Evaluating the impact of early vs delayed ofatumumab initiation and estimating the long-term outcomes of ofatumumab vs teriflunomide in relapsing multiple sclerosis patients in Spain.

OBJECTIVES: To evaluate the impact of early (at first-line) vs delayed (3-year delay) ofatumumab initiation and long-term clinical, societal, and economic outcomes of ofatumumab vs teriflunomide in relapsing multiple sclerosis (RMS) patients from a Spanish societal perspective. METHODS: A cost-consequence analysis was conducted using an Expanded Disability Status Scale (EDSS)-based Markov model. Inputs were sourced from ASCLEPIOS I and II trials and published literature. RESULTS: At the end of 10 years, compared with first-line teriflunomide treatment, early first-line ofatumumab initiation was projected to result in 35.6% fewer patients progressing to EDSS ≥ 7 and 27.8% fewer relapses. The ofatumumab cohort required 7.3% reduced informal care time and had 19% fewer disability-adjusted life years (DALYs) than the teriflunomide cohort. A 3-year delay in ofatumumab treatment (3-year teriflunomide + 7-year ofatumumab) was projected to result in 32.2% more patients progressing to EDSS ≥ 7, 20.2% more relapses, 5.4% increased informal care time, and 16.6% more DALYs compared with early ofatumumab initiation. Early ofatumumab initiation was associated with total annual cost savings (excluding disease-modifying-therapies' acquisition costs) of €35,328 ($34,549; conversion factor 1€= $1.02255) and €24,373 ($23,836) per patient vs teriflunomide and 3-year delayed ofatumumab initiation, respectively. CONCLUSIONS: This study highlights the benefits of early initiation of high-efficacy therapy such as ofatumumab vs its delayed initiation for improving the outcomes in RMS patients (having characteristics similar to those of patients included in the ASCLEPIOS trials). Ofatumumab treatment was projected to provide improved long-term clinical, societal, and economic outcomes vs teriflunomide treatment in RMS patients from a Spanish societal perspective.

The therapeutic benefits of ofatumumab in relapsing multiple sclerosis (RMS) patients have been reported in the ASCLEPIOS I and II trials. Using an Expanded Disability Status Scale-based Markov model, this study aimed to assess the impact of early (i.e. at first-line, as the first treatment after diagnosis) vs delayed (i.e. 3-year delay) ofatumumab initiation in RMS patients from a Spanish societal perspective. In addition, the long-term clinical, societal, and economic outcomes of ofatumumab vs teriflunomide treatment were assessed. Evidence from this study suggests that early initiation of a high-efficacy therapy such as ofatumumab, compared with its delayed initiation, is an effective and cost-saving strategy for improving outcomes in RMS patients. Furthermore, patients receiving ofatumumab for 10 years are projected to experience comparatively better outcomes (clinical, societal, and economic) than those receiving teriflunomide.

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.

Frequency of emergency department visits and hospitalizations due to chronic obstructive pulmonary disease exacerbations in patients included in two models of care / Frecuencia de visitas al departamento de emergencias y hospitalizaciones debido a exacerbaciones de la enfermedad pulmonar obstructiva crónica en pacientes incluidos en dos modelos de atención

INTRODUCTION: Exacerbations of chronic obstructive pulmonary disease (COPD) have a huge impact on lung function, quality of life and mortality of patients. Emergency Department visits and hospitalizations due to exacerbations cause a significant economic burden on the health system. OBJECTIVE: To describe the differences in the number of emergency visits and hospitalizations due to exacerbations of COPD among patients included in two models of care of the same institution. MATERIALS AND METHODS: A historical cohort study in which COPD patients who are users of two models of care were included: COPD integrated care program (CICP) and general consultation of pulmonology (GCP). The first model, unlike the second one, offers additional educational activities, 24/7 telephone service, and priority consultations. The number of emergency visits and hospitalizations due to COPD exacerbations in patients who had completed at least one year of follow-up was evaluated. The multivariable Poisson regression model was used for calculating the incidence rate (IR) and the incidence rate ratio (IRR) with an adjustment for confounding factors. RESULTS: We included 316 COPD patients (166 from the CICP and 150 from the GCP). During the year of follow-up, the CICP patients had 50% fewer emergency visits and hospitalizations than patients from the GCP (IRR=0.50, 95%CI: 0.29-0.87, p=0.014). CONCLUSIONS: COPD patients in the CICP had fewer emergency visits and hospitalizations due to exacerbations. Prospective clinical studies are required to confirm the results and to evaluate the factors that contribute to the differences.

Introducción. Las exacerbaciones de la enfermedad pulmonar obstructiva crónica (EPOC) tienen un gran impacto en la función pulmonar, la calidad de vida y la mortalidad de los pacientes. Las visitas al Departamento de Emergencias y las hospitalizaciones debido a las exacerbaciones, causan una carga económica importante para el sistema de salud. Objetivo. Describir las diferencias en el número de visitas de emergencia y hospitalizaciones debidas a exacerbaciones de la EPOC, entre los pacientes incluidos en dos modelos de atención de la misma institución. Materiales y métodos. Se trata de un estudio de cohorte histórica en el que se incluyeron pacientes que son usuarios de dos modelos de atención: el programa de atención integrada de la EPOC (CICP) y la consulta general de neumología (PCG). El primer modelo, a diferencia del segundo, ofrece actividades educativas adicionales, servicio telefónico las 24 horas del día y consultas prioritarias. Se evaluó el número de visitas de emergencia y hospitalizaciones debido a exacerbaciones de la EPOC en pacientes que habían completado, al menos, un año de seguimiento. Se utilizó el modelo de regresión multivariable de Poisson para calcular la tasa de incidencia (IR) y la razón de tasas de incidencia (IRR), con un ajuste para factores de confusión. Resultados. Se incluyeron 316 pacientes con EPOC, 166 del CICP y 150 de la PCG. Durante el año de seguimiento, los pacientes en el CICP tuvieron 50 % menos visitas de emergencia y hospitalizaciones que los pacientes en la PCG (IRR=0,50; IC95% 0,29-0,87; p=0,014). Conclusiones. Los pacientes con EPOC en el CICP, tuvieron menos visitas de emergencia y hospitalizaciones debido a las exacerbaciones. Se requieren estudios clínicos prospectivos para confirmar los resultados y evaluar los factores que contribuyen a las diferencias.

Frequency of emergency department visits and hospitalizations due to chronic obstructive pulmonary disease exacerbations in patients included in two models of care / Frecuencia de visitas al departamento de emergencias y hospitalizaciones debido a exacerbaciones de la enfermedad pulmonar obstructiva crónica en pacientes incluidos en dos modelos de atención

Introduction: Exacerbations of chronic obstructive pulmonary disease (COPD) have a huge impact on lung function, quality of life and mortality of patients. Emergency Department visits and hospitalizations due to exacerbations cause a significant economic burden on the health system. Objective: To describe the differences in the number of emergency visits and hospitalizations due to exacerbations of COPD among patients included in two models of care of the same institution. Materials and methods: A historical cohort study in which COPD patients who are users of two models of care were included: COPD integrated care program (CICP) and general consultation of pulmonology (GCP). The first model, unlike the second one, offers additional educational activities, 24/7 telephone service, and priority consultations. The number of emergency visits and hospitalizations due to COPD exacerbations in patients who had completed at least one year of follow-up was evaluated. The multivariable Poisson regression model was used for calculating the incidence rate (IR) and the incidence rate ratio (IRR) with an adjustment for confounding factors. Results: We included 316 COPD patients (166 from the CICP and 150 from the GCP). During the year of follow-up, the CICP patients had 50% fewer emergency visits and hospitalizations than patients from the GCP (IRR=0.50, 95%CI: 0.29-0.87, p=0.014). Conclusions: COPD patients in the CICP had fewer emergency visits and hospitalizations due to exacerbations. Prospective clinical studies are required to confirm the results and to evaluate the factors that contribute to the differences.

Introducción. Las exacerbaciones de la enfermedad pulmonar obstructiva crónica (EPOC) tienen un gran impacto en la función pulmonar, la calidad de vida y la mortalidad de los pacientes. Las visitas al Departamento de Emergencias y las hospitalizaciones debido a las exacerbaciones, causan una carga económica importante para el sistema de salud. Objetivo. Describir las diferencias en el número de visitas de emergencia y hospitalizaciones debidas a exacerbaciones de la EPOC, entre los pacientes incluidos en dos modelos de atención de la misma institución. Materiales y métodos. Se trata de un estudio de cohorte histórica en el que se incluyeron pacientes que son usuarios de dos modelos de atención: el programa de atención integrada de la EPOC (CICP) y la consulta general de neumología (PCG). El primer modelo, a diferencia del segundo, ofrece actividades educativas adicionales, servicio telefónico las 24 horas del día y consultas prioritarias. Se evaluó el número de visitas de emergencia y hospitalizaciones debido a exacerbaciones de la EPOC en pacientes que habían completado, al menos, un año de seguimiento. Se utilizó el modelo de regresión multivariable de Poisson para calcular la tasa de incidencia (IR) y la razón de tasas de incidencia (IRR), con un ajuste para factores de confusión. Resultados. Se incluyeron 316 pacientes con EPOC, 166 del CICP y 150 de la PCG. Durante el año de seguimiento, los pacientes en el CICP tuvieron 50 % menos visitas de emergencia y hospitalizaciones que los pacientes en la PCG (IRR=0,50; IC95% 0,29-0,87; p=0,014). Conclusiones. Los pacientes con EPOC en el CICP, tuvieron menos visitas de emergencia y hospitalizaciones debido a las exacerbaciones. Se requieren estudios clínicos prospectivos para confirmar los resultados y evaluar los factores que contribuyen a las diferencias.