Cost-utility of tiotropium in patients with severe asthma.

Add-on therapy with tiotropium was cost-effective when added to usual care in patients who remain uncontrolled despite treatment with medium or high-dose ICS/LABA in a middle-income country. BACKGROUND: A significant proportion of asthma patients remain uncontrolled despite inhaled corticosteroids and long-acting beta-agonists. Some add-on therapies, such as tiotropium bromide, have been recommended for this subgroup of patients. This study aimed to assess the cost-effectiveness of tiotropium as an add-on therapy to inhaled corticosteroids and long-acting b2 agonists for patients with severe asthma. METHODS: A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with severe asthma in Colombia. Total costs and QALYs of two interventions include standard therapy with inhaled corticosteroids and long-acting bronchodilators versus add-on therapy with tiotropium. Multiple sensitivity analyses were conducted. Cost-effectiveness was evaluated at a willingness-to-pay value of $5180. RESULTS: The expected incremental cost per QALY (ICER) is estimated at US$-2637.59. There is a probability of 0.77 that tiotropium + ICS + LABA is more cost-effective than ICS + LABA at a threshold of US$5180 per QALY. The strategy with the highest expected net benefit is Tiotropium, with an expected net benefit of US$800. Our base-case results were robust to parameter variations in the deterministic sensitivity analyses. CONCLUSION: Add-on therapy with tiotropium was cost-effective when added to usual care in patients who remain uncontrolled despite treatment with medium or high-dose inhaled corticosteroids and long-acting bronchodilators. 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.

Cost-effectiveness of linezolid to ventilator-associated pneumonia in Colombia.

INTRODUCTION: Ventilator-associated pneumonia (VAP) is a prominent cause of morbidity and mortality in intensive care unit (ICU) patients. Due to the increase in Methicillin resistant Staphylococcus aureus infection, it is important to consider other more effective and safer alternatives compared to vancomycin. This motivates evaluating whether the use of an apparently more expensive drug such as linezolid can be cost-effective in Colombia. METHODS: A decision tree was used to simulate the results in terms of the cost and proportion of cured patients. In the simulation, patients can receive antibiotic treatment with linezolid (LZD 600 mg IV/12 h) or vancomycin (VCM 15 mg/kg iv/12 h) for 7 days, patients they can experience events adverse (renal failure and thrombocytopenia). The model was analyzed probabilistically, and a value of information analysis was conducted to inform the value of conducting further research to reduce current uncertainties in the evidence base. Cost-effectiveness was evaluated at a willingness-to-pay (WTP) value of US$5180. RESULTS: The mean incremental cost of LZD versus VCM is US$-517. This suggests that LZD is less costly. The proportion of patients cured when treated with LZD compared with VCM is 53 vs. 43%, respectively. The mean incremental benefit of LZD versus VCM is 10 This position of absolute dominance (LZD has lower costs and higher proportion of clinical cure than no supplementation) is unnecessary to estimate the incremental cost-effectiveness ratio. There is uncertainty with a 0.999 probability that LZD is more cost-effective than VCM. Our base-case results were robust to variations in all assumptions and parameters. CONCLUSION: LNZ is a cost-effective strategy for patients, ≥ 18 years of age, with VAP in Colombia- Our study provides evidence that can be used by decision-makers to improve clinical practice guidelines.

Corticosteroids for the treatment of respiratory infection by Mycoplasma pneumoniae in children: A cost-utility analysis.

INTRODUCTION: Increasing evidence has demonstrated the effectiveness and safety of corticosteroids in community-acquired pneumonia in children. More economic evaluations incorporating the new evidence and in the pediatric population are needed to know the efficiency of this treatment. This study aimed to evaluate the cost utility of the use of corticosteroids as adjuvant treatment for children with Mycoplasma pneumonia. METHODS: A decision tree model was used to estimate the cost and quality adjusted life years (QALY) associated with cost-effectiveness as an adjunct treatment for children with Mycoplasma pneumonia with persistent signs after standard treatment with macrolide drugs for ≥1 week. Multiple sensitivity analyses were conducted. RESULTS: The QALYs per person estimated in the model for those treatments were 0.92 with corticosteroids plus antibiotics and 0.91 with antibiotics. The total costs per person were US$965 for corticosteroids plus antibiotics and US$1271 for antibiotics. This position of absolute dominance of corticosteroids plus antibiotics over antibiotics makes it unnecessary to estimate the incremental cost-effectiveness ratio. CONCLUSION: Corticosteroids are cost-effective as an adjunct treatment for children with Mycoplasma pneumoniae pneumonia with persistent signs after standard treatment with macrolide drugs for ≥1 week. Our evidence should motivate the evaluation of this treatment in other countries.

Cost-utility of ambrisentan and bosentan for pediatric pulmonary arterial hypertension.

INTRODUCTION: Despite the increasing evidence supporting the efficacy of ambrisentan and bosentan in improving functional classes among pediatric patients with pulmonary arterial hypertension (PAH), there is a lack of information regarding their cost implications. Therefore, the objective of this study is to assess the cost-utility of bosentan compared to ambrisentan for the treatment of pediatric patients with PAH in Colombia. METHODS: We employed a Markov model to estimate the costs and quality-adjusted life-years (QALYs) associated with the use of ambrisentan or bosentan in pediatric patients diagnosed with pulmonary arterial hypertension (PAH). To ensure the reliability of our findings, we conducted sensitivity analyses to assess the robustness of the model. In our cost-effectiveness analysis, we evaluated the outcomes at a willingness-to-pay (WTP) threshold of US$5,180. RESULTS: The expected annual cost per patient receiving ambrisentan was estimated to be $16,055 (95% CI 15,937 -16,172), while for bosentan it was $14,503 (95% CI 14,489 -14,615). The QALYs per person estimated for ambrisentan were 0.39 (95% CI 0.381-0.382), whereas for bosentan it was 0.40 (95% CI 0.401-0.403). CONCLUSION: Our economic evaluation shows that ambrisentan is not cost-effective regarding bosentan to in treating pulmonary arterial hypertension in C.

Cost-utility of vitamin D supplementation to prevent acute respiratory infections in children.

INTRODUCTION: Increasing evidence has demonstrated the effectiveness and safety of vitamin D supplementation to prevent acute respiratory infections in children. More economic evaluations incorporating the new evidence and in the pediatric population are needed to know the efficiency of this treatment. This study aimed to determine the cost-utility of vitamin D supplementation to prevent acute respiratory infections in pediatric patients. METHODS: A decision tree model was used to estimate the cost and quality-adjusted life-years (QALYs) of vitamin D supplementation in healthy school children between 1 and 16 years. Multiple sensitivity analyses were conducted. Cost-effectiveness was evaluated at a willingness-to-pay (WTP) value of $19,000. RESULTS: The base-case analysis showed that vitamin D supplementation was associated with lower costs and higher QALYs than strategy without this supplementation. The QALYs per person estimated in the model for those treatments were 0,99 with vitamin D supplementation and 0,98 without vitamin D supplementation. The total costs per person were US$ 1354 for vitamin D supplementation and US$ 1948 without vitamin D supplementation. This position of absolute dominance of vitamin D supplementation makes it unnecessary to estimate the incremental cost-effectiveness ratio. CONCLUSION: In conclusion, our study shows that Vitamin D supplementation is a cost-effective strategy to prevent ARI in pediatric patients, from a societal perspective.

Vitamin D supplementation for children with mild to moderate asthma: an economic evaluation.

INTRODUCTION: A large proportion of asthma patients remain uncontrolled despite using inhaled corticosteroids. Some add-on therapies such as vitamin D supplements have been recommended for this subgroup of patients. The purpose of this study was to assess the cost-utility of vitamin D supplementation in children with mild to moderate persistent asthma in Colombia. METHODS: A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with severe asthma in Colombia. The model was analyzed probabilistically, and a value of information (VOI) analysis was conducted to inform the value of conducting further research to reduce current uncertainties in the evidence base. Cost-effectiveness was evaluated at a willingness-to-pay (WTP) value of US$5180. RESULTS: The mean incremental cost of vitamin D supplementation versus no supplementation is USD $44.60. The mean incremental benefit of vitamin D supplementation versus no supplementation is 0.05 QALY. This position of absolute dominance (vitamin D supplementation has lower costs and higher QALYs than no supplementation) is unnecessary to estimate the incremental cost-effectiveness ratio. Our base-case results were robust to variations in all assumptions and parameters. CONCLUSION: Add-on therapy with vitamin D supplementation is a cost-effective strategy for patients between 6 and 17 years of age with mild to moderate asthma in Colombia.

The role of high carbohydrate-rich food intake and severity of asthma exacerbation in children between 2 to 6 years aged.

INTRODUCTION: Over the last decades, dietary habits in developing countries have been characterized by low intake of fruits and vegetables and high consumption of sweetened drinks. Most of the evidence linking carbohydrate intake and asthma comes from children over 6 years of age. The aim of this study was to examine the association between macronutrient intake and the severity of asthma exacerbations in children aged 2-6 years. METHODS: We performed a cross-sectional study that included all children aged 2-6 years hospitalized due to an asthma exacerbation. Dietary data were collected using a food frequency questionnaire (FFQ) validated in the Colombian population. The GINA classification of acute asthma was used to define the severity. To identify factors independently associated with asthma exacerbation severity, we fit the data to ordinal logistic regression. RESULTS: During the study period, 228 cases of patients with asthma exacerbation were included. Asthma severity was dose-dependently associated with protein and carbohydrate-rich intake. The variables included in the multivariable analysis included reactive C protein (OR 1.05, CI 95% (1.03-1.07)), smoking at home (OR 3.92 (1.82-8.44)), atopic dermatitis (OR 3.82 (1.59-9.21)), and protein and carbohydrate-rich food intake (OR 0.11 (0.03-0.33)) and (OR 2.42 (1.09-5.80)), respectively. CONCLUSION: High carbohydrate-rich food intake is associated with the severity of asthma exacerbation adjusted by other known risk factors such as atopy, smoking, and reactive C protein. This evidence should motivate the development of public health policies to control the consumption of sugar-rich products in children under 6 years.

Comparison of three alternatives for the management of moderate asthma in children aged 6-11 years: a cost-utility analysis.

BACKGROUND: Recent asthma guidelines for children 6-11 years with persistent asthma advocate three alternatives: SMART (budesonide/formoterol 80/4.5 mcg qd plus additional doses as needed), fixed combination of budesonide/formoterol, and fixed-dose budesonide. Concerns have arisen as to which of the proposed alternatives has the best possible cost-effectiveness profile. This study aimed to assess the health and economic consequences of SMART, fixed combination, and fixed-dose budesonide therapy in children 6-11 years old with persistent asthma. METHODS: A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with persistent asthma. Total costs and QALYs of SMART, fixed combination, and fixed-dose budesonide therapy were calculated over a time horizon of 6 years. Multiple sensitivity analyses were conducted. RESULTS: The mean QALY per patient was 0.57 and 0.56 QALYs per patient per year of SMART and fixed combination and 0,52 with fixed-dose budesonide. The total mean of discounted costs per patient per cycle were US$111 for SMART, US$133 for fixed combination, and US$67 for fixed-dose budesonide. The net monetary benefit of SMART was US$12,549, US$12278 for fixed combination, and US$11,380 for fixed-dose budesonide. CONCLUSION: Our study showed that SMART was more cost-effective than fixed combination and fixed-dose budesonide. These findings complement and support the GINA 2021 and National Asthma Education and Prevention Program asthma guideline recommendations for use of inhaled corticosteroids-formoterol in children 6-11 years old with persistent asthma.

Fluticasone furoate plus vilanterol in patients with moderate persistent asthma: a cost-utility analysis.

BACKGROUND: In recent years, the combination of fluticasone furoate and vilanterol (FF/VI) has emerged as an alternative therapy, since it is administered every 24 h, in contrast to other ICS/LABAs such as fluticasone propionate plus salmeterol (FP/Salm), which requires administration every 12 h. Concerns have arisen over whether the benefit generated by FF/VI justifies the additional costs it involves over FP/Salm. This study aimed at assessing the health and economic consequences of FF/VI in patients with moderate-severe persistent asthma. METHODS: A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with persistent asthma. Total costs and QALYs for FF/VI and FP/Salm 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: We estimated a gain of 16.8 and 10.7 QALYs per patient per year on FF/VI and FP/Salm, respectively. At the same time, we observed a difference of US$216 in total discounted cost per person-year on FF/VI with respect to FP/Salm. The incremental cost-effectiveness ratio (ICER) of FF/VI was USD $70 per QALY with respect to FP/Salm. In the deterministic and probabilistic sensitivity analyses, our base-case results were robust to variations in all assumptions and parameters. CONCLUSION: FF/VI is more cost-effective than FP/Salm. The evidence supports using FF/VI therapy in Colombia, and the study should be replicated in other middle-income countries.

Tiotropium for children and adolescents with severe asthma.

INTRODUCTION: An important proportion of asthma patients remain uncontrolled despite using inhaled corticosteroids and long-acting beta-agonists. Some add-on therapies, such as tiotropium bromide has been recommended for this subgroup of patients. The purpose of this study was to assess the cost-effectiveness of tiotropium as add-on therapies to ICS + LABA for children and adolescents with uncontrolled allergic asthma. METHODS: A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with severe asthma in Colombia. Total costs and QALYS of two interventions including standard therapy (ICS + LABA), and add-on therapy with tiotropium, were calculated over a time horizon from 6 to 18 years. Probability sensitivity analyses were conducted. RESULTS: For a patient with severe asthma, our Markov model showed that compared to standard therapy, add-on therapy with tiotropium was associated with higher treatment costs and QALY. The incremental cost-effectiveness ratio estimated was US$2,017 in the probabilistic model after Monte-Carlo simulation. Our base-case results were robust to variations in all assumptions and parameters. The incremental net monetary benefit of US$327 with a 95% credible interval of US$396 to US425. CONCLUSION: Add-on therapy with tiotropium was cost-effective when added to usual care in children and adolescents with severe asthma who remained uncontrolled despite treatment with medium or high-dose ICS/LABA. 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.

OM-85 BV in pediatric recurrent respiratory tract infections: a cost-utility analysis.

BACKGROUND: Despite the growing evidence on efficacy, little is known regarding the cost-utility of Vaxom/Imocur (OM-85 BV) supplementation to decrease the probability of recurrent respiratory tract infections in OM-85 BV to reduce the incidence of recurrent respiratory tract infections in children. METHODS: A decision tree model was used to estimate the cost and quality-adjusted life-years (QALYs) of OM-85 BV in a patient aged 1-6 with a history of recurrent respiratory tract infections. Multiple sensitivity analyses were conducted to evaluate the robustness of the model. Cost-effectiveness was evaluated using the willingness-to-pay defined for Colombia of US$5180 per QALY. The time horizon defined was six months. Costs were estimated from a societal perspective. RESULTS: The expected annual cost per patient with OM-85 BV was US$843 and with placebo was US$1167. The QALYs per person estimated with OM-85 BV was 0.91 and with placebo was 0.89. CONCLUSION: In conclusion, our study shows that OM-85 BV is a cost-effective strategy to reduce the incidence of recurrent respiratory tract infections in children. Our study provides evidence that should be used by decision-makers to improve clinical practice guidelines.

Impact of the updating of clinical guidelines for RSV bronchiolitis on the use of diagnostic testing and medications in tertiary hospitals in Colombia.

Introduction: the incidence of Respiratory Syncytial Virus (RSV) infection and their variability in the clinical management, make this disease a candidate for monitoring adequate use of resources. The objective of this study was to evaluate the impact of the updating of clinical guidelines for RSV bronchiolitis on the use of diagnostic testing and medications in tertiary hospitals in Colombia. Methods: we performed a cross-sectional study, evaluating the frequencies of drug prescription and medical tests, before (January-December 2016) and after (January to December 2019) of updating and dissemination of a new protocol for the treatment of RSV bronchiolitis in two tertiary hospitals in Colombia. Results: a total of 108 patients with RSV bronchiolitis were included. The demographic characteristics and clinical manifestations were similar in both groups. The length of hospital stays was similar in both groups. We did not find statistically significant differences in the frequency of medical tests. There was a decrease in the use of salbutamol (67.3% pre-protocol vs 51.8% post-protocol; P < .01). There were also significant reductions in the use of nebulized hypertonic saline solution (91.6% vs 82.6% P = 0.004). Conclusion: our results demonstrate that the updating of clinical guidelines for RSV bronchiolitis was effective, as it achieved decreases in the use of bronchodilators and nebulized hypertonic saline solution. It is necessary to continue developing new strategies targeted to increase adherence to guidelines and evaluate the impact on the use of resources.

Cost-utility analysis of dupilumab add on therapy versus standard therapy in adolescents and adults for severe asthma in Colombia.

INTRODUCTION: Dupilumab is a recombinant human IgG4 monoclonal antibody that inhibits IL-4 and IL-13 signaling. This drug raises concerns about the economic impact in scenarios with constrained resources. This study aimed to estimate the cost-utility of dupilumab plus standard care (SoC) vs SoC alone in adolescents and adults with severe asthma and eosinophilic phenotype. METHODS: A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with uncontrolled allergic asthma in Colombia. Total costs and QALYs of standard therapy (ICS + LABA), add-on therapy with dupilumab, were calculated over a lifetime horizon. Multiple sensitivity analyses were conducted. Cost-effectiveness was evaluated at a willingness-to-pay (WTP) value of $19,000. RESULTS: The base-case analysis showed dupilumab was associated with higher annual annual per-patient costs (US$5,719 for dupilumab and US$1,214 for standard therapy) and higher QALYs than standard therapy (fe  4.06 QALYs vs 3.97 QALYs, respectively). . The incremental cost-effectiveness ratio estimated was US$50,160 per QALY gained. CONCLUSION: Dupilumab is not cost-effective using a WTP of US$19000 per QALY threshold in Colombia. 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.

Cost-utility of azithromycin in patients with severe asthma.

BACKGROUND: An important proportion of asthma patients remain uncontrolled despite the use of inhaled corticosteroids and long-acting beta-agonists. Some add-on therapies, like azithromycin, have been recommended for this subgroup of patients. The purpose of this study was to assess the cost-effectiveness of azithromycin as an add-on therapy to ICS + LABA for patients with severe asthma. METHODS: A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with severe asthma in Colombia. The total costs and QALYS of two interventions, including standard therapy (ICS + LABA), and add-on therapy with azithromycin, 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 0.037 QALYs per patient per year on azithromycin, with a difference of US $718 in favor of azithromycin, showing dominance with respect to SOC. A position of dominance negates the need to calculate an incremental cost-effectiveness ratio. In the deterministic sensitivity analyses, our base-case results were robust to variations in all assumptions and parameters. CONCLUSION: Add-on therapy with azithromycin was found to be cost-effective when added to usual care in patients who remain uncontrolled despite treatment with medium or high-dose ICS/LABA.

Cost-utility analysis and budget impact of benralizumab as add-on therapy to standard care for severe eosinophilic asthma in Colombia.

INTRODUCTION: Benralizumab, amonoclonal antibody for human interleukin-5, has been associated with adecrease in asthma exacerbations. The introduction of this drug raises concerns about the economic impact in scenarios with constraints. This study aimed to estimate the cost-utility of benralizumab plus standard care (SoC) vs. SoC alone in adults with severe uncontrolled asthma with evidence of eosinophilic phenotype. METHODS: We constructed aMarkov model with three health states (asthma on benralizumab and SOC, asthma on SOC alone, and death) from ahealthcare system perspective over alifetime horizon. The model was populated using local costs while utilities were derived from international literature. Cost and transition probabilities were obtained from amixture of Colombian-specific and internationally published data. RESULTS: The incremental cost-effectiveness ratio (ICER) per patient peryear was $US 42,746per QALY gained. Benralizumab treatment would be cost-effective at the recommended societal US 18,000 WTP threshold if the cost of benralizumab is reduced by 41% more than the base case value. CONCLUSION: Benralizumab is not cost-effective using WTP of US$18,000per QALY threshold in Colombia. Our study provides evidence that should be used by decision-makers to improve clinical practice guidelines.

Budget Impact Analysis of Hypertonic Saline Inhalations for Infant Bronchiolitis: The Colombian National Health System Perspective.

OBJECTIVES: Nebulized 3% hypertonic solution (HS) is associated with lower total cost and higher quality-adjusted life-years. Nevertheless, the expected budget impact of this drug had not been explicitly estimated. The aim of this study was to evaluate the budget impact of 3% HS in the treatment of acute bronchiolitis in Colombia. METHODS: A budget impact analysis was performed to evaluate the potential financial impact of the use of 3% HS. The analysis considered a 4-year time horizon and a Colombian national health system perspective. The incremental budget impact was calculated by subtracting the cost of the new treatment, in which 3 % HS (added to humidified oxygen) was reimbursed, from the cost of the conventional treatment without 3 % HS (only humidified oxygen or adrenaline nebulization). Univariate 1-way sensitivity analyses were performed. RESULTS: In the base-case analysis, the 4-year costs associated with HS and non-3% HS were estimated to be $47 792 230 and $53 312 832, respectively, indicating savings for Colombian national health system equal to $5 520 602 if HS is adopted for the routine management of patients with acute bronchiolitis. This result was robust in univariate 1-way sensitivity analysis. CONCLUSION: HS was cost saving in emergency settings for treating infants with acute bronchiolitis. This evidence can be used by decision makers in Colombia to improve clinical practice guidelines and should be replicated to validate their results in other middle-income countries.

SMART therapy in adolescent and adults patients with moderate persistent asthma: a cost-utility analysis.

BACKGROUND: Recent asthma guidelines, recommends for persistent asthma as first alternative low dose inhaled budesonide-formoterol maintenance and reliever over fixed combination of low doses inhaled corticosteroids - long-acting beta-agonist, or fixed-dose inhaled corticosteroids. Concerns arise as to which of the proposed alternatives has the best possible cost-effectiveness profile. This study aimed to assess the health and economic consequences of SMART, fixed combination, and fixed-dose inhaled corticosteroids in patients with moderate-severe persistent asthma. METHODS: A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with persistent asthma. Total costs and QALYs of SMART, fixed combination, and fixed-dose inhaled corticosteroids 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 1.27 and 1.34 QALYs per patient per year on SMART respect to fixed combination and fixed-dose ICS respectively. We observed a reduction of US$4 in total discounted cost per person-year on SMART with respect to fixed combination and US$0.1 respect to fixed-dose ICS. In the deterministic and probabilistic sensitivity analyses, our base-case results were robust to variations of all assumptions and parameters. CONCLUSION: SMART therapy was found to be cost-effective regarding fixed combination and fixed-dose inhaled corticosteroids. This evidence supports the use of SMART therapy in Colombia and must to be replicated in others middle-income countries.