Las combinaciones fijas en hipertensión: análisis de impacto presupuestario para el Sistema Nacional de Salud Español de la comercialización de la combinación fija de olmesartan/amlodipino

ResumenObjetivoRealizar un análisis de impacto presupuestario (AIP) de la introducción en el Sistema Nacional de Salud (SNS) de la combinación fija (CF) de olmesartan/amlodipino (20/5, 40/5 y 40/10mg) en la indicación aprobada.DiseñoModelo de árbol de decisión que refleja el algoritmo de tratamiento más habitual en la práctica clínica de la hipertensión junto con sus probabilidades de ocurrencia.EmplazamientoPerspectiva del SNS para un período de 3 años (2010-2012).ParticipantesPoblación española hipertensa mayor de 35 años.IntervencionesIntroducción de la CF olmesartan/amlodipino en el mercado español.Mediciones principalesCostes financiados por el SNS (a PVP-IVA) para la población de pacientes susceptibles de ser tratados con la CF frente a los asumidos con la combinación libre (CL) olmesartan y amlodipino.ResultadosLa estimación del gasto farmacéutico con olmesartan y amlodipino en CL era de 25,2 M€ (primer año), 26,4 M€ el segundo año y 27,6 M€ el tercero, totalizando 79,2 M€. Según el modelo, la población susceptible de ser tratada con la CF es de 71.283 pacientes (primer año), con una tasa de crecimiento cercana al 4,8% en los sucesivos años, lo que supone un coste anual de 21,2 M€ (2010), 21,8 M€ (2011) y 22,4 M€ (2012), totalizando 65,4 M€. El AIP muestra un ahorro de 13,8 M€, siendo unos resultados robustos confirmados por los análisis de sensibilidad univariantes de tipo umbral.ConclusiónEl AIP de la CF de olmesartan/amlodipino podría generar unos ahorros netos para el SNS en 3 años de 13,8 M€.AbstractObjectiveTo carry out a budget impact analysis (BIA) of olmesartan/amlodipine (20/5, 40/5 and 40/10mg) marketed as a fixed combination (FC) in its approved indication for the National Health System (NHS).DesigWe developed a decision tree model in order to estimate usual hypertension treatment algorithm in Spanish clinical practice.SettingsThe BIA has been developed from the perspective of the NHS for a period of 3 years (years 2010-2012).ParticipantsSpanish hypertensive population ≥ 35 years old.InterventionsIntroduction into the market of a fixed combination (FC) olmesartan/amlodipine in Spain.Primary measuresExpected costs to be assumed by the Spanish NHS (RRP-VAT) for hypertensive population able to be treated with the FC versus currently assumed costs by the NHS with free combination olmesartan and amlodipine.ResultsEstimated pharmaceutical costs in hypertensive population treated with olmesartan and amlodipine (2 pills) would be €25.2M (1st year), €26.4M (2011), €27.6M (2012), with a total 3-year period of €79.2M. According to patient tree model, the population able to be treated with FC would be 71,283 patients (2010), with a growth rate of 4.8% in the successive years, which supposes an annual cost of €21.2M (2010), €21.8M (2011) and €22.4M (2012), with a total 3-year period of €65.4M. The BIA shows savings of €13.8M in a total 3-year period.ConclusionThe BIA of FC olmesartan/amlodipine could generate net savings of €13.8M for the NHS in the period ranging from years 2010 to 2012

Utilización de recursos sanitarios y costes asociados al diagnóstico y tratamiento de cada episodio de trombosis venosa profunda y sangrado en pacientes intervenidos de cirugía ortopédica de cadera o rodilla

Objective: To determine the use of healthcare resources and costs associated with the diagnosis and treatment of thrombosis and bleeding patients who have undergone elective hip or knee replacement surgery, in routine clinical practice conditions. Patients and methods: This multicentre observational and retrospective study extracted data from the medical records of three Spanish public hospitals (2010). Patients ≥40 years who had received prophylaxis-anticoagulation were included. They were randomised into three groups: (a) control (no hospital complications), (b) bleeding, and (c) thrombosis. General variables, use of resources and costs were analysed. Statistical analysis: logistic regression and ANCOVA for model correction (P < .05) was included. Results: A total of 141 patients (control: 60; bleeding: 60; and thrombosis: 21), with a mean age 68.7 (SD: 10.4) years, and 68.1% females were identified. Hip arthroplasty was more frequent (71.6%). The bleeding risk was associated with age (OR = 1.1) and thrombosis with COPD (OR = 1.8); P < .05). The average length of stay for the thrombosis, bleeding and control groups was 13.9, 11.5 and 7.4 days, respectively; P < .001). The total costs for each group were D10,484.3; D8766.4 and D6496.1 respectively; P < .05. All grouped results were comparable between them according to the hospital analysed and the type of replacement. Conclusions: Costs were higher for thrombosis and bleeding patients, respectively. Costs were associated with length of stay and hospital-acquired infections.Objetivo: Conocer la utilización de recursos sanitarios y los costes asociados al diagnóstico y tratamiento de la trombosis y sangrado en pacientes intervenidos de artroplastia primaria total de cadera (ATC) o rodilla (ATR), durante 3 meses de seguimiento. Pacientes y método: Estudio observacional de carácter multicéntrico y retrospectivo, realizado a partir de los registros médicos de pacientes pertenecientes a 3 centros hospitalarios-públicos espanoles ˜ (ano˜ 2010). Se consideraron aleatoriamente 3 grupos de pacientes: a) control (sin complicaciones hospitalarias); b) sangrado, y c) trombosis. Se incluyeron variables generales, de utilización de recursos y sus costes. Análisis estadístico: regresión logística y ANCOVA, p < 0,05. Resultados: Se incluyeron pacientes ≥ 40 anos ˜ y que hubieran recibido profilaxis anticoagulante. Se incluyó un total de 141 pacientes (control: 60; sangrado: 60; y trombosis: 21). La edad media fue de 68,7 (DE: 10,4) anos ˜ y el 68,1% fueron mujeres. La ATR fue la técnica más frecuente (71,6%). El riesgo de sangrado se relacionó con la edad (OR = 1,1) y el de trombosis con la EPOC (OR = 1,8), p < 0,05. El promedio de días de estancia de los grupos de trombosis, sangrado y control fue de 13,9; 11,5 y 7,4 días, respectivamente, p < 0,001). Los costes totales fueron: 10.484,3 D; 8.766,4 D, y 6.496,1 D, respectivamente, p < 0,05. Todos los resultados agrupados fueron comparables entre ellos según el hospital analizado y el tipo de artroplastia. Conclusiones: Los costes más elevados se producen en los pacientes que habían desarrollado una trombosis y sangrado, respectivamente. Los costes se relacionaron con la prolongación de los días de estancia y las infecciones intrahospitalariasMedicin

Pregabalin versus SSRIs and SNRIs in benzodiazepine-refractory outpatients with generalized anxiety disorder: a post hoc cost-effectiveness analysis in usual medical practice in Spain

Marina De Salas-Cansado,1 Jos&amp;eacute; M Olivares,2 Enrique &amp;Aacute;lvarez,3 Jose L Carrasco,4 Andoni Barrueta,5 Javier Rejas,51Trial Form Support Spain, Madrid; 2Department of Psychiatry, Hospital Meixoeiro, Complejo Hospitalario Universitario, Vigo; 3Department of Psychiatry, Hospital de la Santa Creu i San Pau, Barcelona; 4Department of Psychiatry, Hospital Cl&amp;iacute;nico San Carlos, Madrid; 5Health Outcomes Research Department, Medical Unit, Pfizer Spain, Alcobendas, Madrid, SpainBackground: Generalized anxiety disorder (GAD) is a prevalent health condition which seriously affects both patient quality of life and the National Health System. The aim of this research was to carry out a post hoc cost-effectiveness analysis of the effect of pregabalin versus selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) in treated benzodiazepine-refractory outpatients with GAD.Methods: This post hoc cost-effectiveness analysis used secondary data extracted from the 6-month cohort, prospective, noninterventional ADAN study, which was conducted to ascertain the cost of illness in GAD subjects diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria. Benzodiazepine-refractory subjects were those who claimed persistent symptoms of anxiety and showed a suboptimal response (Hamilton Anxiety Rating Scale &amp;ge;16) to benzodiazepines, alone or in combination, over 6 months. Patients could switch to pregabalin (as monotherapy or addon) or to an SSRI or SNRI, alone or in combination. Effectiveness was expressed as quality-adjusted life years gained, and the perspective was that of the National Health System in the year 2008. A sensitivity analysis was performed using bootstrapping techniques (10,000 resamples were obtained) in order to obtain a cost-effectiveness plane and a corresponding acceptability curve.Results: A total of 282 subjects (mean Hamilton Anxiety Rating Scale score 25.8) were identified, comprising 157 in a pregabalin group and 125 in an SSRI/SNRI group. Compared with SSRI/SNRI, pregabalin (average dose 163 mg/day) was associated with higher quality-adjusted life years gained (0.1086 &amp;plusmn; 0.0953 versus 0.0967 &amp;plusmn; 0.1003, P = 0.334), but increased health care costs (&amp;euro;1014 &amp;plusmn; 762 versus &amp;euro;846 &amp;plusmn; 620, P = 0.166) and drug costs (&amp;euro;376 &amp;plusmn; 252 versus 220 &amp;plusmn; 140, P &amp;lt; 0.001), resulting in an incremental cost-effectiveness ratio of &amp;euro;25,304 (95% confidence interval dominant 149,430) per quality-adjusted life years gained for health care costs and &amp;euro;25,454 (dominant 124,562) when drug costs were considered alone. Eighty-six percent of resamples fell below the threshold of &amp;euro;30,000 per quality-adjusted life years.Conclusion: This evaluation suggests that pregabalin may be cost-effective in comparison with SSRIs/SNRIs in benzodiazepine-refractory outpatients with GAD treated in mental health care settings under usual medical practice in Spain.Keywords: cost-effectiveness, generalized anxiety disorder, benzodiazepine-refractory patients, pregabalin, quality-adjusted life year

Cost minimization analysis of treatment with intravenous or subcutaneous trastuzumab in patients with HER2-positive breast cancer in Spain

To describe healthcare professional (HCP) and patient time and related costs associated with trastuzumab intravenous infusion (IV) and trastuzumab subcutaneous (SC) formulations in patients with HER2-positive early breast cancer.This prospective, observational time, and motion study in three Spanish centers was run as a substudy of the PrefHer trial. We recorded active HCP time for trastuzumab SC and IV-related tasks and calculated HCP time as the mean sum of task times over 154 administrations (80 IV, 74 SC). We calculated mean patient infusion chair time and treatment room time. Staff costs were calculated using fully loaded salary costs based on Spanish salaries (a,notsign 2012).The transition from trastuzumab IV to SC led to a 50% reduction in active HCP time [27.2 min (95% CI 21.8-32.6) vs. 13.2 min (95% CI 8.9-17.5) per cycle]. Time savings resulted from avoiding IV catheter installation and removal, line flushing, and drug reconstitution. SC administration led to a fivefold reduction (78-85%) in chair time and a fourfold reduction (59-81%) in patient treatment room time, resulting in 24 h free-up time in the total treatment course (18 cycles). Total estimated direct costs were a,notsign 29,431.75 and a,notsign 28,452.12 for IV and SC, respectively, a saving of a,notsign 979.60 over a full treatment course.Trastuzumab SC provided substantial time savings for HCP and patients, and reduced staff costs vs. trastuzumab IV. Reducing the use of hospital facilities may result in further savings and improved quality of medical care