Risk of asthma exacerbation, asthma-related health care utilization and costs, and adherence to controller therapy in patients with asthma receiving fluticasone propionate/salmeterol inhalation powder 100 µg/50 µg versus mometasone furoate inhalation powder.

OBJECTIVE: National asthma treatment guidelines recommend low/medium-dose inhaled corticosteroids (ICSs) as initial therapy in mild asthma patients. However, low doses of a fixed-dose combination of ICS and long-acting ß-agonists are sometimes used. This study compares asthma-related outcomes and health care utilization and costs in clinical practice in patients starting fluticasone propionate 100 µg and salmeterol 50 µg via Diskus (FSC) or mometasone furoate (MF). METHODS: A retrospective cohort study was conducted to compare asthma-related outcomes in asthma patients who received FSC or MF, using a large health insurance claims dataset spanning January 2004-December 2008. Patients with ≥1 claim with an asthma ICD-9-CM diagnosis code and ≥2 FSC or MF prescriptions were included, stratified into FSC or MF groups by study drug received first and matched using propensity score. RESULTS: A total of 18,283 patients met inclusion criteria (14,044 FSC and 4239 MF); 3799 matched pairs were identified (mean follow-up: FSC 548 days, MF 537 days). FSC patients had lower risk of asthma-related exacerbation (Hazard ratio = 0.88, 95% CI 0.81-0.95, p = .002), defined as either asthma-related emergency department (ED) visits/hospitalizations or receipt of systemic corticosteroids (SCSs); fewer SCS claims (mean 0.28 vs. 0.33, p = .021); and fewer asthma-related physician office (PO) and hospital outpatient (HO) visits (mean 1.17 vs. 1.63, p < .001). However, asthma-related ED visits were higher with FSC (p = .004), and FSC patients had higher total costs of asthma-related health care ($953 vs. $862, p = .002). CONCLUSIONS: In asthma patients initiating ICS therapy, MF had lower asthma-related ED visits. However, FSC may reduce the use of SCS and asthma-related PO/HO visits.

Economic prescribing of corticosteroid nasal sprays in Germany: comparison of mometasone and budesonide nasal sprays on the basis of the DDD, the PDD and reference prices.

AIM: According to the German Social Security Code (SGB V), drugs should be prescribed on a cost-effective basis. An attempt is made to achieve this in Germany with the help of the DDD system and reference prices. Taking the example of the most frequently prescribed corticosteroid nasal sprays containing the active substances budesonide (BNS) or mometasone (MNS), we will show here that the DDD system is not necessarily suitable for tapping economic reserves. Despite the pharmacologic differences between the two substances, a uniformly defined daily dose (DDD) is assumed for both. Moreover, since 2006 they have formed a reference-price group of nasally administered medication with other active substances. Products were compared with regard to potential differences in patient populations and resulting treatment costs. The extent to which the two instruments are suitable for tapping economic reserves were estimated. METHODS: We analyzed longitudinal diagnostic and prescription data in the IMS® Disease Analyzer Database from the period 2006 to July 2010. RESULTS: In total we analyzed data from 16,163 MNS and 4,218 BNS patients from GP practices plus 11,103 MNS and 2,521 BNS patients from ENT practices. The average quantity prescribed per patient differed in favor of MNS by -111.5 (for first prescriptions) to -260.1 puffs (after 730 days) in GP practices and by -137.3 to -488.3 puffs in ENT practices (p < 0.001). The mean calculated treatment cost per year from the point of view of the statutory health insurer was 20.40 € (GP practices) and 30.50 € (ENT practices) for MNS compared to 22.40 € (GP practices) and 32.10 € (ENT practices) for BNS. Based on the price level after the 2011 referenceprice adjustment, the treatment costs are 16.40 € (GP practices) and 24.20 € (ENT practices) for MNS versus 21.20 € (GP practices) and 32.30 € (ENT practices) for BNS. CONCLUSION: The volumes of MNS actually prescribed are significantly lower than those of BNS in the compared patient populations. Based on the actual consumption of the substances, there is no treatment-cost advantage for BNS in comparison to MNS from the statutory health insurer's point of view. By contrast, the reference-price adjustment results in a greater reduction of treatment costs for mometasone, so that in this case the statutory health insurer is able to tap economic reserves. Both the comparative parameters used for calculating the reference price and the DDD system are only conditionally suitable for tapping economic reserves for drugs.

Cost-utility analysis of topical intranasal steroids for otitis media with effusion based on evidence from the GNOME trial.

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.

Mometasone furoate vs fluticasone propionate with salmeterol: multivariate analysis of resource use and asthma-related charges.

OBJECTIVE: Although current National Asthma Education and Prevention Program (NAEPP) guidelines indicate low-dose inhaled corticosteroid (ICS) monotherapy as the preferred treatment for patients with mild persistent asthma, many patients receive ICS and long-acting beta(2)-agonist (LABA) combinations. The objective of the current study was to evaluate asthma-related charges in patients with mild asthma who began treatment with mometasone furoate (MF) versus those who began treatment with a fluticasone propionate/salmeterol (FPS) combination. RESEARCH DESIGN AND METHODS: This retrospective administrative claims database analysis collected data from the 365-day periods before (preindex period) and after (postindex period) the study index date from patients with mild asthma aged 12 to 65 years who began treatment with MF or FPS. Asthma-related inpatient, outpatient, pharmaceutical, and total charges; exacerbations; short-acting beta(2)-agonist (SABA) canister claims; and adherence to therapy were assessed. Matched cohorts of MF and FPS patients were compared using multivariate generalized linear regression models. RESULTS: Among matched MF (n = 4094) and FPS (n = 4094) cohorts, MF patients had significantly lower postindex asthma-related total charges ($2136 vs $2315, respectively; P = 0.0003), lower pharmaceutical charges ($727 vs $925, respectively; P < 0.0001), fewer exacerbations (0.14 vs 0.16, respectively; P = 0.0306), fewer SABA canister claims (0.9 vs 1.0, respectively; P < 0.0001), and greater adherence measured by prescription fills (3.0 vs 2.8, respectively; P < 0.0001). Asthma-related inpatient charges, outpatient charges, and adherence measured by percent of days covered were not significantly different between treatment cohorts. Limitations included a lack of additional ICS and ICS/LABA therapies, a lack of pediatric patients, and the general limitations associated with retrospective database analyses (e.g., no patient records). CONCLUSIONS: These data suggest that MF may be more cost-effective than FPS for the treatment of mild asthma. To effectively and efficiently manage asthma, it is important for clinicians to follow current NAEPP guidelines, which indicate ICS monotherapy as preferred treatment for mild persistent asthma.

Immunotherapy for patients with persistent allergic rhinitis unsatisfied with free chronic pharmacotherapy.

BACKGROUND: Chronic pharmacotherapy is recommended to patients with persistent moderate-severe (PM-S) allergic rhinitis (AR). The cost of pharmacotherapy is the main barrier to achieve symptoms control. AIMS OF THE STUDY: To determine the benefits of mite subcutaneous immunotherapy (SIT) in patients with PM-S AR not satisfied with chronic pharmacotherapy received free of charge. METHODS: Open study with seven (7) patients with PM-S AR not satisfied with chronic pharmacotherapy. Prior to enrollment patients had received monthly for more than five months and free of charge, optimal pharmacotherapy. We compared, off pharmacotherapy, symptoms and quality of life (QOL) before and during SIT. RESULTS: Mite SIT improved nasal symptoms, non nasal symptoms and QOL. Off pharmacotherapy patients reported adequate control of symptoms and were satisfied. CONCLUSIONS: Not all patients with PM-S AR are satisfied with chronic pharmacotherapy, even if medication is received free of charge. SIT control symptoms and satisfies patients with PM-S AR unsatisfied with free chronic pharmacotherapy.

Efficacy, cost-effectiveness, and tolerability of mometasone furoate, levocabastine, and disodium cromoglycate nasal sprays in the treatment of seasonal allergic rhinitis.

BACKGROUND: Current guidelines recommend intranasal glucocorticosteroids as first-line therapy for seasonal allergic rhinitis. OBJECTIVE: To compare the efficacy, cost-effectiveness, and tolerability of the topical glucocorticosteroid mometasone furoate, the topical antihistamine levocabastine hydrochloride, and the cromone disodium cromoglycate in seasonal allergic rhinitis. METHODS: This study was performed during the 2003 grass pollen season as an open, randomized, parallel-group, single-center study of 123 patients assigned to receive mometasone furoate (200 microg once daily), levocabastine hydrochloride (200 microg twice daily), or disodium cromoglycate (5.6 mg 4 times daily). Symptom scores and nasal inspiratory peak flow measurements were recorded in a patient diary. The global efficacy of the study medication was evaluated by patients after treatment. Eosinophil cationic protein concentrations were measured in nasal secretions before and after treatment. Cost-effectiveness was evaluated as medication cost per treatment success. RESULTS: Mometasone furoate therapy was significantly superior to the use of levocabastine or disodium cromoglycate with respect to all nasal symptoms, the global evaluation of efficacy, and eosinophil cationic protein concentration. Furthermore, mometasone furoate therapy was significantly superior to disodium cromoglycate therapy with respect to nasal inspiratory peak flow. Medication cost per treatment success was lowest with mometasone furoate use and highest with levocabastine use. CONCLUSION: This is the first study to compare mometasone furoate nasal spray with nonsteroidal topical treatments for seasonal allergic rhinitis. Mometasone furoate nasal spray was confirmed as a first-choice topical treatment option for seasonal allergic rhinitis.