Cost-effectiveness of combination therapy umeclidinium/vilanterol versus tiotropium in symptomatic copd spanish patients

Purpose: Umeclidinium/vilanterol (UMEC/VI) is a novel fixed dose combination of a long-acting muscarinic receptor antagonist (LAMA) and a long-acting beta 2 receptor antagonist (LABA) agent. This analysis evaluated the incremental cost-effectiveness ratio (ICER) of UMEC/VI compared with tiotropium (TIO), from the Spanish National Health System (NHS) perspective. Methods: A previously published linked equations cohort model based on the epidemiological longitudinal study ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points) was used. Patients included were COPD patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤70% and the presence of respiratory symptoms mea­sured with the modified Medical Research Council dyspnea scale (modified Medical Research Council ≥2). Treatment effect, expressed as change in FEV1 from baseline, was estimated from a 24-week head-to-head phase III clinical trial comparing once-daily UMEC/VI with once-daily TIO and was assumed to last 52 weeks following treatment initiation (maximum duration of UMEC/VI clinical trials). Spanish utility values were derived from a published local observa­tional study. Unitary health care costs (€2015) were obtained from local sources. A 3-year time horizon was selected, and 3% discount was applied to effects and costs. Results were expressed as cost/quality-adjusted life years (QALYs). Univariate and probabilistic sensitivity analysis (PSA) was performed. Results: UMEC/VI produced additional 0.03 QALY and €590 vs TIO, leading to an ICER of €21,475/QALY. According to PSA, the probability of UMEC/VI being cost-effective was 80.3% at a willingness-to-pay of €30,000/QALY. Conclusion: UMEC/VI could be considered as a cost-effective treatment alternative compared with TIO in symptomatic COPD patients from the Spanish NHS perspective

Budget Impact Analysis of Biosimilar Products in Spain in the Period 2009–2019

Since the first biosimilar medicine, Omnitrope® (active substance somatropin) was approved in 2006, 53 biosimilars have been authorized in Spain. We estimate the budget impact of biosimilars in Spain from the perspective of the National Health System (NHS) over the period between 2009 and 2019. Drug acquisition costs considering commercial discounts at public procurement procedures (hospital tenders) and uptake data for both originator and biosimilar as actual units consumed by the NHS were the two variables considered. Two scenarios were compared: a scenario where no biosimilars are available and the biosimilar scenario where biosimilars are effectively marketed. All molecules exposed to biosimilar competition during this period were included in the analysis. The robustness of the model was tested by conducting multiple sensitivity analyses. From the payer perspective, it is estimated that the savings produced by the adoption of biosimilars would reach EUR 2306 million over 11 years corresponding to the cumulative savings from all biosimilars. Three molecules (infliximab, somatropin and epoetin) account for 60% of the savings. This study provides the first estimation of the financial impact of biosimilars in Spain, considering both the effect of discounts that manufacturers give to hospitals and the growing market share of biosimilars. We estimate that in our last year of data, 2019, the savings derived from the use of biosimilars relative total pharmaceutical spending in Spain is 3.92%. Although more research is needed, our evidence supports the case that biosimilars represent a great opportunity to the sustainability of the NHS through rationalizing pharmaceutical spending and that the full potential of biosimilar-savings has not been achieved yet, as there is a high variability in biosimilar uptake across autonomous regions

Clinical and economic impact of ‘ROS1-testing’ strategy compared to a ‘no-ROS1-testing’ strategy in advanced NSCLC in Spain

Background Detection of the ROS1 rearrangement is mandatory in patients with advanced or metastatic non-small cell lung cancer (NSCLC) to allow targeted therapy with specific inhibitors. However, in Spanish clinical practice ROS1 determination is not yet fully widespread. The aim of this study is to determine the clinical and economic impact of sequentially testing ROS1 in addition to EGFR and ALK in Spain. Methods A joint model (decision-tree and Markov model) was developed to determine the cost-effectiveness of testing ROS1 strategy versus a no-ROS1 testing strategy in Spain. Distribution of ROS1 techniques, rates of testing, positivity, and invalidity of biomarkers included in the analysis (EGFR, ALK, ROS1 and PD-L1) were based on expert opinion and Lungpath real-world database. Treatment allocation depending on the molecular testing results was defined by expert opinion. For each treatment, a 3-states Markov model was developed, where progression-free survival (PFS) and overall survival (OS) curves were parameterized using exponential extrapolations to model transition of patients among health states. Only medical direct costs were included (euro 2021). A lifetime horizon was considered and a discount rate of 3% was applied for both costs and effects. Both deterministic and probabilistic sensitivity analyses were performed to address uncertainty. Results A target population of 8755 patients with advanced NSCLC (non-squamous or never smokers squamous) entered the model. Over a lifetime horizon, the ROS1 testing scenario produced additional 157.5 life years and 121.3 quality-adjusted life years (QALYs) compared with no-ROS1 testing scenario. Total direct costs were increased up to euro 2,244,737 for ROS1 testing scenario. The incremental cost-utility ratio (ICUR) was 18,514 euro/QALY. Robustness of the base-case results were confirmed by the sensitivity analysis. Conclusions Our study shows that ROS1 testing in addition to EGFR and ALK is a cost-effective strategy compared to no-ROS1 testing, and it generates more than 120 QALYs in Spain over a lifetime horizon. Despite the low prevalence of ROS1 rearrangements in NSCLC patients, the clinical and economic consequences of ROS1 testing should encourage centers to test all advanced or metastatic NSCLC (non-squamous and never-smoker squamous) patients

Clinical and economic impact of current ALK rearrangement testing in Spain compared with a hypothetical no-testing scenario

Background: Currently biomarkers play an essential role in diagnosis, treatment, and management of cancer. In non-small cell lung cancer (NSCLC) determination of biomarkers such as ALK, EGFR, ROS1 or PD-L1 is mandatory for an adequate treatment decision. The aim of this study is to determine the clinical and economic impact of current anaplastic lymphoma kinase testing scenario in Spain. Methods: A joint model, composed by decision-tree and Markov models, was developed to estimate the long-term health outcomes and costs of NSCLC patients, by comparing the current testing scenario for ALK in Spain vs a hypothetical no-testing. The current distribution of testing strategies for ALK determination and their sensitivity and specificity data were obtained from the literature. Treatment allocation based on the molecular testing result were defined by a panel of Spanish experts. To assess long-term effects of each treatment, 3-states Markov models were developed, where progression-free survival and overall survival curves were extrapolated using exponential models. Medical direct costs (expressed in €, 2019) were included. A lifetime horizon was used and a discount rate of 3% was applied for both costs and health effects. Several sensitivity analyses, both deterministic and probabilistic, were performed in order test the robustness of the analysis. Results: We estimated a target population of 7628 NSCLC patients, including those with non-squamous histology and those with squamous carcinomas who were never smokers. Over the lifetime horizon, the current ALK testing scenario produced additional 5060 and 3906 life-years and quality-adjusted life-years (QALY), respectively, compared with the no-testing scenario. Total direct costs were increased up to € 51,319,053 for testing scenario. The incremental cost-effectiveness ratio was 10,142 €/QALY. The sensitivity analyses carried out confirmed the robustness of the base-case results, being the treatment allocation and the test accuracy (sensitivity and specificity data) the key drivers of the model. Conclusions: ALK testing in advanced NSCLC patients, non-squamous and never-smoker squamous, provides more than 3000 QALYs in Spain over a lifetime horizon. Comparing this gain in health outcomes with the incremental costs, the resulting incremental cost-effectiveness ratio reinforces that testing non-squamous and never-smoker squamous NSCLC is a cost-effective strategy in Spain

Development of an application to configure the smartphone as a stethoscope in health professionals with auditive deficiencies

Introducción y objetivos. La hipoacusia supone un severo hándicap para cualquier profesional cuya actividad se base en el reconocimiento de sonidos. En el caso de profesionales sanitarios, la auscultación constituye una actividad rutinaria y el padecimiento de hipoacusia la limita en grado variable en función de la severidad de la misma. Aquellos profesionales sanitarios que por la severidad de su hipoacusia necesitan del uso de audífonos ven dificultadas las rutinas basadas en el uso del fonendoscopio. El objetivo del presente trabajo es describir el proceso llevado a cabo para desarrollar una aplicación para smartphones, que permita la reproducción en tiempo real, el registro y el análisis de sonidos para facilitar la labor de profesionales sanitarios con hipoacusia. Métodos. Hemos recogido somatosonidos cardiacos, pulmonares y abdominales de sujetos sanos y patológicos a fin de caracterizarles frecuencialmente. Posteriormente, la aplicación ha sido diseñada con el objetivo de facilitar la labor diagnóstica del profesional sanitario hipoacúsico, teniendo en cuenta la caracterización anterior para optimizar la escucha y el análisis de sonidos cardiacos, pulmonares y abdominales. Además, con el objetivo de maximizar el número de dispositivos compatibles, ha sido desarrollada para el sistema operativo Android, el más extendido del mercado. Resultados. Hemos desarrollado una App. para smartphones (a la que hemos llamado STETHOSCOPE) basados en Android que configura el teléfono como un fonendoscopio recogiendo el somatosonido a través de su micrófono (siendo posible utilizar exclusivamente el micrófono interno del smartphone o bien micrófonos externos de alta calidad a través de su conector JACK), procesando la señal hasta enviarla finalmente por Bluetooth a los audífonos del profesional hipoacúsico. Esta aplicación permite grabar y representar gráficamente sonidos cardiacos, pulmonares y abdominales en dispositivos Android y almacenarlos en formato WAV, según las recomendaciones del Instituto de Ingeniería Eléctrica y Electrónica (Institute of Electrical and Electronics Engineers, IEEE), utilizando una codificación FLOAT de 32 bits sin compresión posibilitando su archivo, comparación o compartición con otros profesionales. Conclusiones. En este estudio presentamos una aplicación destinada a utilizar el smartphone como fonendoscopio, haciendo llegar el sonido captado a la ayuda auditiva (por vía inalámbrica) del profesional sanitario hipoacúsico que lo precise.Introduction and objectives. The hearing loss supposes a severe handicap for any professional whose activity is based on the recognition of sounds. In the case of health professionals, auscultation is a routine activity and the condition of hearing loss limits it to a variable degree depending on the severity of the same. Those health professionals who, due to the severity of their hearing loss, need the use of hearing aids, find routines based on the use of the stethoscope difficult. The objective of this work is to describe the process to develop a smartphone application that allows real-time reproduction, recording and analysis of sounds to facilitate the work of health professionals with hearing loss. Methods. We have collected cardiac, pulmonary and abdominal somatosounds from healthy and pathological subjects in order to characterize them spectrographically. Then, the application has been designed in order to facilitate the diagnostic work of the hypoacoustic healthcare professional, considering the previous characterization to optimize listening and analysis of cardiac, pulmonary and abdominal sounds. Moreover, in order to maximize the number of compatible devices, it has been developed for the Android operating system, the most widespread in the market. Results. An App for Android-based smartphones has been developed (called STETHOSCOPE) that configures the phone as a stethoscope, picking up the somatosounds through its microphone (being possible to use only the internal microphone of the Smartphone as external microphones of high quality to through its JACK connector), processing the signal until finally sending it via Bluetooth to the hearing aid of the hearing impaired professional. This application allows you to record and graphically represent heart sounds, lungs and abdominals in Android devices and store them in WAV format without compression with a 32-bit FLOAT IEEE coding, allowing your file, comparison or sharing with other professionals. Conclusion. In this study, we present a novel application designed to use the smartphone as a stethoscope, sending the captured sound to the hearing aid (wirelessly) of the physician with hearing loss

Surgycal anatomy of the thyroid and parathyroid glands

The aim of this article is describe the anatomical details that helps the surgeon to achieve safe surgeries, the style of descriptive or topographic anatomies is avoided trying to produce a truly surgical anatomy. For this, fascias, capsular structures and ligaments that surround the thyroid gland are mentioned. Emphasis is placed on vascularization, mainly in relation to the inferior thyroid artery, essential for the location of the recurrent nerve. Also in relation to the whole of the venous drainage, which with its complicated distribution makes dissection remarkably difficult. We carefully describe the anatomical variants and the anomalies that affect the structures of the región, their knowledge is fundamental to the possibility that the surgeons finds in their surgeries. We describe the appearance, the relationships and the reference to the location of the parathyroid glans. Neccesary details to avoid their inopinate resection in thyroidectomies and for the recognition of the pathological gland in the hyperparathyroidism./n /n Nuestro objetivo es lograr un relato de los detalles anatómicos que ayude al cirujano a conseguir intervenciones seguras, se elude el estilo de las anatomías descriptivas o topográficas tratando de producir una anatomía verdaderamente quirúrgica. Para ello se mencionan las fascias, estructuras capsulares y ligamentos que envuelven a la tiroides. Se hace hincapié en la vascularización, principalmente en lo referente a la arteria tiroidea inferior, fundamental para la localización del nervio recurrente. También en lo relacionado con el conjunto del drenaje venoso, que con su complicada distribución dificulta notablemente la disección. Relatamos minuciosamente las variantes anatómicas y las anomalías que afectan a la estructura de la región, su conocimiento es fundamental ante la posibilidad de que el cirujano encuentre en sus operaciones alguna de ellas. Describimos el aspecto, las relaciones y lo referente a la localización de las glándulas paratiroides, detalles necesarios para evitar su resección inopinada en las tiroidectomías y para el reconocimiento de la glándula patológica en el hiperparatiroidismo

Design, 3D modeling and mechanoacoustical behaviour optimization of a new ventilation tube

Introducción y Objetivos: En este trabajo mostramos un nuevo tubo de ventilación transtimpánico cuyo diseño pretende solventar los efectos indeseables aparecidos durante la inserción de tubos de ventilación actualmente comercializados; analizamos su comportamiento mecánico en un modelo 3D del oído a fin de optimizar su comportamiento acústico. Métodos: Para el diseño del tubo se empleó un software autoCAD; El comportamiento mecánico se analizó en un modelo computadorizado dinámico 3D del oído humano basado en el método de los elementos finitos (FEM). Resultados: El nuevo tubo de ventilación posee un tamaño y una masa significativamente menores a los actualmente disponibles en el mercado lo que provoca un menor interferencia en la vibración del sistema tímpano-osicular; su diseño facilita que permanezca insertado mientras las condiciones del paciente así lo aconsejen evitando su caída hacia la caja o su precoz extrusión. Conclusiones: Las ventajas teóricas biológicas y acústicas del nuevo tubo desarrollado (con menor masa y cuyo diseño evita las complicaciones de los actuales) puede abrir una nueva posibilidad de tratamiento de la otitis media seromucosa crónica.Introduction and Objetive: We show a new trans-tympanic ventilation tube whose design and mass are intended to solve the undesirable effects that appeared during the insertion of currently commercialized ventilation tubes; We analyze its mechanical behavior in a 3D model of the ear in order to optimize its acoustic behavior. Methods: For the design of the tube an autoCAD software was used; The mechanical behavior was analyzed in a 3D dynamic computerized model of the human ear based on the finite element method (FEM). Results: The new ventilation tube has a size and mass significantly smaller than those currently available in the market, which causes less interference in the vibration of the eardrum-osicular system; Its design facilitates it to remain inserted while the patient's conditions so advise avoiding its fall into the middle ear cavity or its early extrusion. Conclusions: The biological and acoustic advantages of the new developed tube (with less mass and whose design avoids the complications of the current ones) can open a new possibility of treatment of chronic seromucous otitis media

Key points in thyroid gland surgery

The aim of this article is to achieve an account of the key surgical points in thyroid and parathyroid surgery that helps the surgeon to achieve safe interventions. A surgery is not enjoyed if the surgeon does not have full knowledge of the applied anatomy of the area to be operated on. In thyroid surgery, having a basic understanding of the embryology of both glands provides great help when it comes to dissection and surgical treatment. The position of the patient and the equipment that we must have before starting the surgical act is essential. Releasing the gland from its support systems: fascia, ligaments and vascular pedicles, effectively and through the correct dissection plane is a key aspect in the proper development of the surgery. The identification of the tubercle of Zuckerkandl indicates the crossroads between the inferior thyroid artery, the superior parathyroid gland and the recurrent nerve. We consider neuromonitoring of the recurrent nerve necessary, because except for the exception of a known non-recurrent recurrent nerve, the complexity in the location of this nerve cannot be determined a priori. The hemostatic instruments that we currently have require their routine use. Thorough knowledge of thyroid surgery makes it easier for the surgeon to perform any surgical treatment of the parathyroid glands.Nuestro objetivo es lograr una descripción de los puntos quirúrgicos clave en la cirugía tiroidea y paratiroidea que ayude al cirujano a conseguir intervenciones seguras. Una cirugía no se disfruta si el cirujano no tiene pleno conocimiento de la anatomía aplicada del área a operar. En la cirugía de tiroides tener un conocimiento básico de la embriología de ambas glándulas aporta una gran ayuda a la hora de la disección y tratamiento quirúrgico. La posición del paciente y el equipo de instrumentos que debemos tener antes de iniciar el acto quirúrgico es fundamental. Desanclar la glándula de sus sistemas de sujeción: fascia, ligamentos y pedículos vasculares, de manera eficaz y por el plano correcto de disección es un aspecto clave en el buen desarrollo de la cirugía. La identificación del tubérculo de Zuckerkandl nos señala la encrucijada entre arteria tiroidea inferior, glándula paratiroides superior y nervio recurrente. Consideramos necesaria la neuromonitorizacion del nervio recurrente, porque salvo en la excepción de un nervio recurrente no recurrente conocido, no se puede determinar a priori la complejidad en la localización de este nervio. Los instrumentos hemostáticos de los que disponemos en la actualidad obligan a su uso rutinario. El minucioso conocimiento de la cirugía de tiroides facilita al cirujano la realización de cualquier tratamiento quirúrgico de las glándulas paratiroides

Transcanalicular laser dacryocystorhinostomy in the treatment of primary acquired nasolacrimal infrasacal duct obstruction

Primary acquired nasolacrimal infrasacal duct obstruction (PANDO) is a common disorder in middle aged an older patients leading to chronic epiphora and blepharitis as well as recurring or chronic dacryocystitis./nIn the treatment of PANDO, external dacryocystorhinostomy (DCR) is still considered to be "the gold standard " with success rates above 85%./nHowever in recent years external DCR is considered an invasive procedure that puts at risk the medial structures of the eyelid including the physiological canalicular pump mechanism and leave patient with an uncosmetic scar./nThese risks are potentially avoidable by performing less invasive techniques or choosing an endonasal approach (endoscopic or laser modified)./nOne disadvantage of laser modified surgery is the economic inversion because of the high cost of the equipment and maintenance.La obstrucción primaria adquirida infrasacal del ducto nasolagrimal es una entidad bastante frecuente en pacientes de edad media y avanzada que origina epífora y blefaritis así como dacriocistitis crónica y/o recurrente./nEn el tratamiento de esta patología se sigue considerando, aunque cada vez menos, la dacriocistorrinostomía (DCR) externa como "el gold standard" con unas tasas de éxito que se sitúan alrededor del 85%./nSin embargo, en la actualidad, es considerada como una opción "invasiva", que pone en riesgo estructuras como el mecanismo de bomba canalicular y puede generar una cicatriz poco cosmética./nEstos riesgos potenciales se pueden evitar con técnicas menos invasivas (DCR endoscópica y la DCR transcanalicular con láser diodo modificada)./nLa principal desventaja que puede presentar la técnica quirúrgica de dacriocistorrinostomía con láser diodo es la inversión económica por el alto coste del aparataje y su mantenimient

Modified type I thyroplasty. How we do It

[ES] La tiroplastia tipo I de Isshiki consiste en medializar la porción membranosa de la cuerda vocal paralizada mediante una prótesis colocada por abordaje externo. Desde que fue descrita numerosas modificaciones de la técnica han aparecido con el objetivo de agilizar y simplificar el procedimiento. Creemos que nuestra modificación en el diseño de la prótesis de titanio permite facilitar su fijación y aumentar su estabilidad. [EN] The Isshiki thyroplasty type is the medialisation of the membranous portion of the paralyzed vocal cord using a prosthesis placed by external approach. Since It was described a lot of modifications of the technique have appeared in order to streamline and simplify the procedure. We consider that our modification in the design of the titanium prosthesis allows easy fixing and increase its stability