Broadening the Perspective of Cost-Effectiveness Modeling in Chronic Obstructive Pulmonary Disease: A New Patient-Level Simulation Model Suitable to Evaluate Stratified Medicine.

OBJECTIVES: To develop a health economic model that included a great diversity of patient characteristics and outcomes for chronic obstructive pulmonary disease (COPD), which can be used to inform decisions about stratified medicine in COPD. METHODS: The choice of patient characteristics and outcomes to include in the model was based on 3 literature reviews on multidimensional prognostic COPD indices, COPD phenotypes, and treatment effects in subgroups. A conceptual model was constructed including 14 patient characteristics, 7 intermediate outcomes (lung function, physical activity, exercise capacity, symptoms, disease-specific quality of life, exacerbations, and pneumonias), and 3 final outcomes (mortality, quality-adjusted life-years [QALYs], and costs). Regression equations describing the statistical associations between the patient characteristics and intermediate and final outcomes were estimated using the longitudinal data of 5 large COPD trials (19,378 patients). A patient-level simulation model was developed in which individual patients from the baseline population of the 5 trials are sampled and their outcomes over lifetime are predicted based on the regression equations. RESULTS: The base-case analysis (single-arm simulation representing treatment with tiotropium) showed that patients had a mean lung function decline of 43 mL/year, 0.62 exacerbations/year, a worsening of their physical activity and quality of life with 1.48 and 1.10 points/year, a life expectancy of 11.2 years, 7.25 QALYs, and total lifetime costs of £24,891. Results for a selection of treatment scenarios and subgroups were shown to demonstrate the potential of the model. CONCLUSIONS: We developed a unique patient-level simulation model that can be used to evaluate COPD treatment options for a variety of subgroups.

Development of an enhanced health-economic model and cost-effectiveness analysis of tiotropium + olodaterol Respimat® fixed-dose combination for chronic obstructive pulmonary disease patients in Italy.

BACKGROUND: The objective of this study was to compare the cost-effectiveness of the fixed-dose combination (FDC) of tiotropium + olodaterol Respimat(®) FDC with tiotropium alone for patients with chronic obstructive pulmonary disease (COPD) in the Italian health care setting using a newly developed patient-level Markov model that reflects the current understanding of the disease. METHODS: While previously published models have largely been based around a cohort approach using a Markov structure and GOLD stage stratification, an individual-level Markov approach was selected for the new model. Using patient-level data from the twin TOnado trials assessing Tiotropium + olodaterol Respimat(®) FDC versus tiotropium, outcomes were modelled based on the trough forced expiratory volume (tFEV1) of over 1000 patients in each treatment arm, tracked individually at trial visits through the 52-week trial period, and after the trial period it was assumed to decline at a constant rate based on disease stage. Exacerbation risk was estimated based on a random-effects logistic regression analysis of exacerbations in UPLIFT. Mortality by age and disease stage was estimated from an analysis of TIOSPIR trial data. Cost of bronchodilators and other medications, routine management, and costs of treatment for moderate and severe exacerbations for the Italian setting were included. A cost-effectiveness analysis was conducted over a 15-year time horizon from the perspective of the Italian National Health Service. RESULTS: Aggregating total costs and quality-adjusted life years (QALYs) for each treatment cohort over 15 years and comparing tiotropium + olodaterol Respimat(®) FDC with tiotropium alone, resulted in mean incremental costs per patient of €1167 and an incremental cost-effectiveness ratio (ICER) of €7518 per additional QALY with tiotropium + olodaterol Respimat(®) FDC. The lung function outcomes observed for tiotropium + olodaterol Respimat(®) FDC in TOnado drove the results in terms of slightly higher mean life-years (12.24 versus 12.07) exacerbation-free months (11.36 versus 11.32) per patient and slightly fewer moderate and severe exacerbations per patient-year (0.411 versus 0.415; 0.21 versus 0.24) versus tiotropium. Probabilistic sensitivity analyses showed tiotropium + olodaterol Respimat(®) FDC to be the more cost-effective treatment in 95.2% and 98.4% of 500 simulations at thresholds of €20,000 and €30,000 per QALY respectively. CONCLUSION: Tiotropium + olodaterol Respimat(®) FDC is a cost-effective bronchodilator in the maintenance treatment of COPD for the Italian health care system.

[Influence of morbidity, metabolic control, and use of resources in subjects with cardiovascular risk in the primary care setting]. / Influencia de la morbilidad, control metabólico y uso de recursos de los sujetos en situación de riesgo cardiovascular en el ámbito de la atención primaria de salud.

OBJECTIVE: To determine the comorbidity, the therapeutic objectives, and economic impact in subjects with cardiovascular risk in primary care (PC). DESIGN: Multicentre, cross-sectional study. SETTING: Five urban PC centres, Spain. PARTICIPANTS: Patients over 55 years seen during the year 2006. Compared according to the presence/absence of a cardiovascular event (CVE). MEASUREMENTS: Demographics, cardiovascular/general comorbidity (adjusted clinical groups), Charlson index, clinical parameters, multiple drugs and semi-fixed direct costs (operational) and variables (tests, referrals, drugs). A logistical regression and ANCOVA analysis was performed to correct the models. SPSSWIN Program (P< .05). RESULTS: Of 24 410 patients, 15.4% (CI, 14.9-15.9) had a CVE. The subjects with a CVE showed a higher mortality (4.0% vs 1.8%) and general morbidity (8.1 vs 6.4 episodes) (P< .001). The CVE had an independent association in males (OR=2.7), Charlson index (OR=2.1), dyslipaemia (OR=1.5), depression (OR=1.4), age (OR=1.3), arterial hypertension (OR=1.2) and diabetes (OR=1.1) (P< .005). In primary prevention worse average cholesterols were obtained (211.6 vs 192.4 mg/dL), while in secondary prevention blood glucose was worse (111.3 vs 104.2 mg/dL; P< .001). The average corrected direct costs were euro1543.55 versus euro1027.65, respectively (P< .001). These differences were maintained in all the cost components. CONCLUSIONS: The presence of a CVE is associated with higher comorbidity, causing an increase in costs. The achievement of therapeutic control objectives could be improved, in primary prevention as well as in secondary. Intervention strategies should be increased to modify life styles in these patients.

Influencia de la morbilidad, control metabólico y uso de recursos de los sujetos en situación de riesgo cardiovascular en el ámbito de la atención primaria de salud / Influence of morbidity, metabolic control, and use of resources in subjects with cardiovascular risk in the primary care setting

Objetivo. Determinar la comorbilidad, los objetivos terapéuticos y el impacto económico de sujetos en situación de riesgo cardiovascular en atención primaria (AP). Diseño. Estudio multicéntrico y transversal. Emplazamiento. Cinco centros de AP urbanos. Participantes. Pacientes mayores de 55 años atendidos durante el año 2006, comparados en función de la presencia/ausencia de episodios cardiovasculares (ECV). Mediciones. Demográficas, comorbilidad cardiovascular/general (Adjusted Clinical Groups), índice de Charlson, parámetros clínicos, polifarmacia y costes directos semifijos (funcionamiento) y variables (pruebas, derivaciones, fármacos). Se efectuó un análisis de regresión logística y de ANCOVA para la corrección de los modelos con el programa SPSSWIN (p < 0,05). Resultados. Se incluyeron en el estudio 24.410 pacientes. Un 15,4% (intervalo de confianza [IC], 14,9-15,9) presentaron algún ECV. Los sujetos con ECV presentaron una mortalidad (el 4,0 frente al 1,8%) y una morbilidad general (8,1 frente a 6,4 episodios) superiores (p < 0,001). El ECV tuvo una relación independiente en varones (odds ratio [OR] = 2,7), índice de Charlson (OR = 2,1), dislipemia (OR = 1,5), depresión (OR = 1,4), edad (OR = 1,3), hipertensión arterial (OR = 1,2) y diabetes (OR = 1,1) (p < 0,005). En prevención primaria se obtuvieron unos peores promedios de colesterol (211,6 frente a 192,4 mg/dl), mientras que en prevención secundaria fueron los de glucemia (111,3 frente a 104,2 mg/dl; p < 0,001). El promedio de los costes directos corregidos fue de 1.543,55 frente a 1.027,65 €, respectivamente (p < 0,001). Estas diferencias se mantuvieron en todos los componentes del coste. Conclusiones. La presencia de ECV se asocia con una mayor comorbilidad, lo que ocasiona un incremento de los costes. La consecución de los objetivos terapéuticos de control debería mejorarse, tanto en el ámbito de la prevención primaria como en el de la secundaria. Se deberían potenciar estrategias de intervención sobre la modificación de los estilos de vida en estos pacientes

Objective. To determine the comorbidity, the therapeutic objectives, and economic impact in subjects with cardiovascular risk in primary care (PC). Design. Multicentre, cross-sectional study. Setting. Five urban PC centres, Spain. Participants. Patients over 55 years seen during the year 2006. Compared according to the presence/absence of a cardiovascular event (CVE). Measurements. Demographics, cardiovascular/general comorbidity (adjusted clinical groups), Charlson index, clinical parameters, multiple drugs and semi-fixed direct costs (operational) and variables (tests, referrals, drugs). A logistical regression and ANCOVA analysis was performed to correct the models. SPSSWIN Program (P<.05). Results. Of 24 410 patients, 15.4% (CI, 14.9-15.9) had a CVE. The subjects with a CVE showed a higher mortality (4.0% vs 1.8%) and general morbidity (8.1 vs 6.4 episodes) (P<.001). The CVE had an independent association in males (OR=2.7), Charlson index (OR=2.1), dyslipaemia (OR=1.5), depression (OR=1.4), age (OR=1.3), arterial hypertension (OR=1.2) and diabetes (OR=1.1) (P<.005). In primary prevention worse average cholesterols were obtained (211.6 vs 192.4 mg/dL), while in secondary prevention blood glucose was worse (111.3 vs 104.2 mg/dL; P<.001). The average corrected direct costs were €1543.55 versus €1027.65, respectively (P<.001). These differences were maintained in all the cost components. Conclusions. The presence of a CVE is associated with higher comorbidity, causing an increase in costs. The achievement of therapeutic control objectives could be improved, in primary prevention as well as in secondary. Intervention strategies should be increased to modify life styles in these patients

Asociación entre el grado de control de la hipertensión arterial, la comorbilidad y los costes en personas de más de 30 años durante el año 2006 / Relationship among the degree of control of arterial hypertension, comorbidity and costs in individuals over age 30 during 2006

Fundamento. La hipertensión arterial (HTA) es uno de los principales motivos de consulta de los centros de atención primaria (AP). El objetivo del estudio fue determinar la asociación entre el grado de control de la HTA, la comorbilidad y los costes directos en atención primaria. Métodos. Diseño retrospectivo-multicéntrico. Se incluyó a sujetos mayores de 30 años pertenecientes a cinco equipos de AP (año 2006). Criterios: buen control (<140/90, y <130/80 mmHg en personas diabéticas y presencia de enfermedad cardiovascular [ECV]). Principales medidas: generales, ECV, índice de Charlson, casuística/comorbilidad (Adjusted Clinical Groups), parámetros clínicos y costes directos (fijos/semifijos y variables [medicamentos, pruebas y derivaciones]). Análisis de regresión logística y de ANCOVA para la corrección del modelo, p<0,05. Resultados. La prevalencia de HTA fue del 26,5% (edad media: 67,1 años; varones: 43,5%). El buen control fue del 52,0% (IC: 51,2-52,8%). El mal control tuvo una relación independiente con la diabetes (OR=3,8), el ECV (OR=2,2) y los varones (OR=1,2), p<0,001. El promedio/unitario/año del coste directo corregido fue de 1.202,13 vs. 1.183,55 € (p=0,032). Conclusiones. Los pacientes en situación de mal control muestran una mayor carga de morbilidad y un similar coste sanitario (AU)

Background. Arterial hypertension is one of the main reasons for primary care consultations. This study is aimed at determining the relationship among the degree to which arterial hypertension is controlled, comorbidity and the direct costs in primary care. Methods. Retrospective, multi-centre design. Subjects over 30 years of age pertaining to five primary care teams (2006) were included. Criteria: good control (<140/90 and <130/80 mmHg in diabetics and those with cardiovascular disease [CVD]. Main general measurements, CVD, Charlson index, casuistic/comorbidity (Adjusted Clinical Groups), clinical parameters and direct costs (fixed/semifixed and variable costs) [medications, tests and referrals]) Logic regression and ANCOVA for correcting the model, p<0.05. Results: The prevalence of arterial hypertension was 26.5% (mean age: 67.1 years; males: 43.5%). Good control totalled 52.0% (CI: 51.2-52.8%). Poor control was independently related to diabetes (Odds Ratio=3.8), CVD (Odds Ratio=2.2) and males (Odds Ratio=1.2), p<0.001. The average/direct unit cost/year was 1,202.13 € vs. 1,183.55 € (p=0.032). Conclusions. Those individuals whose arterial hypertension was poorly controlled displayed a greater burden of morbidity and a similar healthcare cost in comparison to those under good control (AU)

Evaluación clínica y económica según el grado de riesgo cardiovascular en sujetos pertenecientes a un ámbito poblacional español / No disponible

No disponible