[Economic burden assessment for the management of asthma patients at Mexico's National Institute for Respiratory Diseases]. / Evaluación de la carga económica para el tratamiento de pacientes con asma en el Instituto Nacional de Enfermedades Respiratorias de México.

OBJETIVO: Determinar la carga económica anual del asma, desde una perspectiva institucional y con base en la clasificación recomendada por GINA, en una cohorte retrospectiva de adultos atendidos en el Instituto Nacional de Enfermedades Respiratorias (INER) de México. MÉTODOS: Estudio observacional, longitudinal y retrospectivo, llevado a cabo a partir de la información recabada de 247 pacientes femeninas con asma. Se estimaron los costos directos anuales: visitas, pruebas de laboratorio, tratamiento farmacológico y de las crisis o exacerbaciones, para determinar la carga anual de la enfermedad desde una perspectiva institucional, y según la clasificación de la Iniciativa Global para el Asma. RESULTADOS: El costo promedio anual fue de $43,813,92, que aumentó en relación con la necesidad de aumento de dosis de corticoides inhalados y beta-agonistas de acción prolongada. El costo promedio de la consulta médica fue de $2004.57, $982.82 por gestión de crisis y $2645.95 por pruebas de laboratorio. El tratamiento farmacológico representó la principal carga económica, con un costo promedio anual de $38,180.58. CONCLUSIONES: Los resultados resaltan una carga económica del asma estimada en un costo anual por paciente de $43,813.92 MXN (DE=93,348.85), en el contexto del tercer nivel de atención en el sistema de salud público mexicano. La gravedad del asma, los tratamientos y los biológicos fueron los principales factores que aumentaron los costos directos de la atención.

OBJECTIVE: Determine the annual economic burden of the disease from an institutional perspective and based on GINA's recommended classification in a retrospective cohort of adults treated at Instituto Nacional de Enfermedades Respiratorias (INER) of Mexico City. METHODS: A retrospective, longitudinal observational study comprised by data from 247 female asthma patients, annual direct costs were estimated including: visits, laboratory tests, pharmacological treatment and management of crisis or exacerbations, to determine the annual burden of the disease from an institutional perspective and according to Global Initiative for Asthma classification. RESULTS: The average annual cost was $43,813.92, which increased in relation to the need of inhaled corticosteroids and long-acting beta agonists dosage increase. The average doctor's appointment cost was $2,004.57, $982.82 for crisis management and $2,645.95 for laboratory testing. Pharmacological treatment represented the main economic burden with an annual average cost of $38,180.58. CONCLUSIONS: The results highlight an economic burden of asthma estimated at an annual cost per patient of $43,813.92 MXN (SD=93,348.85) in the context of the third level of care in the Mexican public health system. The asthma severity and treatments such as biologics were the main factors that increased direct costs of care.

Benralizumab in severe eosinophilic asthma: A real-world, single-center, observational study from Mexico

Introduction: Urbanization has increased the prevalence of asthma in lower- and middle-income countries. Severe eosinophilic asthma (SEA), a subtype of asthma, can be refractory to standard therapy. Biologics such as benralizumab target interleukin-5 and have demonstrated effectiveness in managing SEA. There exists no real-world evidence on the effectiveness of benralizumab in Mexico. Therefore, this study presents data on the role of benralizumab in managing SEA in Mexican patients. Objective: The effectiveness of benralizumab on the quality of life (QoL), asthma control, lung function, symptoms of asthma, and benralizumab’s safety profile were assessed. Methods: The study sample comprised 10 patients with SEA treated with a subcutaneous (SC) administration of benralizumab 30 mg once in 4 weeks for the first three doses followed by a dose every 8 weeks for 2 years. Laboratory tests, resting spirometry, and skin prick tests were conducted. Levels of fractional exhaled nitric oxide (FeNO) were evaluated, when possible, with the intent to phenotype asthma, as T2 high or non-T2, before starting benralizumab therapy. The Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ), and Asthma Control Test (ACT) were administered to evaluate the effectiveness of benralizumab on asthma control and QoL. Results: All patients showed significant symptom control, QoL, and lung function over 2 years. Mild adverse effects, such as headache and arthralgia, were observed. Conclusion: Benralizumab appears to be a promising agent in controlling SEA. This study has focused on measuring tangible outcomes, such as a reduction in symptoms, a reduction in exacerbation, and an improvement in QoL. Thus, benralizumab may constitute an important addition to the arsenal of medications against SEA (AU)

An independent in-depth analysis proposing adjusted Global Initiative on Asthma Step 1-2 treatment suggestions.

The Global Initiative on Asthma (GINA) strategy included major changes for the treatment of mild asthma in the 2020 version that are even taken to the next level in 2021, leaving a preferred track with only rescue therapy with inhaled corticosteroid and formoterol (ICS-FORM) for steps 1-2 in 12+ years old. It has been questioned how solid the evidence behind these recommendations is. We decided to independently conduct an in-depth analysis of published evidence based on a comprehensive evaluation of original articles and related appendices and publications, including quality of evidence and risk of bias per article. We first defined the major asthma treatment goals and proceeded to review how these were met in publications referenced in the main asthma guidelines. For patients with GINA (2021) Step 1 characteristics, the analysis supports GINA's decision to avoid SABA monotherapy and to prefer ICS-FORM rescue with an alternative ICS rescue every time a SABA is used for ≥12 years, even though evidence is extrapolated from step 2 patients. For 6- to 11-year-olds, we propose to consider ICS-FORM rescue as an alternative, as its use has been approved in this age group, be it not as rescue medication. For patients with GINA 2021 Step 2 characteristics, our proposal slightly differs from GINA 2021. We propose to continue avoiding the separate use of SABA, using ICS rescue whenever a fast-acting bronchodilator is taken (even with ICS maintenance). Also, the superiority of ICS-FORM rescue over classical step 2 treatment is not uniform and year-long experience is lacking. Consequently, for now, both treatment options seem equal: ICS-FORM rescue or ICS maintenance with SABA (+ICS) rescue. For 6- to 11-year-olds, ICS rescue every time a SABA is used has the advantage of lower total ICS dose; as alternative we suggest ICS-FORM rescue. The best treatment option depends on patient characteristics and treatment goals. Recommendations should be reviewed as soon as new evidence becomes available.

Pediatric asthma treatment: What to do when international guideline recommendations do not agree.

BACKGROUND: There was a need for a solid asthma guideline in Mexico to update and unify asthma management. Because high-quality asthma guidelines exist worldwide, in which the latest evidence on asthma management is summarized, the ADAPTE approach allows for the development of a national asthma guideline based on evidence from already existing guidelines, adapted to national needs. OBJECTIVE: To fuse evidence from the best asthma guidelines and adapt it to local needs with the ADAPTE approach. METHODS: The Appraisal of Guidelines for Research and Evaluation (AGREE) II asthma guidelines were evaluated by a core group to select 3 primary guidelines. For each step of asthma management, clinical questions were formulated and replied according to (1) evidence in the primary guidelines, (2) safety, (3) Cost, and (4) patient preference. The Guidelines Development Group, composed of a broad range of experts from medical specialties, primary care physicians, and methodologists, adjusted the draft questions and replies in several rounds of a Delphi process and 3 face-to-face meetings, taking into account the reality of the situation in Mexico. We present the results of the pediatric asthma treatment part. RESULTS: Selected primary guidelines are from the British Thoracic Society and Scottish Intercollegiate Guidelines Network (BTS/SIGN), Global Initiative for Asthma (GINA), and Spanish Guidelines on the Management of Asthma (GEMA) 2015, with 2016 updates. Recommendations or suggestions were made for asthma treatment in Mexico. In this article, the detailed analysis of the evidence present in the BTS/SIGN, GINA, and GEMA sections on the (non) pharmacologic treatment of pediatric asthma, education, and devices are presented for 2 age groups: children 5 years or younger and children 6 to 11 years old with asthma. CONCLUSION: For the pediatric treatment and patient education sections, applying the AGREE II and Delphi methods is useful to develop a scientifically sustained document, adjusted to the Mexican situation, as is the Mexican Guideline on Asthma.

[Mexican Asthma Guidelines: GUIMA 2017]. / Guía Mexicana del Asma: GUIMA 2017.

BACKGROUND: The need for a national guideline, with a broad basis among specialists and primary care physicians was felt in Mexico, to try unifying asthma management. As several high-quality asthma guidelines exist worldwide, it was decided to select the best three for transculturation. METHODS: Following the internationally recommended methodology for guideline transculturation, ADAPTE, a literature search for asthma guidelines, published 1-1-2007 through 31-12-2015 was conducted. AGREE-II evaluations yielded 3/40 most suitable for transculturation. Their compound evidence was fused with local reality, patient preference, cost and safety considerations to draft the guideline document. Subsequently, this was adjusted by physicians from 12 national medical societies in several rounds of a Delphi process and 3 face-to-face meetings to reach the final version. RESULTS: Evidence was fused from British Thoracic Society Asthma Guideline 2014, Global Initiative on Asthma 2015, and Guía Española del Manejo del Asma 2015 (2016 updates included). After 3 Delphi-rounds we developed an evidence-based document taking into account patient characteristics, including age, treatment costs and safety and best locally available medication. CONCLUSIONS: In cooperation pulmonologists, allergists, ENT physicians, paediatricians and GPs were able to develop an evidence-based document for the prevention, diagnosis and treatment of asthma and its exacerbations in Mexico.

Antecedentes: Con el objetivo de unificar el manejo del asma en México se estructuró una guía clínica que conjunta el conocimiento de diversas especialidades y la atención en el primer nivel de contacto. Se seleccionaron 3 guías publicadas en el ámbito internacional para su transculturación. Métodos: Conforme a la metodología ADAPTE se usó AGREE II después de la búsqueda bibliográfica de guías sobre asma publicadas entre 2007 y 2015. Se fusionó la realidad local con la evidencia de 3/40 mejores guías. El documento inicial fue sometido a la revisión de representantes de 12 sociedades médicas en varias rondas Delphi hasta llegar a la versión final. Resultados: Las guías base fueron la British Thoracic Society Asthma Guideline 2014, la Global Initiative on Asthma 2015 y la Guía Española del Manejo del Asma 2015. Después de 3 rondas Delphi se desarrolló un documento en el que se consideraron las características de los pacientes según edad, costos de los tratamientos y perfiles de seguridad de los fármacos disponibles en México. Conclusión: Con la cooperación de neumólogos, alergólogos, otorrinolaringólogos, pediatras y médicos generales se llegó a un consenso basado en evidencia, en el que se incluyeron recomendaciones sobre prevención, diagnóstico y tratamiento del asma y sus crisis.