Cost-effectiveness of mepolizumab for severe eosinophilic asthma in China.

OBJECTIVE: To evaluate the economic value of mepolizumab as an add-on therapy to the standard of care (SoC) for patients with severe eosinophilic asthma in China. METHODS: A Markov model with three health conditions was constructed to calculate the incremental cost per quality-adjusted life year (QALY) in mepolizumab with SoC and SoC only groups from the perspective of the Chinese healthcare system throughout an entire lifespan. The model was populated with local costs, while efficacy parameters were obtained from the global Phase III MENSA trial and mortality was derived from two surveys. One-way and probabilistic sensitivity analyses were conducted. Additional scenario analysis was used to estimate the cost-effectiveness impact of changes in the price of mepolizumab. RESULTS: Over the lifetime treatment horizon, the incremental cost-effectiveness ratio (ICER) of mepolizumab plus SoC compared to SoC alone was $170 648.73 per QALY. Sensitivity analyses focused on these results. Scenario analysis showed that mepolizumab would require a price reduction of at least 82% to reach the current willingness-to-pay (WTP=$38 223.34/QALY) threshold. CONCLUSION: Mepolizumab is not a cost-effective healthcare resource in China at its current pricing.

Association between air pollution levels and drug sales for asthma and allergy in 63 million people in metropolitan France.

INTRODUCTION: Air pollution is known to have an impact on respiratory health. However, the assessment of this relationship is far from complete and is rarely extended to the country level. We used drug sales data, both Over-The-Counter (OTC) and prescription drugs, to assess exhaustively the impact of air pollution on asthma and allergy at the national level in France. METHODS: The WHO Anatomical Therapeutic Chemical (ATC) classification system was used to describe the distribution of sales of drugs of class R03 (Drugs for obstructive airways diseases, overall for asthma) and R06 (Antihistamines for systemic use). We performed a Quasi-Poisson regression model with a generalized additive model (GAM) to estimate the relationship (Relative Risks and 95% Confidence Interval) between drug sales and air pollutants, that is Particulate Matter with a diameter less than 2.5 micrometers (PM2.5) and less than 10 micrometers (PM10) and Nitrogen dioxide (NO2), as assessed using the high-resolution CHIMERE dispersion model. We designed unadjusted and adjusted single-pollutant models as well as two-pollutant models. RESULTS: PM2.5, PM10, and NO2 were significantly and positively associated with sales of R03 and R06 class drugs, after adjustment for potential confounders. Results were confirmed in the two-pollutant model for PM10 and NO2 but not for PM2.5. CONCLUSIONS: Our study confirms the presence of an association between major air pollutants and the sales of drugs against asthma and allergies. Further studies on larger databases and over several years are necessary to confirm and better understand these results.

Real-life cost-effectiveness of benralizumab in patients with severe asthma.

BACKGROUND: Availability of clinically effective and cost-effective treatments for severe asthma would be beneficial to patients and national healthcare systems. The aim of this study was to evaluate clinical outcomes and healthcare expenditure after incorporating benralizumab into the standard treatment of refractory eosinophilic asthma. METHODS: This was a cross-sectional multicentre study of consecutive patients with refractory eosinophilic asthma who received treatment with benralizumab during at least 12 months. Patient follow-up was performed in specialised severe asthma units. The main effectiveness parameters measured were: the avoidance of one asthma exacerbation, a 3-point increase in the asthma control test (ACT) score, and the difference in utility scores (health-related quality of life) between a 1-year baseline treatment and 1-year benralizumab treatment. The health economic evaluation included direct costs and incremental cost-effectiveness ratios (ICERs). RESULTS: After 1 year of treatment with benralizumab, patients with refractory eosinophilic asthma showed an improvement in all the effectiveness parameters analysed: improvement of asthma control and lung function, and decrease in the number of exacerbations, oral corticosteroid (both as corticosteroid courses and maintenance therapy), and inhaled corticosteroid use. The total annual cost per patient for the baseline and benralizumab treatment periods were €11,544 and €14,043, respectively, reflecting an increase in costs due to the price of the biological agent but a decrease in costs for the remaining parameters. The ICER was €602 per avoided exacerbation and €983.86 for every 3-point increase in the ACT score. CONCLUSIONS: All the pharmacoeconomic parameters analysed show that treatment with benralizumab is a cost-effective option as an add-on therapy in patients with refractory eosinophilic asthma.

Clinical and economic burden of severe asthma among US patients treated with biologic therapies.

BACKGROUND: Patients with severe asthma may remain uncontrolled despite biologic therapy in addition to standard therapy, but this disease burden has not been quantified. OBJECTIVE: To estimate the clinical and economic burden in a US national sample. METHODS: Patients who have severe asthma with indicated biologic treatment (earliest use = index date) were selected from the MarketScan database between January 1, 2013, and June 30, 2018. Inclusion criteria were continuous enrollment for 12 months postindex with a minimum of 2 biologic fills, greater than or equal to 12 years of age, evidence of medium- to high-dose inhaled corticosteroids and long-acting ß-agonist combination before the index, and absence of other respiratory diagnoses and malignancies. Disease exacerbations (used to classify asthma control), health care costs, and treatment characteristics were reported during the 12-month postindex period. RESULTS: The sample included 3262 biologic patients; 88% with anti-immunoglobulin E therapy (omalizumab) and 12% non-anti-immunoglobulin E (reslizumab, mepolizumab, benralizumab). The mean age was 49 (±15) years; 64% were women. Prescriptions included inhaled corticosteroids and long-acting ß-agonist (82%), systemic corticosteroids (76%), and leukotriene receptor antagonists (68%). Notably, 63% of patients presented greater than or equal to 1 asthma exacerbation (mean 1.3 per patient/year). Furthermore, 35% of patients were categorized as having controlled asthma, whereas 28% were suboptimally controlled and 29% were uncontrolled. Patients with uncontrolled disease had higher all-cause and asthma-related costs ($69,206 and $45,693, respectively) than patients with suboptimally controlled ($59,407 and $40,793, respectively) or controlled disease ($53,083 and $38,393, respectively). Furthermore, 62% of newly treated patients were persistent with their index biologic. CONCLUSION: Biologic therapies are effective in reducing exacerbations, but a substantial proportion of patients with severe asthma treated with current biologics continue to experience uncontrolled disease, highlighting a remaining unmet need for patients with severe uncontrolled asthma.

The economic burden of severe asthma in children: a comprehensive study.

OBJECTIVE: The economic burden of severe asthma (SA) in children is poorly described. We aimed to determine the healthcare costs of SA in children for the French national health insurance (NHI). METHODS: Children (6-18 years of age) with physician-confirmed diagnoses of SA or non-SA (NSA) were identified. Direct and indirect expenditures related to asthma and associated co-morbidities in the previous six months were determined, based on a physician-guided parental questionnaire and confirmed by medical records. The costs for the French NHI were assessed per child over a six month period. RESULTS: Data from 74 children, including 48 with SA (22 requiring omalizumab) and 26 with NSA, were analyzed. The global cost of SA was €3,982 per child over a six-month period, including €3,821 direct costs and €161.9 indirect costs. The global cost was €6,716 (4,220) for those requiring omalizumab vs. €1,669 (3,108) for those who did not (p < 0.01). For children with SA, 65% of direct costs were attributed to medication. Among those on omalizumab, such treatment accounted for 93% of medication costs. The global cost was 10 times higher for children with SA than those with NSA (€3,982 (4,422) vs. €363.2 (352.6), p < 0.01), and 20 times higher for children with SA on omalizumab than those with NSA (p < 0.01). CONCLUSION: The economic burden of SA in children for the French NHI is substantial and mainly driven by the most severe children requiring biologics.

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.

Economic burden of severe asthma in Turkey: a cost of illness study from payer perspective.

Summary: Objective. To estimate economic burden of severe asthma in Turkey from payer perspective based on expert panel opinion on practice patterns in clinical practice. Methods. This cost of illness study was based on identification of per patient annual direct medical costs for the management of sever easthma in Turkey from payer perspective. Average per patient direct medical cost was calculated based on cost items related to outpatient visits, laboratory and radiological tests, hospitalizations and interventions, drug treatment and equipment, and co-morbidities/complications. Results. Based on total annual per patient costs calculated for outpatient admission ($ 177.91), laboratory and radiological tests ($ 82.32), hospitalizations/interventions ($ 1,154.55), drug treatment/equipment ($ 2,289.63) and co-morbidities ($ 665.39) cost items, total per patient annual direct medical costrelated to management of severe asthma was calculated to be $ 4,369.76 from payer perspective. Drug treatment/equipment (52.4%) was the main cost driver in the management of severe asthma in Turkey, as followed by hospitalizations/interventions (26.4%) and co-morbidities (15.2%). Conclusions. In conclusion, our findings indicate that managing patients with severe asthma pose a considerable burden to health economics in Turkey, with medications as the main cost driver.

Cost-effectiveness of implementing objective diagnostic verification of asthma in the United States.

BACKGROUND: Asthma diagnosis in the community is often made without objective testing. OBJECTIVE: The aim of this study was to evaluate the cost-effectiveness of implementing a stepwise objective diagnostic verification algorithm among patients with community-diagnosed asthma in the United States. METHODS: We developed a probabilistic time-in-state cohort model that compared a stepwise asthma verification algorithm on the basis of spirometry testing and a methacholine challenge test against the current standard of care over 20 years. Model input parameters were informed from the literature and with original data analyses when required. The target population was US adults (≥15 years old) with physician-diagnosed asthma. The final outcomes were costs (in 2018 dollars) and quality-adjusted life years (QALYs), discounted at 3% annually. Deterministic and probabilistic analyses were undertaken to examine the effect of alternative assumptions and uncertainty in model parameters on the results. RESULTS: In a simulated cohort of 10,000 adults with diagnosed asthma, the stepwise algorithm resulted in removal of the diagnosis of 3,366. This was projected to be associated with savings of $36.26 million in direct costs and a gain of 4,049.28 QALYs over 20 years. Extrapolating these results to the US population indicated an undiscounted potential savings of $56.48 billion over 20 years. The results were robust against alternative assumptions and plausible changes in values of input parameters. CONCLUSION: Implementation of a simple diagnostic testing algorithm to verify asthma diagnosis might result in substantial savings and improvement in patients' quality of life.

Health and cost impact of stepping down asthma medication for UK patients, 2001-2017: A population-based observational study.

BACKGROUND: Guidelines recommend stepping down asthma treatment to the minimum effective dose to achieve symptom control, prevent adverse side effects, and reduce costs. Limited data exist on asthma prescription patterns in a real-world setting. We aimed to evaluate the appropriateness of doses prescribed to a UK general asthma population and assess whether stepping down medication increased exacerbations or reliever use, as well as its impact on costs. METHODS AND FINDINGS: We used nationwide UK primary care medical records, 2001-2017, to identify 508,459 adult asthma patients managed with preventer medication. Prescriptions of higher-level medication: medium/high-dose inhaled corticosteroids (ICSs) or ICSs + add-on medication (long-acting ß2-agonist [LABA], leukotriene receptor antagonist [LTRA], theophylline, or long-acting muscarinic antagonist [LAMA]) steadily increased over time (2001 = 49.8%, 2017 = 68.3%). Of those prescribed their first preventer, one-third were prescribed a higher-level medication, of whom half had no reliever prescription or exacerbation in the year prior. Of patients first prescribed ICSs + 1 add-on, 70.4% remained on the same medication during a mean follow-up of 6.6 years. Of those prescribed medium/high-dose ICSs as their first preventer, 13.0% already had documented diabetes, cataracts, glaucoma, or osteopenia/osteoporosis. A cohort of 125,341 patients were drawn to assess the impact of stepping down medication: mean age 50.4 years, 39.4% males, 39,881 stepped down. Exposed patients were stepped down by dropping their LABAs or another add-on or by halving their ICS dose (halving their mean-daily dose or their inhaler dose). The primary and secondary outcomes were, respectively, exacerbations and an increase in reliever prescriptions. Multivariable regression was used to assess outcomes and determine the prognostic factors for initiating stepdown. There was no increased exacerbation risk for each possible medication stepdown (adjusted hazard ratio, 95% CI, p-value: ICS inhaler dose = 0.86, 0.77-0.93, p < 0.001; ICS mean daily = 0.80, 0.74-0.87, p < 0.001; LABA = 1.01, 0.92-1.11, p = 0.87, other add-on = 1.00, 0.91-1.09, p = 0.79) and no increase in reliever prescriptions (adjusted odds ratio, 95% CI, p-value: ICS inhaler dose = 0.99, 0.98-1.00, p = 0.59; ICS mean daily = 0.78, 0.76-0.79, p < 0.001; LABA = 0.83, 0.82-0.85, p < 0.001; other add-on = 0.86, 0.85-0.87, p < 0.001). Prognostic factors to initiate stepdown included medication burden, but not medication side effects. National Health Service (NHS) indicative prices were used for cost estimates. Stepping down medication, either LABAs or ICSs, could save annually around £17,000,000 or £8,600,000, respectively. Study limitations include the possibility that prescribed medication may not have been dispensed or adhered to and the reason for stepdown was not documented. CONCLUSION: In this UK study, we observed that asthma patients were increasingly prescribed higher levels of treatment, often without clear clinical indication for such high doses. Stepping down medication did not adversely affect outcomes and was associated with substantial cost savings.

Cost-effectiveness of omalizumab for the treatment of inadequately controlled severe allergic asthma in Chinese children.

Objective: The addition of omalizumab to standard therapy has proven to be efficacious in children with severe allergic asthma. The goal of this study was to assess the cost-effectiveness of adding omalizumab to standard treatment for asthma in Chinese pediatric patients.Methods: A Markov model was constructed to project the health and economic outcomes in pediatric patients with severe allergic asthma. Model inputs were obtained from the literature. Cost and quality-adjusted life-years (QALYs) were measured over a five-year time horizon. One-way and probabilistic sensitivity analyses were conducted.Results: For the base-case analysis, the addition of omalizumab to standard therapy yielded an incremental cost of $49,047 for 0.232 incremental QALY, led to an incremental cost-effectiveness ratio of $211,217/QALY. Sensitivity analyses were robust for these results.Conclusions: This study found that the addition of omalizumab is not a cost-effective strategy compared with standard therapy for children with severe allergic asthma in China due to its high cost.

Identifying which children with persistent asthma have preventive medications available at home.

Objective: To compare caregiver-reported preventive medication use and pharmacy data with medications available at home for children with persistent asthma, and identify factors associated with having preventive medication at home.Methods: We analyzed baseline data from the School-Based Telemedicine Enhanced Asthma Management (SB-TEAM) study, including medication use, symptoms, and demographics. Research assistants documented all asthma medications available during home visits. We reviewed pharmacy records for a subset of children. Bivariate and multivariate analyses identified factors associated with having any preventive medication in the home.Results: We included 335 children (mean 7.7 years, 56% Black, 34% Hispanic, 77% Medicaid; participation 79%). Most caregivers (69%) reported preventive medication use, yet only 45% had preventive medication at home. Compared to families with preventive medication at home, more families without preventive medication reported discontinuous insurance in the prior year (7% vs. 15%, p = .02) and medication sharing (22% vs. 32%, p = .04). For the subset with pharmacy records (n = 192), 40% filled a preventive medication in the past year and 15% had a preventive medication at home. In multivariate analyses, children were less likely to have preventive medication at home when caregivers reported no preventive medication use in the past 2 weeks (OR 0.25; 95% CI 0.14, 0.43), discontinuous insurance (OR 0.42; 95% CI 0.19, 0.97), medication sharing (OR 0.54; 95% CI 0.32, 0.91), or caregiver education ≥ HS (OR 0.59; 95% CI 0.35, 0.99).Conclusion: Among urban children with persistent asthma, neither caregiver report nor pharmacy data reflect home preventive medication availability. Inquiring about insurance coverage and medication sharing may improve preventive medication availability for these children.

Barriers to and competency with the use of metered dose inhaler and its impact on disease control among adult asthmatic patients in Ethiopia.

BACKGROUND: Asthma is one of the chronic diseases which affects the airway, and inhalers are the preferred medications to treat this problem. Improper inhalational technique leads to decreased efficacy of the medication by reducing its deposition in the lungs. The aim of this study was to assess the barriers to and competency with the use of Metered Dose Inhaler (MDI) and its impact on disease control among adult asthmatic patients. METHODS: A prospective cross-sectional study was conducted in University of Gondar comprehensive specialized hospital outpatient department (OPD) chronic follow up from 12-March-2018 to 15-May- 2018. Patients were interviewed face to face with questions which determined their competency, asthma control level and barriers for inhaler use. RESULT: Overall, 307 asthmatic patients were included in the study. More than half of participants were females, 170 (55.4%) and lived in urban area 185 (60.3%). The mean age of the respondents was 51.77 years with a standard deviation of ±15.40. The cost of medication, 282 (91.9%) and the perception that medication should be used in response to symptoms but not on a regular basis 277 (90.2%) were the most identified barriers. Only 56 (18.2%) were competent for Metered Dose Inhaler use (MDIU) and 17 (5.5%) patients had well controlled asthma. Being not competent AOR 0.168[0.41-0.687] was one of the factors decreasing asthma control. CONCLUSION: Generally from this study, cost of the medication and the perception that medication should be used only for symptoms were the major identified barriers that affect the MDI use among asthmatic patients. Patients show very poor competence to their MDI which in turn led to poor asthma control. So, patients need to be taught the correct inhaler technique in the hospital and pharmacy while they came for follow up every time.

Can medicines development improve outcomes in asthma and chronic obstructive pulmonary disease management by driving effectiveness?

Despite the availability of treatment guidelines and inhaled medications for asthma and chronic obstructive pulmonary disease (COPD), much remains to be done to lessen the burden of these respiratory diseases for patients. The challenge of selecting effective and efficacious drugs for patients is a key focus area for healthcare professionals. Here we discuss the concept of "drivers of effectiveness"- features of a medicine which may increase or decrease its effectiveness in the presence of real-world factors - and highlight the importance of considering these drivers in the early stages of drug development, and exploring their impact in carefully designed pragmatic trials. Using the Salford Lung Studies (SLS) in asthma and COPD as an illustrative example, we discuss various features of the inhaled corticosteroid/long-acting ß2-agonist combination, fluticasone furoate/vilanterol (FF/VI), as potential drivers of effectiveness that may have contributed to the improved patient outcomes observed with initiation of FF/VI versus continuation of usual care in the UK primary care setting.

A Systematic Review of Decision-Analytic Models for Evaluating Cost-Effectiveness of Asthma Interventions.

OBJECTIVE: To demonstrate the landscape of model-based economic studies in asthma and highlight where there is room for improvement in the design and reporting of studies. DESIGN: A systematic review of the methodologies of model-based, cost-effectiveness analyses of asthma-related interventions was conducted. Models were evaluated for adherence to best-practice modeling and reporting guidelines and assumptions about the natural history of asthma. METHODS: A systematic search of English articles was performed in MEDLINE, EMBASE, and citations within reviewed articles. Studies were summarized and evaluated based on their adherence to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS). We also studied the underlying assumptions about disease progression, heterogeneity in disease course, comorbidity, and treatment effects. RESULTS: Forty-five models of asthma were included (33 Markov models, 10 decision trees, 2 closed-form equations). Novel biological treatments were evaluated in 12 studies. Some of the CHEERS' reporting recommendations were not satisfied, especially for models published in clinical journals. This was particularly the case for the choice of the modeling framework and reporting on heterogeneity. Only 13 studies considered any subgroups, and 2 explicitly considered the impact of comorbidities. Adherence to CHEERS requirements and the quality of models generally improved over time. CONCLUSION: It would be difficult to replicate the findings of contemporary model-based evaluations of asthma-related interventions given that only a minority of studies reported the essential parameters of their studies. Current asthma models generally lack consideration of disease heterogeneity and do not seem to be ready for evaluation of precision medicine technologies.

Cost-effectiveness and comparative effectiveness of biologic therapy for asthma: To biologic or not to biologic?

OBJECTIVE: To evaluate relevant studies and documents that address the cost-effectiveness and comparative effectiveness of biologics current approved by the US Food and Drug Administration for the treatment of asthma. DATA SOURCES: Publications currently available on biologics, the Global Initiative for Asthma pocket book on difficult-to-treat asthma in adolescents and adults, and the recent Institute for Clinical and Economic Review on biologic therapies for the treatment of asthma. STUDY SELECTIONS: Priority was placed on studies that speak to the cost-effectiveness and comparative effectiveness of biologic therapies published from 2016 to 2019. RESULTS: Current pricing for all biologics exceeds measures of cost-effectiveness. To meet available measures indicating cost-effectiveness, prices would have to be reduced by a minimum of approximately 60%. The effect of biologics on exacerbations is similar but should be interpreted in the context of comparable patient phenotypes. The effect on quality of life is deemed modest based on the available study designs. CONCLUSION: To maximize cost-effectiveness of the biologics, emphasis should be placed on identifying predictors of response, focusing on those patients receiving oral corticosteroid therapy, and assessing the effect of treatment for decisions that relate to continuation. Multidisciplinary stakeholder efforts are needed to ensure responsible application of biologic therapy.

Evaluating direct costs and productivity losses of patients with asthma receiving GINA 4/5 therapy in the United States.

BACKGROUND: Despite the low prevalence for all patients with asthma, those with severe disease account for a disproportionately large economic burden. OBJECTIVE: To evaluate current direct health care and productivity loss costs associated with patients with asthma receiving Global Initiative for Asthma Step 4/5 therapy ("G4/5 asthma") in the United States. METHODS: Asthma patients aged 12 years or older were identified in the IBM MarketScan Research Databases between January 1, 2012 and December 31, 2015. Patients were indexed on their earliest medical claim for asthma and were required to have at last 2 years of continuous eligibility. The G4/5 asthma classification required 1 or more medium- or high-dosage inhaled corticosteroids (ICS)/long-acting beta-agonist (LABA) claims, 1 or more omalizumab claims, or systemic corticosteroids covering at least 50% of the 12-month baseline period. The European Respiratory Society/American Thoracic Society criteria for severe uncontrolled asthma were modified for claims data and used to identify patients with exacerbations or high rescue medication use ("Ex/R″). Direct health care costs and productivity loss costs attributable to workplace absence or short-term or long-term disability were measured during the 12-month post-index period. RESULTS: A total of 605,614 patients with asthma were identified. Annual health care costs were $4,384 greater for G4/5 asthma vs non-G4/5 patients with asthma; asthma-related costs contributed $2,183 of this difference (P < .001). Differences were primarily driven by G4/5 patients with asthma with Ex/R, whose costs were $5,019 greater than G4/5 patients without Ex/R (P < .001). For patients with 1 or more absences or short-term disability claims, G4/5 patients missed 7.2 more work hours for absence and had 3.9 more days of work lost for short-term disability than non-G4/5 patients with asthma, respectively (P < .05). CONCLUSION: G4/5 patients with asthma incurred significantly greater direct and indirect costs than non-G4/5 patients with asthma. Differences were largely driven by those with Ex/R.

Childhood asthma in low and middle-income countries: Where are we now?

Pediatric asthma has been increasing in LMICs (Low Middle-Income Countries), leading to an important burden for both children and national health systems. Implementing measures to achieve control are influenced by the degree of organization health systems have, the availability and affordability of essential asthma medications, and the effective implementation of asthma programs and asthma guidelines. In this review authors give an updated view of the current situation of these components of asthma management in LMICs.

Economic impact of severe asthma in Spain: multicentre observational longitudinal study.

Objective: Estimate the economic impact of severe asthma from the Spanish social perspective through the estimation of the associated annual direct and indirect costs. Methods: Observational, longitudinal, retrospective study carried out in 20 Spanish secondary settings (Pulmonology and Allergy Services) among patients aged ≥18, diagnosed with severe asthma according to European Respiratory Society/American Thoracic Society consensus and who have not experienced an exacerbation in the previous 2 months. Asthma-related healthcare resource utilization as well as asthma-related days off work were collected over a retrospective 12-month period from medical records review (inclusion period: June to November 2016). Total costs were calculated by multiplying the natural resource units used within 1 year by the corresponding unit cost. Costs were expressed in Euros for 2018. Results: A total of 303 patients were included, mean age was 54 years old and 67% were women. There were 5.7 physician visits per patient (3.3 in secondary care). The most common pharmacologic treatment was fixed dose combination of inhaled corticosteroids/long-acting ß2-adrenergic agonists (96.7%), followed by leukotriene receptor antagonists (57.1%). 134 patients (44.2%) had at least one severe asthma exacerbation (mean: 1.9 exacerbation/patient), of whom 22 patients required hospitalization, with a mean hospital stay of 10.9 days/patient. Mean sick leave due to severe asthma was 9.1 days per patient per year. Mean annual direct cost (confidence interval 95%) was €7472/patient (€6578-8612). The cost per exacerbation was €1410/patient. When indirect costs were added (€1082/patient [€564-1987]), the total annual mean cost rose to €8554/patient (€7411-10199). Conclusions: Taking the social perspective, the economic impact of severe asthma in Spain was estimated to be €8554/patient/year.

A cost-effectiveness analysis of reslizumab in the treatment of poorly controlled eosinophilic asthma.

Introduction: Poorly controlled severe eosinophilic asthma is difficult and costly to manage. Reslizumab, an add-on treatment for adults with severe eosinophilic asthma, reduces the number of exacerbations and improves the quality of life (QoL). The objective of this study was to evaluate the cost-effectiveness of reslizumab. Methods: A Markov model was used to compare the cost-effectiveness of add-on reslizumab with the standard-of-care (SOC) from the US societal perspective over a five-year time horizon. Efficacy and safety inputs for the model were based on data from two clinical trials (NCT01287039 and NCT01285323). Other model inputs, including mortality rates, costs, and utility, were estimated from literature, the Centers for Disease Control and Prevention (CDC), the US Department of Veterans Affairs (VA) and the Centers for Medicare and Medicaid Services (CMS). One-way, threshold, and probabilistic sensitivity analyses (PSA) were performed. Adherence, treatment response, and the placebo effect were evaluated in separate scenario analyses. Results: The base case incremental cost-effectiveness ratio (ICER) was $697 403 (2017 USD) per quality-adjusted life-years (QALYs). In the PSA, reslizumab becomes cost-effective in 50% of the iterations at a willingness-to-pay (WTP) threshold of $689 000. The model is most sensitive to the QoL improvement with reslizumab treatment in the one-way and threshold analyses. The response and adherence models had lower ICERs than the base model but still above $500 000. The ICER of the placebo effect model was $29 820. Conclusions: The improvement in QoL and exacerbation rates with reslizumab are associated with high costs, making reslizumab unlikely to be cost-effective at the $200 000 WTP threshold.

Impact of a population-based asthma management program in France (Sophia Asthme): A matched controlled before-and-after quasi-experimental study using the French health insurance database (SNDS).

PURPOSE: Sophia Asthme (SA) is a chronic disease management program of the French national health insurance for adult patients with asthma. We evaluated the early impact of this intervention. METHODS: We conducted a matched controlled, before-and-after quasi-experimental study within the French Health Insurance Database (Système National Des Données de Santé [SNDS]). The SA program was implemented in a set of 18 Départements in France and targeted 18- to 44-year-old subjects, with at least two reimbursement dates for asthma drug therapy during the 12-month period prior to program targeting. Change in outcomes was assessed from the "before program" period (January-December 2014) to the "after program implementation" period (March 2015-February 2016) in the program group (eligible to SA program in the 18 Départements) and in the matched controlled group. The main outcome measure was the before-after change in proportion of subjects with a controllers/(controllers+relievers) ratio greater than 50%. RESULTS: Of the 99 578 subjects of the program group, 9225 (9.3%) actually participated in SA program. The program had no significant impact on the proportion of subjects with a ratio greater than 50%. However, subjects exposed to SA program were significantly more likely to be dispensed controller medications (OR = 1.04; 95% CI, 1.01-1.07) and to sustain their use of these medications (OR = 1.08; 95% CI, 1.05-1.12). CONCLUSION: We did not demonstrate any significant impact of the program on the primary outcome. The modest yet encouraging findings of this early evaluation suggest the need for reformulation of the program and its evaluation.