Manufacturer Revenue on Inhalers After Expiration of Primary Patents, 2000-2021.

This study quantifies the revenue earned on all brand-name inhalers approved by the US Food and Drug Administration from 2000 to 2021 and compared earnings before and after expiration of primary patents on these products.

Cost-utility of as-needed ICS-formoterol versus to maintenance ICS in mild to moderate persistent asthma.

BACKGROUND: Recent asthma guidelines, such as the Global Initiative for Asthma (GINA), recommend in adult patients as-needed inhaled corticosteroids (ICS)-formoterol as an alternative to maintenance ICS in mild to moderate persistent asthma. The introduction of these recommendations concerns whether using as-needed budesonide-formoterol would be more cost-effective than to maintenance ICS. This study aimed to evaluate the cost-effectiveness of as-needed combination low-dose budesonide-formoterol compared to short-acting ß2-agonist (SABA) reliever therapy in patients with mild asthma. METHODS: A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with mild asthma in Colombia. Total costs and QALYs of low-dose budesonide-formoterol compared to short-acting ß2-agonist (SABA) were calculated over a lifetime horizon. Multiple sensitivity analyses were conducted. Cost-effectiveness was evaluated at a willingness-to-pay value of $19,000. RESULTS: The model suggests a potential gain of 0.37 QALYs and per patient per year on as-needed ICS-formoterol and a reduction in the discounted cost per person-year, of as-needed ICS-formoterol to maintenance ICS, of US$40. This position of dominance of as-needed ICS-formoterol negates the need to calculate an incremental cost-effectiveness ratio. In the deterministic and probabilistic sensitivity analysis, our base-case results were robust to variations in all assumptions and parameters. CONCLUSION: Low-dose budesonide-formoterol as a reliever was cost-effective when added to usual care in patients with mild asthma. Our study provides evidence that should be used by decision-makers to improve clinical practice guidelines and should be replicated to validate their results in other middle-income countries.

Trends in Medicaid spending on inhalers in the United States, 2012-2018.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) and asthma are common respiratory diseases that impose a significant economic burden on Medicaid. Inhalers are the mainstay treatment for relieving symptoms and improving outcomes for COPD and asthma patients. OBJECTIVE: To describe the total spending and trends of Medicaid expenditures on inhalers between 2012 and 2018 in the United States. METHODS: We analyzed the deidentified data from the Medicaid Drug Spending Dashboard and utilization datasets from 2012 to 2018. We identified 9 classes of inhalers and described the Medicaid total spending on and relative annual changes for those inhalers. We also described the spending on available generic inhalers and compared the Medicaid spending by manufacturers during this time frame. RESULTS: Medicaid spent $26.2 billion on inhalers from 2012 to 2018. This spending increased by $2.5 billion (120%) over this time frame. During this specified period, the highest Medicaid spending was on the group of inhaled corticosteroid (ICS)-containing inhalers ($14.9 billion). Within this group, the inhaler class of ICS/long-acting beta-2 adrenoceptor agonists contributed to the highest Medicaid spending (53%), with a growth of 607% between 2012 and 2018. Of the $26.2 billion that Medicaid spent on inhalers, $35.5 million (less than 0.01%) was spent on 2 generic inhalers: fluticasone propionate with salmeterol and levalbuterol tartrate hydrofluoroalkane. CONCLUSIONS: Between 2012 and 2018, on average, $3.5 billion per year was spent by Medicaid on inhalers. Decreasing the price of inhalers by introducing more generic inhalers in the market can potentially reduce the cost burden on Medicaid. DISCLOSURES: This study was funded by the American Foundation for Pharmaceutical Education (AFPE). The funders had no role in study design, data collection, and analysis, decision to publish, or preparation of the manuscript. The authors declare no conflicts of interest.

Controller Medication Use and Exacerbations for Children and Adults With Asthma in High-Deductible Health Plans.

Importance: High-deductible health plans (HDHPs) are increasingly common and associated with decreased medication use in some adult populations. How children are affected is less certain. Objective: To examine the association between HDHP enrollment and asthma controller medication use and exacerbations. Design, Setting, and Participants: For this longitudinal cohort study with a difference-in-differences design, data were obtained from a large, national, commercial (and Medicare Advantage) administrative claims database between January 1, 2002, and December 31, 2014. Children aged 4 to 17 years and adults aged 18 to 64 years with persistent asthma who switched from traditional plans to HDHPs or remained in traditional plans (control group) by employer choice during a 24-month period were identified. A coarsened exact matching technique was used to balance the groups on characteristics including employer and enrollee propensity to have HDHPs. In most HDHPs, asthma medications were exempt from the deductible and subject to copayments. Statistical analyses were conducted from August 13, 2019, to January 19, 2021. Exposure: Employer-mandated HDHP transition. Main Outcomes and Measures: Thirty-day fill rates and adherence (based on proportion of days covered [PDC]) were measured for asthma controller medications (inhaled corticosteroid [ICS], leukotriene inhibitors, and ICS long-acting ß-agonists [ICS-LABAs]). Asthma exacerbations were measured by rates of oral corticosteroid bursts and asthma-related emergency department visits among controller medication users. Results: The HDHP group included 7275 children (mean [SD] age, 10.8 [3.3] years; 4402 boys [60.5%]; and 5172 non-Hispanic White children [71.1%]) and 17 614 adults (mean [SD] age, 41.1 [13.4] years; 10 464 women [59.4%]; and 12 548 non-Hispanic White adults [71.2%]). The matched control group included 45 549 children and 114 141 adults. Compared with controls, children switching to HDHPs experienced significant absolute decreases in annual 30-day fills only for ICS-LABA medications (absolute change, -0.04; 95% CI, -0.07 to -0.01). Adults switching to HDHPs did not have significant reductions in 30-day fills for any controllers. There were no statistically significant differences in PDC, oral steroid bursts, or asthma-related emergency department visits for children or adults. For the 9.9% of HDHP enrollees with health savings account-eligible HDHPs that subjected medications to the deductible, there was a significant absolute decrease in PDC for ICS-LABA compared with controls (-4.8%; 95% CI, -7.7% to -1.9%). Conclusions and Relevance: This cohort study found that in a population where medications were exempt from the deductible for most enrollees, HDHP enrollment was associated with minimal or no reductions in controller medication use for children and adults and no change in asthma exacerbations. These findings suggest a potential benefit from exempting asthma medications from the deductible in HDHPs.

Availability of substances for use in personal vaporisers on three online cryptomarkets.

BACKGROUND: Personal vaporisers are gaining popularity as an alternative route of administration for a range of substances. Online cryptomarkets are becoming increasingly popular among people who use substances due to their perceived anonymity, ease of use, and reduced risk of violence compared to traditional face-to-face dealers. We examined the diversity of substances marketed for use in a personal vaporiser on these marketplaces. METHODS: Vaping related listings were extracted from three online cryptomarkets ('Agartha', 'Cryptonia', and 'Tochka') using The Onion Router browser. Data collection occurred between October and November 2019. RESULTS: We identified 1929 listings from 201 unique sellers. The top product on Agartha, Cryptonia, and Tochka were vape cartridges prefilled with the e-liquid (70.4 %, 39.4 %, 52.3 % respectively). The most common substance in these products was cannabis oil (96.1 %, 82.1 %, 87.8 %), followed by synthetic cannabinoids (3.7 %, 9.7 %, 9.8 %) and psychedelic substances (0.2 %, 6.4 %, 1.2 %). Vendors were primarily from the USA. Many products offered worldwide shipping (96.3 %, 42.4 %, 51.2 %). CONCLUSION: Vaping products listed on online cryptomarkets in 2019 primarily contained cannabis oils. Future studies should continue to examine cryptomarkets to identify emerging trends of substances that can be used in personal vaporisers.

An Efficient and Cost-Effective Nose-Only Inhalational Chamber for Rodents: Design, Optimization and Validation.

The mainstay treatment of pulmonary disorders lies around the direct drug targeting to the lungs using a nebulizer, metered-dose inhaler, or dry powder inhaler. Only few inhalers are available in the market that could be used for inhalational drug delivery in rodents. However, the available rodent inhalers invariably require high cost and maintenance, which limits their use at laboratory scale. The present work, therefore, was undertaken to develop a simple, reliable, and cost-effective nose-only inhalation chamber with holding capacity of three mice at a time. The nebulized air passes directly and continuously from the central chamber to mouthpiece and maintains an aerosol cloud for rodents to inhale. Laser diffraction analysis indicated volume mean diameter of 4.02 ± 0.30 µm, and the next-generation impactor studies, however, revealed mean mass aerodynamic diameter of 3.40 ± 0.27 µm, respectively. An amount of 2.05 ± 0.20 mg of voriconazole (VRC) was available for inhalation at each delivery port of the inhaler. In vivo studies indicated the deposition of 76.12 ± 19.50 µg of VRC in the mice lungs when nebulized for a period of 20 min. Overall, the developed nose-only inhalation chamber offers a reliable means of generating aerosols and successfully exposing mice to nebulization.

Incorporating the Environmental Impact into a Budget Impact Analysis: The Example of Adopting RESPIMAT® Re-usable Inhaler.

BACKGROUND: RESPIMAT® re-usable enables patients to re-use the inhaler and its availability therefore reduces the number of inhalers and associated wastage. OBJECTIVE: The objective of this study was to perform an economic evaluation that incorporates the ecological impact of adopting RESPIMAT re-usable into the healthcare system in Germany. METHODS: Inhaler costs and environmental impact over 5 years in Germany in a scenario with RESPIMAT re-usable compared to a scenario without RESPIMAT re-usable were estimated using a budget impact model. The carbon emissions were derived for each treatment pattern considering the whole life cycle (cradle-to-grave) of the inhaler product. The cost of carbon emissions was estimated using a societal cost per ton of carbon emission. RESULTS: By introducing RESPIMAT re-usable in Germany, it was estimated that by 2023, the number of inhalers used would have decreased by 5,748,750 compared to a scenario without RESPIMAT re-usable. In addition, this measure would reduce the environmental burden of inhaler use while at the same time reducing medical cost of inhalers. CONCLUSIONS: Adopting RESPIMAT® re-usable to the national healthcare services may be a cost-saving option, which has the additional benefit of reducing the societal cost of carbon emissions.

A Budget Impact Model to Estimate the Environmental Impact of Adopting RESPIMAT® Re-usable in the Nordics and Benelux.

INTRODUCTION: The healthcare sector contributes 5-8% of the global greenhouse gas emissions. Global and regional organizations and governments have started to design and implement measures to reduce global greenhouse gas emissions in the healthcare sector, e.g. by green public procurement policies and inclusion of ecological considerations in the decision-making process for purchasing and funding of healthcare technologies. The objective of this study was to perform budget impact analysis of adopting RESPIMAT re-usable in the Nordics and Benelux that considered both the traditional healthcare costs as well as the environmental impact. METHODS: Inhaler costs and environmental impact over 5 years in the Nordics and Benelux in a scenario with RESPIMAT re-usable compared to a scenario without RESPIMAT re-usable were estimated using an budget impact model. RESPIMAT re-usable enables patients to re-use the inhaler device and its availability therefore reduces the number of inhalers and associated wastage. The carbon emissions were derived for each treatment pattern considering the whole life cycle (cradle-to-grave) of the inhaler product. The cost of carbon emissions was estimated using a societal cost per ton of carbon emission. RESULTS: Progressively introducing RESPIMAT re-usable in the Nordics and Benelux was estimated to decrease the number of inhalers used by 2023 by 7,466,621 compared to a scenario without RESPIMAT re-usable, which would result in a reduction of the environmental burden of inhaler use of 4717 tCO2e and a decrease in societal cost of €205,888. CONCLUSIONS: Adopting RESPIMAT re-usable would lead to a substantial reduction in CO2 emissions, leading to savings from a societal perspective. FUNDING: Boehringer Ingelheim.

Cost saving of switching to equivalent inhalers and its effect on health outcomes.

BACKGROUND: Switching inhalers to cheaper equivalent products is often advocated as a necessary cost saving measure, yet the impact on patient's health and healthcare utilisation has not been measured. METHODS: We identified asthma and chronic obstructive pulmonary disease (COPD) patients from UK primary care electronic healthcare records between 2000 and 2016. A self-controlled case series was used to estimate incidence rate ratios (IRR); comparing outcome rates during the risk period, 3 months after the exposure (financially motivated switch), and control periods (preswitch and postrisk period). Four outcomes were assessed: disease exacerbation, general practitioner consultation, non-specific respiratory events and adverse-medication events. Medication possession ratio (MPR) was calculated to assess adherence. 2017 National Health Service indicative prices were used to estimate cost differences per equivalent dose. RESULTS: We identified a cohort of 569 901 asthma and 171 231 COPD regular inhaler users, 2% and 6% had been switched, respectively. Inhaler switches between a brand-to-generic inhaler, and all other switches (brand-to-brand, generic-to-generic, generic-to-brand), were associated with reduced exacerbations (brand-to-generic: IRR=0.75, 95% CI 0.64 to 0.88; all other: IRR=0.79, 95% CI 0.71 to 0.88). Gender, age, therapeutic class, inhaler device and inhaler-technique checks did not significantly modify this association (p<0.05). The rate of consultations, respiratory-events and adverse-medication events did not change significantly (consultations: IRR=1.00, 95% CI 0.99 to 1.01; respiratory-events: IRR=0.96, 95% CI 0.95 to 0.97; adverse-medication-events: IRR=1.05, 95% CI 0.96 to 1.15). Adherence significantly increased post-switch (median MPR: pre-switch=54%, post-switch=62%; p<0.001). Switching patients, in the cohort of regular inhaler users, to the cheapest equivalent inhaler, could have saved around £6 million annually. CONCLUSION: Switching to an equivalent inhaler in patients with asthma or COPD appeared safe and did not negatively affect patient's health or healthcare utilisation.

Inhaler Review in Older Adults with Asthma or COPD: A Cost-Effectiveness Study and a Perspective in Portugal.

OBJECTIVES: Older patients with asthma or chronic obstructive pulmonary disease are particularly susceptible to exacerbations that may be associated with incorrect use of inhalers. Educational programs with inhaler technique review seem to be effective, but no studies have addressed their cost-effectiveness in older adult patients. The objective was to perform a cost-effectiveness analysis of education programs in older patients and estimate the cost benefit of applying such a program in Portugal. DESIGN: We developed a decision tree analysis from a healthcare perspective, according to intervention costs and the exacerbation rates and costs described in a previous meta-analysis. A sensitivity analysis of worst and best case scenarios was performed to estimate thresholds for intervention affordable limits, as well as cost-saving estimations and incremental cost-effectiveness ratios (ICERs) for a Portuguese scenario. SETTING AND PARTICIPANTS: We estimated cost-effectiveness thresholds applicable in all settings and performed a sensitivity analysis of a theoretical intervention model in all patients including an inhaler technique review at an annual appointment with a doctor and a nurse. RESULTS: In the best case scenario, the intervention affordable budget could be up to almost 1800€ (US $1585.24) per patient per year. Mean intervention-associated savings in Portugal would be 311.88€ (US $274.68) per patient per year, representing annual savings up to €131 million (US $150 million) for the whole health system, already including intervention costs. ICERs for Portugal vary between 93.73€ (US $82.55) and 437.43€ (US $385.25) per exacerbation avoided. CONCLUSION: A model of an intervention program with an inhaler technique review in older adult patients suggests that this intervention is cost-effective and can generate significant savings. J Am Geriatr Soc 1-7, 2019.

"You've got to breathe, you know" - asthma patients and carers' perceptions around purchase and use of asthma preventer medicines.

OBJECTIVE: To explore influences on patients' purchase and use of asthma preventer medicines and the perceived acceptability of financial incentives via reduced patient co-payments. METHODS: Semi-structured telephone or face-to-face interviews were conducted with adults and carers of children with asthma. Interviews were recorded, transcribed verbatim and coded. Data were analysed using thematic analysis via grounded theory. RESULTS: Twenty-four adults and 20 carers for children aged 3-17 years with asthma were interviewed. For medicines choice, most participants did not consider themselves the primary decision-maker; cost of medicines was an issue for some, but effectiveness was described as more important. For adherence, cost, side-effects, perceived benefit and patient behaviours were important. CONCLUSIONS: Patient barriers to adherence with asthma preventer medicines including cost are ongoing. Healthcare professionals need to encourage empathic discussion with patients about cost issues. Implications for public health: Asthma patients and carers could benefit from greater involvement and respect within shared decision-making. Healthcare professionals should be aware that cost may be a barrier for patient adherence, and provided with information about the relative costs of guideline-recommended asthma medicines. Patients and healthcare professionals need education around the efficacy of ICS-alone treatment and the rationale behind co-payments, for initiatives around quality use of medicines to succeed.

Cost-effectiveness of twice-daily indacaterol/glycopyrrolate inhalation powder for the treatment of moderate to severe COPD in the US.

BACKGROUND: Indacaterol 27.5 µg/glycopyrrolate 15.6 µg (IND/GLY 27.5/15.6 µg) inhalation powder, a twice-daily, fixed-dose combination of a long-acting beta2-agonist (LABA) and a long-acting antimuscarinic antagonist (LAMA), is indicated in the US for long-term maintenance treatment of airflow obstruction in patients with COPD. The safety and efficacy of IND/GLY 27.5/15.6 µg have been established, but cost-effectiveness is not yet known. This study compared the cost-effectiveness of IND/GLY 27.5/15.6 µg with other long-acting COPD maintenance therapies. METHODS: A Markov model was constructed from the US payer perspective. Health states were defined as mild (post-bronchodilator FEV1 ≥80% of predicted), moderate (50% ≤FEV1 <80% of predicted), severe (30% ≤FEV1 <50% of predicted), and very severe (FEV1 <30% of predicted) COPD. Patients entering the model transitioned through health states based on placebo-adjusted change from baseline in trough FEV1 for each comparator at week 12. Comparators included other US Food and Drug Administration-approved LABA/LAMA fixed-dose combinations as well as commonly prescribed LAMA and LABA/inhaled corticosteroid agents. One-way and probabilistic sensitivity analyses were conducted to test the model assumptions and the overall robustness of the results. RESULTS: Using the model, IND/GLY 27.5/15.6 µg treatment for 12 weeks resulted in total costs of US $23,375 vs US $9,365 for placebo. Compared with placebo, IND/GLY 27.5/15.6 treatment resulted in the highest improvement in FEV1 across all comparators and the lowest cost per decline in 100 mL FEV1. IND/GLY 27.5/15.6 µg was also among the most cost-effective treatment option as measured by St George's Respiratory Questionnaire response rate, at US $3,518 per additional responder at 12 weeks compared with placebo. In addition, IND/GLY 27.5/15.6 µg had the lowest cost per severe exacerbation avoided vs placebo across all comparators (US $87,686). CONCLUSION: This model, developed from the US payer perspective with a 5-year time horizon, found IND/GLY 27.5/15.6 µg to be a cost-effective treatment option for patients with moderate to severe COPD.

Personalising adherence-enhancing interventions using a smart inhaler in patients with COPD: an exploratory cost-effectiveness analysis.

Four inhaler adherence clusters have been identified using the INCA audio device in COPD patients: (1) regular use/good technique, (2) regular use/frequent technique errors, (3) irregular use/good technique, and (4) irregular use/frequent technique errors. Their relationship with healthcare utilization and mortality was established, but the cost-effectiveness of adherence-enhancing interventions is unknown. In this exploratory study, we aimed to estimate the potential cost-effectiveness of reaching optimal adherence in the three suboptimal adherence clusters, i.e., a theoretical shift of clusters 2, 3, and 4 to cluster 1. Cost-effectiveness was estimated over a 5-year time horizon using the Irish healthcare payer perspective. We used a previously developed COPD health-economic model that was updated with INCA trial data and Irish national economic and epidemiological data. For each cluster, interventions would result in additional quality-adjusted life years gained at reasonable investment. Cost-effectiveness was most favorable in cluster 3, with possible cost savings of €845/annum/person.

Cost-utility analysis of an intervention designed to reduce the critical handling error of insufficient inspiratory effort.

OBJECTIVES: Up to 70-80% of patients use inhalers incorrectly. Dry-powder inhalers (DPIs) require forceful inhalation for optimal delivery, and approximately 40% of Global Initiative for Asthma (GINA)-defined Step-3+ patients inhale corticosteroid and long-acting beta-agonist through DPIs. The CRITIKAL study (Price et al. in J Allergy Clin Immunol Pract 5:1071-e9-1081-e9, 2017) found a statistically significant association between 'insufficient inspiratory effort' error and increased risk of uncontrolled asthma and hospitalisation-requiring exacerbations. This paper explores the cost-effectiveness of an error-targeted intervention. METHODS: A probabilistic Markov cost-utility model simulated patients transitioning between controlled and uncontrolled health states over one year. Odds ratios (ORs, from the CRITIKAL study) of a patient having uncontrolled asthma conditional on making the error were applied to baseline transition probabilities sourced from the literature, both indirectly via an adjustment formula (Zhang et al. in JAMA 280:1690-1691, 1998) and directly by assuming OR approximates relative risk (RR). The analysis explored complete/partial eradication of the error when the intervention was priced to match comparators, as well as impact of indirect costs based on lost/reduced productivity. RESULTS: The intervention dominated both DPI comparators over one year, with direct cost savings of £45/£86 with 0.0053/0.0102 additional quality-adjusted life years (QALYs), and had the highest probability of being cost-effective at a £20,000/QALY threshold. Key factors driving variance were weekly utilities per state and RR of moving to an uncontrolled state. CONCLUSION: The analysis demonstrated the economic and societal costs of 'insufficient inspiratory effort' and potential economic benefits of introducing an effective intervention to reduce/eradicate this error. Further research should assess the economic impact of other handling errors.

Impact of Copayment Changes on Children's Albuterol Inhaler Use and Costs after the Clean Air Act Chlorofluorocarbon Ban.

OBJECTIVE: To examine changes in children's albuterol use and out-of-pocket (OOP) costs in response to increased copayments after the Food and Drug Administration banned inhalers with chlorofluorocarbon (CFC) propellants. SETTING: Four health maintenance organizations (HMOs), two that increased copayments for albuterol inhalers that went from generic CFC-containing to branded CFC-free versions, and two that retained generic copayments for CFC-free inhalers (controls). We included children with asthma aged 4-17 years with commercial coverage from 2007 to 2010. DESIGN: Interrupted time series with comparison series. DATA: We obtained enrollee and plan characteristics from enrollment files, and utilization data from pharmacy and medical claims; OOP expenditures were extracted from pharmacy claims for two HMOs with cost data available. FINDINGS: There were no significant differences in albuterol use between the group with increased cost-sharing and controls with respect to changes after the policy change. There was a postpolicy increase of $6.11 OOP per month per child using albuterol among those with increased cost-sharing versus $0.36 in controls; the difference between groups was significant (p < .01). CONCLUSIONS: Increased copayments for brand-name CFC-free albuterol after the CFC ban did not lead to a decrease in children's albuterol use, but it led to a modest increase in OOP costs.

Cost Evaluation of Inhaler Therapies Used in Respiratory Diseases: 1998--2015 Period in Turkey.

BACKGROUND: With the rise in life expectancy, the burden of chronic diseases, including obstructive pulmonary diseases, has increased throughout the world. OBJECTIVES: To evaluate the sales trends of inhaler pharmaceuticals. METHODS: The changes in box sales and sales amounts (in Turkish lira) of inhaler pharmaceuticals during the period 1998 to 2015 were examined and sales were projected for the next 3 years. Pharmaceuticals were classified according to form and pharmacological groups. RESULTS: The sales of inhaler pharmaceuticals have increased rapidly since 2008. The fastest increase in consumption has occurred in short-acting ß2 agonist preparations and nebulizer pharmaceuticals. Inhaled corticosteroid and long-acting ß2 agonist combination sales have been the highest since 2002, when these products entered the Turkish market. CONCLUSIONS: The inhaler pharmaceutical market has grown over the years, and this growth will continue in the future. The increased use of short-acting preparations, which should be used as symptom relievers, indicates that treatment management continues to be inadequate.

Once-Daily Triple Therapy in Patients with Advanced COPD: Healthcare Resource Utilization Data and Associated Costs from the FULFIL Trial.

INTRODUCTION: Chronic obstructive pulmonary disease is associated with a high healthcare resource and cost burden. Healthcare resource utilization was analyzed in patients with symptomatic chronic obstructive pulmonary disease at risk of exacerbations in the FULFIL study. Patients received either once-daily, single inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol) 100 µg/62.5 µg/25 µg or twice-daily dual inhaled corticosteroid/long-acting beta agonist therapy (budesonide/formoterol) 400 µg/12 µg. METHODS: FULFIL was a phase III, randomized, double-blind, double-dummy, multicenter study. Unscheduled contacts with healthcare providers were recorded by patients in a daily electronic diary; the costs of healthcare resource utilization were calculated post hoc using UK reference costs. RESULTS: Over 24 weeks, slightly fewer patients who received fluticasone furoate/umeclidinium/vilanterol (169/911; 18.6%) required contacts with healthcare providers compared with budesonide/formoterol (180/899; 20.0%). Over 52 weeks in an extension population, fewer patients who received fluticasone furoate/umeclidinium/vilanterol required unscheduled contacts with healthcare providers compared with budesonide/formoterol (25.2% vs. 32.7%). Non-drug costs per treated patient per year were lower in the fluticasone furoate/umeclidinium/vilanterol group than the budesonide/formoterol group over 24 and 52 weeks (£653.80 vs. £763.32 and £749.22 vs. £988.03, respectively), with the total annualized cost over 24 weeks being slightly greater for fluticasone furoate/umeclidinium/vilanterol than budesonide/formoterol (£1,289.35 vs. £1,267.45). CONCLUSIONS: This healthcare resource utilization evidence suggests that, in a clinical trial setting over a 24- or 52-week timeframe, non-drug costs associated with management of a single inhaler fluticasone furoate/umeclidinium/vilanterol are lower compared with twice-daily budesonide/formoterol. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT02345161. FUNDING: GSK.

A Cost Analysis of Salbutamol Administration by Metered-Dose Inhalers with Spacers versus Nebulization for Patients with Wheeze in the Pediatric Emergency Department: Evidence from Observational Data in Nova Scotia.

BACKGROUND: Despite evidence demonstrating the advantages of metered-dose inhalers with spacers (MDI-s), nebulization (NEB) remains the primary method of asthma treatment in some pediatric emergency departments (PEDs). There is a perception that delivering salbutamol by MDI-s is more costly than by NEB. This research evaluates the relative costs of MDI-s and NEB using local, hospital-specific, patient-level data. METHODS: Regression models estimated associations between the salbutamol inhalation method and costs, length of stay (LOS) in the PED and hospital, and the probability of admission. Our population was a random sample of 822 patients presenting with wheeze to the PED in 2008/2009. Control variables included age, sex, triage acuity, time of PED visit, other medications, and vitals. Costs were calculated using the prices and quantities of medical resources used per treatment. Probabilistic sensitivity analysis was used. RESULTS: Treatment with MDI-s versus NEB was associated with an absolute decrease in hospitalization of 4.4% (p<0.05) and a 25-hour (p<0.001) reduction in average inpatient stay, after controlling for triage acuity and patient characteristics. This resulted in savings of $24/patient in the PED and $180/patient overall (p<0.001). Inpatient care accounted for more than 90% of total patient costs. CONCLUSIONS: Our results suggest economic gains associated with MDI-s for salbutamol inhalation in PEDs. Sensitivity analyses show that this conclusion is not affected by changes in model parameters that may differ by jurisdiction. Since most facilities already collect the data used for this study, our methods could be adopted for a cross-jurisdictional account of the cost effectiveness of MDI-s.