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.

Randomized clinical trial of nutritional counseling for malnourished hospital patients. / Ensayo clínico aleatorizado del asesoramiento nutricional en pacientes desnutridos hospitalizados.

INTRODUCTION: Malnutrition is associated with an increased risk of mortality and morbidity, longer hospital stays and general loss of quality of life. The aim of this study is to assess the impact of dietary counseling for malnourished hospital patients. PATIENTS AND METHODS: Prospective, randomized, open-label study of 106 hospital patients with malnutrition (54 in the control group and 52 in the intervention group). The intervention group received dietary counseling, and the control group underwent standard treatment. We determined the patients' nutritional state (body mass index, laboratory parameters, malnutrition universal screening tool), degree of dependence (Barthel index), quality of life (SF-12), degree of satisfaction (CSQ-8), the number and length of readmissions and mortality. RESULTS: The patients who underwent the "intervention" increased their weight at 6 months, while the controls lost weight (difference in body mass index, 2.14kg/m(2); p<.001). The intervention group had better results when compared with the control group in the Malnutrition Universal Screening Tool scores (difference, -1.29; p<.001), Barthel index (difference, 7.49; p=.025), SF-12 (difference, 13.72; p<.001) and CSQ-8 (difference, 4.34, p<.001) and required fewer readmissions (difference, -0.37; p=.04) and shorter stays for readmissions (difference, -6.75; p=.035). Mortality and laboratory parameters were similar for the 2 groups. CONCLUSIONS: Nutritional counseling improved the patients' nutritional state, quality of life and degree of dependence and decreased the number of hospital readmissions.

[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).

Proyecto "Revisa(R)". Impacto del servicio de revisión del uso de los medicamentos en España. Informe de tiempos y costes / The "I-VALOR" program: standardized, protocolized, and registered drug indications for community pharmacy

En el año 2013 la Sociedad Española de Farmacia Familiar y Comunitaria (SEFAC), mediante la subcomisión de revisión del uso de los medicamentos (RUM), integrada en la comisión de servicios profesionales e inspirada en el servicio británico MUR (Medicines Use Review), puso en marcha el proyecto Revisa(R) con el fin de implantar este servicio en España. Desde entonces se han realizado cursos de capacitación, elaborado documentos de especificaciones y protocolos normalizados que permitan al farmacéutico comunitario prestar de manera adecuada y homogénea este servicio a la población. También se desarrolló un módulo para la gestión de este servicio en SEFAC e_XPERT, aplicación informática desarrollada por SEFAC para la gestión de los servicios profesionales farmacéuticos. En 2016 SEFAC llevó a cabo el primer estudio de investigación relacionado con el servicio de revisión del uso de los medicamentos con el fin de pilotar su prestación en la práctica farmacéutica. En este informe se presentan los resultados de tiempo y costes obtenidos del análisis de los datos del proyecto Revisa(R) realizado en 64 farmacias de España durante los meses de marzo a julio de 2016. Se pretende con ello facilitar al farmacéutico comunitario la información necesaria para permitirle establecer unos honorarios para la prestación de este servicio apoyado en la evidencia obtenida en la práctica farmacéutica (AU)

In 2013, the Sociedad Española de Farmacia Familiar y Comunitaria (SEFAC) [Spanish Society of Community Pharmacy] launched the Revisa(R) project. Managed by the Medicines Use Review (MUR) Subcommittee, part of the Professional Services Committee, the project takes its inspiration from the British MUR service and seeks to introduce a similar service throughout Spain. Since then, training courses have been delivered, specification documents drawn up, and protocols standardized, to enable community pharmacy to deliver the service to the public in an appropriate and consistent manner. A module to manage the service has also been developed in SEFAC e_XPERT, a computer program designed by SEFAC to manage professional pharmaceutical services. In 2016, SEFAC completed the first research study linked to the medicines use review service, designed to pilot its work in pharmaceutical practice. This report presents the time and cost results obtained by analyzing the data collected as part of the Revisa(R) project from 64 pharmacies in Spain between March and July 2016. The aim is to provide community pharmacy with the information required to establish the appropriate fees for the delivery of this service, based on evidence obtained from pharmaceutical practice (AU)

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

Objetivo. Realizar un estudio de coste-utilidad en pacientes asmáticos en tratamiento con beclometasona/formoterol en combinación fija en Atención Primaria de Salud. Material y métodos. Se seleccionó de forma no probabilística un grupo de pacientes asmáticos con severidad persistente moderada/grave (GEMA 2009), en tratamiento con beclometasona/formoterol a dosis fijas, mayores de 18 años, que habían otorgado su consentimiento informado. El período de observación del estudio fue de 6 meses. Las variables estudiadas fueron: edad, sexo, duración de la enfermedad, recursos sanitarios empleados, análisis de la calidad de vida relacionada con la salud mediante EQ-5D y SF-36, y el cuestionario específico Asthma Quality of Life Questionnaire. Para las variables cualitativas se analizó la frecuencia y la proporción. Para las cuantitativas, la media, la DE y el IC 95%. En la estadística inferencial se utilizaron los test de Chi-cuadrado, t de Student y ANOVA. Las comparaciones se realizaron con una significación estadística de 0,05. Resultados. Sesenta y cuatro pacientes completaron el estudio; el 59,4% eran mujeres. La edad media fue de 49 años y la duración media de la enfermedad fue de 93 meses. Para el control del asma el 53% de los pacientes tenían una pauta prescrita de uno/12 h. Todas las escalas de calidad de vida relacionada con la salud se modificaron respecto del inicio del estudio y las diferencias fueron estadísticamente significativas. Nuestros pacientes lograron mejores puntuaciones en calidad de vida relacionada con la salud que la cohorte española de asma. El coste-utilidad incremental de beclometasona/formoterol frente a la opción habitual de tratamiento fue de 6.256 €/AVAC (AU)

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/12 h. 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 (AU)

Resultados en salud y eficiencia del fentanilo intranasal en pectina en el dolor irruptivo en la práctica clínica habitual / No disponible

OBJETIVO: Conocer la efectividad y eficiencia del fentanilo intranasal en pectina comparado con otros tratamientos empleados en el dolor irruptivo oncológico a través de un análisis farmacoeconómico. RESULTADOS Y CONCLUSIONES: En la evaluación farmacoeconómica realizada, todas las opciones analizadas fueron coste-efectivas para una disposición a pagar (invertir) de 30.000 € por AVAC ganado (ratio coste/efectividad < 30.000 €). La opción más eficiente (mayor efectividad y menor coste) en todos los casos analizados es el espray intranasal de fentanilo en pectina (FPNS). En el análisis incremental, FPNS fue la opción dominante sobre todas las demás evaluadas: FST, OTFC, FBT e INFS. Del análisis de los datos de nuestro estudio de modelización de coste/efectividad del espray intranasal de fentanilo en pectina FPNS se concluye: - INFS sin proporcionar más eficacia ha demostrado ser significativamente más caro (+15 %). - FST, OTFC, FBT han demostrado una efectividad un 18 % menor que FPNS y además ser significativamente más caros (+9 %; +15 %; +10 %, respectivamente). Abreviaturas: AVAC: años ganados con buena calidad de vida. FPNS: PecFent®. FST: Abstral®. OTFC: Actiq®. FBT: Effentora®. INFS: Instanyl®

OBJECTIVE: Determine, with a pharmacoeconomic evaluation, the effectiveness and efficiency of fentanyl pectin intranasal spray for BTPc versus other indicated treatments. RESULTS AND CONCLUSIONS: All the treatments analyzed in the pharmacoeconomic evaluation were cost-effective in terms of a willingness to pay (invest) of € 30,000 per AVAC gained (cost / effectiveness ratio < € 30,000). The most efficient option (greater effectiveness and lower cost) of all the treatments analyzed was the fentanyl pectin nasal spray (FPNS). In the incremental analysis FPNS was the dominant treatment option over all the others evaluated: FST, OTFC, FBT and INFS. From the analysis of the data of our cost/effectiveness modeling study of the fentanyl pectin nasal spray, FPNS, we can conclude: - INFS without providing greater effectiveness has been shown to be significantly more expensive (+15 %). - FST, OTFC, FBT have demonstrated -18 % less effectiveness and also been shown to be significantly more expensive than FPNS (+9 %; +15 %; +10 %, respectively). Abbreviations: AVAC: Years gained with good quality of life. FPNS: PecFent®. FST: Abstral®. OTFC: Actiq®. FBT: Effentora®. INFS: Instanyl®

Ensayo clínico aleatorizado del asesoramiento nutricional en pacientes desnutridos hospitalizados / Randomized clinical trial of nutritional counseling for malnourished hospital patients

Introducción. La desnutrición se asocia a un mayor riesgo de mortalidad y morbilidad, a estancias hospitalarias más largas y a un deterioro general de la calidad de vida. Este estudio se propone evaluar en pacientes desnutridos hospitalizados el impacto del asesoramiento dietético. Pacientes y métodos. Estudio prospectivo, aleatorizado, abierto, en 106 pacientes hospitalizados con desnutrición (54 grupo control, 52 en el de «intervención»). El grupo «intervención» recibió asesoramiento dietético y el grupo control el tratamiento habitual. Se determinó el estado nutricional (índice de masa corporal, parámetros analíticos, Malnutrition Universal Screening Tool), el grado de dependencia (índice de Barthel), la calidad de vida (SF-12), el grado de satisfacción de los pacientes (CSQ-8), el número y días de reingresos hospitalarios y la mortalidad. Resultados. Los pacientes sometidos a «intervención» aumentaron de peso a los 6 meses, mientras que los controles perdieron peso (diferencia en el IMC de 2,14kg/m2 [p<0,001]). El grupo «intervención» mostró mejores resultados respecto al grupo control en las puntuaciones obtenidas en el Malnutrition Universal Screening Tool (diferencia –1,29; p<0,001), Barthel (diferencia 7,49; p=0,025), SF-12 (diferencia 13,72; p<0,001), y CSQ-8 (diferencia 4,34, p<0,001), y precisaron de un menor número de reingresos (diferencia –0,37; p=0,04) y de días de rehospitalización (diferencia –6,75; p=0,035). La mortalidad y los parámetros analíticos fueron similares en grupos. Conclusiones. El asesoramiento nutricional mejoró el estado nutricional, la calidad de vida y el grado de dependencia de los pacientes, además disminuyó el número de reingresos hospitalarios (AU)

Introduction. Malnutrition is associated with an increased risk of mortality and morbidity, longer hospital stays and general loss of quality of life. The aim of this study is to assess the impact of dietary counseling for malnourished hospital patients. Patients and methods. Prospective, randomized, open-label study of 106 hospital patients with malnutrition (54 in the control group and 52 in the intervention group). The intervention group received dietary counseling, and the control group underwent standard treatment. We determined the patients’ nutritional state (body mass index, laboratory parameters, malnutrition universal screening tool), degree of dependence (Barthel index), quality of life (SF-12), degree of satisfaction (CSQ-8), the number and length of readmissions and mortality. Results. The patients who underwent the “intervention” increased their weight at 6 months, while the controls lost weight (difference in body mass index, 2.14kg/m2; p<.001). The intervention group had better results when compared with the control group in the Malnutrition Universal Screening Tool scores (difference, –1.29; p<.001), Barthel index (difference, 7.49; p=.025), SF-12 (difference, 13.72; p<.001) and CSQ-8 (difference, 4.34, p<.001) and required fewer readmissions (difference, –0.37; p=.04) and shorter stays for readmissions (difference, –6.75; p=.035). Mortality and laboratory parameters were similar for the 2 groups. Conclusions. Nutritional counseling improved the patients’ nutritional state, quality of life and degree of dependence and decreased the number of hospital readmissions (AU)

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)