OBJECTIVE: To evaluate efficacy and cost-effectiveness of budesonide/formoterol (Symbicort) maintenance (one dose once or twice daily) plus additional doses as needed (Symbicort Maintenance And Reliever Therapy, SMART) compared with a higher fixed dose of budesonide/formoterol with formoterol as needed in patients with persistent asthma.
STUDY DESIGN AND METHODS: 6-month, open, randomised study of 465 patients either not well controlled on an inhaled corticosteroid (ICS), or well controlled on a combination of ICS and a long-acting beta(2)-agonist (LABA).
TREATMENTS: budesonide/formoterol 160/4.5 microg, one inhalation, once or twice daily maintenance plus additional doses as-needed (1 x SMART or 2 x SMART), or budesonide/formoterol 160/4.5 microg two inhalations twice daily plus formoterol 4.5 microg as needed (2 x 2 FIX + F). Children 6-11 years old used an 80/4.5 microg dose strength. Primary variables of efficacy were the changes in the Asthma Control Questionnaire (ACQ(5)) and morning peak expiratory flow (PEF).
RESULTS: Mean age of patients 40 years (range 6-82 years); 53% female. No differences between the groups were found in ACQ(5) scores or asthma exacerbation rates. Morning PEF was higher in the 2 x 2 FIX + F group vs. the 1 x SMART and 2 x SMART groups (differences 13 L/min and 9 L/min, respectively; p < 0.002). The 1 x SMART group showed a significant decrease in asthma controlled days compared with the two other groups. No difference was seen between the 2 x SMART group and the 2 x 2 FIX + F group. Treatment costs were significantly lower in the SMART groups compared with the 2 x 2 FIX + F group.
CONCLUSION: Compared with the 2 x 2 FIX + F treatment the use of budesonide/formoterol was 30-40% lower in the SMART groups while maintaining equal ACQ(5) scores. Daily asthma control improved equally with 2 x SMART compared to 2 x 2 FIX + F with a reduction in asthma medication cost. The one dose once daily maintenance treatment (1 x SMART) resulted in a low level of treatment failure (exacerbations) but led to more days with symptoms. Therefore, a daily dose of two inhalations seems to be the lowest appropriate dose in patients with moderate persistent asthma.
OBJECTIVES: To compare the costs and effectiveness of adjustable maintenance dosing with budesonide/formoterol in a single inhaler versus fixed dosing in adults with asthma.
METHODS: In this prospective, randomised, open-label, parallel-group, multicentre trial conducted in Germany, patients with asthma received budesonide/formoterol 160 microg/4.5 microg in a single inhaler (Symbicort Turbuhaler with two inhalations twice daily for a 4-week run-in period. Patients were then randomised to either adjustable maintenance dosing (one inhalation twice daily, stepping up to four inhalations twice daily for 1 week if asthma worsened; n=1679) or fixed dosing (two inhalations twice daily; n=1618) for 12 weeks. The primary efficacy variable was the change in health-related quality of life (HR-QOL), measured using the Asthma Quality of Life Questionnaire (standardised) during the randomised treatment period. Resource utilisation data were collected in parallel and combined with German unit costs to estimate direct and indirect costs (year 2001 values).
RESULTS: Both treatment regimens were equally effective in maintaining HR-QOL and asthma control during the randomised treatment period. However, overall, patients in the adjustable maintenance dosing group took fewer daily inhalations of budesonide/formoterol than those in the fixed-dosing group (mean: 2.63 vs 3.82 inhalations; p<0.001). Adjustable maintenance dosing was associated with significantly lower asthma-related direct costs compared with fixed dosing (mean: 221 euro vs 292 euro; p<0.001). This pattern was maintained when patients were stratified into those with peak expiratory flow (PEF) of 60% to <80% predicted normal and those with PEF of>/=80% predicted normal and when total costs were considered.
CONCLUSION: Adjustable maintenance dosing with budesonide/formoterol in a single inhaler maintained HR-QOL in adult patients with asthma at a significantly lower cost than fixed dosing.
BACKGROUND: The severity of asthma varies between individuals and over time. As a result individuals may have marked variation in their need for asthma treatment. Adjustable dosing enables patients to assume greater involvement in managing their own condition.
OBJECTIVE: To compare the costs and effectiveness of fixed dosing of budesonide/formoterol (Symbicort Turbohaler) with adjustable maintenance dosing.
METHODS: A cost-effectiveness analysis was conducted from the perspective of the UK NHS. Adults with established asthma currently maintained on > or =400 microg per day inhaled corticosteroid were enrolled in 365 primary care centres in the UK. Patients were run-in on 2 inhalations twice daily of budesonide/formoterol 80/4.5 microg or budesonide/formoterol 160/4.5 microg (depending on steroid requirement) for 4 weeks and were then randomised to the Symbicort adjustable maintenance dosing plan (SAMD) (n = 782; budesonide/formoterol 1-4 inhalations twice daily depending on symptoms) or Symbicort fixed dosing (n = 771; 2 inhalations twice daily) for a further 12 weeks. The primary effectiveness variable was clinically meaningful change in quality of life (QoL) assessed by the miniasthma quality of life questionnaire (AQLQ). Secondary effectiveness measures included symptom-free days with no short-acting beta-agonist use. We assessed the costs of study medication, asthma-related concomitant medication, primary care and hospital contacts. Confidence intervals were generated by nonparametric boot-strapping.
RESULTS: Clinically meaningful improvement in QoL during the first 4 weeks was reported by 40.8% of enrolled patients. During the following 12 weeks, a net 1% (95% CI: -4%, 6%) of SAMD patients and 6% (95% CI: 1%, 10%) of fixed dosing patients reported further improvement. Effectiveness parameters did not differ significantly between groups during the study period. Mean daily cost per patient was pound sterling 1.13 (95% CI: pound sterling 1.08, pound sterling 1.18) in the SAMD group and pound sterling 1.31 (95% CI: pound sterling 1.27, pound sterling 1.34) in the fixed dosing. The difference in mean daily cost resulted in an annual per patient cost difference of pound sterling 65.70. Adjustable maintenance dosing with budesonide/formoterol provided equivalent QoL to fixed dosing at significantly lower cost.
BACKGROUND: Inhaled corticosteroids are the most effective class of anti-inflammatory agents and are recommended for patients with persistent asthma.
OBJECTIVE: To compare the effectiveness of (1) fluticasone propionate, 100 microg, and salmeterol, 50 microg; (2) fluticasone propionate, 100 microg; and (3) montelukast, 10 mg, as first-line maintenance treatment for persistent asthma.
METHODS: Combined analysis of 4 clinical trials, 2 that compared fluticasone propionate-salmeterol with montelukast and 2 that compared fluticasone propionate with montelukast as initial asthma therapy.
RESULTS: The 4 studies had a total of 1,910 patients 15 years or older with symptomatic asthma previously treated with inhaled short-acting beta2-agonists alone. At the end point, there were significantly greater increases in forced expiratory volume in 1 second with fluticasone propionate-salmeterol (0.57 L; P < or = .004) vs fluticasone propionate (0.48 L) and montelukast (0.31 L) and significantly greater increases in morning peak expiratory flow rate (84.9 L/min; P < .001) vs fluticasone propionate (56.0 L/min) and montelukast (36.1 L/min). Fluticasone propionate-salmeterol significantly increased the percentage of symptom- and rescue-free days and significantly reduced albuterol use vs fluticasone propionate and montelukast (P < or = .04 for both). Patients treated with fluticasone propionate and montelukast had 2.6 and 3.6 greater risk, respectively, of having an asthma-related exacerbation vs fluticasone propionate-salmeterol users. In addition, mean daily exacerbation costs per treated patient were dollars 0.41 for fluticasone propionate-salmeterol, dollars 4.60 for fluticasone propionate, and dollars 7.57 for montelukast, whereas mean daily costs per patient exacerbation for fluticasone propionate-salmeterol, fluticasone propionate, and montelukast were dollars 29, dollars 128, and dollars 154, respectively.
CONCLUSIONS: Patients with symptomatic asthma previously treated with short-acting beta2-agonists only who require maintenance therapy are likely to have greater clinical benefits, lower risk of an asthma exacerbation, and reduced exacerbation-related costs when initiating therapy with fluticasone propionate-salmeterol vs fluticasone propionate or montelukast.
BACKGROUND: Omalizumab can reduce hospitalization and emergency department visits and improve quality of life in patients with moderate-to-severe, suboptimally controlled allergic asthma. Given the high cost and modest efficacy of this agent, it is not clear that it is cost-effective if given to a broad population with asthma.
OBJECTIVE: The purpose of this study was to evaluate the cost-effectiveness of omalizumab in adults and adolescents with moderate-to-severe allergic asthma.
METHODS: A retrospective economic analysis was performed to determine the cost-effectiveness of omalizumab using 52-week data from 2 randomized controlled clinical trials in adults and adolescents with moderate-to-severe allergic asthma. The analysis was conducted from a third-party payer's perspective, and only direct costs were considered.
RESULTS: The incremental cost-effectiveness ratios showed that the cost to achieve an additional successfully controlled day was $523, and the daily cost to achieve at least a 0.5-point increase in Asthma Quality of Life Questionnaire score was $378 in 2003 dollars.
CONCLUSION: From a pharmacoeconomic standpoint, omalizumab would be better used in allergic asthmatic patients with poorly controlled symptoms despite maximal therapy, given the high cost and modest efficacy of this agent. It could be cost saving if given to nonsmoking patients who are hospitalized 5 or more times or 20 days or longer per year despite maximal asthma therapy.
STUDY OBJECTIVES: To compare clinical efficacy, patient outcomes, and medical costs in hospitalized patients treated with levalbuterol to those treated with racemic albuterol.
DESIGN: Retrospective chart review.
SETTING: A 180-bed community hospital.
PATIENTS: Patients admitted to Halifax Regional Hospital with a diagnosis code for COPD or asthma from July 1 to December 31, 1998, and from July 1 to December 31, 1999, were eligible. In 1998, 125 patients were treated with nebulized racemic albuterol (2.5 mg q4h). In 1999, 109 patients were treated with levalbuterol (1.25 mg q8h).
MEASUREMENTS AND RESULTS: Clinical efficacy was evaluated by the number of nebulizer treatments, improvement in symptoms and objective clinical findings, the length of hospital stay, and hospital discharge disposition. Medication and total hospital costs were calculated based on Red Book listings and Medicare reimbursement rates. Levalbuterol-treated patients required significantly fewer treatments with beta-agonists (mean [+/- SD] number of treatments, 19.0 +/- 12.7 vs 30.8 +/- 24.0; p < 0.001) and ipratropium bromide (mean number of treatments, 9.4 +/- 11.5 vs 23.2 +/- 25.1; p < 0.001) than did racemic albuterol-treated patients. The mean length of hospital stay in the levalbuterol group was almost 1 day less than that in the racemic albuterol group (4.7 +/- 2.9 vs 5.6 +/- 4.2 days, respectively; p < 0.058). Significantly more patients were readmitted to the hospital within 30 days in the racemic albuterol group compared with the levalbuterol group (16.4% vs 5.7%, respectively; p = 0.01). The mean total cost of nebulizer therapy was significantly greater for patients receiving racemic albuterol than for those receiving for levalbuterol ($112 +/- 101 vs $61 +/- 43, respectively; p < 0.001). The mean total hospital costs per patient were less for levalbuterol compared with racemic albuterol ($2756 +/- 2079 vs $3225 +/- 2714, respectively; p = 0.11). Regression analysis controlling for diagnosis, baseline FEV(1), and ipratropium use indicated that levalbuterol was associated with a length-of-stay savings of 0.91 days (p = 0.015), a total cost savings of $556 (p = 0.013), and a decrease in the likelihood of hospital readmission of 67% (p = 0.056).
CONCLUSION: Compared with patients treated with racemic albuterol, those treated with levalbuterol required less medication, had shorter lengths of hospital stay, had decreased costs for nebulizer therapy and hospitalization, and appeared to have a more prolonged therapeutic benefit. These findings support using levalbuterol as first-line therapy for hospitalized adults with COPD or asthma.
BACKGROUND: The Inhaled Steroid as Regular Therapy in Early Asthma (START) study reported that early intervention with budesonide in mild persistent asthma reduces severe asthmatic events and improves symptom outcomes and lung function in adults and children.
OBJECTIVE: We sought to estimate the incremental cost-effectiveness of early intervention with budesonide, as observed within the START study.
METHODS: START was a randomized, 3-year controlled trial of budesonide in early onset mild asthma among 7165 subjects ages 5 to 66 years. Three age groups (5-10, 11-17, and >or=18 years) were studied separately and overall. Differences in the probability of emergency treatments, symptom-free days (SFDs), and costs of health care were determined. Incremental cost-effectiveness ratios were estimated from the health care payer and societal perspectives.
RESULTS: Compared with usual therapy, patients receiving budesonide experienced an average of 14.1 (SE, 1.3) more SFDs per year (P <.001), fewer hospital days (69%, P <.001), and fewer emergency department visits (67%, P <.05). From the health care payer perspective, the net cost of early use of budesonide was an additional US dollars 0.42 (SE, dollars 0.04) per day, and the resultant cost-effectiveness ratio was US dollars 11.30 (95% CI, US dollars 8.60-US dollars 14.90) per SFD gained. From the societal perspective, the cost offsets of lower absence from school or work reduced the net cost of early budesonide to US dollars 0.14 (SE, US dollars 0.07) per day and decreased the cost-effectiveness ratio to US dollars 3.70 (95% CI, US dollars 0.10-US dollars 8.00). Early intervention was more effective and cost saving in the youngest age group.
CONCLUSION: Long-term treatment with budesonide appears to be cost-effective in patients with mild persistent asthma of recent onset.
OBJECTIVE: To determine whether levalbuterol resulted in fewer hospital admissions than racemic albuterol when used for treatment of acute asthma. Study design A randomized, double-blind, controlled trial was conducted in the emergency department (ED) and inpatient asthma care unit of an urban tertiary children's hospital. Children age 1 to 18 years (n=482) provided a total of 547 enrollments. Patients received a nebulized solution of either 2.5 mg racemic albuterol or 1.25 mg levalbuterol every 20 minutes (maximum six doses). Patients admitted to the asthma care unit were treated in a standardized fashion by using the same blinded drug assigned in the ED. Hospitalization rate was the primary outcome.
RESULTS: Hospitalization rate was significantly lower in the levalbuterol group (36%) than in the racemic albuterol group (45 %, P=.02). The adjusted relative risk of admission in the racemic group compared with the levalbuterol group was 1.25 (95% confidence interval, 1.01-1.57). Hospital length of stay was not significantly shorter in the levalbuterol group (levalbuterol, 44.9 hours; racemic albuterol, 50.3 hours; P=.63). No significant adverse events occurred in either group.
CONCLUSIONS: Substituting levalbuterol for racemic albuterol in the ED management of acute asthma significantly reduced the number of hospitalizations.
