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.

Cost-utility analysis of an integrated care program for children with asthma in a medium-income country.

OBJECTIVE: To evaluate the cost-utility of an integrated care program (ASMAIRE Infantil Program [PAI]) for children with asthma compared with standard of care. METHODS: A decision-analytic model was used to compare an integrated care program compared to the standard of care in children with asthma in Bogota, Colombia. Baseline characteristics of the patients were established according to the distribution of patients in the PAI database. Other inputs were obtained from published meta-analysis, local registries, medical bills, general mortality data, and expert opinion. Costs were presented in 2017 Colombian pesos. Outcomes included quality-adjusted life-years (QALYs). Costs and outcomes were discounted by 5% per year. Incremental cost-utility ratios were presented for PAI compared with standard of care. Univariate and multivariate probabilistic sensitivity analyses were conducted to assess model robustness to parameter uncertainty. RESULTS: The model predicted that patients that are part of the PAI would accrue more QALYs than patients on standard of care. The incremental results suggest that the PAI is a cost-effective treatment (incremental cost-utility ratio of Colombian pesos $33 753 817/QALY) compared with standard of care. Sensitivity analyses suggest that results are most sensitive to cost of care (with and without PAI) and costs of severe exacerbation. However, the PAI is cost-effective irrespective of variation in any of the input parameters. CONCLUSION: Our model predicted that an integrated intervention for the management of asthma in pediatric patients improves QALYs, reduces number of disease related exacerbations compared to standard therapy and is cost-effective for the long-term control of the disease in Colombia.

At-risk registers integrated into primary care to stop asthma crises in the UK (ARRISA-UK): study protocol for a pragmatic, cluster randomised trial with nested health economic and process evaluations.

BACKGROUND: Despite effective treatments and long-standing management guidelines, there are approximately 1400 hospital admissions for asthma weekly in the United Kingdom (UK), many of which could be avoided. In our previous research, a secondary analysis of the intervention (ARRISA) suggested an improvement in the management of at-risk asthma patients in primary care. ARRISA involved identifying individuals at risk of adverse asthma events, flagging their electronic health records, training practice staff to develop and implement practice-wide processes of care when alerted by the flag, plus motivational reminders. We now seek to determine the effectiveness and cost-effectiveness of ARRISA in reducing asthma-related crisis events. METHODS: We are undertaking a pragmatic, two-arm, multicentre, cluster randomised controlled trial, plus health economic and process evaluation. We will randomise 270 primary care practices from throughout the UK covering over 10,000 registered patients with 'at-risk asthma' identified according to a validated algorithm. Staff in practices randomised to the intervention will complete two 45-min eLearning modules (an individually completed module giving background to ARRISA and a group-completed module to develop practice-wide pathways of care) plus a 30-min webinar with other practices. On completion of training at-risk patients' records will be coded so that a flag appears whenever their record is accessed. Practices will receive a phone call at 4 weeks and a reminder video at 6 weeks and 6 months. Control practices will continue to provide usual care. We will extract anonymised routine patient data from primary care records (with linkage to secondary care data) to determine the percentage of at-risk patients with an asthma-related crisis event (accident and emergency attendances, hospitalisations and deaths) after 12 months (primary outcome). We will also capture the time to crisis event, all-cause hospitalisations, asthma control and any changes in practice asthma management for at-risk and all patients with asthma. Cost-effectiveness analysis and mixed-methods process evaluations will also be conducted. DISCUSSION: This study is novel in terms of using a practice-wide intervention to target and engage with patients at risk from their asthma and is innovative in the use of routinely captured data with record linkage to obtain trial outcomes. TRIAL REGISTRATION: ISRCTN95472706 . Registered on 5 December 2014.

Cost-Effectiveness of Biological Asthma Treatments: A Systematic Review and Recommendations for Future Economic Evaluations.

BACKGROUND: Recently developed asthma biological therapies have been shown to provide relief for severe asthma patients not controlled by inhaled treatment. Given the relatively high costs of biological therapies, cost-effectiveness analyses (CEAs) may be required as a prerequisite for coverage and reimbursement. OBJECTIVE: We aimed to systematically review published literature on the economic impact of biological asthma therapies and to identify key drivers that impact cost-effectiveness in order to provide recommendations for future economic evaluations. METHODS: We conducted a systematic literature search in PubMed and Google Scholar. We included studies that assessed the cost-effectiveness of asthma biologics and were published in English between 2000 and 2018. The Quality of Health Economic Studies (QHES) instrument was used to evaluate quality. RESULTS: Twenty asthma biological CEAs were identified. Nineteen studies analyzed the cost-effectiveness of omalizumab, and one study analyzed mepolizumab. Ten studies concluded that omalizumab was cost-effective in base-case scenarios, four studies concluded omalizumab was not cost-effective, and the remaining studies concluded omalizumab or mepolizumab was cost-effective only when targeted to specific severe subgroups or given considerable price discounts. Key drivers of cost-effectiveness included day-to-day health-related quality of life (HRQoL), asthma-related mortality, acquisition price of the biological therapy, and time horizon. CONCLUSIONS: Most studies recommended carefully targeting biological therapy to specific populations such as responders or discounting acquisition price in order to further improve value. The quality of the studies was generally satisfactory, but improved evidence is needed linking HRQoL to utilities as well as understanding interventions' impact on asthma-related mortality. Key recommendations from this review may allow for greater comparability across future cost-effectiveness studies.

[The patients' cost of the montelukast therapy due to the generic substitution]. / A montelukasztterápia betegterheinek változása a generikus árverseny hatására.

INTRODUCTION AND AIM: The aim of our study was to analyse the public price of the montelukast sodium therapy in Hungary. METHOD: Data derived from the nationwide pharmaceutical database of the Hungarian National Health Insurance Fund Administration. We observed the turnover and price of the medicaments containing the active substance montelukast sodium from 2007 to 2015. Accordingly, our indicators were: consumer price, DCT (daily cost of therapy), co-payment, quasi co-payment, DOT (days of treatment). RESULTS: Due to the increasing DOT, the total amount of the public price paid by the patients increased until 2011, reaching the amount of 1 million USD; then, due to the generic competition and the blind bid methods, it decreased to 490 000 USD. The total amount of the public price of the brand-name Singulair moved to the generics during 3 years (2011-2014). The DCT of the originator Singulair 10 mg tablets decreased from 1.1 USD to 0.34 USD; the DCT of the generic product Montelukast TEVA decreased from 0.67 USD to 0.16 USD in the period under review. CONCLUSION: Due to the generic competition, the patients' access to drugs containing montelukast sodium increased significantly: the DOT increased, the co-payment decreased. Orv Hetil. 2018; 159(17): 682-687.

Clinical and economic impact of a one-year treatment with omalizumab in patients with severe allergic asthma within a drug programme in Poland.

BACKGROUND: Allergic asthma is the most prevalent phenotype of severe asthma where treatment with omalizumab (OMB) has been proven to be particularly beneficial. In Poland, OMB therapy is available and reimbursed within a drug programme where strict inclusion and exclusion criteria are defined. The objective of this study was to present a descriptive analysis regarding the trends in outcomes (clinical, quality of life, costs) among a cohort of patients who satisfy inclusion criteria for the initiation of OMB treatment and who successfully responded to OMB according to a set of objective criteria. METHODS: A retrospective analysis of data collected during the 52 weeks of OMB treatment was carried out. The study population was adolescents and adults with severe allergic asthma that was uncontrolled despite a combination of high-dose inhaled corticosteroids (ICS)/long-acting beta-agonists (LABA) and/or other controllers (leukotriene receptor antagonists (LTRA), sustained-release theophylline, and short- or long-acting muscarinic antagonists (SAMA/LAMA), who were the first to finish the one-year treatment. A clinical and cost analysis for patients included in the programme was conducted comparing the one-year pre-treatment period to the one-year treatment period outcomes. RESULTS: Data of 85 patients who completed the first year of therapy were reviewed and analysed. Add-on OMB treatment resulted in a median decrease in exacerbation rate of 66% relative to the baseline and a reduction in oral steroid (OCS) dose by an average of 7.7 mg. At the end of the 52 weeks of therapy the changes in the quality of life questionnaire (AQLQ) and the asthma control questionnaire (ACQ) scores were 1.86 and 1.45 points, respectively. The mean cost of asthma treatment increased by an average of 15,979 EUR per patient per year (baseline period - 802 EUR/patient/year; OMB treatment - 16,781 EUR/patient/year). The cost to avoid one exacerbation was 17721 EUR. CONCLUSION: The clinical outcomes for the observed subset of patients were highly improved. At the same time, costs of the treatment increased, mainly due to the high OMB costs. Other costs associated with a lower number of hospitalizations and ED and office visits and a reduction in OCS dose decreased. These descriptive data can be used for further investigation in defining patients who benefit the most from OMB treatment in clinical practice.

Barriers to medication adherence in asthma: The importance of culture and context.

OBJECTIVE: Significant disparities exist in asthma outcomes. Racial and ethnic minorities have lower controller medication adherence, which may contribute to differences in asthma morbidity between minority and non-minority groups. The objective of this review is to identify individual, patient-provider communication, and systems issues that contribute to this pattern of medication underuse and to discuss potential strategies for intervention. DATA SOURCES: Data were gathered from numerous sources, including reports of pharmacy and medical records, observational studies, and trials. STUDY SELECTIONS: Studies analyzed factors contributing to patterns of asthma medication adherence that differ by race and ethnicity. RESULTS: There is clear evidence of underuse of asthma controller medications among racial and ethnic minorities in prescription receipt, prescription initiation, and medication use once obtained. Individual factors such as medication beliefs and depressive symptoms play a role. Provider communication is also relevant, including limited discussion of complementary and alternative medicine use, difficulties communicating with patients and caregivers with limited English proficiency, and implicit biases regarding cultural differences. Systems issues (eg, insurance status, cost) and social context factors (eg, exposure to violence) also present challenges. Culturally informed strategies that capitalize on patient strengths and training providers in culturally informed communication strategies hold promise as intervention approaches. CONCLUSION: Disparities in controller medication use are pervasive. Identifying the sources of these disparities is a critical step toward generating intervention approaches to enhance disease management among the groups that bear the greatest asthma burden.

Assessing the value of mepolizumab for severe eosinophilic asthma: a cost-effectiveness analysis.

BACKGROUND: Adding mepolizumab to standard treatment with inhaled corticosteroids and controller medications could decrease asthma exacerbations and use of long-term oral steroids in patients with severe disease and increased eosinophils; however, mepolizumab is costly and its cost effectiveness is unknown. OBJECTIVE: To estimate the cost effectiveness of mepolizumab. METHODS: A Markov model was used to determine the incremental cost per quality-adjusted life year (QALY) gained for mepolizumab plus standard of care (SoC) and for SoC alone. The population, adults with severe eosinophilic asthma, was modeled for a lifetime time horizon. A responder scenario analysis was conducted to determine the cost effectiveness for a cohort able to achieve and maintain asthma control. RESULTS: Over a lifetime treatment horizon, 23.96 exacerbations were averted per patient receiving mepolizumab plus SoC. Avoidance of exacerbations and decrease in long-term oral steroid use resulted in more than $18,000 in cost offsets among those receiving mepolizumab, but treatment costs increased by more than $600,000. Treatment with mepolizumab plus SoC vs SoC alone resulted in a cost-effectiveness estimate of $386,000 per QALY. To achieve cost effectiveness of approximately $150,000 per QALY, mepolizumab would require a more than 60% price discount. At current pricing, treating a responder cohort yielded cost-effectiveness estimates near $160,000 per QALY. CONCLUSION: The estimated cost effectiveness of mepolizumab exceeds value thresholds. Achieving these thresholds would require significant discounts from the current list price. Alternatively, treatment limited to responders improves the cost effectiveness toward, but remains still slightly above, these thresholds. Payers interested in improving the efficiency of health care resources should consider negotiations of the mepolizumab price and ways to predict and assess the response to mepolizumab.

Establishment of a standard reference material (SRM) herbal DNA barcode library of Vitex negundo L. (lagundi) for quality control measures.

The majority of the population in the Philippines relies on herbal products as their primary source for their healthcare needs. After the recognition of Vitex negundo L. (lagundi) as an important and effective alternative medicine for cough, sore throat, asthma and fever by the Philippine Department of Health (DOH), there was an increase in the production of lagundi-based herbal products in the form of teas, capsules and syrups. The efficiency of these products is greatly reliant on the use of authentic plant material, and to this day no standard protocol has been established to authenticate plant materials. DNA barcoding offers a quick and reliable species authentication tool, but its application to plant material has been less successful due to (1) lack of a standard DNA barcoding loci in plants and (2) poor DNA yield from powderised plant products. This study reports the successful application of DNA barcoding in the authentication of five V. negundo herbal products sold in the Philippines. Also, the first standard reference material (SRM) herbal library for the recognition of authentic V. negundo samples was established using 42 gene accessions of ITS, psbA-trnH and matK barcoding loci. Authentication of the herbal products utilised the SRM following the BLASTn and maximum-likelihood (ML) tree construction criterion. Barcode sequences were retrieved for ITS and psbA-trnH of all products tested and the results of the study revealed that only one out of five herbal products satisfied both BLASTn and ML criterion and was considered to contain authentic V. negundo. The results prompt the urgent need to utilise DNA barcoding in authenticating herbal products available in the Philippine market. Authentication of these products will secure consumer health by preventing the negative effects of adulteration, substitution and contamination.

Cost-Effectiveness of Bronchial Thermoplasty, Omalizumab, and Standard Therapy for Moderate-to-Severe Allergic Asthma.

BACKGROUND: Bronchial thermoplasty (BT) is a recently developed treatment for patients with moderate-to-severe asthma. A few studies have suggested the clinical efficacy of this intervention. However, no study has evaluated the cost-effectiveness of BT compared to other alternative treatments for moderate-to-severe allergic asthma, which currently include omalizumab and standard therapy. OBJECTIVE: To evaluate the cost-effectiveness of standard therapy, BT, and omalizumab for moderate-to-severe allergic asthma in the USA. METHODS: A probabilistic Markov model with weekly cycles was developed to reflect the course of asthma progression over a 5-year time horizon. The study population was adults with moderate-to-severe allergic asthma whose asthma remained uncontrolled despite using high-dose inhaled corticosteroids (ICS, with or without long-acting beta-agonists [LABA]). A perspective of the health-care system was adopted with asthma-related costs as well as quality-adjusted life years (QALYs) and exacerbations as the outcomes. RESULTS: For standard therapy, BT, and omalizumab, the discounted 5-year costs and QALYs were $15,400 and 3.08, $28,100 and 3.24, and $117,000 and 3.26, respectively. The incremental cost-effectiveness ratio (ICER) of BT versus standard therapy and omalizumab versus BT was $78,700/QALY and $3.86 million/QALY, respectively. At the willingness-to-pay (WTP) of $50,000/QALY and $100,000/QALY, the probability of BT being cost-effective was 9%, and 67%, respectively. The corresponding expected value of perfect information (EVPI) was $155 and $1,530 per individual at these thresholds. In sensitivity analyses, increasing the costs of BT from $14,900 to $30,000 increased its ICER relative to standard therapy to $178,000/QALY, and decreased the ICER of omalizumab relative to BT to $3.06 million/QALY. Reducing the costs of omalizumab by 25% decreased its ICER relative to BT by 29%. CONCLUSIONS: Based on the available evidence, our study suggests that there is more than 60% chance that BT becomes cost-effective relative to omalizumab and standard therapy at the WTP of $100,000/QALY in patients with moderate-to-severe allergic asthma. However, there is a substantial uncertainty in the underlying evidence, indicating the need for future research towards reducing such uncertainty.

[The effect of generic price competition on drug consumption and health insurance pharmaceutical expenditures in Hungary]. / A generikus árverseny hatása a gyógyszerforgalomra es a társadalombiztosítási támogatás kiáramláisra Magyarországon.

AIM: The aim of our study was to analyze the Hungarian montelukast sodium drug market. We examined the effect of the appearance of generic drugs on the price and turnover of the brand-name drug, Singulair. DATA AND METHODS: Data derived from the nationwide pharmaceutical database of Hungarian National Health Insurance Fund Administration (2007-2014). We analized the turnover and price of the medicaments containing the active substance montelukast sodium. Accordingly our indicators were: consumer price, social insurance subsidy, patients' co-payment and days of treatment (DOT). RESULTS: First the generics started from a significantly lower price of 18 USD which was lower than the price of brand-name Singulair (32 USD). Then the prices of the generics started to diminish. While in 2007 the DOT was below 2 million, it increased over 10 million days by 2014. The increase of DOT was followed by the increase of health insurance subsidy until 2011. Then the amount of health insurance subsidy decreased from 10,5 million USD to 7 million USD in 2012. In 2013 and 2014 there was a further reduction, the amount of the health insurance subsidy decreased to 4,1 million USD in 2013, and in 2014 it was reduced to 2.2 million USD. CONCLUSIONS: Following the introduction of generic drugs, the price of the medicaments containing montelukast sodium was significantly reduced, while the days on treatment (DOT) increased. The patients' access to drugs containing montelukast sodium increased significantly. The annual health insurance subsidy was significantly reduced as well.

The "e" in cost-effectiveness analyses. A case study of omalizumab efficacy and effectiveness for cost-effectiveness analysis evidence.

This article is a call for increased use of real-world evidence in health technology assessment and related policy and decision making. There is currently a disconnect between evidence used to guide regulatory approval of therapies and evidence used to inform therapeutic coverage and reimbursement decisions. Public and private payers need to understand not only whether an intervention works but also whether it offers good value compared with licensed alternatives (not placebo) as they are used in the real-world practice and population (not in a controlled trial environment). Addressing such concerns requires evidence to be drawn from a wide range of study designs, but with consideration and weighting given to their relative strengths and weaknesses, as well as their position on the pragmatic-explanatory (i.e., effectiveness-efficacy) continuum. The potential impact of using different types of evidence to inform cost-effectiveness analysis (CEA) is discussed for omalizumab, comparing and contrasting a CEA model informed by an omalizumab efficacy trial to a CEA model drawing primarily on evidence from effectiveness observational studies of omalizumab. There was reasonable agreement between the two omalizumab CEA models, although the incremental cost-effectiveness ratio generated by the effectiveness observational study-driven model was more favorable for omalizumab. Health technology assessment bodies and payers must use their judgment to determine which components of efficacy-based and effectiveness-based CEA evidence are most closely aligned with their goals. For each CEA evidence component, perhaps the two E's form bounds of the truth as well as a fuller picture of the uncertainty surrounding the truth.

Comparison of the adherence and persistence to inhaled corticosteroids among adult patients with public and private drug insurance plans.

BACKGROUND: Despite important differences in reimbursement procedures between private and public drug insurance plans in Quebec (Canada), no study has evaluated the impact of the type of drug insurance on the use of essential medications such as inhaled corticosteroids (ICS). The lack of data might be attributable, at least in part, to the absence of a provincial medication database for patients with private drug insurance. OBJECTIVES: To compare patient's adherence and persistence to ICS between Quebec residents (Canada) with private and public drug insurance. METHODS: A matched cohort design with patients selected from the database of the Régie de l'assurance maladie du Québec (RAMQ) and from reMed, a database that we have put in place for Quebec residents covered by a private drug insurance, was used. ICS users with private drug insurance were selected from reMed between 2008 and 2010 and matched to ICS users with public drug insurance selected from the RAMQ database. Patient's adherence, measured with the proportion of prescribed days covered (PPDC) and persistence over one year, was compared between patients privately and publicly insured using linear regression and Cox regression models. RESULTS: This study included 330 and 1,109 ICS users with private and public drug insurance, respectively. Patients privately insured were significantly less adherent than patients publicly insured (adjusted mean difference of PPDC: -9.7%; 95% CI: -13.2% to -6.5%). Moreover, patients privately insured were found to be 52% more likely to stop ICS during the first year than patients publicly insured (adjusted HR=1.5; 95% CI: 1.2 to 2.0). CONCLUSIONS: Although adherence and persistence were rather low in both groups, patients with public drug insurance appeared to have greater adherence and persistence to ICS than patients with private drug insurance. Differences in reimbursement policies might explain the observed differences.

[On general practitioners' care of patients with asthma]. / HausärztlicheVersorgung von Patienten mit Asthma.

UNLABELLED: This review offers readers new aspects for the guideline-compliant care of asthma patients. Here, attention is focused on illustrating the bottlenecks in the administration of good and practicable therapeutic care and listing these as "major challenges for GPs". The interdisciplinary team of authors - consisting of three hospital-based pulmonologists, one pulmonologist in private practice, one internist in general practice, one pharmacist and one health economist discussed aspects of asthma therapy relevant in clinical practice. RESULTS AND CONCLUSIONS: Practicable results for the reader included an asthma pentagram, a graphic depicting the links and interactions between diagnosis, symptom management, communication, application and costs. From this emerged a consensus on four recommendations that can help GPs improve their care of their patients: (1) Whenever possible, have a specialist verifythe diagnosis. (2) Practice inhalation techniques with the patient and check up on their technique at regular intervals. (3) Monitor and fine-tune the therapeutic goals set down together with the patient. (4) Clearly define the (patient's) responsibilities and who is organizing care (communication between GP-specialist-patient-pharmacist-family members).

Economic costs for adult asthmatics according to severity and control status in Korean tertiary hospitals.

OBJECTIVE: The prevalence of asthma is increasing, and asthma causes considerable socioeconomic burden worldwide. Few studies have been conducted to evaluate the risk factors associated with economic cost of asthma in Korea. This study evaluated asthma cost according to severity, control, and patient factors in Korean tertiary hospitals. METHODS: Direct and indirect costs were assessed in physician-diagnosed adult asthmatics recruited from eight tertiary hospitals in Korea. Official direct medical costs were derived from the analysis of 1-year expenditures related to hospital care utilization and asthma medication. Nonofficial medical costs, nonmedical direct costs, and indirect costs were investigated using a questionnaire designed specifically for the study. RESULTS: A total of 314 patients with persistent asthma were recruited. Both direct and indirect costs were significantly higher for patients with severe persistent asthma than for those with mild and moderate persistent asthma ($2214 vs. $871 and $978, p < .001; $2927 vs. $490 and $443, p < .001, respectively). Costs of asthma increased significantly in poorly controlled compared with somewhat controlled and well-controlled asthma ($7009.8 vs. $2725.3 vs. $1517.3, respectively; p < .001). After stratification for severity, a significant cost increase in the poorly controlled asthma group was observed only for indirect costs and not for direct costs. A multivariate analysis showed that female gender was a risk factor for increased indirect costs. CONCLUSION: The burden of asthma was higher both for patients with severe persistent asthma and for patients with poorly controlled asthma. More effective strategies are needed to improve control status, particularly targeting patients with severe asthma.

[Cost effectiveness of treatment with salmeterol/fluticasone compared to montelukast for the control of persistent asthma in children]. / Costo-efectividad del tratamiento de salmeterol/fluticasona en comparación con leucotrieno montelukast para el control del asma infantil.

OBJECTIVE: To assess the incremental cost-effectiveness of SFC compared with MON for the control of persistent asthma in children. METHODS: We conducted an economic evaluation on a 12-week prospective randomized open-label parallel-group comparison of SFC versus MON in children with symptomatic asthma receiving inhaled corticosteroids and short-acting ß2-agonists. Asthma-related medication, unscheduled physician contacts and hospitalizations were collected prospectively. The main effectiveness measure was percentage of asthma-controlled week with no short-acting ß2-agonist use during the study period. The analysis was conducted from the Mexican healthcare perspective using 2010 unit cost prices, and only direct costs were considered, all costs are reported in US dollar. . The model was made fully probabilistic to reflect the joint uncertainty in the model parameters. RESULTS: Over the whole treatment period, the median percentages of asthma-controlled weeks were 83.3% in the SFC group and 66.7% in the MON group (SFC-MON difference, 16.7%; 95% CI, 8.3-16.7; P < 0.001 in favor of SFC). The mean total cost of the SFC regimen was $ 2,323 compared with $ 3,230 for the MON regimen. The SFC was the dominant strategy (both more effective and less expensive) using the SFC was associated with an incremental cost per additional asthma-controlled of $ (5,467). Probabilistic sensitivity analysis tested numerous assumptions about the model cost and efficacy parameters and found that the results were robust to most changes. CONCLUSIONS: This analysis demonstrates that, compared with MON, SFC may be cost saving from the Mexican health care perspective for the treatment of pediatric patients with asthma. SFC provided a reduction in the number of severe exacerbations, frequent asthma symptoms and rescue medication use. Incremental cost-effectiveness analysis indicated the dominance of SFC because of both lower costs and greater efficacy.

Towards the Grade of Recommendations, Assessment, Development and Evaluation system: methods and results of budesonide/formoterol maintenance and reliever therapy research.

PURPOSE OF REVIEW: Guidelines for clinical practice are expected to gather evidence-based recommendations to support optimal medical behaviours. The aim of the current review is to explore how currently available research regarding the strategy of using budesonide/formoterol (BUD/FORM) as maintenance and reliever therapy (Symbicort SMART) covers the items considered by the Grade of Recommendations, Assessment, Development and Evaluation (GRADE) system, through a comparative analysis of methodological approaches, clinical outcomes, patient-reported outcomes and costs, in order to highlight uncovered areas. RECENT FINDINGS: Thirteen trials providing data on 21 095 analysed patients were available. No serious limits in methodological study features were found. Evaluation of the clinical outcome was consistent with the efficacy of BUD/FORM maintenance and reliever therapy. As the time to first exacerbation was the primary outcome in most of the studies, conclusive indications cannot be drawn regarding other clinical outcomes or patient-reported outcomes, which were investigated as secondary outcomes. A comprehensive systematic review exploring all critical and important outcomes is desirable, but further research concerning the safety issues of Long Acting ß2 Agonists (LABA) and patients' reported outcomes about the SMART in respect to alternative strategies is likely to affect a clear recommendation in the near future. SUMMARY: The efficacy of BUD/FORM maintenance and reliever therapy in extending the time to first exacerbation appears consistent between studies. Further studies exploring all patients' important outcomes are needed. Clinical and economic assessments are worthy of being investigated to verify the directness of the evidence in respect to real life patients and different geographical realities.

Regional variation and adherence to guidelines for drug treatment of asthma.

AIMS: To describe the utilization of antiasthmatic drugs in Sweden and to explore regional variations in drug utilization and adherence to guidelines for rational drug prescribing of antiasthmatics and their rationale. METHODS: Data on antiasthmatic drugs dispensed between July 2005 and December 2008 to all Swedish citizens aged between 18 and 44 years were obtained from the Swedish National Prescribed Drug Register. The period prevalence was determined by analyzing the number of users/1000 inhabitants, and the incidence by analyzing the number of new users after an 18-month drug-free wash-out period. Three drug-related indicators were used to assess the adherence to guidelines. All measures were analyzed by gender and region. RESULTS: A total of 161,000 patients were dispensed antiasthmatics in 2007, corresponding to a prevalence of 4 and 6% among men and women, respectively; the incidence rates were 2 and 3%, respectively. The total drug utilization and adherence to guidelines varied between regions. The total drug expenditures of antiastmatics were 258 million SEK (28 million euro), with fixed dose combinations accounting for 46% of the expenditure. No relation was found between models for allocating prescribing budgets or clear Drug and Therapeutics Committee recommendations and adherence to guidelines. CONCLUSION: There are large regional variations in the utilization of antiasthmatics between Swedish regions, with substantial room for improvement in the adherence to guidelines. New methods of influencing physician behavior may be needed in the future to enhance adherence.