Cost-Effectiveness and Budget Impact of Lumacaftor/Ivacaftor in the Treatment of Cystic Fibrosis.

BACKGROUND: Cystic fibrosis (CF) is a chronic, progressive, genetic disease affecting more than 30,000 people in the United States and 70,000 people globally. The goals of treatment are to slow disease progression, reduce pulmonary exacerbations, relieve chronic symptoms, and improve the patient's quality of life. Lumacaftor/ivacaftor is a new therapy for CF that has demonstrated good clinical outcomes, including improved absolute percentage predicted forced expiratory volume in 1 second (FEV1%). However, given the high cost of therapy, there is a need to evaluate the overall value of lumacaftor/ivacaftor in CF management. OBJECTIVES: To (a) conduct a cost-effectiveness analysis (CEA) of lumacaftor/ivacaftor to understand the overall effectiveness of the drug compared with its costs and (b) conduct a budget impact analysis (BIA) to understand the potential financial effect of introducing a new drug in a health plan. METHODS: Two static decision models were developed using Microsoft Excel to evaluate the cost-effectiveness and budget impact of lumacaftor/ivacaftor over a 1-year time frame from a payer perspective. Model inputs included drug costs (wholesale acquisition costs), drug monitoring schedules (package inserts), drug monitoring costs (Centers for Medicare & Medicaid physician fee schedule and published literature), FEV1% predicted and pulmonary exacerbation values (clinical trials), and cost to treat pulmonary exacerbations (published literature). The outcomes in the CEA included total cost of therapy; average cost-effectiveness ratio (ACER), defined as cost per FEV1% predicted; and incremental cost-effectiveness ratio (ICER), defined as the difference in the ratio of cost per FEV1% predicted of lumacaftor/ivacaftor and placebo. Outcomes in the BIA included total budget impact; cost per member per month (PMPM), defined as total budget impact per hypothetical plan population; and cost per treated member per month (PTMPM), defined as total budget impact per target CF population. All costs were adjusted to 2016 dollars, and one-way sensitivity analyses were conducted to test the model robustness given uncertainty in model inputs and study assumptions. RESULTS: The annual cost of therapy per patient for lumacaftor/ivacaftor was $379,780. The ACER for lumacaftor/ivacaftor was $151,912, while the ICER for lumacaftor/ivacaftor compared with placebo was $95,016 per FEV1% predicted. The annual total budget impact due to the inclusion of lumacaftor/ivacaftor on the health plan formulary was $266,046. The PMPM cost was $0.02 and the PTMPM cost was $6.21. CONCLUSIONS: In patients with CF, lumacaftor/ivacaftor has demonstrated better clinical effectiveness compared with placebo alongside an increased drug acquisition cost. However, the therapy may be a viable alternative to existing standard therapy over a short time horizon. Health care payers, both private and public, need to evaluate the cost-effectiveness and the financial effect when considering expansion of new drug coverage in CF management. DISCLOSURES: No outside funding supported this study. Covvey and Kamal have received research funding from Novartis Pharmaceuticals. Covvey, Giannetti, and Kamal have received research funding from the College of Psychiatric and Neurologic Pharmacists. Kamal serves as a consultant to the Lynx Group (Cranbury, NJ) and Manticore Consulting Group (Scottsdale, AZ). Mukherjee has nothing to disclose. A related poster abstract was presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting; March 27-30, 2017; Denver, CO.

The Impact of Care Specialty on Survival-Adjusted Medical Costs of COPD Patients After a Hospitalization: a longitudinal analysis.

BACKGROUND: Little is known about the impact of care provider's specialty on the medical costs of COPD patients over time. OBJECTIVE: To compare the long-term medical costs between newly hospitalized COPD patients whose post-discharge care was initiated by a pulmonary specialist versus by a general practitioner. DESIGN: Retrospective matched cohort study. PARTICIPANTS: We identified patients with an incident COPD-related hospitalization from the administrative health database (January 1, 1996, to December 31, 2012) of British Columbia, Canada. MAIN MEASURES: Patients were categorized as receiving specialist care or primary care within the first 90 days after discharge from an incident COPD-related hospitalization. Using propensity scores, we matched each patient who initially received specialist care to a patient who received primary care based on demographics, COPD severity, comorbidity, and admission time. A survival-adjusted, multi-part generalized linear model was used to estimate direct medical costs (in 2015 Canadian dollars, [$], including inpatient, outpatient, pharmacy, and community care costs) as overall and as COPD-specific and comorbidity-related costs over the following 5 years. KEY RESULTS: The sample included 7710 patients under each group. The initial specialist-care recipients had a modestly higher 5-year survival than the generalist-care recipients (0.564 [95% CI 0.535, 0.634] vs 0.555 [95% CI 0.525, 0.625]; P < .001). Meanwhile, the former incurred $2809 higher all-cause medical costs over 5 years compared to the latter (95% CI $2343, $2913; P < .001), mainly driven by higher medication costs (difference $1782 [95% CI $1658, $1830]; P < .001) particularly related to COPD medications ($1170 [95% CI $1043, $1225]; P < .001). Specialist care recipients also incurred higher costs of COPD-related hospitalization ($1144 [95% CI $650, $1221]; P < .001). CONCLUSIONS: Compared to generalist care, specialist care following COPD hospitalization is slightly more expensive, mainly driven by medication costs especially COPD-specific medications. Future studies should compare differences in health-related quality of life and COPD functional status.

Cost(s) of caring for patients with cystic fibrosis.

PURPOSE OF REVIEW: Cystic fibrosis (CF) has received a lot of attention in the past few years because of increased longevity and the emergence of ground-breaking new drugs targeting the molecular and cellular defects, making a huge clinical difference, and - not incidentally - carrying massive price tags. The prices of these new drugs make the question of overall costs of CF care highly relevant. RECENT FINDINGS: This article reviews recent developments in CF science and treatment, and highlights areas that contribute to costs of CF care, emphasizing how these costs have increased. SUMMARY: This article should help the pediatrician stay abreast of high points of CF care, with an awareness of the factors that wield the biggest influence on overall costs, to patients, families and the US healthcare system.

Health economic evaluation in idiopathic pulmonary fibrosis in France.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a specific form of chronic, progressive, fibrosing interstitial pneumonia of unknown cause. To date, there is no specific cure for IPF, and only two treatments (pirfenidone and nintedanib) have marketing authorizations and recommendations in international and French guidelines. OBJECTIVES: A cost-utility analysis (CUA) has been conducted to evaluate the efficiency of nintedanib, in comparison to all available alternatives, in a French setting using the official methodological guidelines. METHODS: A previously developed lifetime Markov model was adapted to the French setting by simulating the progression of IPF patients in terms of lung function decline, incidence of acute exacerbations, and death. Considering the effect of IPF on patients' quality-of-life, a CUA integrating quality adjusted life years (QALY) was chosen as the primary outcome measure in the main analysis. One-way, probabilistic, and scenario sensitivity analyses were performed to evaluate the robustness of the model. RESULTS: Treatment with nintedanib resulted in an estimated total cost of €76,414 (vs €82,665 for pirfenidone). In comparison with all other available options, nintedanib was predicted to provide the most QALY gained (3.34 vs 3.29). This analysis suggests that nintedanib has a 59.0% chance of being more effective than pirfenidone and s 77.3% chance of being cheaper than pirfenidone. Sensitivity analyses showed the results of the CUA to be robust. CONCLUSIONS: In conclusion, this CUA has found that nintedanib appears to be a more cost-effective therapeutic option than pirfenidone in a French setting, due to fewer acute exacerbations and a better tolerability profile.

The role of inhaled prostacyclin in treating acute respiratory distress syndrome.

Acute respiratory distress syndrome (ARDS) is a syndrome of acute lung injury that is characterized by noncardiogenic pulmonary edema and severe hypoxemia second to a pathogenic impairment of gas exchange. Despite significant advances in the area, mortality remains high among ARDS patients. High mortality and a limited spectrum of therapeutic options have left clinicians searching for alternatives, spiking interest in selective pulmonary vasodilators (SPVs). Despite the lack of robust evidence, SPVs are commonly employed for their therapeutic role in improving oxygenation in patients who have developed refractory hypoxemia in ARDS. While inhaled epoprostenol (iEPO) also impacts arterial oxygenation by decreasing ventilation-perfusion (V/Q) mismatching and pulmonary shunt flow, this effect is not different from inhaled nitric oxide (iNO). The most effective and safest dose for yielding a clinically significant increase in PaO2 and reduction in pulmonary artery pressure (PAP) appears to be 20-30 ng/kg/min in adults and 30 ng/kg/min in pediatric patients. iEPO appears to have a ceiling effect above these doses in which no additional benefit may be derived. iNO and iEPO have shown similar efficacy profiles; however, they differ with respect to cost and ease of therapeutic administration. The most beneficial effects of iEPO have been seen in adult patients with secondary ARDS as compared with primary ARDS, most likely due to the difference in etiology of the two disease states, and in patients suffering from baseline right ventricular heart failure. Although iEPO has demonstrated improvements in hemodynamic parameters and oxygenation in ARDS patients, due to the limited number of randomized clinical trials and the lack of studies investigating mortality, the use of iEPO cannot be recommended as standard of care in ARDS. iEPO should be reserved for those refractory to traditional therapies.

Outcomes and costs of treating chronic obstructive pulmonary disease with inhaled fixed combinations: the Italian perspective of the PATHOS study.

PURPOSE: Fixed-dose combinations of inhaled corticosteroids and long-acting ß2-agonists have proven to prevent and reduce chronic obstructive pulmonary disease (COPD) exacerbations. The aim of this analysis was to explore the clinical consequences and direct health care costs of applying the findings of the PATHOS (An Investigation of the Past 10 Years Health Care for Primary Care Patients with Chronic Obstructive Pulmonary Disease) study to the Italian context. PATIENTS AND METHODS: Effectiveness data from the PATHOS study, a population-based, retrospective, observational registry study conducted in Sweden, in terms of reduction in COPD and pneumonia-related hospitalizations, were considered, in order to estimate the differences in resource consumption between patients treated with budesonide/formoterol and fluticasone/salmeterol. The base case considers the average dosages of the two drugs reported in the PATHOS study and the actual public price in charges to the Italian National Health Service, while the difference in hospitalization rates reported in the PATHOS study was costed based on Italian real-world data. RESULTS: The PATHOS study demonstrated a significant reduction in COPD hospitalizations and pneumonia-related hospitalizations in patients treated with budesonide/formoterol versus fluticasone/salmeterol (-29.1% and -42%, respectively). In the base case, the treatment of a patient for 1 year with budesonide/formoterol led to a saving of €499.90 (€195.10 for drugs, €193.10 for COPD hospitalizations, and €111.70 for pneumonia hospitalizations) corresponding to a -27.6% difference compared with fluticasone/salmeterol treatment. CONCLUSION: Treatment of COPD with budesonide/formoterol compared with fluticasone/salmeterol could lead to a reduction in direct health care costs, with relevant improvement in clinical outcomes.

Caffeine for apnea of prematurity: a neonatal success story.

Caffeine, a methylxanthine and nonspecific inhibitor of adenosine receptors, is an example of a drug that has been in use for more than 40 years. It is one of the most commonly prescribed drugs in neonatal medicine. However, until 2006, it had only a few relatively small and short-term studies supporting its use. It is thanks to the efforts of Barbara Schmidt and the Caffeine for Apnea of Prematurity (CAP) Trial Group that we now have high-quality and reliable data not only on short-term but also long-term outcomes of caffeine use for apnea of prematurity. CAP was an international, multicenter, placebo-controlled randomized trial designed to determine whether survival without neurodevelopmental disability at a corrected age of 18 months is improved if apnea of prematurity is managed without methylxanthines in infants at a high risk of apneic attacks. CAP was kept simple and pragmatic in order to allow for maximum generalizability and applicability. Infants with birth weights of 500-1,250 g were enrolled during the first 10 days of life if their clinicians considered them to be candidates for methylxanthine therapy. The most frequent indication for therapy reported in CAP was treatment of documented apnea, followed by the facilitation of the removal of an endotracheal tube. Only about 20% of the neonatologists in the trial started caffeine for the prevention of apnea and the findings of CAP cannot automatically be extrapolated to an exclusive prophylactic indication. However, recent data suggest that the administration of prophylactic methylxanthine by neonatologists is now common practice.

Comorbidities and medication burden in patients with chronic obstructive pulmonary disease attending pulmonary rehabilitation.

PURPOSE: Chronic obstructive pulmonary disease (COPD) is characterized by concomitant systemic manifestations and comorbidities such as cardiovascular disease. Little data exist on the prevalence of comorbidities and medication burden in people with COPD attending pulmonary rehabilitation (PR) programs in Australia. This study aimed to determine the prevalence of comorbidities and describe the type and number of medications reported in a sample of patients with COPD referred to PR. METHODS: A retrospective audit was conducted on patients referred to PR over a 1-year period. Data were collected on patient demographics, disease severity, comorbidities, and medications by review of patient notes, physician referral, and self-reported medication use. RESULTS: Data were available on 70 patients (forced expiratory volume in 1 second = 37.5 [26.0] % predicted). Ninety-six percent of patients had at least 1 comorbidity, and 29% had 5 or more. The most common comorbidities were associated with cardiovascular disease (64% of patients). Almost half of the sample was overweight or obese (49%). Prescription medication use was high, with 57% using between 4 and 7 medications, and 29% using 8 or more. CONCLUSIONS: Patients with COPD attending PR in Australia have high rates of comorbidity. The number of medications prescribed for these individuals is similar to that seen in other chronic disease states such as chronic heart failure. Pulmonary rehabilitation presents opportunities for clinicians to educate patients on self-management strategies for multiple comorbidities, review medication usage, and discuss strategies aimed at optimizing adherence with medication regimes.

[Costs of illness for asthma and COPD in adults in Germany]. / Krankheitskosten für Asthma und COPD bei Erwachsenen in der Bundesrepublik Deutschland.

UNLABELLED: BACKGROUND; Asthma and COPD have a high and growing epidemiological impact worldwide, and it is often indicated that significant economic costs are linked to this. The aim of this review is to estimate the cost-of-illness for both diseases for adults in Germany. METHODS: A systematic search of Pubmed, Embase, EconLit and Business Source Complete was performed for the years 1995-2012 to identify German cost-of-illness studies for asthma and COPD in German or English language. 6 studies for asthma, 7 studies for COPD and 1 for both diseases met the inclusion criteria. The results of the identified studies were extrapolated to 2010 prices and compared within the same disease. RESULTS: In spite of the heterogeneity in methodology and results, medication was identified as the most important component of direct costs and work loss as the most important component of indirect costs. All in all, the estimated costs per case of illness and year for asthma sum up to 445 to 2 543 € and for COPD to 1 212 to 3 492 €. CONCLUSION: The analysed cost-of-illness studies confirm that asthma and COPD are costly but results vary markedly. COPD due to its higher costs per case and its similar prevalence causes higher macroeconomic costs. Our results emphasise the economic relevance of prevention and disease management for these lung diseases.

Factors influencing the prescription of drugs of different price levels.

PURPOSE: Socioeconomic factors have been suggested to influence the prescribing of newer and more expensive drugs. In the present study, individual and health care provider factors were studied in relation to the prevalence of differently priced drugs. METHODS: Register data for dispensed drugs were retrieved for 18 486 individuals in a county council in Sweden. The prevalence of dispensed drugs was combined with data for the individual's gender, age, education, income, foreign background, and type of caregiver. For each of the diagnostic groups (chronic obstructive pulmonary disease [COPD], depression, diabetes, and osteoporosis), selected drugs were dichotomized into cost categories, lower and higher price levels. Univariate and multivariate logistic regressions were performed using cost category as the dependent variable and the individual and provider factors as independent variables. RESULTS: In all four diagnostic groups, differences were observed in the prescription of drugs of lower and higher price levels with regard to the different factors studied. Age and gender affected the prescription of drugs of lower and higher price levels more generally, except for gender in the osteoporosis group. Income, education, foreign background, and type of caregiver affected prescribing patterns but in different ways for the different diagnostic groups. CONCLUSIONS: Certain individual and provider factors appear to influence the prescribing of drugs of different price levels. Because the average price for the cheaper drugs versus more costly drugs in each diagnostic group was between 19% and 69%, there is a risk that factors other than medical needs are influencing the choice of drug.

Direct costs of chronic obstructive pulmonary disease among managed care patients.

PURPOSE: To estimate patient- and episode-level direct costs of chronic obstructive pulmonary disease (COPD) among commercially insured patients in the US. METHODS: In this retrospective claims-based analysis, commercial enrollees with evidence of COPD were grouped into five mutually exclusive cohorts based on the most intensive level of COPD-related care they received in 2006, ie, outpatient, urgent outpatient (outpatient care in addition to a claim for an oral corticosteroid or antibiotic within seven days), emergency department (ED), standard inpatient admission, and intensive care unit (ICU) cohorts. Patient- level COPD-related annual health care costs, including patient- and payer-paid costs, were compared among the cohorts. Adjusted episode-level costs were calculated. RESULTS: Of the 37,089 COPD patients included in the study, 53% were in the outpatient cohort, 37% were in the urgent outpatient cohort, 3% were in the ED cohort, and the standard admission and ICU cohorts together comprised 6%. Mean (standard deviation, SD) annual COPD-related health care costs (2008 US$) increased across the cohorts (P < 0.001), ranging from $2003 ($3238) to $43,461 ($76,159) per patient. Medical costs comprised 96% of health care costs for the ICU cohort. Adjusted mean (SD) episode-level costs were $305 ($310) for an outpatient visit, $274 ($336) for an urgent outpatient visit, $327 ($65) for an ED visit, $9745 ($2968) for a standard admission, and $33,440 for an ICU stay. CONCLUSION: Direct costs of COPD-related care for commercially insured patients are driven by hospital stays with or without ICU care. Exacerbation prevention resulting in reduced need for inpatient care could lower costs.

Inhaler costs and medication nonadherence among seniors with chronic pulmonary disease.

BACKGROUND: Chronic pulmonary diseases (CPDs) such as asthma and COPD are associated with particularly high rates of cost-related medication nonadherence (CRN), but the degree to which inhaler costs contribute to this is not known. Here, we examine the relationship between inhaler-specific out-of-pocket costs and CRN in CPD. METHODS: Using data obtained in 2006 in a national stratified random sample (N = 16,072) of community-dwelling Medicare beneficiaries aged >or= 65 years, we used logistic regression to examine the relationship between inhaled medications, various types of out-of-pocket costs, and CRN in persons with CPD. RESULTS: The prevalence of CRN in Medicare recipients with CPD using inhalers was 31%. In multivariate models, the odds that respondents with CPD using inhalers would report CRN was 1.43 (95% CI, 1.21-1.69) compared with respondents without CPD who were not using inhalers. Adjustment for out-of-pocket inhaler costs-but not adjustment for total medication costs or non-inhaler costs-eliminated this excess risk of CRN (OR, 0.95; 95% CI, 0.71-1.28). Patients paying > $20 per month for inhalers were at significantly higher risk for CRN compared with those who had no out-of-pocket inhaler costs. CONCLUSIONS: Individuals with CPD and high out-of-pocket inhaler costs are at increased risk for CRN relative to individuals on other medications. Physicians should be aware that inhalers can pose a particularly high risk of medication nonadherence for some patients.

Thiopurine S- methyltransferase [corrected] testing in idiopathic pulmonary fibrosis: a pharmacogenetic cost-effectiveness analysis.

Azathioprine in combination with N-acetylcysteine (NAC) and steroids is a standard therapy for idiopathic pulmonary fibrosis (IPF). Its use, however, is limited by its side effects, principally leukopenia. A genotypic assay, thiopurine S-methyltransferase (TPMT), has been developed that can potentially identify those at risk for developing leukopenia with azathioprine, and thereby limit its toxicity. In those with abnormal TPMT activity, azathioprine can be started at lower dose or an alternate regimen selected. Determine the cost-effectiveness of a treatment strategy using TPMT testing before initiation of azathioprine, NAC, and steroids in IPF by performing a computer-based simulation. We developed a decision analytic model comparing three strategies: azathioprine, NAC and steroids with and without prior TPMT testing, and conservative therapy, consisting of only supportive measures. Prevalence of abnormal TPMT alleles and complication rates of therapy were taken from the literature. We assumed a 12.5% incidence of abnormal TPMT alleles, 4% overall incidence of leukopenia while taking azathioprine, and that azathioprine, NAC, and steroids in combination reduced IPF disease progression by 14% during 12 months. TPMT testing before azathioprine, NAC, and steroids was the most effective and most costly strategy. The marginal cost-effectiveness of the TPMT testing strategy was $49,156 per quality adjusted life year (QALY) gained versus conservative treatment. Compared with azathioprine, NAC and steroids without prior testing, the TPMT testing strategy cost only $29,662 per QALY gained. In sensitivity analyses, when the prevalence of abnormal TPMT alleles was higher than our base case, TPMT was "cost-effective." At prevalence rates lower than our base case, it was not. TPMT testing before initiating therapy with azathioprine, NAC, and steroids is a cost-effective treatment strategy for IPF.

Discontinued drugs 2008: pulmonary and allergy.

This is the annual perspectives paper on discontinued drugs in the field of pulmonary disease and allergy. It is part of a series of papers discussing drugs dropped from clinical development in the previous year and presented according to therapeutic indication. Specifically, this paper presents the six pulmonary and five allergy drugs discontinued in 2008. Information for this perspective was derived from a search of the Pharmaprojects database for drugs discontinued after reaching Phase I - III clinical trials.

Exacerbation rate, health status and mortality in COPD--a review of potential interventions.

COPD is prevalent in Western society and its incidence is rising in the developing world. Acute exacerbations of COPD, about 50% of which are unreported, lead to deterioration in quality of life and contribute significantly to disease burden. Quality of life deteriorates with time; thus, most of the health burden occurs in more severe disease. COPD severity and frequent and more severe exacerbations are all related to an increased risk of mortality. Inhaled corticosteroids (ICS) have similar effects on quality of life but ICS/long-acting bronchodilator combinations and the long-acting antimuscarinic tiotropium all improve health status and exacerbation rates and are likely to have an effect on mortality but perhaps only with prolonged use. Erythromycin has been shown to decrease the rate of COPD exacerbations. Pulmonary rehabilitation and regular physical activity are indicated in all severities of COPD and improve quality of life. Noninvasive ventilation is associated with improved quality of life. Long-term oxygen therapy improves mortality but only in hypoxic COPD patients. The choice of an inhaler device is a key component of COPD therapy and this requires more attention from physicians than perhaps we are aware of. Disease management programs, characterized as they are by patient centeredness, improve quality of life and decrease hospitalization rates. Most outcomes in COPD can be modified by interventions and these are well tolerated and have acceptable safety profiles.

Pharmacoeconomics in COPD: lessons for the future.

COPD exerts a substantial burden on health and health care systems globally and will continue to do so for the foreseeable future. Treatment however can be costly and health care providers are interested in both whether treatments can offer improvements in disease burden and whether they represent value for money. Economic evaluations seek to resolve this issue by producing results that can be used to inform and assist the decision maker in allocating scarce health care resources. In this paper we introduce economic evaluation and then use these themes to review and critically appraise the existing COPD economic evaluations, in order to assess quality in light of today's standards. The use of existing economic evaluations in informing the decision maker is then discussed. Ten out of the fifteen studies were clinical trial or observational study based, and the remaining five on a decision analytic model. Study design, interventions, outcome measures and the use of uncertainty varied considerably; consequentially the results are difficult to compare in any consistent manner. Efforts for future studies to harmonize study design and methodology, particularly towards adopting a modeling framework, using current treatment as comparator and adopting a common effectiveness measure, such as the QALY, should be made in order to produce results that are comparable and useful to a decision maker.

Chronic airflow limitation in developing countries: burden and priorities.

Respiratory disease has never received priority in relation to its impact on health. Estimated DALYs lost in 2002 were 12% globally (similar for industrialized and developing countries). Chronic airflow limitation (due mainly to asthma and COPD) alone affects more than 100 million persons in the world and the majority of them live in developing countries. International guidelines for management of asthma (GINA) and COPD (GOLD) have been adopted and their cost-effectiveness demonstrated in industrialized countries. As resources are scarce in developing countries, adaptation of these guidelines using only essential drugs is required. It remains for governments to set priorities. To make these choices, a set of criteria have been proposed. It is vital that the results of scientific investigations are presented in these terms to facilitate their use by decision-makers. To respond to this emerging public health problem in developing countries, WHO has developed 2 initiatives: "Practical Approach to Lung Health (PAL)" and the Global Alliance Against Chronic Respiratory Diseases (GARD)", and the International Union Against Tuberculosis and Lung Diseases (The Union) has launched a new initiative to increase affordability of essential asthma drugs for patients in developing countries termed the "Asthma Drug Facility" (ADF), which could facilitate the care of patients living in these parts of the world.