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El Geoparque mundial de la UNESCO Orígens, situado en los Pirineos catalanes, alberga paisajes impresionantes y un rico patrimonio geológico, paleontológico y cultural. Sus paisajes cuentan con el reconocimiento internacional de la comunidad científica, que los consideran un laboratorio al aire libre único para el estudio y la comprensión de los procesos geológicos. En consecuencia, geólogos de todo el mundo, ya sean estudiantes, académicos o profesionales, lo visitan todos los años para aprender o investigar temas de diferentes ramas de la Geología.

Objective: To estimate the burden of nosocomial infections induced by carbapenem resistant Gram-negative (CRGN) pathogens in Spain, focusing on both the clinical and economic impact. Methods: The burden of disease was estimated using data from 2017 according to the availability of data sources. The impact, both clinical and economic, of the most frequent CRGN nosocomial infections (those produced by Klebsiella pneumoniae, Pseudomonasaeruginosa and Acinetobacter baumannii) was analysed. Incidence and mortality of CRGN nosocomial infections were estimated, as well as the direct and indirect costs produced by this health problem. Results: Approximately 376,346 patients are believed to have suffered a nosocomial infection in Spain in 2017; 3.2% of them due to CRGN bacilli. Infections by carbapenem-resistant P. aeruginosa produced the highest mortality rates (2578 deaths) when compared with A. baumannii (1571) and K. pneumoniae (415). Total economic costs of CRGN nosocomial infections in Spain were estimated to be (sic)472 million in 2017, with 83% of the total cost caused by direct costs. Conclusion: CRGN nosocomial infections have a high clinical impact on patients' lives, high mortality rates, and represent one of the hospitalisation episodes with the most associated costs. Efforts should be focussed to implement preventive policies in order to avoid infections due to CRGN pathogens and the resulting burden, and to reduce direct costs due to morbimortality, specifically in those infections produced by P. aeruginosa. (C) 2020 Published by Elsevier Espana, S.L.U.

Background Pricing and reimbursement decisions for orphan drugs are faced with differences access between European countries depending on each reimbursement policies, evaluation processes and timings. In 2013, the therapeutic positioning report was introduced in the pricing and reimbursement process in Spain. The present study aims to identify orphan drugs authorised in Spain and approved by the European Commission between January 2003 and December 2019, analyse the impact of the therapeutic positioning report in the pricing and reimbursement process of orphan drugs in Spain and to assess additional potential criteria that could influence pricing and reimbursement decisions for orphan drugs. Results Ninety-four orphan drugs have been approved by the European Commission between January 2003 and December 2019 and have marketing authorisation in Spain. Out of the 94 orphan drugs, 46 (48.9%) had received pricing and reimbursement approval. Before the inclusion of the therapeutic positioning report in year 2013, the mean time from European Commission approval to pricing and reimbursement approval for orphan drugs in Spain was 25.1 +/- 16.5. After 2013, timelines have been reduced by an average of 9 months. The mean regulatory time from European Commission approval to Spanish marketing authorisation has decreased nearly 4 months (from 7.5 +/- 10.2 months in years 2003-2013 to 3.8 +/- 7.6 months in years 2014-2019). The instauration of the therapeutic positioning report could be associated with a reduction of the mean time from the Spanish marketing authorisation to pricing and reimbursement approval by an average of 5 months (from 17.3 +/- 13.1 months in years 2003-2013 to 12.3 +/- 5 months in years 2014-2019). In addition, orphan drugs with a positive conclusion in the therapeutic positioning report would be more likely to be reimbursed in Spain (p < 0,0001). Conclusions This study shows that the therapeutic positioning report plays a key role in the pricing and reimbursement process in Spain. A positive conclusion of the therapeutic positioning report seems to favourably affect pricing and reimbursement decisions in Spain and, since its introduction, has also contributed to reduce pricing and reimbursement approval timelines in Spain.

PURPOSE Several frameworks have been developed to define and quantify the value of oncologic therapies and to support decision making; however, they define treatment value mainly in terms of clinical benefit. As part of its mission to improve oncologic care, the ECO Foundation (Excellence and Quality in Oncology) directed this pilot study aimed at developing a reflective multicriteria decision analysis (MCDA)-based framework for evaluating and positioning oncologic drugs in the clinical setting. METHODS The framework was developed following Evidence and Value: Impact on Decision-Making methodology, and literature was reviewed to identify relevant criteria. The selected criteria were then presented to a group of experts composed of 9 clinical oncologists who assessed each criterion for inclusion in the framework and suggested modifications in their definition and/or response scale. The framework was tested in 2 case studies (abemaciclib for advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer and TAS-102 for metastatic colorectal cancer) to validate the proposed framework; this was followed by a discussion of the results. RESULTS Eight of the 15 criteria presented to the experts were included in the framework: disease severity, unmet needs, comparative efficacy, comparative safety/tolerability, treatment intent, comparative treatment cost, comparative other medical costs, and quality of evidence. Framework validation in 2 drug cases resulted in similar value scores, although they were based on different contributing criteria and resulted in different clinical recommendations. CONCLUSION We developed and validated a reflective MCDA framework for the assessment and positioning of oncologic therapies in Spain. Additional work is needed to create a manual for practical decision making in the clinical setting. (c) 2020 by American Society of Clinical Oncology

Patients with moderate to severe haemophilia A are at a higher risk of developing FVIII inhibitors that require the use of more costly and less effective treatments. The objective of this study was to determine the value of emicizumab for the prophylaxis of haemophilia A with inhibitors compared to the current therapeutic alternatives, activated prothrombin complex concentrate and recombinant factor VIIa through reflective Multi-Criteria Decision Analysis. The EVIDEM framework adapted to orphan drugs and weighted by a sample of 98 national and regional Spanish evaluators was used. Two structured evidence matrices were developed: emicizumab against activated prothrombin complex concentrate and emicizumab against recombinant factor VIIa. A multidisciplinary team of haemophilia experts rated each of the criteria. Mean and standard deviation were calculated by each criterion and discussed among all participants. Haemophilia A with inhibitors was perceived as a severe disease with high unmet needs. Emicizumab was rated with higher efficacy, therapeutic benefit and quality of life than comparators. When administered alone for the prevention of bleeding events, emicizumab had slightly better safety and tolerability profile than activated prothrombin complex concentrate and similar with recombinant factor VIIa. The inclusion of emicizumab in clinical practice guidelines was valued positively by the members of the panel. Overall, value of emicizumab was higher than activated prothrombin complex concentrate and recombinant factor VIIa, mostly because of efficacy and therapeutic benefit in reducing treated haemorrhages. Reflective Multi-Criteria Decision Analysis has proven to be a feasible method to determine the value contribution of comparative therapies in haemophilia.