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Inhaled salmeterol/fluticasone propionate combination

A pharmacoeconomic review of its use in the management of asthma

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Summary

Abstract

Asthma guidelines recommend an inhaled corticosteroid plus a long-acting inhaled β2-agonist (β2-adrenoceptor agonist) as the preferred maintenance therapy for moderate and severe persistent asthma. Advair®/Seretide® Diskus®, also registered as Accuhaler®, is fixed-dose salmeterol (a long-acting inhaled β2-agonist) and fluticasone propionate (a corticosteroid) administered via a single powder inhalation device.

The clinical effectiveness of salmeterol/fluticasone propionate in patients with persistent asthma symptoms has been established in comparative clinical trials. Pharmacoeconomic analyses, based on data from these clinical trials, have been conducted from a healthcare payer perspective in various countries. In patients with asthma not controlled with inhaled corticosteroids, salmeterol/fluticasone propionate was associated with more favourable (lower) cost-effectiveness ratios than fluticasone propionate monotherapy, oral montelukast plus inhaled fluticasone propionate, inhaled budesonide, and inhaled formoterol plus budesonide. As the initial maintenance therapy in patients with persistent asthma symptoms while receiving short-acting β2-agonists alone, salmeterol/fluticasone propionate was cost effective relative to montelukast monotherapy. Although the total cost of asthma management tended to be slightly higher with salmeterol/fluticasone propionate than with fluticasone propionate or montelukast monotherapy, salmeterol/fluticasone propionate consistently had a more favourable cost-effectiveness ratio in terms of per successfully treated week or symptom-free day and/or was associated with small incremental costs to achieve significant additional clinical benefits. In clinical practice, salmeterol plus fluticasone propionate was associated with lower asthma-related costs than treatment with other maintenance therapies.

In patients with asthma symptoms despite treatment with inhaled corticosteroids, salmeterol/fluticasone propionate produced clinically meaningful improvements in overall Asthma Quality of Life Questionnaire (AQLQ) scores relative to salmeterol or placebo monotherapy, in emotional function domain scores relative to fluticasone propionate or budesonide, and in asthma symptoms domain scores relative to budesonide. In patients with persistent asthma symptoms while receiving short-acting β2-agonists alone, salmeterol/fluticasone propionate produced clinically meaningful improvements in overall AQLQ scores compared with fluticasone propionate or montelukast.

Conclusions: Pharmacoeconomic analyses indicate that salmeterol/fluticasone propionate administered via a single inhaler represents a cost-effective treatment option (relative to fluticasone propionate at the same nominal dosage, budesonide, formoterol plus budesonide and montelukast plus fluticasone propionate) in patients with asthma not controlled with inhaled corticosteroid therapy. In patients with asthma not controlled with short-acting β2-agonists alone, salmeterol/fluticasone propionate is a cost effective treatment relative to monotherapy with montelukast. Importantly, salmeterol/fluticasone propionate is also associated with improvements in health-related quality of life.

Asthma

Asthma, a chronic inflammatory disease of the airways, is among the most common chronic diseases worldwide and is increasing in prevalence. Among affected adults, lung function declines over time to a greater extent, and mortality rates are somewhat higher, than in individuals without asthma.

Asthma places a considerable economic burden on affected individuals and society at large. Healthcare costs are approximately twice as high in patients with asthma than in similar patients without asthma. Prescription medications and hospitalisation are the largest contributors to direct healthcare costs; loss of work is the largest contributor to indirect healthcare costs.

The cost of treating asthma increases if the underlying disease is severe or poorly controlled. Exacerbations, which result from poor control, may require costly physician and emergency room visits and hospitalisation. The use of appropriate maintenance therapy, although initially increasing drug and physician-based costs, may subsequently reduce direct healthcare costs and indirect costs by improving asthma control.

The symptoms of asthma can impair the individual’s health-related QOL (HR-QOL), and many physical activities, along with emotional and social aspects of a patient’s life, may be limited by the disease.

A stepwise approach to treatment based on the underlying severity of asthma symptoms is recommended in recent global asthma treatment guidelines to control symptoms and maintain normal activity levels. Use of an inhaled corticosteroid plus a long-acting inhaled β2-agonist β2-adrenoceptor agonist) is the preferred controller therapy in patients with moderate and severe persistent asthma.

Clinical Profile of Inhaled Salmeterol/Fluticasone Propionate

The long-acting inhaled β2-agonist salmeterol and the corticosteroid fluticasone propionate are administered in a single powder Diskus® (Accuhaler®) inhalation device, hereafter referred to as salmeterol/fluticasone propionate. The combination appears to have complementary effects and targets both smooth muscle dysfunction and inflammation.

In randomised, double-blind, comparator-controlled, multicentre trials in patients with asthma that were used as the basis for pharmacoeconomic analyses, salmeterol/fluticasone propionate was at least as effective clinically as other combination asthma treatments.

Salmeterol/fluticasone propionate twice daily for 12 weeks was more effective in improving most measures of lung function and asthma symptom outcomes than monotherapy twice daily with its individual components at the same nominal dosage in patients with asthma symptoms despite existing treatment with inhaled corticosteroids, salmeterol or short-acting β2-agonists alone.

Salmeterol/fluticasone propionate 50/100 or 50/250μg twice daily was significantly more effective in improving morning peak expiratory flow than monotherapy with budesonide 400 or 800μg twice daily, and at least as effective as the long-acting inhaled β2-agonist formoterol 12μg plus budesonide 800μg twice daily administered via separate inhalers, in 12- or 24-week studies in patients with moderate-to-severe asthma not controlled with inhaled corticosteroids.

In 12-week clinical trials in patients with asthma despite previous treatment with inhaled corticosteroids or short-acting β2-agonists alone, salmeterol/fluticasone propionate 50/100μg twice daily was significantly more effective in improving lung function and increasing the number of asthma-free days than the leukotriene modifier montelukast 10 mg/day alone or in combination with inhaled fluticasone propionate 100μg twice daily. In patients with persistent asthma symptoms while receiving short-acting inhaled β2-agonists alone, salmeterol/fluticasone propionate also demonstrated greater improvements than montelukast in the proportion of symptom- and rescue β2-agonist-free days, and nights with no awakenings.

Salmeterol/fluticasone propionate 50/100μg twice daily was more effective than inhaled beclomethasone 1000μg twice daily as a step-down therapy after treatment with high-dose corticosteroids in a small trial.

In clinical practice, salmeterol/fluticasone propionate improved asthma control (as assessed by the frequency of prescription refills for short-acting inhaled β2-agonists in retrospective studies) and compliance relative to other asthma maintenance treatments.

The type and severity of adverse events associated with each component drug may be expected in patients receiving salmeterol/fluticasone propionate in a single inhaler. Headache, throat irritation, hoarseness and candidiasis were the most frequent (incidence of each ≤4%) drug-related adverse effects associated with salmeterol/fluticasone propionate. The majority of the adverse events were mild to moderate in severity.

Pharmacoeconomic Analyses of Salmeterol/Fluticasone Propionate

Several cost-effectiveness analyses have been conducted on salmeterol/fluticasone propionate from the perspective of a healthcare payer in various countries; many of these results are currently available only in the form of abstracts. These analyses incorporated key clinical effectiveness and, in most analyses, prospective resource-use data from 12- or 24-week randomised, double-blind clinical studies of salmeterol/fluticasone propionate versus other asthma therapies. Each economic analysis included only direct healthcare costs (e.g. those associated with drug acquisition, rescue medication, unscheduled resource utilisation related to asthma exacerbation or treatment-related adverse events) of asthma using costs specific to the country of the analysis.

Salmeterol/fluticasone propionate 50/100, 50/250 and 50/500μg twice daily was clinically more effective than the same nominal dosage of fluticasone propionate twice daily in patients with asthma symptoms despite receiving treatment with inhaled corticosteroids. In three separate Swedish cost-effectiveness analyses, salmeterol/fluticasone propionate 50/100, 50/250 and 50/500μg had more favourable (lower) cost-effectiveness ratios than the corresponding dosage of fluticasone propionate. In a UK analysis based on a Markov model, salmeterol/fluticasone propionate 50/100μg had a mean incremental cost of each additional successfully controlled week of £20.83 per week (2000 values) relative to fluticasone propionate 100μg, and a 1.4-fold higher proportion of successfully controlled weeks per patient. In a probabilistic sensitivity analysis, salmeterol/fluticasone propionate was the dominant (more effective and less costly) strategy in 25% of cases. If decision makers are willing to pay approximately £45 for an additional successfully controlled week, salmeterol/fluticasone propionate will be the more cost-effective strategy in this patient population for 80% of the time.

Treatment with salmeterol/fluticasone propionate was less costly than treatment with budesonide or formoterol plus budesonide in patients with asthma not controlled with previous corticosteroid therapy in separate analyses. In pharmacoeconomic analyses in Sweden, Germany, Singapore and the UK, salmeterol/fluticasone propionate 50/100 or 50/250μg twice daily was associated with more effective treatment and lower asthma management costs than budesonide 400 or 800μg twice daily. Although clinical efficacy outcomes were similar between salmeterol/fluticasone 50/250μg twice daily and formoterol/budesonide 12/400μg twice daily administered via a single inhalation device, salmeterol/fluticasone propionate was less costly in pharmacoeconomic analyses that used a Markov model in Spain, Sweden and the UK. Similarly, in cost minimisation analyses in Australia, Canada, Norway, Spain and the UK, the total daily treatment costs with salmeterol/fluticasone propionate 50/250μg were approximately 16–46% lower than with formoterol 12μg plus budesonide 800μg.

Separate analyses have shown that salmeterol/fluticasone propionate 50/100μg twice daily was more cost effective than montelukast 10 mg/day with or without concurrent fluticasone propionate 100μg twice daily in patients with asthma. Although higher costs were associated with salmeterol/fluticasone propionate treatment than with montelukast monotherapy, cost-effectiveness ratios were more favourable (lower cost per outcome) with salmeterol/fluticasone propionate as the initial maintenance therapy in patients with persistent asthma not controlled with short-acting β2-agonists alone in US analyses. Compared with montelukast monotherapy, salmeterol/fluticasone propionate costs an extra $US0.46–1.33/day for each additional successfully treated patient, and an extra $US0.73–1.69/day for an additional symptom-free day (year of costing 2001 or not reported). Sensitivity analyses did not change the overall inferences, indicating that the results were robust to assumptions used in the economic analyses. In an analysis in The Netherlands, salmeterol/fluticasone propionate was more effective and less costly per week than montelukast plus fluticasone propionate in patients with asthma symptoms despite previous therapy with inhaled corticosteroids.

These pharmacoeconomic analyses are limited by the difficulty in predicting long-term treatment effects from data from short-term clinical trials (e.g. clinical trials may not capture all asthma- and drug-related adverse events and healthcare utilisations, and the source population may differ from patients treated in the community). Other limitations of these analyses include the lack of sensitivity analysis results, the lack of a common outcome measure, and the inclusion of only direct healthcare costs.

From the perspective of the French healthcare payer in 2000, the introduction of salmeterol/fluticasone propionate for the management of persistent asthma would be cost effective and affordable according to a budget impact model. Assuming 100% treatment compliance, total annual cost savings of €2.7 million and €1.9 million would result if 100% of patients were switched to salmeterol/fluticasone propionate from salmeterol plus fluticasone propionate or from formoterol plus budesonide. These changes in treatment equate to an additional 4067 and 2939 patients receiving salmeterol/fluticasone propionate for the same budget.

In patients with asthma enrolled in US managed-care plans, treatment with salmeterol plus fluticasone propionate was less costly than treatment with an inhaled corticosteroid plus another maintenance medication (e.g. another inhaled corticosteroid plus salmeterol or an inhaled corticosteroid plus an oral leukotriene modifier) in retrospective studies that considered only direct healthcare costs.

QOL Assessments

The achievement of asthma control is related to improvements in HR-QOL. Overall and individual Asthma Quality of Life Questionnaire (AQLQ) domain scores (symptoms, emotional function, activity limitation and environmental stimuli) were assessed in some of the clinical trials of salmeterol/fluticasone propionate in patients with persistent asthma. A change ≥ 0.5 points in overall or domain scores is considered clinically meaningful.

Overall and individual AQLQ domain scores improved from baseline to a clinically meaningful extent with salmeterol/fluticasone 50/100 and 50/250€g twice daily in patients with asthma symptoms despite previous treatment with inhaled corticosteroids or short-acting β2-agonists alone.

In addition, in patients with asthma symptoms not controlled with short-acting β2-agonists alone, clinically meaningful and statistically significant improvements in overall AQLQ scores were shown with salmeterol/fluticasone propionate 50/100μg twice daily compared with monotherapy with fluticasone propionate 100μg twice daily or montelukast 10mg once daily. All between-group differences in individual AQLQ domain scores for salmeterol/fluticasone propionate versus montelukast were statistically significant and, with the exception of activity limitation in both trials and environmental exposure in one trial, clinically meaningful in favour of salmeterol/fluticasone propionate.

Moreover, in patients with asthma symptoms despite receiving inhaled corticosteroids, overall AQLQ scores improved by a statistically significantly greater extent with salmeterol/fluticasone propionate than with twice-daily monotherapy with its individual components, placebo or budesonide 800μg. Clinically meaningful changes from baseline in overall and AQLQ domain scores were shown with salmeterol/fluticasone propionate compared with salmeterol monotherapy or placebo, in emotional function compared with fluticasone propionate 100 or 250μg monotherapy, and in emotional function and asthma symptoms compared with budesonide.

The majority (68%) of 3603 patients with asthma in an observational study showed clinically meaningful improvements from baseline in overall AQLQ score after receiving salmeterol/fluticasone propionate 50/250μg twice daily for 8 weeks. According to this study, 1.5 patients needed to be treated with salmeterol/fluticasone propionate in order for one patient to demonstrate a ≥0.5 point improvement in AQLQ score.

As a corticosteroid step-down therapy, salmeterol/fluticasone maintained the improvements in HR-QOL achieved with high-dose inhaled corticosteroid therapy. In contrast, patients receiving beclomethasone 200μg twice daily lost some of these improvements.

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    Katherine A. Lyseng-Williamson & Greg L. Plosker

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Lyseng-Williamson, K.A., Plosker, G.L. Inhaled salmeterol/fluticasone propionate combination. Pharmacoeconomic 21, 951–989 (2003). https://doi.org/10.2165/00019053-200321130-00004

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