Real-life cost-effectiveness of benralizumab in patients with severe asthma.

BACKGROUND: Availability of clinically effective and cost-effective treatments for severe asthma would be beneficial to patients and national healthcare systems. The aim of this study was to evaluate clinical outcomes and healthcare expenditure after incorporating benralizumab into the standard treatment of refractory eosinophilic asthma. METHODS: This was a cross-sectional multicentre study of consecutive patients with refractory eosinophilic asthma who received treatment with benralizumab during at least 12 months. Patient follow-up was performed in specialised severe asthma units. The main effectiveness parameters measured were: the avoidance of one asthma exacerbation, a 3-point increase in the asthma control test (ACT) score, and the difference in utility scores (health-related quality of life) between a 1-year baseline treatment and 1-year benralizumab treatment. The health economic evaluation included direct costs and incremental cost-effectiveness ratios (ICERs). RESULTS: After 1 year of treatment with benralizumab, patients with refractory eosinophilic asthma showed an improvement in all the effectiveness parameters analysed: improvement of asthma control and lung function, and decrease in the number of exacerbations, oral corticosteroid (both as corticosteroid courses and maintenance therapy), and inhaled corticosteroid use. The total annual cost per patient for the baseline and benralizumab treatment periods were €11,544 and €14,043, respectively, reflecting an increase in costs due to the price of the biological agent but a decrease in costs for the remaining parameters. The ICER was €602 per avoided exacerbation and €983.86 for every 3-point increase in the ACT score. CONCLUSIONS: All the pharmacoeconomic parameters analysed show that treatment with benralizumab is a cost-effective option as an add-on therapy in patients with refractory eosinophilic asthma.

[Pharmacoeconomic study of the treatment of advanced Parkinson's disease]. / Estudio farmacoeconomico del tratamiento de la enfermedad de Parkinson avanzada.

INTRODUCTION: When oral or transdermal drug therapy in Parkinson's disease becomes less effective, there are three therapies using assisted devices that can reduce motor and non-motor complications: subcutaneous apomorphine infusion pump (SAIP), continuous levodopa/carbidopa duodenal infusion (LDI) and deep brain stimulation (DBS). AIM: Conduct a comparative pharmacoeconomic analysis of the use of SAIP, with LDI and DBS. As a secondary objective arises discuss the profile of the ideal candidate for each of the technicals. PATIENTS AND METHODS: Information on life years gained and quality adjusted life years (QALY) according to Hoehn and Yahr scale was obtained, as well as data on costs and resource use for each of the alternatives. The perspective of the analysis was the National Health System and the time horizon was 5 years for costs and patient´s lifetime for utilities. Outcome measures used were life years gained and QALYs, and incremental cost/utility ratio for comparison. RESULTS: Cost/utility ratio was obtained for each option: 31,956 euros/QALY for DBS, 38,249 euros/QALY for SAIP, and 75,206 euros/QALY for LDI. CONCLUSIONS: Our results allow us to add information about effectiveness of different treatments, as these are presented in gain of years lived in full health (QALY). Data obtained contribute to decision making that determine planning and management of each case, without forgetting patient and neurologist preferences, as well as budgetary limitations.

TITLE: Estudio farmacoeconomico del tratamiento de la enfermedad de Parkinson avanzada.Introduccion. Cuando el tratamiento farmacologico oral o transdermico de la enfermedad de Parkinson pierde eficacia, se dispone de tres terapias mediante dispositivos asistidos que pueden reducir las complicaciones motoras y no motoras: la apomorfina en infusion subcutanea (ASBI), la bomba de infusion duodenal continua de levodopa/carbidopa (IDL) y la estimulacion cerebral profunda (ECP). Objetivo. Efectuar un analisis farmacoeconomico comparativo del uso de ASBI con IDL y ECP; como objetivo secundario, discutir el perfil del candidato ideal para cada una de las tecnicas. Pacientes y metodos. Se extrajo informacion sobre datos de años de vida ganados y años de vida ganados ajustados por calidad (AVAC) segun la escala de Hoehn y Yahr, e informacion sobre costes y consumo de recursos para cada alternativa. La perspectiva del analisis fue la del Sistema Nacional de Salud, y el horizonte temporal fue de cinco años para los costes y toda la vida del paciente para las utilidades. Las medidas de resultado utilizadas fueron los años de vida ganados y AVAC, y en su comparacion se uso la ratio coste-utilidad incremental. Resultados. El coste-utilidad obtenido para cada opcion fue: 31.956 euros/AVAC para la ECP, 38.249 euros/AVAC para la ASBI y 75.206 euros/AVAC para la IDL. Conclusiones. Los resultados permiten evaluar la efectividad y utilidad de los diferentes tratamientos para la enfermedad de Parkinson avanzada, pues se presentan en ganancias de años vividos en plena salud. Los datos obtenidos contribuyen a la toma de decisiones que determinen la planificacion y gestion de cada caso, sin olvidar las preferencias del paciente y del neurologo, asi como las limitaciones presupuestarias.

[Quality of life of patients with asthma on beclomethasone/formoterol. Cost-utility analysis]. / Calidad de vida del paciente asmático con beclometasona/formoterol. Análisis de coste-utilidad.

AIM: To perform a cost-utility analysis on asthmatic patients on beclomethasone/formoterol fixed combination in Primary Health Care. Material and methods Non-probability sampling was used to select a group of asthmatic patients with moderate/severe persistent severity (GEMA 2009), treated with beclomethasone/formoterol fixed combination, over 18 years, had given their informed consent. The study observation period was 6 months. The variables studied were: age, sex, duration of disease, health resources used, analysis of health related quality of life by EQ-5D and SF-36, and the specific Asthma Quality of Life Questionnaire. For the qualitative variables, the frequency and percentages were calculated, and for the quantitative variables, the mean, SD and 95% CI. Chi-square, Student t-test and ANOVA were used for statistical inference. Comparisons were made with a statistical significance of 0.05. RESULTS: Of the 64 patients that completed the study, 59.4% were female. The mean age was 49 years, and mean disease duration was 93 months. For asthma control, 53% of patients had a prescription pattern of one/12h. All health related quality of life scales were modified with respect to the baseline and the differences were statistically significant. Our patients had a better health related quality of life than Spanish asthma cohort. The incremental cost utility beclomethasone/formoterol versus usual treatment option was € 6,256/QALY.

Effectiveness of surgery in liver metastasis from colorectal cancer: experience and results of a continuous improvement process.

PURPOSE: The aim of this study was to estimate the effectiveness of surgery in liver metastasis from colorectal cancer. METHODS: We conducted a prospective and observational study of patients with colorectal liver metastasis operated on at the San Cecilio University Hospital of Granada from March 2003 until June 2013. The primary variables of the result were survival and morbidity before 30 days of the post-operative period. We also measured preoperative and surgical variables. RESULTS: A total of 147 patients with liver metastasis of colorectal origin underwent surgical removal during the period of study, 38 of whom had repeat surgery. 34 had a second resection, 3 had a third one and one only patient had a fourth one, for a total of 185 registered operations. The global 5-year survival rate was 38 and 17 % after 10 years. There were 115 patients who had neither radiofrequency nor exploratory laparotomy, 38 % of them survived over 60 months. The average disease-free time was 23.6 months ± 47.3, with significant differences observed between types of procedures. Patients that were operated on just once (n = 25) had a five-year actuarial survival rate of 35 %, a morbidity rate of 24 % and a mortality rate of 0.6 % (1 patient only). The average hospital stay was 13.8 days and the disease-free time was 15.8 months. CONCLUSION: The results obtained in our surgical unit in terms of morbidity, mortality and five-year actuarial survival rates are comparable to those of other units at large institutions, which are currently considered the standards of quality.

[Cost-effectiveness analysis of fixed dose antihypertensive drugs]. / Análisis coste-eficacia de los antihipertensivos en dosis fijas.

OBJECTIVE: The aim of this study is to compare the efficiency of different fixed-dose combinations of renin-angiotensin-aldosterone system (RAAS) blockers and calcium channel blockers, to use it as a guide to assist the rational prescribing in antihypertensive therapy. METHODS: The efficacy of each drug was obtained from intervention studies randomized, double-blind, made with these combinations and a utility-cost modeling from the model proposed and used by NICE. The perspective of our analysis is the National Health System and the time horizon is long enough to achieve therapeutic goals. MAIN OUTCOME MEASURES: Cost per mmHg reduction in BP, percentage of reduction necessary to achieve the therapeutic goals for hypertension control and cost, and finally quantity and quality of life gained with these treatments in patients with hypertension, diabetes. RESULTS: We studied three fixed-dose combinations: amlodipine/olmesartán, amlodipine/valsartan and manidipine/delapril. The cost per mmHg systolic BP ranged from 24.93 to 12.34 €/mmHg, and diastolic BP ranged from 34.24 to 18.76 €/mmHg, depending on the drug used. For an initial value of 165mmHg systolic BP the most efficient treatment to achieve the therapeutic goal of hypertension control (<140mmHg) is manidipine/delapril with a cost of 67.76 €. The use of these drugs to control diabetic and hypertensive patients resulted in all cases being cost-effective (more effective and lower cost compared to "no treatment"). Manidipine/delapril showed the best relation cost-utility (1,970 €/QALY (quality-adjusted life year)) followed by amlodipine/olmesartan and amlodipine/valsartan (2,087 and 2,237 €/QALY, respectively).

Análisis coste-eficacia de los antihipertensivos en dosis fijas / Cost-effectiveness analysis of fixed dose antihypertensive drugs

Objetivo. Comparar la eficiencia de las combinaciones en dosis fijas del bloqueo del SRAA con antagonistas del calcio, para que sirva como guía de ayuda a la prescripción racional del tratamiento antihipertensivo. Metodología. La eficacia de cada uno de los medicamentos ha sido obtenida de los estudios de intervención aleatorizados, doble ciego, realizados con estas combinaciones y una modelización de coste utilidad a partir del modelo propuesto por el NICE. La perspectiva de nuestro análisis es la del Sistema Nacional de Salud y el horizonte temporal ha sido un tiempo suficiente para alcanzar objetivos terapéuticos. Mediciones principales Coste por mmHg de descenso de la PA; porcentaje de descenso necesario para alcanzar los objetivos terapéuticos de control de la HTA y su coste y, finalmente, cantidad y calidad de vida ganada con estos tratamientos en pacientes hipertensos-diabéticos. Resultados. Se estudiaron 3 combinaciones fijas: amlodipino/olmesartán, amlodipino/valsartán y manidipino/delapril. Respecto a la PAS el coste por mmHg de PA reducido osciló entre 24,93 y 12,34€/mmHg, y para la PAD los costes fueron de 34,24 y 18,76 €/mmHg, dependiendo del fármaco empleado. Para una cifra inicial de PAS de 165 mmHg hay 3 opciones terapéuticas que pueden alcanzar la cifra de objetivo terapéutico (< 140 mmHg), siendo la más eficiente manidipino/delapril con 67,76 €. Estos fármacos fueron coste-efectivos respecto al no tratamiento en el control de pacientes hipertensos diabéticos. El medicamento que mostró mejor relación coste-utilidad fue manidipino/delapril (1.970 €/AVAC) seguido de amlodipino/olmesartán y amlodipino/valsartán (2.087 y 2.237 €/AVAC) (AU)

Objective. The aim of this study is to compare the efficiency of different fixed-dose combinations of renin-angiotensin-aldosterone system (RAAS) blockers and calcium channel blockers, to use it as a guide to assist the rational prescribing in antihypertensive therapy. Methods. The efficacy of each drug was obtained from intervention studies randomized, double-blind, made with these combinations and a utility-cost modeling from the model proposed and used by NICE. The perspective of our analysis is the National Health System and the time horizon is long enough to achieve therapeutic goals. Main outcome measures. Cost per mmHg reduction in BP, percentage of reduction necessary to achieve the therapeutic goals for hypertension control and cost, and finally quantity and quality of life gained with these treatments in patients with hypertension, diabetes. Results. We studied three fixed-dose combinations: amlodipine/olmesartán, amlodipine/valsartan and manidipine/delapril. The cost per mmHg systolic BP ranged from 24.93 to 12.34 €/mmHg, and diastolic BP ranged from 34.24 to 18.76 €/mmHg, depending on the drug used. For an initial value of 165 mmHg systolic BP the most efficient treatment to achieve the therapeutic goal of hypertension control (< 140 mmHg) is manidipine/delapril with a cost of 67.76 €. The use of these drugs to control diabetic and hypertensive patients resulted in all cases being cost-effective (more effective and lower cost compared to "no treatment"). Manidipine/delapril showed the best relation cost-utility (1,970 €/QALY (quality-adjusted life year)) followed by amlodipine/olmesartan and amlodipine/valsartan (2,087 and 2,237 €/QALY, respectively) (AU)

[Cost-effectiveness analysis of tiotropium compared to ipratropium and salmeterol]. / Análisis del coste-eficacia del tiotropio frente al ipratropio y salmeterol.

OBJECTIVE: The constant increase in health care costs, in a context of limited resources and the appearance of more costly though more effective drugs, justifies an assessment of the pharmacoeconomics of these drugs. The objective of this study was to evaluate the cost-effectiveness of one of the newest drugs for the treatment of chronic obstructive pulmonary disease (COPD)-tiotropium. MATERIAL AND METHOD: A cost-effectiveness analysis (costs and outcomes) within the framework of the Spanish National Health System was done. The alternatives to tiotropium analyzed were ipratropium and salmeterol. Direct health care costs associated with hospital treatment were calculated. Forced expiratory volume in 1 second, quality of life (with the Saint George's Respiratory Questionnaire), dyspnea transitional index, mean stay in hospital, and exacerbations were the variables used to measure effectiveness. Values for these variables were taken from the main reviews and randomized clinical trials published for tiotropium. RESULTS: For COPD patients, treatment with tiotropium leads to a greater reduction in exacerbations (37% compared to ipratropium and 25% compared to salmeterol 25%), and a reduction in the number of days in hospital (33% compared to ipratropium and 14% compared to salmeterol). Therefore, use of tiotropium could save ;100 000 for the current rates of admission and lengths of hospital stay in Spain. CONCLUSIONS: Tiotropium was more effective than ipratropium and salmeterol as measured by objective clinical variables (forced expiratory volume in 1 second) and subjective ones (the Saint George's Respiratory Questionnaire and dyspnea transitional index). Hospital stays were shorter and exacerbations fewer with tiotropium. In all cases, tiotropium was more cost-effective than the alternatives, thus use of tiotropium could help hospitals to save money.

Análisis del coste-eficacia del tiotropio frente al ipratropio y salmeterol / Cost-effectiveness analysis of tiotropium compared to ipratropium and salmeterol

Objetivo: El incesante incremento de los costes en un marco en el que los recursos son limitados, así como la aparición de nuevos medicamentos más costosos y a la vez más eficaces, justifica la evaluación económica de los medicamentos. El objetivo de este trabajo es evaluar el coste-eficacia de uno de los fármacos más novedosos para el tratamiento de la enfermedad pulmonar obstructiva crónica (EPOC), el tiotropio. Material y método: Se ha realizado un análisis de coste-eficacia (costes y consecuencias) desde la perspectiva del Sistema Nacional de Salud. Las alternativas analizadas han sido ipratropio y salmeterol. Se han considerado sólo costes sanitarios directos en el ámbito hospitalario. Los parámetros de eficacia analizados han sido: volumen espiratorio forzado en el primer segundo, calidad de vida (mediante el Saint George's Respiratory Questionnaire), índice transicional de disnea, estancias medias y exacerbaciones. Dichos parámetros se han obtenido de las principales revisiones y ensayos clínicos aleatorizados publicados sobre el tiotropio. Resultados: Teniendo en cuenta la reducción del número de exacerbaciones conseguida con el tiotropio frente al ipratropio y salmeterol (el 37 y el 25%, respectivamente) y del número de días de estancia hospitalaria (el 33 y el 14%, respectivamente), su utilización puede suponer un ahorro superior a los 100.000 € para las cifras actuales de tasa de ingresos y días de estancia hospitalaria de los pacientes con EPOC en España. Conclusiones: El tiotropio ha sido más efectivo que el ipratropio y salmeterol tanto en parámetros clínicos (objetivos, como el volumen espiratorio forzado en el primer segundo, y subjetivos, como el Saint George's Respiratory Questionnaire y el índice transicional de disnea) como en disminución de estancias hospitalarias y exacerbaciones. En todos los casos resulta más coste-efectivo que sus alternativas, lo que supone importantes ahorros en el ámbito hospitalario

Objective: The constant increase in health care costs, in a context of limited resources and the appearance of more costly though more effective drugs, justifies an assessment of the pharmacoeconomics of these drugs. The objective of this study was to evaluate the cost-effectiveness of one of the newest drugs for the treatment of chronic obstructive pulmonary disease (COPD)-tiotropium. Material and method: A cost-effectiveness analysis (costs and outcomes) within the framework of the Spanish National Health System was done. The alternatives to tiotropium analyzed were ipratropium and salmeterol. Direct health care costs associated with hospital treatment were calculated. Forced expiratory volume in 1 second, quality of life (with the Saint George's Respiratory Questionnaire), dyspnea transitional index, mean stay in hospital, and exacerbations were the variables used to measure effectiveness. Values for these variables were taken from the main reviews and randomized clinical trials published for tiotropium. Results: For COPD patients, treatment with tiotropium leads to a greater reduction in exacerbations (37% compared to ipratropium and 25% compared to salmeterol 25%), and a reduction in the number of days in hospital (33% compared to ipratropium and 14% compared to salmeterol). Therefore, use of tiotropium could save €100 000 for the current rates of admission and lengths of hospital stay in Spain. Conclusions: Tiotropium was more effective than ipratropium and salmeterol as measured by objective clinical variables (forced expiratory volume in 1 second) and subjective ones (the Saint George's Respiratory Questionnaire and dyspnea transitional index). Hospital stays were shorter and exacerbations fewer with tiotropium. In all cases, tiotropium was more cost-effective than the alternatives, thus use of tiotropium could help hospitals to save money

Salud autopercibida, apoyo social y familiar de los pacientes con enfermedad pulmonar obstructiva crónica / Quality of life, familiar and social network of patients with chronic obstructive pulmonary disease

Fundamentos: la EPOC es una enfermedad crónica e invalidante con gran repercusión en la calidad de vida del paciente así como en su dinámica familiar y social. La percepción por parte del paciente de sus limitaciones genera un sentimiento de baja autoestima que pone en peligro su posición ante la familia y la sociedad. Objetivos: describir características sociodemográficas y conocer en los pacientes con EPOC la calidad de vida autopercibida, el apoyo social con que cuentan y su dinámica familiar.Diseño: descriptivo transversal.Material y métodos: selección mediante muestreo consecutivo de 278 pacientes diagnosticados de EPOC. Mediante entrevista personal se recogió : perfil sociodemográfico, hábito tabáquico y antecedentes clínicos (comorbilidad), salud autopercibida (perfil de salud de Nottingham, NHP, y Cuestionario Respiratorio St George, SGRQ), apoyo social (Escala de Duke-Unc) y apoyo familiar (test de AP GAR familiar). Estadística descriptiva.Resultados: variables sociodemográficas: varones (88 por ciento), de 66,9ñ8,9 años, casados (87 por ciento), analfabetos (46,7 por ciento), jubilados (77 por ciento). Fumadores (76 por ciento) de 53,2 paquetes/año. Comorbilidad: 76 por ciento pacientes. Los principales resultados de salud autopercibida fueron (medias e IC 95 por ciento): perfil de Salud de Nottingham (0-100): subescalas de energía 40 (35,6-44,4), dolor 35,9 (32,3-39,5), emotividad 32,5 (29,4-38,6), sueño 41,9 (37,8-45,9), so cial 15,3 (12,7-17,9), movilidad 36,7 (33,9-39,5) y total 33,4 (30,8-36). Cuestionario de St. George (0-100): subescalas de impacto 38,01 (35,0840,18), actividad 53,8 (50,2-57,4), síntoma 37,7 (35,2-40,3) y total 40,9 (38,6-43,2). Apoyo social Conclusiones: la calidad de vida de los pacientes con EPOC resultó estar bastante alterada fundamentalmente en las dimensiones de sueño, energía y movilidad del NHP y en la subescala que valora la limitación de la actividad a causa de la disnea del SGRQ. Algo más de la mitad de los pacientes referían buen apoyo social, siendo mayor el afectivo que el confidencial. Consideramos importante el porcentaje de disfunción familiar (20,3 por ciento) (AU)

[A retrospective evaluation of the behaviour of groups under out-patient care at a health center]. / Evaluación retrospectiva del comportamiento de los grupos de cuidados ambulatorios en un centro de salud.

OBJECTIVES: To study and analyse the Out-Patient Care Groups (OCGs), and evaluate how they affect use of health resources. DESIGN: An observational, retrospective study. SETTING: Ciudad Jardín Health Centre, Málaga. PARTICIPANTS: 2999 patients with a clinical history opened before 31.12.95, chosen from 5 of the 17 medical lists at the Health Centre, were included. RESULTS: The statistical analysis was performed with the SPSS software package of the Calculation Centre at Málaga University. A descriptive test produced the following results: 33% of the patients were classified in OCG 41 (combination of 2 or 3 out-patient diagnosis groups in people over 34); 19% belonged to groups of stable or unstable chronic illnesses (OCGs 8, 9 and 10); and 9% had acute children's diseases. Then multiple regression constructed a model with the OCGs as independent variable and annual visits, further tests performed and referral to specialists as dependent variables. In this model the OCGs were able to explain 20.3% of resource consumption. CONCLUSIONS: In the retrospective study and with a limited sample of 2999 patients, the OCGs are able to explain 20.3% of resource consumption. However, it does seem a valid model for discriminating between normal and over-using patients.

[Hypertensive patients treated in Spain, 1990-1993]. / Estudio sobre los enfermos hipertensos en tratamiento en España durante el período 1990-1993.

BACKGROUND: The main goal of our work was to gain knowledge from the pharmaco-epidemiological perspective on the use of anti-hypertensive drugs in our country, in order to obtain a rough estimation of the number of hypertensive patients under treatment in various Autonomous Communities. METHODS: The data regarding the consumption of hypertensive drugs (mono-medicines) from 1990 to 1993 have been obtained from the Vice-Directorate General for Treatment and Pharmaceutical Planning. The methodology used to calculate the "Estimated Prevalence Patient-day" under treatment with these drugs is based on the WHO recommendations for the Studies on the use of Medicines. Estimated Prevalence of Patient-day (EPPD) has been calculated by using the Defined Daily Dosage of each anti-hypertensive drug. RESULTS: The number of hypertensive patients under treatment with these drugs was 1.763.937, 1.966.396, 2.226.225 and 2.435.294, from 1990 to 1993, respectively. At the end of our study, in 1993, the number of hypertensive patients under treatment in Spain is nearly 50% of the total number of hypertensive patients. There are some differences amongst regions; thus, the Autonomous Communities of Aragón, Castilla-La Mancha, Cataluña, País Valenciano and Murcia are noticeable as regions where the number of hypertensive patients treated exceeds the national average. CONCLUSIONS: The number of hypertensive patients under treatment has considerably increased between 1990 to 1993 (+ 40%). An increase is observed in the number of hypertensive patients treated with calcium antagonists and ECA inhibitors and a decrease is observed in the proportion of hypertensive patients under treatment with Beta-blockers and diuretics.

Differences between rat dorsal and ventral hippocampus in muscarinic receptor agonist binding and interaction with phospholipase C.

Carbachol, a full muscarinic receptor agonist, stimulated [3H]inositol phosphate accumulation in both the ventral and dorsal hippocampus, but its efficacy and affinity were higher in the former area. The partial agonist oxotremorine had a weak stimulatory effect in both regions. The affinity profiles of pirenzepine and AF-DX 116 in antagonizing carbachol-stimulated [3H]inositol phosphate accumulation indicated that M1 and M3 receptors contributed equally to the response in either region. On the other hand, there were no differences in the receptor density, or in the distribution of muscarinic receptor subtypes between the two regions of the hippocampus which could account for the effect as determined in binding experiments with selective antagonists. Analysis of carbachol binding curves did, instead, indicate a difference in the way the agonist interacted with the receptors within the hippocampus, i.e., carbachol recognized three agonist affinity states (superhigh, high and low) in the ventral hippocampus, and only two (high and low) in the dorsal part. The findings thus suggested that the regional diversity in the efficacy of carbachol in stimulating phosphoinositide turnover was related to the complexity with which it bound to muscarinic receptors. Transduction processes that intervene between changes in the muscarinic receptors' conformation and activation of phospholipase C might be relevant to these differences.