically also superior to urokinase alone (EUR8773 vs EUR9663).Conclusions: Based on the preliminary findings of the PROMPT trial, the use of abciximab as an adjunct to urokinase in patients with subacute peripheral artery occlusions may be the favourable strategy compared with urokinase alone, in terms of clinical and economic outcomes. Further trials are needed to confirm these clinical and economic findings. The preliminary clinical benefits experienced by patients treated with abciximab plus urokinase in the PROMPT trial translated into cost savings in terms of reduced direct medical costs at 3 months. These cost savings more than offset the cost of abciximab. The use of abciximab as an adjunct to urokinase in patients with subacute peripheral artery occlusions may be the favourable strategy compared with urokinase-alone in terms of clinical and economic outcomes, but further trials are needed to confirm the these clinical and economic findings. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy and cost effectiveness of two treatments of pressure sores on the heel: a collagenase-containing ointment and a hydrocolloid dressing.Design: Study and cost data were collected prospectively in a randomised clinical trial in The Netherlands by counting the resource use for each patient until wound healing occurred.Study Participants: All 24 female study participants were inpatients from the same hospital with grade IV pressure sores on the heel following orthopaedic surgery.Interventions: Two different treatment strategies were analysed: a collagenase-containing ointment (Novuxol) and a hydrocolloid dressing (Duoderm).Perspective: Hospital perspective.Main Outcome Measures and Results: The average costs per patient for treatment with the hydrocolloid dressing were about 5% higher than those with the collagenase-containing ointment. The treatment costs were similarly distributed within both groups, with 34% for materials and 66% for personnel. The cost-effectiveness analysis revealed that cost savings of 899 Dutch guilders (1998 values) per successfully treated patient could be expected using the collagenase-containing ointment instead of the hydrocolloid dressing. In addition, wound healing was achieved, on average, within a shorter time period with the collagenase treatment (10 weeks) compared with the hydrocolloid treatment (14 weeks). The robustness of the results were also tested using sensitivity analyses. These analyses served to confirm that collagenase treatment provides a better cost-effectiveness ratio than hydrocolloid treatment.Conclusions: With regard to overall costs and costs per successfully treated patient, this study showed collagenase treatment to be more cost effective than the hydrocolloid treatment in patients with grade IV pressure sores on the heel and that the amount of time needed for wound healing was shorter. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to compare the total costs associated with the administration of two different tumour necrosis factor (TNF) strategies used in the treatment of rheumatoid arthritis (RA): etanercept, a soluble TNF receptor that can be administered at home by subcutaneous injection, versus infliximab, an antibody that requires an intravenous infusion in a hospital outpatient setting.Design and Setting: The main analytical framework of the study was a cost-cost analysis comparing the total annual costs associated with the administration of etanercept and infliximab in adult RA patients. The perspective of the study was that of the Dutch society. An economic model was constructed to determine the costs of both treatments. The cost evaluation included direct medical costs, direct nonmedical costs and indirect costs. The base-case analysis compared monotherapy with etanercept versus a combination therapy with infliximab and methotrexate. Data for the economic model came from published literature, expert opinion and official price and tariff lists. All costs were in 1999 values.Patients and Participants: The analysis was performed for the adult RA population eligible for treatment with etanercept or infliximab in The Netherlands.Main Outcome Measures and Results: The analysis showed that the total annual drug costs per patient do not differ substantially between infliximab and etanercept, with costs of Netherland guilders (NLG)31,526 (12,610 US dollars) and NLG31,334 (12,534 US dollars), respectively. However, the other medical costs (i.e. excluding the costs of the two drugs themselves) are substantially higher for infliximab due to the additional costs associated with administration in an outpatient clinic and the use of methotrexate [NLG 12,621 (5048 US dollars) versus NLG269 (107 US dollars) for etanercept]. The impact of direct nonmedical costs (transportation) and indirect costs were negligible. Overall treatment with infliximab is more expensive than treatment with etanercept with total costs of NLG45 115 (18,046 US dollars) and NLG3I,621 (12,648 US dollars), respectively (42.7% increase).Conclusions: Based on the assumptions used in the model, we may conclude that the use of etanercept compares favourably with infliximab from a budgetary and health economic perspective: the total costs are substantially lower when the efficacy of etanercept is assumed to be at least equivalent to the efficacy of infliximab. [ABSTRACT FROM AUTHOR]

Because of the high incidence of morbidity and mortality associated with hypertension in the elderly, the treatment of hypertension in this patient group must involve consideration of clinical, humanistic and economic outcomes. The most frequently used method of pharmacoeconomic analysis for antihypertensive therapy involves cost-effectiveness analysis, although several other methods are available. Current evidence reveals a trend toward cost effectiveness of antihypertensive treatment in elderly patients. However, these formal analyses are limited by the need for extrapolation of data regarding efficacy and level of risk from epidemiological and randomised trials, information which is often lacking. To incorporate economic factors into clinical decision making, other measures of economic impact should be explored. The economic impact of antihypertensive therapy is affected by the level of risk for the patient and the efficacy of the treatment. Data indicate that the risk of morbidity and mortality related to hypertension increases with age and that current antihypertensive drugs reduce this risk. When choosing an antihypertensive agent, the following parameters should be considered: acquisition cost, likelihood of adverse effects and other determinants of treatment adherence, and individual predictors of response. The economic outcomes will be maximised if prudent drug selection is supplemented by appropriate diagnostic and classification procedures and reduction of cardiovascular risk factors other than hypertension. The accumulation of data addressing the risks and benefits of therapy for the very old and the comparative efficacy of newer antihypertensive therapies will further clarify the decision-making process. [ABSTRACT FROM AUTHOR]

The progressive disability of Parkinson's disease results in substantial burdens for patients, their families and society in terms of increased health resource use, poorer quality of life, caregiver burden, disrupted family relationships, decreases in social and leisure activities, deteriorating emotional well-being, and direct and indirect costs of illness. Health-related quality of life (HR-QOL) measures have been used successfully in cross-sectional studies to identify and characterise these burdens; however, there is not yet substantial evidence that these instruments will be responsive to changes in patients over time and that the results will provide patients and health professionals with clinically meaningful information useful in making decisions about treatment strategies. The few studies documenting direct and indirect costs indicate increased use of ancillary health and community services, significant adaptations in home and transportation, increased use of mobility and self-care aids, and lack of access to appropriate healthcare providers. Patients with Parkinson's disease incur higher hospital expenses, have increased number of prescriptions, and experience earnings loss; the latter also applies to family caregivers. The choice, intensity and timing of therapy are determined by a variety of factors: presenting symptoms, age, employment status, comorbidity, cognitive impairment and level of functional impairment. Choices must be individually tailored to a patient's physical and personal needs. To be useful for patients with Parkinson's disease in clinical practice, clinicians should be able to use HR-QOL measures to identify appropriate medical interventions or socio-behavioural modifications to modify the HR-QOL deficits. However, while the interplay of interventions and clinical outcomes are often well understood, the effects of interventions on HR-QOL outcomes have not been studied extensively. Little research has been done that explicitly links the signs and symptoms of Parkinson's disease to the HR-QOL outcomes. The only Parkinson's disease cost-effectiveness study as yet performed indicated higher costs for patients receiving pramipexole than for those not taking the drug, but additional quality life-years were gained. Longer term effectiveness of many treatment strategies, and the usefulness of HR-QOL instruments to assess these treatments for individual patients over time, are critical areas for future research. [ABSTRACT FROM AUTHOR]

Chronic obstructive pulmonary disease (COPD) is a major cause of mortality and morbidity. Relatively few pharmacoeconomic studies have been conducted on this disease. This article reviews available information about the utilisation of healthcare resources and cost of care, and the cost or cost effectiveness of therapeutic interventions reported for this disease. Burden-of-illness data indicate that hospital care, medications and oxygen therapy were the major cost drivers in these studies. Mean annual Medicare expenditures in the US were $US11 841 (2000 values) for patients with COPD compared with $US4901 for all covered patients. Utilisation was skewed; the most expensive 10% of the Medicare beneficiaries accounted for nearly 50% of total expenditures for this disease. Costs are associated with health status, age, physician specialty, geographic location and type of insurance coverage. Six types of interventions were assessed in the literature - pharmacotherapy, oxygen therapy, home care, surgery, exercise and rehabilitation and health education. The studies used different analytic strategies (e.g. cost-minimisation and cost-effectiveness analyses) and even within the realm of cost-effectiveness analyses, no uniformity existed as to how outcome was measured. Patient severity was not always delineated, and the length of the follow-up period, while quite short, varied. Only 11 of the 34 evaluations were based on randomised controlled trials. Cost-minimisation studies generally found no significant difference in the cost of antimicrobial treatment for first-line, second-line and third-line agents. Studies of bronchodilators indicated that ipratropium bromide alone or in combination with salbutamol (albuterol) was the preferred medication. The major area for achieving cost savings is by reducing hospital utilisation. As the annual rate of hospitalisation is relatively low, large patient samples will be required to demonstrate an economic advantage for a new therapy. The major challenges will be financing such a study, and selecting an outcome measure that satisfies both clinical and economic conventions. [ABSTRACT FROM AUTHOR]

Pharmacological treatment of hypertension has been shown to reduce the risk of stroke, coronary events, heart failure and progression of renal disease. However, rates of successful blood pressure control remain low among treated patients while antihypertensive medication represents a large and increasing proportion of healthcare expenditure in many countries. Several influential pharmacoeconomic analyses have confirmed the cost effectiveness of conventional antihypertensive treatments, usually involving monotherapy with diuretics or beta-blockers, compared with alternative strategies. Recent research has shown that a considerable proportion of the total cost of antihypertensive treatment in general practice is due to factors such as inadequate blood pressure control, poor compliance with therapy, discontinuation and switching between therapies. These factors operate to a much lesser extent in well-conducted clinical trials, and have not been fully incorporated into most economic studies. Some novel strategies, particularly low dose combinations of antihypertensive agents, may offer advantages in terms of efficacy, reduced adverse effects and improved compliance with treatment. There is therefore a need for comprehensive pharmacoeconomic analyses of novel strategies, taking these additional factors into account. Until such studies are available, the wider use of low dose combination therapy and other novel strategies should not be held back on the basis of earlier economic studies that have not included all relevant considerations. [ABSTRACT FROM AUTHOR]

Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in the treatment of patients with HIV infection. Both US and British treatment guidelines for HIV infection recommend NNRTI- or protease inhibitor-based combinations [i.e. with nucleoside reverse transcriptase inhibitors (NRTIs)] as first-line treatment options in the management of HIV disease. Results of a pivotal randomised study (DMP 266-006) comparing efavirenz- versus indinavir-based triple combination therapy in patients with HIV infection (the majority of whom were antiretroviral therapy-naive) showed the efavirenz-based regimen was better tolerated and had greater success in achieving reductions in viral load below the limit of detection. These and other clinical data were incorporated into economic models in 2 analyses, one conducted in the US and the other in Canada. The US analysis examined long term clinical and economic outcomes predicted on the basis of response (viral load and CD4+ cell counts), tolerability and willingness to adhere to therapy. The efavirenz-based regimen was the dominant treatment strategy as it was predicted to improve survival and reduce direct medical costs in the US healthcare system. Compared with the indinavir-containing regimen, survival was increased by 11% (absolute difference) and cumulative costs were reduced by $US10 326 per patient (1998 discounted costs) at 5 years after starting treatment with efavirenz-based therapy. The Canadian analysis was conducted from the perspective of the Ontario healthcare system. This study did not consider differences in clinical efficacy between treatment groups, costs of study medication or outcomes beyond 1 year - all factors that would have favoured the efavirenz-based regimen. Of the 2 treatment options, the efavirenz-based regimen was associated with 7.4% lower average annual medical care costs, primarily because of greater costs associated with adverse clinical events with the indinavir-based regimen. In conclusion, current treatment guidelines for HIV infection recognise efavirenz-based combination regimens as a first-line treatment option. A pivotal comparative clinical trial (DMP 266-006) showed a significantly greater virological response to efavirenz- than indinavir-based triple combination therapy, and the efavirenz-based regimen was better tolerated. These clinical data are supported by pharmacoeconomic analyses conducted in the US and Canada, both of which showed lower medical care costs with the efavirenz-based regimen. The US analysis also predicted long term health benefits, such as improved survival, with efavirenz- versus indinavir-based triple combination therapy. These results must be weighed against the inherent difficulties of predicting long term treatment failure rates from short term data, and the limited number of pharmacoeconomic analyses conducted with efavirenz to date. [ABSTRACT FROM AUTHOR]

The prevalence of depression and the high costs associated with its treatment have increased interest in pharmacoeconomic evaluations of drug treatment, particularly in the 1990s as the use of selective serotonin (5-hydroxytryptamine; 5-HT) reuptake inhibitors (SSRIs) expanded substantially. This review presents results from specific studies representing the key study designs used to address the pharmacoeconomics of SSRI use: retrospective administrative database analyses, clinical decision analysis models, and randomised clinical trials. Methodological considerations in interpreting results are highlighted. In retrospective administrative database analyses, most comparisons have been made between SSRIs and tricyclic antidepressants (TCAs). A few studies have addressed differences between SSRIs. The studies focused on healthcare cost (to payer) and cost-related outcomes (e.g. treatment duration, drug switching). Although SSRIs are generally associated with higher drug acquisition costs than are TCAs, total healthcare costs are at least offset, if not decreased, by reductions in costs associated with use of SSRIs. Although studies from the early 1990s show some advantage for fluoxetine, the results are limited by use of data from shortly after the introduction of paroxetine and sertraline; studies from the mid- 1990s on that compare drugs within the SSRI class show general equivalence in terms of cost. Important methodological advances are occurring in retrospective studies, with selection bias and other design limitations being addressed statistically. Clinical decision analysis models permit flexibility in terms of ability to specify different alternative treatment scenarios and varying durations. Sensitivity analysis aids interpretability, although model inputs are limited by data availability. Results from short term (1 year duration or less) studies comparing SSRIs and TCAs suggest that SSRIs are more cost effective or that there is no difference. Longer term studies (lifetime Markov models) focus more on the impact of maintenance antidepressant therapy and show more mixed results, generally favouring SSRIs over TCAs. The results indicate that the effect of SSRIs is mainly through prevention of relapse. Important assumptions of these models include fewer serious adverse effects and lower treatment discontinuation rates with SSRIs. Naturalistic clinical trials provide greater generalisability than traditional randomised clinical trials. One naturalistic trial found that nearly half of TCA-treated patients switched to another antidepressant within 6 months; only 20% of SSRI-treated patients switched. Cost differences between groups were minimal. These studies indicate few differences in medical costs, depression outcomes and health-related quality of life between TCAs and fluoxetine, although fewer fluoxetine-treated patients switched treatment. [ABSTRACT FROM AUTHOR]

The development of mutations associated with resistance to antiretroviral therapy (ART) has been shown to be a major cause of treatment failure in patients infected with HIV-1. These resistance mutations can be assessed by a genotyping test that probes for specific mutations within the HIV genome or sequences specific genes, at a cost $US500/test (2000 prices). The stated goal of HIV-1 genotyping is to target HIV therapy effectively. This, as shown in the preliminary research, should result in better clinical outcomes and a lower incidence of virological failure and may be associated with lower costs of treatment. Failure of ART may result in an increase in costs of at least $US250 per patient per month, as assessed in 1 study, with costs rising further as patients experience multiple virological failures. Therefore, there is an economic as well as a therapeutic premium on the prevention of ART failure. The actual economic cost of genotyping has been preliminarily explored in the context of the antiretroVIRal ADAPTation (VIRADAPT) trial, which found no significant difference in the 1-year treatment cost of patients with and without genotyping. There is some evidence of cost neutrality or savings with genotypic testing but it needs to be further explored within the context of carefully framed prospective trials. [ABSTRACT FROM AUTHOR]

Objective: To estimate the economic impact of using tibolone 2.5 mg compared with 17 beta-estradiol 2 mg/norethisterone acetate 1 mg (E2/NETA) in postmenopausal women with climacteric symptoms.Design and Setting: This was a modelling study performed from the perspective of the UK's National Health Service (NHS).Methods: The clinical outcomes from a previously reported trial were used as the clinical basis for the analysis, which showed that 48 weeks' treatment with tibolone and E2/NETA significantly alleviated the climacteric symptoms experienced by postmenopausal women. These data were combined with resource utilisation estimates derived from a panel of 10 GPs and 3 gynaecologists, enabling us to construct a Markov model depicting changes in the health status of postmenopausal women. The model was used to estimate the expected NHS costs and consequences after 48 weeks' treatment with tibolone and E2/NETA.Main Outcome Measures and Results: The mean expected direct healthcare cost of using tibolone and E2/NETA to manage postmenopausal women for 48 weeks was estimated to be 260 Pounds and 239 Pounds (1997/1998 prices) per patient, respectively. Starting hormone replacement therapy (HRT) with tibolone instead of E2/NETA was equally effective in alleviating climacteric symptoms (65.9 and 62.2%, respectively; p = 0.516) over 48 weeks and significantly reduced the incidence of vaginal bleeding by 36% (p < 0.0001) and breast tenderness by 57% (p < 0.0001) for a mean additional cost of 21 Pounds (ranging between -3 Pounds and 42 Pounds) per patient. The acquisition cost of HRT was the primary cost driver for tibolone-treated patients, whereas the cost of managing adverse events was the primary cost driver for E2/NETA-treated patients.Conclusions: The true cost of prescribing tibolone and E2/NETA is impacted on by a broad range of resources, not only drug acquisition costs. Although the acquisition cost of tibolone is higher than that of E2/NETA, the difference in the expected NHS cost of the first year of treatment between the 2 HRTs is negligible. This is because of the higher incidence of adverse events among E2/NETA-treated patients, which also results in a higher continuation rate among tibolone-treated patients. Factors such as patient preferences should also be taken into consideration so that treatment choices are not decided solely on the basis of acquisition costs. [ABSTRACT FROM AUTHOR]

Pharmacotherapeutic advances in the treatment of depression have included the development of the selective serotonin reuptake inhibitors (SSRIs), thereby providing alternatives to tricyclic antidepressants. Concurrent with these events have been significant structural (e.g. pharmaceutical formularies) and regulatory (e.g. required pharmacoeconomic evaluations) changes in the delivery, financing, and oversight of healthcare programmes throughout the world. International cost-containment initiatives are increasingly mandating a demonstration of value for money, defined in terms of a measurable health and/or financial outcome, and, in the case of medicines, attributable to a given expenditure, for a given pharmacotherapeutic option. We examine the inherent strengths and weaknesses of 5 study designs used to discern and contrast financial outcomes stemming from the use of antidepressant pharmacotherapy for the treatment of depressive illness [randomised controlled trials (RCTs); meta-analyses; decision-analytical models (DAMs); retrospective database investigations; randomised naturalistic inquiry]. We argue that the economic appraisal of pharmacotherapy requires an iterative process extending from the developmental (RCTs; meta-analyses; DAMs) through to the postmarketing phase (database reviews; naturalistic inquiry), thereby resulting in a portfolio of evidence as to the safety, efficacy and effectiveness of a given pharmacotherapeutic category (e.g. SSRIs) and/or a specific medication. Database reviews, while nonrandomised, and prospective naturalistic inquiry afford greater insight into the patterns of use and financial merits of prescribing specific pharmacotherapeutic options for the treatment of depression within the context of clinical practice as compared with RCTs, meta-analyses and DAMs. The portfolio of evidence to date indicates that the first-line use of SSRIs in the treatment of depression is clinically warranted, and represents value for money. [ABSTRACT FROM AUTHOR]

Objectives: To perform an evaluation from the societal perspective of the cost of treatment with enoxaparin sodium versus unfractionated heparin (UFH) in patients with unstable angina and non-Q wave myocardial infarction in France.Design: Four complementary cost-minimisation analyses based on the results of the Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q wave Coronary Events (ESSENCE) international trial were conducted. We assessed differences in medical resource consumption and in duration of hospital stay in the whole study population (n = 3171) and for the French patients (n = 133).Results: Results were consistent for the study group as a whole and for the French subgroup. Among patients treated with enoxaparin sodium, there was a statistically significant reduction in the use of angiography and percutaneous transluminal coronary angioplasty (whole group study: p = 0.024 and 0.006, respectively) and a trend towards shorter lengths of hospital stay. The differences in angiography and angioplasty rates led to estimated average net cost savings with enoxaparin sodium of French Francs (FF)1555 per treated patient (whole study population) and FF9993 (French subgroup) [1996 values]. The analyses based on the duration of hospital stay resulted in estimated net cost savings with enoxaparin sodium of between FF1014 per treated patient (whole study population) and FF2804 (French subgroup).Conclusion: Our study confirmed earlier results which show that enoxaparin sodium is cost saving in the treatment of unstable angina. [ABSTRACT FROM AUTHOR]

Unlabelled: Abciximab is a monoclonal antibody fragment that inhibits platelet aggregation through antagonism of glycoprotein IIb/IIIa. The drug is used in conjunction with heparin and aspirin to prevent ischaemic complications associated with percutaneous coronary revascularisation in patients with coronary heart disease. Large and well designed clinical studies have shown abciximab, as an adjunct to aspirin and heparin, to reduce by around one-third to one-half the incidence of ischaemic complications within 30 days of percutaneous coronary revascularisation. Use of the drug appears advantageous in patients at high risk, and abciximab also reduces complications in patients undergoing coronary stenting, although the drug does not appear to inhibit restenotic tissue volume within stents. Longer term benefit has also been reported, with emerging 1-year data from a study in patients at all levels of risk showing reductions in a composite end-point of death, myocardial infarction (MI) or urgent repeat revascularisation. Three-year benefit has been reported in high risk patients. Meta-analysis results, and 1-year data from patients receiving stents, have shown reduced mortality with abciximab. Abciximab therapy had an incremental cost over standard therapy from a hospital perspective of $US293 per patient (1991/1992 values) over 6 months in a prospective economic substudy from a major US clinical trial of the drug in high risk patients. Abciximab was cost saving in patients with unstable angina. A mean net cost of hospitalisation of $US476 per patients (1995 costs) has been shown in a further study in patients with a broad range of levels of risk, and observational data indicate reduced duration of hospitalisation with abciximab. Cost-effectiveness data favoured abciximab with aspirin and heparin over a 6-month period in Spanish and Dutch analyses in which data from the above trial were combined with local cost data, but not in an Australian analysis. Subgroup analyses have indicated enhanced cost effectiveness in high risk patients. Available data also show clinical benefit and cost effectiveness of abciximab therapy in conjunction with coronary stent placement.Conclusions: Data indicate intravenous bolus plus 12-hour infusion regimens of abciximab to be economically viable in patients at high or low risk of ischaemic complications after percutaneous coronary revascularisation. The drug has been shown to be cost effective in patients receiving the drug in conjunction with coronary stents, and subgroup analyses indicate additional cost effectiveness in certain groups of patients at high risk of ischaemic complications (notably those with acute MI and unstable angina). [ABSTRACT FROM AUTHOR]

Donepezil is a specific acetylcholinesterase inhibitor that can improve symptoms in patients with mild-to-moderate Alzheimer's disease; cognitive function is maintained above baseline levels for up to 1 year and normal decline of cognitive function is slowed. The ability of the patient to perform daily activities and neuropsychiatric symptoms may also be improved by donepezil, but data are limited. Donepezil is not expected to alter the underlying neurodegenerative process, and the response to the drug varies between individuals. In the absence of validated instruments to measure quality of life, it is not clear how donepezil affects this parameter. In a US survey of caregivers of patients with Alzheimer's disease who were being cared for at home at the start of the 6-month study period, treatment with donepezil did not increase overall direct medical costs. The acquisition cost of the drug was balanced by reduced institutionalisation costs. Economic analyses using Markov models from the US, UK and Canada suggest that donepezil initiated in the early stages of disease may be effectively cost neutral as a result of patients remaining in a nonsevere state of disease for a longer time. [ABSTRACT FROM AUTHOR]