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Background: To estimate the potential cost savings by following the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline recommendations in patients being treated for chronic obstructive pulmonary disease (COPD) with the combination of long-acting β(2)-agonist (LABA), long-acting muscarinic antagonist (LAMA) or inhaled corticosteroids (ICS)., Methods: The Geisinger Health System (GHS) database was utilized to identify subjects between January 1, 2004 to March 12, 2007. The index date was based on the first prescription of a LAMA plus LABA, LAMA plus LABA/ICS, or LABA plus ICS. Patients were included in the study if they: had a COPD diagnosis; had data representative of treatment 12 months prior to and 12 months post index date; were 40 years of age or over; had no prior diagnosis for asthma; and had pulmonary function test (PFT) data. We examined the baseline characteristics of these patients along with their healthcare resource utilization. Based on PFT data within 30 days of the index date, a subgroup was classified as adhering or non-adhering to GOLD guidelines., Results: A total of 364 subjects could be classified as adhering or non-adherent to current GOLD guidelines based on their PFT results. The adherent subgroup received COPD medications consistent with current GOLD guidelines. Of the LAMA plus LABA cohort, 25 patients adhered and 39 patients were non-adherent to current GOLD guidelines. In the cohort of LABA plus ICS, 74 patients were adherent and 180 patients non-adherent to current GOLD guidelines. In the cohort of LAMA plus LABA/ICS, 21 patients were adherent and 25 patients non-adherent to current GOLD guidelines. GOLD adherence was associated with mean total cost of all services savings of $5,889 for LAMA plus LABA, $3,330 for LABA + ICS, and $10,217 for LAMA plus LABA/ICS cohorts., Conclusion: Staging of COPD with a PFT and adherence to current GOLD guidelines was associated with lower costs in subjects with moderate to severe COPD. Appropriate use of LAMA plus LABA, LABA plus ICS, and LAMA plus LABA/ICS has economic as well as clinical benefits for patients and payers.

Purpose: Frequent exacerbations which are both costly and potentially life-threatening are a major concern to patients with chronic obstructive pulmonary disease (COPD), despite the availability of several treatment options. This study aimed to assess the lifetime costs and outcomes associated with alternative treatment regimens for patients with severe COPD in the UK setting., Patients and Methods: A Markov cohort model was developed to predict lifetime costs, outcomes, and cost-effectiveness of various combinations of a long-acting muscarinic antagonist (LAMA), a long-acting beta agonist (LABA), an inhaled corticosteroid (ICS), and roflumilast in a fully incremental analysis. Patients willing and able to take ICS, and those refusing or intolerant to ICS were analyzed separately. Efficacy was expressed as relative rate ratios of COPD exacerbation associated with alternative treatment regimens, taken from a mixed treatment comparison. The analysis was conducted from the UK National Health Service (NHS) perspective. Parameter uncertainty was explored using one-way and probabilistic sensitivity analysis., Results: Based on the results of the fully incremental analysis a cost-effectiveness frontier was determined, indicating those treatment regimens which represent the most cost-effective use of NHS resources. For ICS-tolerant patients the cost-effectiveness frontier suggested LAMA as initial treatment. Where patients continue to exacerbate and additional therapy is required, LAMA + LABA/ICS can be a cost-effective option, followed by LAMA + LABA/ICS + roflumilast (incremental cost-effectiveness ratio [ICER] versus LAMA + LABA/ICS: £16,566 per quality-adjusted life-year [QALY] gained). The ICER in ICS-intolerant patients, comparing LAMA + LABA + roflumilast versus LAMA + LABA, was £13,764/QALY gained. The relative rate ratio of exacerbations was identified as the primary driver of cost-effectiveness., Conclusion: The treatment algorithm recommended in UK clinical practice represents a cost-effective approach for the management of COPD. The addition of roflumilast to the standard of care regimens is a clinical and cost-effective treatment option for patients with severe COPD, who continue to exacerbate despite existing bronchodilator therapy.

Background: Multiple myeloma (MM) is the second most common haematological cancer in the UK. MM is not curable but can be treated with a combination of supportive measures and chemotherapy that aim to extend the duration and quality of survival. The majority of patients are not able to withstand intensive treatment, such as high-dose chemotherapy with autologous stem cell transplantation (SCT), and so they are offered single-agent or combination chemotherapy. Combination therapies typically include chemotherapy with an alkylating agent and a corticosteroid. More recently, combination therapies have incorporated drugs such as thalidomide (Thalidomide Celgene®, Celgene) and bortezomib (Velcade®, Janssen-Cilag)., Objective: To assess the clinical effectiveness and cost-effectiveness of bortezomib or thalidomide in combination chemotherapy regimens with an alkylating agent and a corticosteroid for the first-line treatment of MM., Data Sources: Electronic bibliographic databases, including MEDLINE, EMBASE and The Cochrane Library, were searched from 1999 to 2009 for English-language articles. Bibliographies of articles, grey literature sources and manufacturers' submissions were also searched. Experts in the field were asked to identify additional published and unpublished references., Review Methods: Titles and abstracts were screened for eligibility by two reviewers independently. The inclusion criteria specified in the protocol were applied to the full text of retrieved papers by one reviewer and checked independently by a second reviewer. Data extraction and quality assessment were undertaken by one reviewer and checked by a second reviewer. Differences in opinion were resolved through discussion at each stage. A cost-utility decision-analytic model was used to compare the cost-effectiveness estimates of bortezomib in combination with melphalan and prednisolone/prednisone (VMP), thalidomide in combination with cyclophosphamide and attenuated dexamethasone (CTDa), and thalidomide in combination with melphalan and prednisolone/prednisone (MPT) versus melphalan and prednisolone/prednisone (MP)., Results: A total of 1436 records were screened and 40 references were retrieved for the systematic review of clinical effectiveness. Five randomised controlled trials (RCTs) met the inclusion criteria for the review: one RCT evaluated VMP, three evaluated MPT and one evaluated CTDa. The comparator in all of the included trials was MP. The review found that VMP and MPT can both be considered more clinically effective than MP for the first-line treatment of MM in people for whom high-dose therapy and SCT would not be appropriate. CTDa was more effective than MP in terms of complete response but data on survival outcomes did not meet the inclusion criteria. Cost-effectiveness analysis indicated that MPT has a greater probability of being cost-effective than either VMP or CTDa., Limitations: For most RCTs, details needed to judge study quality were incompletely reported. All studies stated that the analyses followed intention-to-treat principles but none adequately reported data censoring. Only one RCT contributed data on VMP and the published peer-reviewed follow-up data were immature. For MPT, overall survival data from two trials were eligible for inclusion but the doses of thalidomide differed between the trials and the treatment period was not reflective of current UK practice so the generalisability of the findings was uncertain. Two RCTs had a maintenance phase with thalidomide that did not meet the inclusion criteria so some of these results were not eligible for the review. Limited evidence on health-related quality of life (HRQoL) was provided by the single trial of VMP versus MP., Conclusions: Service provision is unlikely to change greatly. As uncertainties remain, further research is needed regarding the use of bortezomib- and thalidomide-containing combination regimens. Head-to-head trials of bortezomib- and thalidomide-containing combination regimes are required, including assessments of patient HRQoL in response to treatment., Funding: The National Institute for Health Research Health Technology Assessment programme.

Objective: To study the effectiveness and safety in a real-life setting of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy® (Symbicort SMART®), a simplified management approach with one inhaler, compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma., Design: Open-label randomized controlled parallel-group trial, 6-month treatment., Participants: A total of 654 adult patients, with persistent asthma receiving treatment with inhaled corticosteroids (ICS), either alone or in conjunction with long-acting β(2)-agonist., Main Outcome Measures: Time to first severe asthma exacerbation and number of severe asthma exacerbations., Results: No difference between groups was seen in time to first severe exacerbation (p = .2974). Exacerbation rates were low in both groups. A total of 22 patients in the Symbicort SMART group experienced a total of 24 severe asthma exacerbations, and 31 patients in the CBP group experienced a total of 34 severe asthma exacerbations (annual rate 0.16 vs. 0.22, p = .2869). The mean daily dose of ICS expressed in beclomethasone dipropionate equivalent was significantly lower in the Symbicort SMART group (including as-needed use) versus the CBP group (799 μg vs.1184 μg; p < .001). Mean scores in Asthma Control Questionnaire, five-question version, improved significantly in the SMART group compared with the CBP group (p = .0292). Symbicort SMART and CBP were equally well tolerated. The mean drug cost per patient per 6 months was lower for the patients in the SMART group compared with patients receiving CBP (€295.32 vs. €387.98, p < .0001)., Conclusions: A simplified regimen using budesonide/formoterol maintenance and reliever therapy (Symbicort SMART) was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and lower drug costs.

Objective: To examine patterns of pharmacotherapy and health care utilization and costs prior to total knee replacement (TKR) or total hip replacement (THR) in patients with osteoarthritis (OA)., Methods: Using a large US health insurance claims database, we identified all patients with OA who were ages ≥40 years and had undergone TKR or THR between January 1, 2006 and December 31, 2007. Patients with <2 years of complete data prior to TKR or THR were excluded, as were those with evidence of other conditions for which TKR or THR may be performed (e.g., rheumatoid arthritis). We then examined patterns of health care utilization and costs over the 2-year period preceding surgery., Results: A total of 16,527 patients met all study entry criteria. Their mean ± SD age was 56.6 ± 6.1 years, and 56% of them were women. In the 2 years preceding surgery, 55% of patients received prescription nonsteroidal antiinflammatory drugs, 58% received opioids, and 50% received injections of corticosteroids. The numbers of patients receiving these drugs increased steadily during the presurgery period. The mean ± SD total health care costs in the 2 years preceding surgery were $19,466 ± 29,869, of which outpatient care, inpatient care, and pharmacotherapy represented 45%, 20%, and 20%, respectively. Costs increased from $2,094 in the eighth calendar quarter prior to surgery to $3,100 in the final quarter., Conclusion: Patients with OA who undergo THR or TKR have relatively high levels of use of pain-related pharmacotherapy and high total health care costs in the 2-year period preceding surgery. Levels of utilization and cost increase as the date of surgery approaches., (Copyright © 2011 by the American College of Rheumatology.)

Purpose of Review: Guidelines for clinical practice are expected to gather evidence-based recommendations to support optimal medical behaviours. The aim of the current review is to explore how currently available research regarding the strategy of using budesonide/formoterol (BUD/FORM) as maintenance and reliever therapy (Symbicort SMART) covers the items considered by the Grade of Recommendations, Assessment, Development and Evaluation (GRADE) system, through a comparative analysis of methodological approaches, clinical outcomes, patient-reported outcomes and costs, in order to highlight uncovered areas., Recent Findings: Thirteen trials providing data on 21 095 analysed patients were available. No serious limits in methodological study features were found. Evaluation of the clinical outcome was consistent with the efficacy of BUD/FORM maintenance and reliever therapy. As the time to first exacerbation was the primary outcome in most of the studies, conclusive indications cannot be drawn regarding other clinical outcomes or patient-reported outcomes, which were investigated as secondary outcomes. A comprehensive systematic review exploring all critical and important outcomes is desirable, but further research concerning the safety issues of Long Acting β2 Agonists (LABA) and patients' reported outcomes about the SMART in respect to alternative strategies is likely to affect a clear recommendation in the near future., Summary: The efficacy of BUD/FORM maintenance and reliever therapy in extending the time to first exacerbation appears consistent between studies. Further studies exploring all patients' important outcomes are needed. Clinical and economic assessments are worthy of being investigated to verify the directness of the evidence in respect to real life patients and different geographical realities.

Objective: To assess the incremental cost-effectiveness of SFC compared with MON for the control of persistent asthma in children., Methods: We conducted an economic evaluation on a 12-week prospective randomized open-label parallel-group comparison of SFC versus MON in children with symptomatic asthma receiving inhaled corticosteroids and short-acting β2-agonists. Asthma-related medication, unscheduled physician contacts and hospitalizations were collected prospectively. The main effectiveness measure was percentage of asthma-controlled week with no short-acting β2-agonist use during the study period. The analysis was conducted from the Mexican healthcare perspective using 2010 unit cost prices, and only direct costs were considered, all costs are reported in US dollar. . The model was made fully probabilistic to reflect the joint uncertainty in the model parameters., Results: Over the whole treatment period, the median percentages of asthma-controlled weeks were 83.3% in the SFC group and 66.7% in the MON group (SFC-MON difference, 16.7%; 95% CI, 8.3-16.7; P < 0.001 in favor of SFC). The mean total cost of the SFC regimen was $ 2,323 compared with $ 3,230 for the MON regimen. The SFC was the dominant strategy (both more effective and less expensive) using the SFC was associated with an incremental cost per additional asthma-controlled of $ (5,467). Probabilistic sensitivity analysis tested numerous assumptions about the model cost and efficacy parameters and found that the results were robust to most changes., Conclusions: This analysis demonstrates that, compared with MON, SFC may be cost saving from the Mexican health care perspective for the treatment of pediatric patients with asthma. SFC provided a reduction in the number of severe exacerbations, frequent asthma symptoms and rescue medication use. Incremental cost-effectiveness analysis indicated the dominance of SFC because of both lower costs and greater efficacy., (Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

The rapid action of the long acting beta agonist formoterol allows it to be used as both a preventer and reliever in the management of asthma. The Symbicort® SMART dosing regime has been shown to reduce the number of asthma exacerbations. The aim was to determine the current prescribing of Symbicort®, the prescribing of the SMART regimen and the co-prescribing of a short acting beta agonist with this regimen by means of an audit of prescriptions dispensed in a pharmacy multiple in the U.K. Anonymised data were collected on a standard form. Symbicort® prescribing data for six months were extracted from the pharmacy Patient Medication Record (PMR). Data were stratified by age and analysed to determine adherence with Symbicort® SMART prescribing as defined by the U.K. product license. Data were received from 51 of the 118 (43.2%) pharmacies contacted. Complete information from 2484 PMRs was included in the study. 2.81% (70/2484) of patients were prescribed SMART as defined by the U.K. summary of product characteristics. Of the 18-35 year age group 7.44% (27/363) were prescribed SMART correctly. However, Symbicort® was prescribed twice a day and when required, with either the co-prescription of a SABA, or at an unlicensed dose in 2.46% (61/2484) and 0.28% (7/2484) patients respectively. The incidence of Symbicort® SMART prescribing in this study is low but may be underestimated due to unclear dosing instructions., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

The aim of this study was to evaluate the relationship between inappropriate overuse of inhaled corticosteroids and self-reported health status and the annual cost of patients with stable chronic obstructive pulmonary disease (COPD) recruited in the primary-care setting. An observational, crossover, descriptive study was conducted. Patients with stable COPD and aged ≥40 years, evaluated in primary care, were included. Data collected were demographic variables, clinical characteristics, self-reported health status (SF-12), the severity of the illness, treatment, and health-care resource utilization in the past year. The patients were recruited during a period of 3 months (from January 1 to March 31, 2003). Use was considered inappropriate when corticosteroids were prescribed by physicians for patients not meeting criteria for its use as recommended in guidelines. A total of 10,711 patients [75.6% males; mean age = 67.1 (SD = 9.66) years] were evaluated. Disease severity was mild in 35.5% of the cases, moderate in 53.4%, and severe in 11.2%. Among them, 3,697 (34.5%) subjects were prescribed inhaled corticosteroids or drug combinations containing such therapies, with a rate of inappropriate use of 18.2%. Physical health status was significantly lower among patients showing inappropriate corticosteroids use: 37.35 (SD = 9.53) vs. 40.7 (SD = 9.80) (p < 0.05). The annual cost per patient of COPD management was significantly higher in the group with inappropriate inhaled corticosteroids use: 1,590 (SD = 1,834) vs. 1,157 (SD = 1,536) (p < 0.05). Factors statistically associated with inappropriate use of corticosteroids were educational attainment [OR: 2.77 (95% CI: 1.36-5.63) for nonuniversity training], a history of heart disease [OR: 1.42 (95% CI: 1.02-1.97)], depression [OR: 1.47 (95% CI: 1.05-2.05)], any allergy [OR 1.69 (95% CI: 1.13-2.54)], and physical health status [OR 0.97 (95% CI: 0.96-0.98)]. Lack of adherence to the recommended criteria for using inhaled corticosteroids therapy in the management of COPD patients was associated with lower self-reported health status and higher costs. Factors statistically associated with inappropriate use of corticosteroids were educational attainment, a history of heart disease, depression, any allergy, and physical health status.

Background: Recent consensus statements on the diagnosis of chronic rhinosinusitis (CRS) now require endoscopic or radiographic evidence of paranasal sinus inflammation. The timing of point-of-care (POC) computed tomography (CT) scan in the workup of these patients remains to be elucidated, particularly when endoscopy is negative. The objective of this research was to prospectively evaluate 2 algorithms for the initial management of patients with symptoms of CRS who manifest a normal nasal endoscopic examination., Methods: A total of 40 such patients were randomized to 1 of 2 pathways: POC-CT at the initial visit followed by medical therapy based upon CT results (pre-CT group; n = 20), or empiric medical therapy (EMT) followed by POC posttreatment CT if symptoms persisted (EMT group; n = 20)., Results: The 2 groups were demographically and symptomatically similar with regard to 2003 Task Force major criteria. Otolaryngology follow-up was recommended in 11 of 20 pre-CT patients, all of whom (100%) returned. In contrast, only 10 of 20 EMT patients (50%) followed up as instructed (p < 0.05). Radiographic confirmation of CRS was found in 8 of 20 pre-CT patients, and only 2 of 9 patients after EMT (p = 0.61). EMT patients received more antibiotic prescriptions (relative ratio [RR], 2.50; 95% CI, 1.46-4.27), while pre-CT patients received more CT scans (RR, 2.22; 95% CI, 1.37-3.61). Overall prescriptions costs were similar to the EMT group ($253 vs $218; p = 0.37) and the overall number of otolaryngology visits was similar., Conclusion: In patients with symptoms of CRS but negative endoscopy, POC at initial presentation results in substantially less unnecessary antibiotic prescriptions and significantly greater compliance with otolaryngology care but does result in a higher utilization of radiographic imaging., (Copyright © 2011 American Rhinologic Society-American Academy of Otolaryngic Allergy, LLC.)

Traditionally, half of the direct costs associated with chronic inflammatory bowel diseases (IBD) [Crohn's disease (CD) and ulcerative colitis (UC)] have related to hospital inpatient treatment for a sub-group of more severely affected, often therapy-resistant individuals. The advent of effective but relatively expensive biological agents has increased the contribution of drugs to overall medical care costs. This has focussed interest on the relative cost effectiveness of rival therapies for IBD and, in particular, on the affordability of long-term biological therapy. The purpose of this article is to review the available literature on this topic and to identify areas for future research. Head-to-head trials of competing treatment options are uncommon and clinical trials have seldom addressed cost effectiveness. In UC, models have explored the cost utility of 'high-' versus 'standard-' dose 5-aminosalicylic acid (5-ASA) therapy and the theoretical impact of improved adherence with once-daily formulations. In CD, cost-utility models for anti-tumour necrosis factor (TNF) drugs versus standard care have suggested consistently that incremental benefits are achieved at increased overall cost. However, studies of varying design have produced a wide spectrum of incremental cost-effectiveness ratio estimates, which highlights the challenges and limitations of existing modelling techniques.

Background: In Italy, chronic obstructive pulmonary disease (COPD) has progressively received increasing attention in the last decade, and its impact has been investigated extensively in both clinical and pharmacoeconomic terms., Methods: In 2004, the national health authorities stated the appropriateness of long-acting β(2) agonists (LABA) and inhaled corticosteroids (ICS) fixed combinations for treating COPD, even though this pharmaceutical option was limited to the severe and very severe stages of the disease (forced expiratory volume in one second [FEV(1)] <50% predicted). The effectiveness in primary care of this official recommendation has been investigated in 1125 COPD patients together with the appropriateness of the therapeutic approach to the disease., Results: and conclusions: Clinical and economic outcomes were monitored over the 3 years before (2001-2003) and the 3 years following this recommendation (2004-2006), and statistically compared (t-test). In general, the overall impact of COPD changed progressively after the pronunciation of the public health authorities. In particular, since the point when LABA/ICS fixed combinations were officially recommended, both morbidity of COPD and the corresponding consumption of healthcare resources have progressively lowered. Moreover, the appropriateness of the pharmaceutical approach increased in the same period, thus emphasizing the importance of the optimization of therapeutic strategies in reducing the long-term impact of the disease.

Objective: To assess the economic impact of initiating inhaled corticosteroids (ICS) without evidence of prior exacerbation among elderly patients with chronic obstructive pulmonary disease (COPD) in the US., Methods: This retrospective study used administrative claims to identify newly diagnosed COPD patients between 1/1/2005 and 6/30/2006 who were dispensed ICS. The dispense date of the first ICS was set as the index date. Patients with prior diagnoses for asthma, cystic fibrosis, or lung cancer were excluded. Cohorts were constructed based on whether ICS therapy was concordant with recommended guidelines of having prior COPD exacerbation. Each COPD patient with prior exacerbation was matched to four patients without exacerbation based on age, gender, Charlson Comorbidity Index, and whether COPD diagnosis code was not elsewhere specified (i.e., 496). Multivariate regressions were estimated to assess the association between use of ICS therapy without prior exacerbation and total healthcare costs, controlling for demographics and clinical characteristics., Results: The study included 3650 patients: 730 with prior exacerbation and 2920 without prior exacerbation. Patients were 76 years of age and 54% were male. Those with prior exacerbation were more likely to have inpatient stays both prior to (74.4 vs. 44.1%, p<0.05) and following (37.0 vs. 33.1%, p<0.05) the index date. Controlling for patient characteristics, patients who were dispensed ICS without prior exacerbation had $1859 higher in total costs (p<0.05) compared to patients with prior exacerbation during the 12 months following ICS initiation., Limitations: The retrospective design of this study limits the interpretation of findings as association and not causality. This study is subject to selection bias due to unobservable confounders., Conclusions: Among COPD patients, initiation of ICS without prior exacerbation appears to be associated with increased healthcare costs. These findings suggest that ICS initiation without evidence of exacerbation as consistent with guidelines is associated with adverse economic consequences.

Objective: To assess whether increased short-acting β(2)-adrenergic agonist (SABA) claims are associated with asthma exacerbations and increased healthcare costs., Study Design: Cross-sectional study., Methods: Patients (N = 93,604) were health plan members aged 6-56 years with at least 2 years of enrollment between July 1, 2003, and June 30, 2007, an asthma diagnosis, and at least 1 asthma medication claim per study year. Two years of administrative claims were collected. SABA use was categorized as 0 (none), (1/2) to 2 (low), 2(1/2) to 6 (moderate), 6(1/2) to 12 (high), and more than 12 (excessive) canister equivalents per year. Multivariate analyses were adjusted for age, sex, geographic region, comorbidities, specialist consultation, controller medication use, and asthma severity., Results: Half of high and excessive SABA users had few or no controller claims. Compared with SABA nonusers, high and excessive SABA users had significantly higher odds (odds ratio [95% confidence interval]) of asthma-related emergency department/urgent care visits (6.47 [5.25, 7.98] and 7.68 [6.04, 9.76], respectively), hospitalizations (5.37 [6.04, 9.76]; 6.90 [4.90, 9.73]), and oral corticosteroid use (2.89 [2.72, 3.08]; 3.71 [3.41, 4.03]). Excessive SABA users had 3.0 times ($1791) and high SABA users had 2.2 times ($1326) higher asthma-related healthcare costs than low SABA users ($595). Total costs also increased with higher SABA use, but with smaller incremental differences between excessive and high SABA users and low SABA users., Conclusions: Increased SABA use is associated with higher total and asthma-related healthcare costs. Opportunity exists to lessen overreliance on SABAs.

In this article a French working party critically review the international literature to revise the definition, pathophysiology, treatment and cost of exacerbations of adult asthma. The various guidelines do not always provide a consistent definition of exacerbations of asthma. An exacerbation can be defined as deterioration of clinical and/or functional parameters lasting more than 24 hours, without return to baseline, requiring a change of treatment. No single clinical or functional criterion can be used as an early marker of an exacerbation. Innate and acquired immune mechanisms, modified by contact with infectious, irritant or allergenic agents, participate in the pathogenesis of exacerbations, which are accompanied by bronchial inflammation. In 2010, mortality is related to progression of exacerbations, often occurring before the patient seeks medical attention. The objective of treatment is to control asthma and prevent exacerbations. However, many factors can trigger exacerbations and often cannot be controlled. The efficacy of inhaled corticosteroids has been demonstrated on reduction of the number of exacerbations and the number of asthma-related deaths. This treatment is cost-effective, especially in terms of reduction of exacerbations., (Copyright © 2010. Published by Elsevier Masson SAS.)

Background: Omalizumab, an anti-immunoglobulin E antibody, reduces exacerbations and symptoms in uncontrolled allergic asthma. The study objective was to estimate the costs and consequences of omalizumab compared to usual care from a US payer perspective., Methods: We estimated payer costs, quality-adjusted survival (QALYs), and the incremental cost-effectiveness ratio (ICER) of omalizumab compared to usual care using a state-transition simulation model that included sensitivity analyses. Every 2 weeks, patients could transition between chronic asthma and exacerbation health states. The best available evidence informed the clinical and cost input estimates. Five years of omalizumab treatment followed by usual care was assumed to estimate a lifetime horizon. Omalizumab responders (60.5% of treated) were modeled as a separate scenario where nonresponders reverted back to usual care after 16 weeks of active treatment., Results: The mean lifetime discounted costs and QALYs were $83,400 and 13.87 for usual care and $174,500 and 14.19 for omalizumab plus usual care resulting in $287 200/QALY (95% interval: $219,300, $557, 900). The ICER was $172 300/QALY when comparing omalizumab to usual care in the responder scenario. One-way sensitivity analyses indicated that the results were sensitive to the difference in treatment-specific utilities for the chronic state, exacerbation-associated mortality, omalizumab price, exacerbation rates, and response definition., Conclusions: The results suggest that adding omalizumab to usual care improves QALYs at an increase in direct medical costs. The cost-effectiveness of omalizumab is similar to other chronic disease biologics. The value increases when omalizumab response is used to guide long-term treatment.

Objectives: To estimate the cost-effectiveness of topical intranasal steroids for the treatment of otitis media with effusion (OME) in primary care from the perspective of the UK National Health Service., Methods: An economic evaluation was conducted based on evidence from the double-blind, randomized, placebo-controlled GPRF [General Practice Research Framework] Nasal Steroids for Otitis Media with Effusion (GNOME) trial. Participants comprised 217 children aged 4-11 years who had at least one episode of otitis media or related ear problem in the previous 12 months and had tympanometrically confirmed bilateral OME. Children were randomly allocated to receive either mometasone furoate 50 microg or placebo spray once daily into each nostril for 3 months. The main outcome measure was the incremental cost per quality-adjusted life-year (QALY) gained for topical steroids compared with placebo. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves at alternative willingness to pay thresholds., Results: Children receiving topical steroids accrued nonsignificantly higher costs (incremental cost/child: pound11, 95% confidence interval [CI]: - pound199 to pound222) and nonsignificantly fewer QALYs (incremental QALY gain/child: -0.0166, 95% CI: -0.0652 to 0.0320) than those receiving placebo. Topical steroids had a 24.19% probability of being cost-effective at a pound20,000 per QALY gained threshold, a 23.82% probability of being more effective and a 46.25% probability of being less costly. Sensitivity and subgroup analyses showed incremental costs and benefits to be highly sensitive to the methods used and the patient group considered, although differences between groups did not reach statistical significance in any analysis., Conclusions: Topical steroids are unlikely to be a cost-effective treatment for OME in general practice.

Background: The purpose of this study was to measure change in quality of life (QoL) and estimate health-related utility in adults with moderate and severe atopic dermatitis (AD) following the use of either tacrolimus ointment or topical corticosteroids., Methods: Data were analysed from a double-blind, randomized controlled trial comparing the treatment of adults with moderate and severe AD with either tacrolimus ointment or a standard corticosteroid regimen. Following randomisation, patients applied their medication twice-daily for 6 months. Monthly assessments determined response and QoL. Health-related utility (EQ5Dindex) was estimated by Monte Carlo simulation from SF-12 responses via a published mapping algorithm., Results: At baseline, estimated utility data were available for 926 (95%) of the intention-to-treat patients, 57% of whom had AD of moderate severity (43% severe). The mean age at baseline was 32.5 years (SD +/- 11.8), 46.2% were male, with a mean EQ5Dindex for moderate cases of 0.770 (SD +/- 0.157), and 0.665 (SD +/- 0.225) for those with severe disease (P < 0.001). Patients treated with tacrolimus ointment showed significantly greater improvement in all but one domain of the SF-36. At baseline, there was no difference in estimated utility between the two groups; however, a difference in utility in favour of tacrolimus ointment emerged after 1 month's treatment (0.849 vs. 0.820; P = 0.004). Over the 6-month study period, the mean, marginal utility difference between the study arms was 0.032 U (utility) in favour of tacrolimus (P < 0.001)., Conclusion: Treatment with 0.1% tacrolimus ointment rather than a standard topical corticosteroid ointment regimen was associated with clinically significant, incremental improvement in QoL, sustained over a 6-month period. A within-trial cost-utility estimate based on study medication cost alone suggests that tacrolimus ointment is highly cost-effective given existing willingness-to-pay thresholds.

Objectives: The primary aims of the study were to: (a) describe the trajectories of adherence to daily inhaled corticosteroid (ICS) medication for a year in economically disadvantaged, African-American youth with asthma based on growth curve modeling; and (b) test the relationship of treatment adherence to symptom control, quick-relief medication, and healthcare utilization., Methods: This prospective study measured adherence to daily ICS treatment using electronic monitoring in 92 children and adolescents with moderate to severe asthma for 9-12 months and assessed clinical outcomes, including asthma-related symptoms, quick-relief medication, and healthcare utilization., Results: Youth showed a decrement in treatment adherence to less than half of prescribed corticosteroid treatment over the course of the study, which related to increased healthcare utilization (p < .04), but not to asthma symptoms or albuterol use., Conclusion: Economically disadvantaged youth with asthma demonstrate high rates of chronic nonadherence that warrant identification and intervention to reduce asthma-related healthcare utilization.

Background: Forecasting clinical and economic outcomes in ulcerative colitis (UC) and Crohn's disease (CD) patients is complex, but necessary., Aims: To determine: the frequency of treatment-classified clinical states; the probability of transition between states; and the economic outcomes., Methods: Newly diagnosed UC and CD patients, allocated into seven clinical states by medical and surgical treatments recorded in serial 3-month cycles, underwent Markov analysis., Results: Over 10 years, 630 UC and 318 CD patients had 22,823 and 11,871 cycles. The most frequent clinical outcomes were medical/surgical remission (medication-free) and mild disease (on 5-aminosalicylates, antibiotics, topical corticosteroids), comprising 28% and 62% of UC cycles and 24% and 51% of CD cycles respectively. The probability of drug-response in patients receiving systemic corticosteroids/immunomodulators was 0.74 in UC, 0.66 in CD. Both diseases had similar likelihood of persistent drug-dependency or drug-refractoriness. Surgery was more probable in CD, 0.20, than UC, 0.08. In terms of economic outcomes, surgery was costlier in UC per cycle, but the outlay over 10 years was greater in CD. Drug-refractory UC and CD cases engendered high costs in the cohort., Conclusions: Most patients on 5-aminosalicylates, corticosteroids and immunomodulators had favourable clinical and economic outcomes over 10 years. Drug-refractory and surgical patients exhibited greater long-term expenses.

Background: Several clinical studies have suggested that the overuse of short-acting beta-agonists (SABAs) and the underuse of inhaled corticosteroids are prevalent and may compromise patient health and increase the use of scarce health-care resources., Objective: To examine the impact of an intervention designed to reduce SABA metered-dose inhaler (MDI) overdispensing on asthma-related drug and healthcare utilization endpoints in a mail order pharmacy benefit population., Methods: Retrospective pre- and postintervention analysis was conducted on all new SABA prescriptions indicating a quantity more than 1 SABA MDI per month and on asthma patients who were continuously enrolled in the Medco Health Solutions prescription benefit program from July 1, 2006, to June, 30, 2007 (preintervention), and July 1, 2007, to June 30, 2008 (postintervention). The intervention involved a written or verbal request to the prescriber to reduce the quantity of SABA MDIs dispensed to less than 1 SABA MDI per month if determined appropriate by the prescriber. Effectiveness of the intervention on asthma-related drug and health-care utilization outcomes were measured in the overall Medco pharmacy population and in asthma patients receiving more than 1 SABA MDI per month., Results: The percentage of new SABA prescriptions dispensed for more than 1 SABA MDI per month was significantly reduced during year 2 (22.9% vs 9.7%, p < 0.01). Of the 1835 asthma patients who received more than 1 SABA MDI per month in year 1, 1230 (67%) received fewer than 1 SABA MDI per month during year 2. The incidence of asthma-related hospitalizations, emergency department visits, and oral corticosteroid use did not significantly change from year 1 to year 2., Conclusions: This analysis shows that an intervention can succeed in reducing the overdispensing of quick-relief medication without compromising asthma control. Further investigation is warranted to better understand the interplay between reduction in excessive SABA use and improved clinical outcomes.

The TOwards a Revolution in COPD Health (TORCH) study was a 3-yr multicentre trial of 6,112 patients randomised to salmeterol (Salm), fluticasone propionate (FP), a Salm/FP combination (SFC) or placebo (P). Here the cost-effectiveness of treatments evaluated in the TORCH study is assessed. For four regions, 3-yr all-cause hospitalisation, medication and outpatient care costs were calculated. The sample was restricted to the 21 countries (n = 4,237) in which European quality of life five-dimension (EQ-5D) data were collected in order to estimate the number of quality-adjusted life years (QALYs). Regression models were fitted to survival, study medication cost, other medication cost and EQ-5D data in order to estimate total cost, number of QALYs and cost per QALY, adjusted for missing data and region. SFC had a trial-wide estimate of cost per QALY of 43,600 US dollars (USD) compared with P (95% confidence interval 21,400-123,500 USD). Estimates for Salm versus P (197,000 USD) and FP versus P (78,000 USD) were less favourable. The US estimates were greater than those from other regions; for SFC versus P, the cost per QALY was 77,100 (46,200-241,700) USD compared to 24,200 (15,200-56,100) USD in Western Europe. Compared with P, SFC has a lower incremental cost-effectiveness ratio than either FP or Salm used alone, and is, therefore, preferred to these monotherapies on the grounds of cost-effectiveness.

Objective: To investigate differences in demographics, physician specialty, and medication use between patients who achieve high versus low ratios of controller to total asthma medications., Study Design: Cohort analysis., Methods: We used a Health Insurance Portability and Accountability Act-compliant claims database to identify patients aged 5 to 56 years with persistent asthma during a premeasurement year and a measurement year. Based on values in the measurement year, the ratio of controller to total asthma medications ratio was defined using the following formula: (Units of Controllers) / (Units of Controllers + Relievers). Descriptive analysis and multivariate logistic regression models were used to examine patients with high and low ratios., Results: The final study group comprised 38,538 patients with persistent asthma; 28,496 (73.9%) had high ratios. Specialty of usual-care physician differed (P <.001), with more high-ratio patients than low-ratio patients having an allergist or pulmonologist. Patients who received combination inhaled corticosteroid-long-acting beta-agonist therapy (odds ratio [OR], 2.4) or leukotriene receptor antagonist therapy (OR, 3.5) were more likely to be in the high-ratio group compared with those dispensed a single inhaled corticosteroid. High-group and low-group assignment could be calculated by partial-year data: assignment based on 1 quarter of data was concordant with assignment based on full-year ratio in 91% of cases (Pearson product moment correlation coefficient, 0.864; kappa statistic, 0.761), and assignment based on 2 quarters of data was concordant with full-year results in 94% of cases (Pearson product moment correlation coefficient, 0.928; kappa statistic, 0.843)., Conclusions: A high ratio of controller to total asthma medications is associated with greater controller adherence and with more controller fills. The ratio can be calculated using 1 or 2 quarters of pharmacy claims data, at a time when intervention may reduce asthma-related exacerbations. Interventions that may improve the ratio include changing from single inhaled corticosteroid therapy and from asthma specialist care.

Background: Information is lacking on the relative effectiveness and cost effectiveness--in a real-life primary-care setting--of leukotriene receptor antagonists (LTRAs) and long-acting beta2 adrenergic receptor agonists (beta2 agonists) as add-on therapy for patients whose asthma symptoms are not controlled on low-dose inhaled corticosteroids (ICS)., Objective: To estimate the cost effectiveness of LTRAs compared with long-acting beta2 agonists as add-on therapy for patients whose asthma symptoms are not controlled on low-dose ICS., Methods: An economic evaluation was conducted alongside a 2-year, pragmatic, randomized controlled trial set in 53 primary-care practices in the UK. Patients aged 12-80 years with asthma insufficiently controlled with ICS (n = 361) were randomly assigned to add-on LTRAs (n = 176) or long-acting beta2 agonists (n = 185). The main outcome measures were the incremental cost per point improvement in the Mini Asthma Quality of Life Questionnaire (MiniAQLQ), per point improvement in the Asthma Control Questionnaire (ACQ) and per QALY gained from perspectives of the UK NHS and society., Results: Over 2 years, the societal cost per patient receiving LTRAs was pounds sterling 1157 versus pounds sterling 952 for long-acting beta2 agonists, a (significant, adjusted) increase of pounds sterling 214 (95% CI 2, 411) [year 2005 values]. Patients receiving LTRAs experienced a non-significant incremental gain of 0.009 QALYs (95% CI -0.077, 0.103). The incremental cost per QALY gained from the societal (NHS) perspective was pounds sterling 22,589 (pounds sterling 11,919). Uncertainty around this point estimate suggested that, given a maximum willingness to pay of pounds sterling 30,000 per QALY gained, the probability that LTRAs are a cost-effective alternative to long-acting beta2 agonists as add-on therapy was approximately 52% from both societal and NHS perspectives., Conclusions: On balance, these results marginally favour the repositioning of LTRAs as a cost-effective alternative to long-acting beta2 agonists as add-on therapy to ICS for asthma. However, there is much uncertainty surrounding the incremental cost effectiveness because of similarity of clinical benefit and broad confidence intervals for differences in healthcare costs., Trial Registration: UK National Research Register N0547145240; Controlled Clinical Trials ISRCTN99132811.

Background: Information is lacking on the relative effectiveness and cost effectiveness--in a primary-care setting--of leukotriene receptor antagonists (LTRAs) as an alternative to inhaled corticosteroids (ICS) for initial asthma controller therapy., Objective: To compare the cost effectiveness of LTRAs versus ICS for patients initiating asthma controller therapy., Methods: An economic evaluation was conducted alongside a 2-year, pragmatic, randomized controlled trial set in 53 primary-care practices in the UK. Patients aged 12-80 years with asthma and symptoms requiring regular anti-inflammatory therapy (n = 326) were randomly assigned to LTRAs (n = 162) or ICS (n = 164). The main outcome measures were the incremental costs per point improvement in the Mini Asthma Quality of Life Questionnaire, per point improvement in the Asthma Control Questionnaire and per QALY gained from the UK NHS and societal perspectives., Results: Over 2 years, resource use was similar between the two treatment groups, but the cost to society per patient was significantly higher for the LTRA group, at pounds sterling 711 versus pounds sterling 433 for the ICS group (adjusted difference pounds sterling 204; 95% CI 74, 308) [year 2005 values]. Cost differences were driven primarily by differences in prescription drug costs, particularly study drug costs. There was a nonsignificant (imputed, adjusted) difference between treatment groups, favouring ICS, in QALYs gained at 2 years of -0.073 (95% CI -0.143, 0.010). Therapy with LTRAs was, on average, a dominated strategy, and, at a threshold for willingness to pay of pounds sterling 30,000 per QALY gained, the probability of LTRAs being cost effective compared with ICS was approximately 3% from both societal and NHS perspectives., Conclusions: There is a very low probability of LTRAs being cost effective in the UK, at 2005 values, compared with ICS for initial asthma controller therapy., Trial Registration: UK National Research Register N0547145240; Controlled Clinical Trials ISRCTN99132811.

A question with respect to asthma therapy revolves around the issue of whether better efficacy occurs with an ultrafine-particle inhaled corticosteroid because of better lung deposition into the distal airways. This article reviews particle size and delivery devices of different steroids, clinical outcomes of small- versus large-particle steroids, and the issue of pharmacoeconomics.

Objective: To examine the effect of the level of patient copayment on the rate of purchase of inhaled corticosteroids (ICS) by patients with obstructive lung disease., Design and Setting: Cross-sectional study of records of all prescriptions for ICS dispensed to general and concessional beneficiaries aged 15 years or over in the period January 2003 to December 2006. Data were obtained from the Pharmaceutical Benefits Scheme, which subsidises medication costs for all Australians., Main Outcome Measures: The number of prescriptions for ICS dispensed to government concession card holders compared with the number dispensed to general beneficiaries, expressed as a rate ratio., Results: ICS prescriptions were dispensed to over 1.6 million people during the study period. Concession card holders were dispensed ICS prescriptions at a higher rate than general beneficiaries, both overall (43.7 v 9.1 ICS prescriptions per 100 person-years) and in all population subgroups. After adjusting for age, sex, remoteness category and socioeconomic status, people holding a concession card were dispensed over 2.5 times the number of ICS prescriptions (alone or in combination with a long-acting beta(2)-agonist) compared with general beneficiaries. Similar patterns were seen after adjusting for differences between the two groups in the prevalence of obstructive lung disease., Conclusions: As the patient copayment for general beneficiaries is over six times higher than for concession card holders, our findings imply that cost is a barrier to the purchase of ICS prescriptions for obstructive lung disease, independent of socioeconomic status.

Objective: To examine health care utilization measures indicating which asthma patients are appropriate for inhaled corticosteroid and long-acting beta(2)-adrenergic agonist (ICS/LABA) therapy and determine whether two ICS/LABA therapies were initiated in accordance with guidelines., Research Design and Methods: A retrospective cohort study of commercially insured asthma patients aged > or =12 years that initiated fluticasone propionate/salmeterol (FSC) or budesonide/formoterol fumarate dihydrate (BFC) combination therapy in 2007 was conducted. Use was considered appropriate if patients met any of the following during a 1-year period before ICS/LABA initiation: ICS or leukotriene receptor antagonist (LTRA) use; an asthma-related emergency department (ED) visit or hospitalization; > or =2 oral corticosteroids (OCS) courses; or > or =6 short-acting beta(2)-adrenergic agonist (SABA) canisters. Multivariate logistic regression was used to assess factors associated with appropriate ICS/LABA use. Certain limitations inherent to the use of claims data for research apply to this study., Results: Of 24,231 patients who initiated ICS/LABA therapy, 993 received BFC and 23,238 received FSC. Among all patients, 37.6% met > or =1 criteria for appropriate use. However, compared with FSC users, BFC users had a significantly higher likelihood of meeting > or =1 of these criteria (odds ratio, 2.01; 95% CI, 1.76-2.30; p < 0.001), and a higher proportion of BFC than FSC patients met 4 of the 5 appropriate use criteria. In total, 58.4% of BFC patients versus 36.7% of FSC patients met > or =1 criteria for appropriate use. Other factors associated with appropriate use included age, region, Charlson comorbidity score, number of medications, and prescriber specialty., Conclusion: Fewer than half of all patients fulfilled the specified criteria for being appropriate for ICS/LABA therapy. However, a significantly higher proportion of BFC than FSC users met the criteria for appropriate use of ICS/LABA therapy. These results may suggest a need for improved physician awareness of consensus guidelines for the initiation of ICS/LABA therapy.

Introduction: In budesonide/formoterol (Symbicort(R) Turbuhaler(R), AstraZeneca, Lund, Sweden) maintenance and reliever therapy (SMART), patients with asthma take a daily maintenance dose of budesonide/formoterol, with the option of taking additional doses for symptom relief instead of a short-acting beta(2)-agonist (SABA). This study assesses the cost-effectiveness of SMART compared with usual care in patients with mild-to-moderate persistent asthma treated by general practitioners in the Netherlands from a societal perspective., Methods: The study was linked to a randomized, active-controlled, open-label, multicenter, 12-month clinical trial, with a prospective collection of resource use. One hundred and two patients > or =18 years with mild-to-moderate persistent asthma and daily inhaled corticosteroids (ICS) prior to the trial were included. SMART was given as two inhalations of budesonide/formoterol (100/6 microg) once daily, plus additional doses as needed. The control group was treated according to guidelines, which prescribe medium daily doses of ICS plus an SABA if needed. A long-acting beta(2)-agonist (LABA) is added if necessary. Effectiveness was measured as the proportion of asthma-control days, Asthma Control Questionnaire (ACQ) scores, the net proportion of patients with relevant ACQ improvement, and the proportion of well-controlled patients. Costs included asthma medication, physician contacts, and absence from work., Results: Mean total costs for SMART were 134.81 lower (95% CI: -439.48; 44.85). Production losses were 94.10 (95% CI: -300.60; 0.29) lower for SMART (10.77 vs. 104.87). No significant differences in health outcomes were seen, with 3.81 fewer asthma-control days per patient-year for SMART (95% CI: -36.8; 30.8), a 0.049 better ACQ score (95% CI: -0.21; 0.29), a 5.8% larger net proportion of improved patients (95% CI: t15.6%; 27.3%), and a 2.1% (95% CI: -25.5; 20.8%) smaller increase in the proportion of well-controlled patients., Conclusions: Treating primary care patients with mild-to-moderate persistent asthma with SMART instead of ICS plus bronchodilators does not affect health outcomes and does not increase costs; therefore, is likely to be an alternative for guideline-directed treatment, from a health and economic perspective.

Objective: To comprehensively evaluate clinical, economic, and patient-reported outcomes associated with various therapeutic classes of asthma controller medications., Patients and Methods: This observational study, which used administrative claims data from US commercial health plans, included patients with asthma aged 18 through 64 years who filled a prescription for at least 1 asthma controller medication from September 1, 2003, through August 31, 2005. Outcome metrics included the use of short-acting beta-agonists (SABAs), the use of oral corticosteroids, inpatient (INP)/emergency department (ED) visits, and asthma-related health care costs. A subset of 5000 patients was randomly selected for a survey using the Mini-Asthma Quality of Life Questionnaire, the Work Productivity and Activity Impairment questionnaire, and the Asthma Therapy Assessment Questionnaire., Results: Of 56,168 eligible patients, 823 returned completed questionnaires. Compared with inhaled corticosteroids (ICSs), leukotriene modifiers (LMs) were associated with lower odds of INP/ED visits (odds ratio [OR], 0.80; P<.001), lower odds of using 6 or more SABA canisters (OR, 0.81; P<.001), and higher annual cost ($193; P<.001). In the subgroup analysis of adherent patients, LMs were associated with higher odds of INP/ED visits (OR, 1.74; P=.04), lower odds of using 6 or more SABA canisters (OR, 0.46; P<.001), and higher annual cost ($235; P<.001). Inhaled corticosteroids and LMs had a comparable impact on all patient-reported outcomes. For combination therapy, ICS plus a long-acting beta-agonist consistently showed at least equivalent or better outcomes in the use of SABAs and oral corticosteroids, the risk of INP/ED visits, cost, asthma control level, quality of life, and impairment in productivity and activity., Conclusion: Inhaled corticosteroids were associated with a lower risk of INP/ED visits, and a lower cost if adherence was achieved. When adherence cannot be achieved, LMs may be a reasonable alternative. Combination therapy with ICS plus a long-acting beta-agonist was associated with better or equivalent clinical, economic, and patient-reported outcomes.

Oral corticosteroids (OCS) are a key part of therapy regimens for a diverse variety of conditions. Despite their efficacy, they are associated with a wide variety of adverse events. The purpose of this review was to identify the range of adverse events that have been reported to be related to oral corticosteroids, examine the factors that influence their incidence and estimate the economic burden caused by these adverse events. In 61 identified studies, 21 different categories of OCS related adverse events were reported with increased fracture risk being the category most frequently described. Most studies that examined factors linked to the incidence of OCS related adverse events found that dose, age, gender, duration of use, treatment history, smoking habits or cholesterol level were influential in determining risk. Additionally, a cumulative economic analysis of selected adverse events found the annual cost of treating these events in the UK to be at least 165 pounds per patient taking OCS. The clinical and economic burden of OCS related adverse events highlights the need for OCS sparing therapies to be developed.

Background: Psoriasis vulgaris is one of the most common dermatologic diseases in Germany with a prevalence of about 2%. Along with efficacy and safety, costs are an important criterion for selecting appropriate therapy for this chronic disease. The majority of the patients with mild to moderate psoriasis vulgaris can be successfully treated with topical therapy alone. The most important agents are vitamin D(3) analogs and corticosteroids either as single agents or in a fixed combination (Daivobet)., Methods: For the evaluation of the cost-effectiveness of different topical psoriasis treatments, a Markov model was developed that compares a fixed combination treatment followed by calcipotriol with a morning/evening application of the individual agents, as well as a comparison with tacalcitol., Results: The pharmacoeconomic evaluation showed a higher cost-effectiveness of the fixed combination treatment compared to using single agents (morning/evening) and to the tacalcitol. Treatment with the fix combination is more effective and more economic. Additional sensitivity analyses demonstrated that the advantage remains even when assuming a maximum compliance for twice daily usage, and varying the effectiveness of the fixed combination by 10%., Conclusions: The treatment of mild to moderate psoriasis with a fixed calcipotriol/betamethasone combination is a more cost-effective treatment than a treatment with the single agents or tacalcitol monotherapy.

Background: As more inhaled corticosteroid (ICS) devices become available, there may be pressure for health-care providers to switch patients with asthma to cheaper inhaler devices. Our objective was to evaluate impact on asthma control of inhaler device switching without an accompanying consultation in general practice., Methods: This 2-year retrospective matched cohort study used the UK General Practice Research Database to identify practices where ICS devices were changed without a consultation for > or =5 patients within 3 months. Patients 6-65 years of age from these practices whose ICS device was switched were individually matched with patients using the same ICS device who were not switched. Asthma control over 12 months after the switch was assessed using a composite measure including short-acting beta-agonist and oral corticosteroid use, hospitalizations, and subsequent changes to therapy., Results: A total of 824 patients from 55 practices had a device switch and could be matched. Over half (53%) of device switches were from dry powder to metered-dose inhalers. Fewer patients in switched than matched cohort experienced successful treatment based on the composite measure (20% vs. 34%) and more experienced unsuccessful treatment (51% vs. 38%). After adjusting for possible baseline confounding factors, the odds ratio for treatment success in the switched cohort compared with controls was 0.29 (95% confidence interval [CI], 0.19 to 0.44; p < 0.001) and for unsuccessful treatment was 1.92 (95% CI, 1.47 to 2.56; p < 0.001)., Conclusion: Switching ICS devices without a consultation was associated with worsened asthma control and is therefore inadvisable.

Background and Objective: Intranasal corticosteroids are considered to be highly effective in patients with perennial or seasonal allergic rhinitis. Multiple intranasal corticosteroid products are available; however, an intranasal corticosteroid that treats nasal and ocular seasonal allergic rhinitis symptoms may be more cost effective by reducing the need for concomitant drugs. The purpose of this study was to compare the utilization and costs of concomitant allergic rhinitis drugs among commonly used branded intranasal corticosteroid drugs., Methods: Pharmacy claims data between 1 April 2006 and 31 January 2008 were obtained from the Wolters Kluwer SourceLx dataset. Patients with at least one pharmacy claim for a branded intranasal corticosteroid agent (fluticasone furoate, budesonide, mometasone or triamcinolone) during the index period of 1 April 2007 through 31 July 2007 were included. Study outcomes assessed were time to concomitant use of prescription allergic rhinitis drugs (other than intranasal corticosteroids) and costs of those medications and intranasal corticosteroid drugs during a 60-day post-index period., Results: A total of 793 349 patients were included in the study. At index, a majority of the patients were using mometasone (62.9%), followed by triamcinolone (21.1%), budesonide (15.1%) and fluticasone furoate (1.0%). After controlling for other covariates, patients receiving fluticasone furoate had on average a 21% lower risk of concomitant prescription allergic rhinitis drug use (adjusted hazard ratio [HR] 0.79; 95% CI 0.75, 0.83) compared with the other three branded intranasal corticosteroid agents. Compared with fluticasone furoate, all other branded intranasal corticosteroid agents incurred statistically significant higher costs of concomitant allergic rhinitis drugs (6.3%, p = 0.002), resulting in increased costs to health plans of $US5-$US6 per patient over a 60-day period. Mean intranasal corticosteroid costs per patient during the 60-day follow-up period were lowest for budesonide ($US70.15), followed by fluticasone furoate ($US70.86), triamcinolone ($US73.23) and mometasone ($US75.48)., Conclusion: In this cohort of intranasal corticosteroid users, fluticasone furoate was shown to reduce the need for concomitant prescription allergic rhinitis medications compared with other leading branded intranasal corticosteroid therapies, resulting in lower costs per patient and potentially leading to significant savings for health plans.

Aims: This retrospective, observational cohort study aimed to compare treatment outcomes and healthcare costs in the year after initiation of maintenance treatment with budesonide/formoterol or salmeterol/fluticasone in a German healthcare setting., Methods: Data on German asthma patients initiating treatment with budesonide/formoterol or salmeterol/fluticasone between June 2001 and June 2005 were obtained from the IMS Disease Analyzer database. The primary outcome was the probability of treatment success, defined according to short-acting beta(2)-agonist prescriptions and switches or addition of controller medications, during the postindex year. A secondary definition of treatment success included hospitalisations and oral corticosteroid (OCS) prescriptions. Secondary outcomes included severe asthma exacerbations, defined as >or=1 OCS prescription, asthma-related hospitalisation and/or referral. The effect of treatment on costs was estimated using generalised linear models, adjusting for patient and physician characteristics., Results: There were no significant differences between the budesonide/formoterol (n = 1456) and salmeterol/fluticasone (n = 982) groups in disease severity markers in the pre-index year. Patients on budesonide/formoterol had a 44% greater probability of treatment success [odds ratio (OR): 1.44; p = 0.0003] according to the primary definition and a 26% greater probability (OR: 1.26; p = 0.0119) according to the secondary definition, fewer severe exacerbations (-33.4%; p = 0.0123) and fewer OCS prescriptions (-31.5%; p = 0.0082) compared with salmeterol/fluticasone, after controlling for baseline characteristics. Adjusting for covariates, budesonide/formoterol had a significant inverse relationship on asthma-related costs compared with salmeterol/fluticasone (-13.4%; p < 0.001). Total cost (asthma- and non-asthma-related costs) was 12.6% lower for budesonide/formoterol (p < 0.0001)., Conclusion: This study suggests that for patients with chronic asthma in Germany, budesonide/formoterol rather than salmeterol/fluticasone had a higher likelihood of treatment success, and that budesonide/formoterol is the less costly option. Although the cohorts appeared to be well matched at baseline, the results should be interpreted with caution given the observational nature of the study.

Objective: To assess costs, effectiveness, and cost-effectiveness of inhaled corticosteroids (ICS) augmenting bronchodilator treatment for chronic obstructive pulmonary disease (COPD)., Data Sources: Claims between 1997 and 2005 from a large managed care database., Study Design: Individual-level, fixed-effects regression models estimated the effects of initiating ICS on medical expenses and likelihood of severe exacerbation. Bootstrapping provided estimates of the incremental cost per severe exacerbation avoided., Data Extraction Methods: COPD patients aged 40 or older with > or = 15 months of continuous eligibility were identified. Monthly observations for 1 year before and up to 2 years following initiation of bronchodilators were constructed., Principal Findings: ICS treatment reduced monthly risk of severe exacerbation by 25 percent. Total costs with ICS increased for 16 months, but declined thereafter. ICS use was cost saving 46 percent of the time, with an incremental cost-effectiveness ratio of $2,973 per exacerbation avoided; for patients > or = 50 years old, ICS was cost saving 57 percent of time., Conclusions: ICS treatment reduces exacerbations, with an increase in total costs initially for the full sample. Compared with younger patients with COPD, patients aged 50 or older have reduced costs and improved outcomes. The estimated cost per severe exacerbation avoided, however, may be high for either group because of uncertainty as reflected by the large standard errors of the parameter estimates.

From July 1996 to November 2006, 46 patients received kidney transplants at five pediatric centers in Thailand. The male-female ratio was 1.9:1. The primary causes of end-stage renal disease (ESRD) included hypoplastic or dysplastic kidney, chronic glomerulonephritis, reflux nephropathy, pyelo nephritis or interstitial nephritis, focal segmental glomerulosclerosis, and rapidly progressive glomerulonephritis. Mean (SD) age at onset of ESRD was 10.1 (3.1) years, and at transplantation was 11.1 (2.9) years. Preemptive transplantation was performed in 2 patients. Cadaveric donors were used in 67.4% of procedures. Induction of immunosuppression with interleukin (IL)-2 monoclonal antibody was used in 41.3% of the patients. At 1 year posttransplantation, maintenance therapy included corticosteroids in 100% of patients, cyclosporine in 81.6%, tacrolimus in 15.8%, azathioprine in 31.6%, and mycophenolate mofetil in 57.9%. Standardized height z scores at transplantation and last follow-up (mean [SD], 40.0 [28.3] months) remained the same at -1.9. Mean (SD) serum creatinine level at the last follow-up was 1.3 (0.8) mg/dL. Patient survival at 1 and 5 years was 96% and 88%, respectively. Graft survival at 1 and 5 years was 98% and 84%, respectively. The medical expenses at 1, 6, and 12 months were US$601, US$464, and US$384 per month, respectively. The Thai per gross domestic product per capita was US$758 per month. Medical expenses were paid by the government in 44.2% of cases, charity foundations in 39.5%, and the patients' parents in 16.3%. Although the causes, management, and outcomes of ESRD were not different from those in other countries, access to treatment and medical expenses may be substantial barriers in developing countries.

Background: Patients face increasing insurance restrictions on prescription drugs, including generic-only coverage. There are no generic inhaled corticosteroids (ICS), which are a mainstay of asthma therapy, and patients pay the full price for these drugs under generic-only policies. We examined changes in ICS use following the introduction of generic-only coverage in a Medicare Advantage population from 2003-2004., Methods: Subjects were age 65+, with asthma, prior ICS use, and no chronic obstructive pulmonary disorder (n = 1,802). In 2004, 74.0% switched from having a $30 brand-copayment plan to a generic-only coverage plan (restricted coverage); 26% had $15-25 brand copayments in 2003-2004 (unrestricted coverage). Using linear difference-in-difference models, we examined annual changes in ICS use (measured by days-of-supply dispensed). There was a lower-cost ICS available within the study setting and we also examined changes in drug choice (higher- vs. lower-cost ICS). In multivariable models we adjusted for socio-demographic, clinical, and asthma characteristics., Results: In 2003 subjects had an average of 188 days of ICS supply. Restricted compared with unrestricted coverage was associated with reductions in ICS use from 2003-2004 (-15.5 days-of-supply, 95% confidence interval (CI): -25.0 to -6.0). Among patients using higher-cost ICS drugs in 2003 (n = 662), more restricted versus unrestricted coverage subjects switched to the lower-cost ICS in 2004 (39.8% vs. 10.3%). Restricted coverage was not associated with decreased ICS use (2003-2004) among patients who switched to the lower-cost ICS (18.7 days-of-supply, CI: -27.5 to 65.0), but was among patients who did not switch (-38.6 days-of-supply, CI: -57.0 to -20.3). In addition, restricted coverage was associated with decreases in ICS use among patients with both higher- and lower-risk asthma (-15.0 days-of-supply, CI: -41.4 to 11.44; and -15.6 days-of-supply, CI: -25.8 to -5.3, respectively)., Conclusion: In this elderly population, patients reduced their already low ICS use in response to losing drug coverage. Switching to the lower-cost ICS mitigated reductions in use among patients who previously used higher-cost drugs. Additional work is needed to assess barriers to switching ICS drugs and the clinical effects of these drug use changes.

Background: The treatment of mild persistent asthma is controversial., Objectives: A retrospective database approach was used to evaluate different alternatives to treating mild persistent asthma. We hypothesized that treatment with inhaled corticosteroids (ICS) would result in lowest costs than treatment with leukotriene modifiers (LM) and combination therapy with ICS long-acting inhaled beta(2)-agonists (LABA) because it would be associated with fewer acute care visits and hospitalizations than LM and it would have lower drug acquisition costs than both ICS+LABA and LM., Methods: Costs and resource utilization were compared in 1,283 mild persistent asthma patients initiating regular use of either ICS, ICS+LABA, or LM. Mild persistent asthma patients were identified from a privately insured claims database (1999-2005) using an established algorithm. Wilcoxon rank-sum tests and generalized linear models were used to compare costs., Results: Of the total patients who met study criteria, 319 patients (24.9%) initiated regular ICS use, 414 (32.3%) ICS+LABA use, and 550 (42.9%) LM use. Over the 1 year after controller therapy initiation, asthma-related direct costs were significantly lower with ICS compared with ICS+LABA or LM ($819 for ICS, $1,094 for ICS+LABA, and $869 for LM, p < 0.001 for all comparisons). There were no significant differences in resource use., Conclusion: In this analysis, physicians, despite guideline recommendations, chose to treat patients with mild persistent asthma more often with LM and ICS+LABA than with ICS. However, therapy with ICS was less costly than treatment with either LM or ICS+LABA, primarily due to differences in drug costs, and provided similar outcomes.

Objectives: To assess the clinical and cost-effectiveness of inhaled corticosteroids (ICS) alone and ICS used in combination with a long-acting beta2 agonist (LABA) in the treatment of chronic asthma in adults and children aged over 12 years., Data Sources: Major electronic bibliographic databases, e.g. MEDLINE and EMBASE, were searched up to February/March 2006 (and updated again in October 2006)., Review Methods: A systematic review of clinical and cost-effectiveness studies was conducted. Cost comparison and cost-consequence analyses were performed where appropriate., Results: The assessment of clinical effectiveness was based on the 67 randomised controlled trials selected from the 5175 reports identified through the systematic literature search. The most frequently reported relevant outcomes were lung function, symptoms, use of rescue medication and adverse events. The trials varied considerably. In the trials that compared low-dose ICS versus ICS and high-dose ICS versus ICS, there were few significant differences in clinical effectiveness, although a few of the trials had assessed non-inferiority between the comparators rather than superiority. At doses of 400, 800 and 'high-level' doses of 1500 or 1600 microg/day, beclometasone dipropionate (BDP) appears to be the current cheapest ICS product both with the inclusion and exclusion of chlorofluorocarbon (CFC)-propelled products. A significant treatment benefit for combination ICS/LABA therapy across a range of outcomes compared with ICS alone was identified [when the ICS was double the accepted clinically equivalent dose of the ICS in the combination inhaler, and dry powder inhalers (DPIS) were used to deliver the drugs]. When a formoterol fumarate (FF)/salmeterol (SAL) combination inhaler and a budesonide (BUD)/FF combination inhaler were each compared with their constituent drugs delivered in separate inhalers, there were very few statistically significant differences between the treatments across the various efficacy outcomes and the rate of adverse events. Combination inhalers were more often cheaper than doubling the dose of ICS alone. However, the costs were highly variable and dependent on both the dose required and the preparation used in the trials. The estimated mean annual cost of FP/SAL combination varied from being 94 pounds cheaper to 109 pounds more expensive than the alternative of BUD at a higher dose. The BUD/FF combination varied from being 163 pounds cheaper to 66 pounds more expensive than the higher dose of either BUD or FP. When the combination inhalers were compared to each other, the results were mixed, with the FP/SAL combination significantly superior on some outcomes and the BUD/FF combination superior on others; however, meta-analysis showed that there were no significant differences between the two treatments in the rate of adverse events. Taking an ICS with a LABA as either of the two currently available combination products, FP/SAL and BUD/FF, is usually cheaper than taking the relevant constituent drugs in separate inhalers. At very high doses of BUD (1600 microg/day), however, the BUD/FF combination inhaler can be up to 156 pounds more expensive than having the same drugs in separate inhalers. In terms of the relative costs associated with taking one of the combination inhalers, at low dose (400 microg BUD or 200 microg FP/day) the cheapest combination inhaler is FP/SAL as a pressurised metered dose inhaler (pMDI) (Seretide Evohaler). However, this is only slightly cheaper than using BUD/FF as a DPI (Symbicort Turbohaler). At higher dose levels (800 microg BUD or 500 microg FP/day) FP/SAL as either pMDI aerosol (Seretide Evohaler) or a DPI (Seretide Accuhaler) is the cheapest combination product available, but again only slightly cheaper than the DPI BUD/FF combination (Symbicort Turbohaler). It should be highlighted, however, that the three head-to-head trials that compared the effects of FP/SAL with BUD/FF used the FP/SAL DPI combination inhaler, Seretide Accuhaler., Conclusions: The evidence indicates that there are few consistent significant differences in effects between the five ICS licensed for use in adults and adolescents over the age of 12 years, at either low or high dose. On average, BDP products currently tend to be the cheapest ICS available and tend to remain so as the daily ICS dose required increases. There is evidence that the addition of a LABA to an ICS is potentially more clinically effective than doubling the dose of ICS alone, although consistent significant differences between the two treatment strategies are not observed for all outcome measures. The cost differences between combination therapy compared with ICS monotherapy are highly variable and dependent on the dose required and the particular preparations used. For the combination therapies of ICS/LABA there are potential cost savings with the use of combination inhalers compared with separate inhalers, with few differences between the two treatment strategies in terms of effects. The only exception to this cost saving is with BUD/FF at doses higher than 1200 microg/day, where separate inhaler devices can become equivalent to or cheaper than combination inhalers. Neither of the two combination inhalers (FP/SAL or BUD/FF) is consistently superior in terms of treatment effect. A comparison of the costs associated with each combination therapy indicates that at low dose FP/SAL delivered via a pMDI is currently the cheapest combination inhaler but only marginally cheaper than BUD/FF delivered as a DPI. At higher doses, both the FP/SAL combination inhalers (PMDI and DPI) are marginally cheaper than BUD/FF (DPI). Future trials of treatment for chronic asthma should standardise the way in which outcome measures are defined and measured, with a greater focus on patient-centred outcomes. For informing future cost-utility and cost-effectiveness analyses from a UK NHS perspective, there is a need for longitudinal studies that comprehensively track the care pathways followed when people experience asthma exacerbations of different severity. Further research synthesis, quantifying the adverse effects of the different ICS, is required for treatment choices by patients and clinicians to be fully informed.

Objectives: To assess the clinical and cost-effectiveness of inhaled corticosteroids (ICS) alone and ICS used in combination with a long-acting beta2 agonist (LABA) in the treatment of chronic asthma in children aged under 12 years., Data Sources: Major electronic bibliographic databases, e.g. MEDLINE and EMBASE, were searched up to February/March 2006 (and updated again in October 2006)., Review Methods: A systematic review of clinical and cost-effectiveness studies and economic analyses were carried out. A flexible framework was used to allow different types of economic analyses as appropriate, with either a cost comparison or cost-consequence comparison conducted., Results: Of 5175 records identified through systematic literature searching, 34 records describing 25 studies were included (16 were fully published randomised controlled trials, six were systematic reviews, and three were post-2004 conference abstracts). The most frequently reported relevant outcomes in the 16 RCTs were peak expiratory flow rate (13 trials), FEV1 (13 trials), symptoms (13 trials), adverse events or exacerbations (13 trials), use of rescue medication (12 trials), markers of adrenal function (e.g. blood or urine cortisol concentrations) (13 trials), height and/or growth rate (seven trials) and markers of bone metabolism (two trials). In the trials that compared low-dose ICS versus ICS and high-dose ICS versus ICS, no consistent significant differences or patterns in differential treatment effect among the outcomes were evident. Where differences were statistically significant at high doses, such as for lung function and growth, they favoured formoterol fumarate (FF), but this was generally in studies that did not compare the ICS at the accepted clinically equivalent doses. Differences between the drugs in impact on adrenal suppression were only significant in two studies. At doses of 200, 400 and 800 microg/day, beclometasone dipropionate (BDP) appears to be the current cheapest ICS product both with the inclusion and exclusion of chlorofluorocarbon (CFC)-propelled products. In the trials comparing ICS at a higher dose with ICS and LABA in combination, most outcomes favoured the combined inhaler. Only the combination inhaler, Seretide Evohaler, is slightly cheaper than the weighted mean cost of all types of ICS at increased dose except BDP 400 microg/day (including CFC-propelled products). Both the combination inhalers, Seretide Accuhaler and Symbicort Turbohaler, are more expensive than the weighted mean cost for all types of ICS at a two-fold increased dose. Compared with the lowest cost preparation for each ICS drug, all the combination inhalers are always more expensive than the ICS products at increased dose., Conclusions: The limited evidence available indicates that there are no consistent significant differences in effectiveness between the three ICS licensed for use in children at either low or high dose. BDP CFC-propelled products are often the cheapest ICS currently available at both low and high dose, and may remain so even when CFC-propelled products are excluded. Exclusion of CFC-propelled products increases the mean annual cost of all budesonide (BUD) and BDP, while the overall cost differences between the comparators diminish. There is very limited evidence available for the efficacy and safety of ICS and LABAs in children. From this limited evidence, there appear to be no significant clinical differences in effects between the use of a combination inhaler versus the same drugs in separate inhalers. There is a lack of evidence comparing ICS at a higher dose with ICS and LABA in combination and comparing the combination products with each other. In the absence of any evidence concerning the effectiveness of ICS at higher dose with ICS and LABA, a cost-consequence analysis gives mixed results. There are potential cost savings with the use of combination inhalers compared to separate inhalers. At present prices, the BUD/FF combination is more expensive than those containing FP/SAL, but it is not known whether there are clinically significant differences between them. A scoping review is required to assess the requirements for additional primary research on the clinical effectiveness of treatment for asthma in children under 5 years old. Such a review could also usefully include all treatment options, pharmacological and non-pharmacological, for asthma. A direct head-to-head trial that compares the two combination therapies of FP/SAL and BUD/FF is warranted, and it is important to assess whether the addition of a LABA to a lower dose of ICS could potentially be as effective as an increased dose of ICS alone, but also be steroid sparing. There is also a need for the long-term adverse events associated with ICS use to be assessed systematically. Future trials of treatment for chronic asthma in children should aim to standardise further the way in which outcome measures are defined. There should be a greater focus on patient-centred outcomes to provide a more meaningful estimation of the impact of treatment on asthma control. Methods of reporting also require standardisation.

Objective: Asthma is a major public health problem with considerable economic impact. The highest costs being observed in patients with severe asthma. Furthermore, despite the use of recommended therapies, asthma control can still be poor. Therefore, the objective of this study was to assess the extent of uncontrolled disease and associated medical costs in severe asthma., Methods: The PHARMO Record Linkage System includes among others drug dispensing and hospitalizations for > or = 2 million subjects in The Netherlands. Severe asthma patients used long-acting beta-agonists and inhaled corticosteroids for over 200 days and short-acting beta-agonists for at least 100 days in 2004. Severe uncontrolled asthma was defined as a hospitalization for asthma or use of multiple short courses of oral corticosteroids assessed in 2004. Reimbursed costs of asthma drugs and hospitalizations were calculated during this year. A matched nested-case control study was performed to identify treatment-related risk factors for uncontrolled disease. Information on clinical diagnosis of (severity of) asthma was not available., Results: About 17% of patients with severe asthma aged 12-49 years (N = 1158) showed lack of control. Excess drug costs for severe uncontrolled asthma with hospitalization mounted up to 700 Euro per patient per year and 300 Euro per patient per year for patients without hospitalization. Including hospital admission costs, excess costs mounted up to over 10,000 Euro per patient per year. Lack of control did not seem to be caused by under-treatment., Conclusion: Poor control of severe asthma leads to disproportionately increased direct costs compared to severe controlled asthma, especially when hospital admission is required.