Concise Review: The High Cost of High Tech Medicine: Planning Ahead for Market Access.

Cellular therapies and other regenerative medicines are emerging as potentially transformative additions to modern medicine, but likely at a staggering financial cost. Public health care systems' budgets are already strained by growing and aging populations, and many private insurer's budgets are equally stretched. The current systems that most payers employ to manage their cash flow are not structured to absorb a sudden onslaught of very expensive prescriptions for a large portion of their covered population. Despite this, developers of new regenerative medicines tend to focus on the demands of regulators, not payers, in order to be compliant throughout the clinical trials phases, and to develop a product that ultimately will be approvable. It is not advisable to assume that an approved product will automatically become a reimbursed product, as examples from current practice in hematopoietic stem cell transplantation in the U.S. demonstrate; similarly, in Europe numerous Advanced-therapy Medicinal Products achieved market authorization but failed to secure reimbursement (e.g., Glybera, Provenge, ChondroCelect, MACI). There are however strategies and approaches that developers can employ throughout clinical development, in order to generate clinical and health economic data which will be necessary to demonstrate the value proposition of the new product and help ensure market access for patients; furthermore, performance based managed entry agreements coupled with post-launch evidence generation can help overcome challenges around product uncertainty at launch and reduce market access delays. Stem Cells Translational Medicine 2017;6:1723-1729.

Comentarios sobre el artículo "Intubación transcutánea tras un intento autolítico como método alternativo en el control de la vía aérea". Respuesta de los autores / Coments on the article "Intubation through a self-inflicted wound to control the airway after a suicide attempt". Author's reply

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[Robotic medicine in Germany: quo vadis?]. / Robotische Medizin in Deutschland: quo vadis?

Today, one can hardly imagine the medical daily routine without computer-assisted systems, although their benefit usually is not investigated by prospective randomised trials. While in the industrial working environment computer-assisted systems are thoroughly accepted because of their precision and endurance, in medicine there are fierce debates about their use at considerably high costs. At least the perioperative advantages (e.g. less blood loss, shorter period of hospitalization), to a large extent, are beyond dispute. The high costs may be compensated by a higher volume of treated patients. Only the treatment of a higher volume of patients will lead to a reduction of infrastructure costs per case. On the other hand, only a large number of cases ensure the achievement of skills to handle such a complex system. This, in return, reduces the chance of the occurrence of complications and shorter operation times will lead to economic advantages.

Identificación bacteriana mediante espectrometría de masas matrix-assisted laser desorption ionization time-of-flight. Comparación con la metodología habitual en los laboratorios de Microbiología Clínica / Identifying bacteria using a matrix-assisted laser desorption ionization time-of-flight (MALDI-TOF) mass spectrometer. Comparison with routine methods used in clinical microbiology laboratories

Introducción Los métodos de identificación bacteriana usados habitualmente en Microbiología Clínica, aunque miniaturizados y automatizados, se siguen basando en principios similares a las pruebas de identificación clásicas. Sin embargo, se van produciendo avances tecnológicos que pueden modificar radicalmente estas metodologías. En el presente estudio se determina la utilidad de la mass spectrometry (MS, ‘espectrometría de masas’) matrix-assisted laser desorption ionization time-of-flight (MALDI-TOF) para la identificación bacteriana habitual en el laboratorio de Microbiología Clínica. Métodos Se analizaron 294 aislamientos bacterianos aerobios y anaerobios facultativos (65 grampositivos y 229 gramnegativos) obtenidos a partir de diferentes muestras clínicas mediante metodología microbiológica habitual (Wider, Francisco Soria Melguizo, Madrid, España; Vitek-2, API Staph, API 20 Strep, API Coryne y API NH, BioMérieux, Marcy L’Etoile, Francia) y mediante un dispositivo de MS MALDI-TOF Autoflex III (Bruker Daltonics GmbH, Leipzig, Alemania). Los aislamientos de Salmonella se tipificaron con sueros específicos. Los aislamientos que no ofrecieron una fiabilidad en la identificación superior al 95% en Vitek-2 o Wider se corroboraron mediante API. Los aislamientos en los que los sistemas API no ofrecieron un perfil fiable se descartaron. La identificación mediante MS MALDI-TOF se puntúa automáticamente por el software del sistema de 0–3 en función de su fiabilidad. Los aislamientos con puntuaciones inferiores a 1,5 se consideraron no fiables. La correlación entre ambas (..) (AU)

Introduction The methods routinely used for bacterial identification in Clinical Microbiology Laboratory, although miniaturized and automated, are still based on the same basic principles as classical identification methods. Nevertheless, technological advances are emerging which could modify these routine methods. We report a comparative study between conventional identification methods and mass spectrometry MALDI-TOF (MS MALDI-TOF) for bacterial identification in the Clinical Microbiology Laboratory. Methods We analysed 294 facultative anaerobic and aerobic isolates (65 Gram positives and 229 Gram negatives), obtained from different clinical samples, using conventional microbiological methods (Wider, Fco. Soria Melguizo, Madrid, Spain; Vitek-2, APIStaph, API 20 Strep, API Coryne and API NH, bioMérieux, Marcy L’Etoile, France) and an Autoflex III MS with a MALDI-TOF device (Bruker Daltonics GmbH, Leipzig, Germany). Salmonella isolates were also typed by using specific sera. Isolates identified with a confidence rate <95% were checked by using API systems. Isolates which were not accurately identified by API systems were rejected. MS MALDI-TOF identification is automatically scored by the system software between 1 and 3 points. Isolates with scores <1.5 were classified as unreliable. Correlation between both identifications was classified as correlation at the species level, at the genus level or no correlation. Results Correlation at the species level in Gram positives was 100%. Correlation in Gram negatives was 87.7% at the species level and 97.7% at the genus level. There was no correlation in 2.2% of Gram negatives studied. Identification failures occurred in the genera (..) (AU)

Aplicación de las nuevas tecnologías a la educación sanitaria / No disponible

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Diffusion and utilization of magnetic resonance imaging in Asia.

OBJECTIVES: An assessment of the current status of magnetic resonance imaging (MRI) was undertaken to provide input for future government decisions on the introduction of new technologies in Asia. The objective of the study is to describe and explain the diffusion pattern of this costly technology in several Asian settings. METHODS: Data on the diffusion pattern of MRI for different Asian countries (the Republic of Korea, Malaysia, Indonesia, the Philippines and Thailand) and regions (the cities of Shanghai and Hong Kong in China and the state of Tamil Nadu in India) were obtained from national representatives of professional bodies by using standardized questionnaires for the year 1997-98. In addition, utilization data were collected at the hospital level in three countries before and after the economic crisis in the region. For four countries plus Hong Kong, background information on the legal framework for "big ticket" technologies was collected. RESULTS: Since the introduction of the first MRI in the region in 1987, the number of MRIs has gradually increased both in public and private facilities in Asia. In 1998 the average number of MRI machines installed varied from less than 0.5 machine per million population to more than 5 machines per million population. The maintenance and operating costs, and not the absence of regulation, account for the low number of MRIs in the Philippines and Malaysia. Overall, installed MRIs have low magnetic field strength, vary with respect to brand and type, and are mostly in the private sector and in the urban areas of the region. The diffusion pattern of MRIs in countries of the Asian region appears to follow two types of patterns of diffusion: one set of countries seems to be composed of mostly early adopters and another set of countries appears to be composed mostly of late adopters. CONCLUSIONS: Total number of MRIs per population in this region, though quite small compared to most OECD countries, reflects a higher share of the country's health-resource devoted to expensive high-technology devices. It is difficult to state the appropriate number of MRIs for each country; however, the study shows that there are observable problems in terms of efficiency, equity, and quality of MRI services. The research team proposes a few key recommendations to counteract these problems. Purchasing and regulatory bodies must be empowered with skill and knowledge of health technology assessment. Likewise, the fundamental problems resulting from inefficient and unfair health financing should not be overlooked, so that there is more equitable use of the technology.