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The aim of this study was to analyse the impact of treating chronic hepatitis C (CHC) with direct-acting agents (DAA) on the use of healthcare resources. We included all patients treated with DAA for CHC from January 2015 to December 2017 in Catalonia whose medical records from 12 months before to 24 months after treatment were available. Data were obtained from the Catalan Health Surveillance System. A total of 12,199 patients in Catalonia were treated with DAA for CHC. Of these, 11.3% had no-minimal fibrosis (F0-F1), 24.0% had moderate fibrosis (F2), 50.3% had significant fibrosis or cirrhosis (F3-F4), and 14.4% had decompensated cirrhosis. Use of healthcare resources decreased from the pre-treatment period to the post-treatment period for the following: hospital admissions due to complications of cirrhosis, from 0.19 to 0.12 per month per 100 patients (RR 0.57; 95% CI 0.47-0.68); length of hospital stay, from 12.9 to 12.2 days (RR 0.93; 95% CI 0.91-0.94); outpatient visits, from 65.0 to 49.2 (RR 0.75; 95% CI 0.74-0.75); and number of medication containers per patient per month, from 13.9 to 12.5 (RR 0.837; 95% CI 0.835-0.838). However, the number of invoices for antineoplastic treatment increased after DAA treatment, especially for patients with high morbidity or advanced fibrosis stage. In conclusion, a decrease in health resource use was seen in CHC patients treated with DAA, as measured by length of hospital stay, number of admissions due to cirrhosis complications, outpatient visits and overall drug invoicing. However, use of antineoplastic drugs increased significantly, especially in patients with cirrhosis and high morbidity.

Registre de pacients; Medicaments hospitalaris; Dades clíniques Patient registration; Hospital medicines; Clinical data Registro de pacientes; Medicamentos hospitalarios; Datos clínicos Durante el año 2011 se diseñó el actual Registro de Pacientes y Tratamientos MHDA (RPT-MHDA), un único registro específico y centralizado para todos los hospitales del SISCAT, con el objetivo de recoger, de forma sistemática, información sobre utilización, efectividad y seguridad de los MHDA en condiciones de práctica clínica habitual, así como el grado de adherencia a los criterios definidos por el PHF.

Catalan healthcare; Decision-making; Multi-criteria decision analysis; Orphan drugs Sanitat catalana; Presa de decisions; Anàlisi de decisions multicriteri; Medicaments orfes Sanidad catalana; Toma de decisiones; Análisis de decisiones multicriteria; Medicamentos huérfanos BACKGROUND: Orphan medicines show some characteristics that hinder the evaluation of their clinical added value. The often low level of evidence available for orphan drugs, together with a high budget impact and an incremental cost-effectiveness ratio many times higher than drugs used for non-orphan diseases, represent challenges in their appraisal and effective access to clinical use. In order to explore how to handle these hurdles, the Catalan Health Service (CatSalut) began an initiative on a multidimensional assessment of drugs value during the appraisal process. Reflective multicriteria decision analysis (MCDA) using analytical methods was chosen, since it may help to standardise and contextualize all the relevant data related with the drug that could contribute to a decision. The aim of the study was to determine whether the implementation of reflective MCDA methodology could support the decision-making process about orphan medicines in the context of CatSalut. METHODS: The assessment and decision-making process for orphan drugs in the Programa d'Harmonització Farmacoterapeutica (PHF) of CatSalut was prioritized to test the implementation of the reflective MCDA both a qualitative and quantitatively. A staged approach was used with the following main steps: selection and structuration of quantitative criteria (Core Model) and qualitative criteria (Contextual Tool), framework scoring and assessment of three orphan drug case studies. This proof-of-concept would grant a continued refinement of the methodology and, if and when validated, its potential integration to other therapeutic areas of the PHF. RESULTS: The final framework was composed by 10 quantitative criteria (Core Model) and 4 qualitative criteria (Contextual Tool) according to the PHF goals being the most important criteria "disease severity", "unmet need", "comparative effectiveness" and "comparative safety /tolerability". The matrix developed for the case studies served as a guide for the selection of the essential information that the decision-makers were expected to include in a framework. The reflective discussion was considered the most relevant phase of the approach to support inputs for health decision-making processes reflecting both drug value and place in therapy. CONCLUSIONS: The study showed that reflective MCDA methodology could be implemented to complement the decision-making process in CatSalut, as an aid to determine the clinical added value for orphan medicines. MCDA provided transparency and a structured discussion during the committee meetings, thus increasing transparency and predictability of the relevant items supporting the agreements adopted on orphan drugs access.

Objectives:The aim of this study was to adapt and assess the value of a Multi-Criteria Decision Analysis (MCDA) framework (EVIDEM) for the evaluation of Orphan drugs in Catalonia (Catalan Health Service).Methods:The standard evaluation and decision-making procedures of CatSalut were compared with the EVIDEM methodology and contents. The EVIDEM framework was adapted to the Catalan context, focusing on the evaluation of Orphan drugs (PASFTAC program), during a Workshop with sixteen PASFTAC members. The criteria weighting was done using two different techniques (nonhierarchical and hierarchical). Reliability was assessed by re-test.Results:The EVIDEM framework and methodology was found useful and feasible for Orphan drugs evaluation and decision making in Catalonia. All the criteria considered for the development of the CatSalut Technical Reports and decision making were considered in the framework. Nevertheless, the framework could improve the reporting of some of these criteria (i.e., “unmet needs” or “nonmedical costs”). Some Contextual criteria were removed (i.e., “Mandate and scope of healthcare system”, “Environmental impact”) or adapted (“population priorities and access”) for CatSalut purposes. Independently of the weighting technique considered, the most important evaluation criteria identified for orphan drugs were: “disease severity”, “unmet needs” and “comparative effectiveness”, while the “size of the population” had the lowest relevance for decision making. Test–retest analysis showed weight consistency among techniques, supporting reliability overtime.Conclusions:MCDA (EVIDEM framework) could be a useful tool to complement the current evaluation methods of CatSalut, contributing to standardization and pragmatism, providing a method to tackle ethical dilemmas and facilitating discussions related to decision making.

BACKGROUND:Introduction of new drugs is a dynamic process with a high impact on consumption and expenditure.OBJECTIVE:To analyze the prescription of new drugs and the associated costs in public health care in Catalunya, Spain, in 2002. The analysis also attempts a perspective of consumption in relation to the grade of therapeutic innovation of the new drugs.METHODS:Prescription data on all 86 new drugs licensed for use during 1998–2002 were analyzed, using the prescription item as unit and the cost.RESULTS:Prescription for new drugs in 2002 represented 4% of overall items prescribed and 13% of the cost. The mean new drug item cost was ¢39, while that of overall drugs was ¢13. New drug item increase over the previous year was 18.6% compared with 5.2% of the overall drugs, and the proportional cost increased by 25.7% and 9.9%, respectively. Ten new drugs represented 55.1% of the expenditure of this group. Antiasthmatic drugs represented 20.7% of the expenditure on new drugs, angiotensin-receptor blockers represented 18.6%, antiaggregants 9.7%, and nonsteroidal antiinflammatory drugs 6.9%. New drugs providing significant or modest therapeutic improvement represented 25.6% of overall new drug items and 32.3% of their cost.CONCLUSIONS:New drugs have a mean cost growth rate greater than that of existing drugs, with only a quarter of them offering advantages over existing drugs. More detailed evaluations of new medications are warranted before they can be recommended for general use so that a better distribution of the limited resources available may be made when prescribing drugs that are newly available through prescription.

Fundamento El objetivo del estudio fue la investigacion clinica, epidemiologica y microbiologica de un brote de toxiinfeccion alimentaria por el consumo de ostras. Pacientes y metodos Se realizo un estudio de cohortes historicas sobre consumo de 15 alimentosy sintomatologia de los casos. La implicacion de cada alimento se estudio con el riesgo relativoestratificado de Mantel-Haenszel (RRM-H) y su intervalo de confianza (IC) del 95% y seconfirmo mediante el analisis de dosis-respuesta con la prueba de la χ2 de tendencia. Se investigaronlas heces de 5 enfermos y de 2 manipuladores. Resultados La tasa de ataque global fue del 38,0% (19/50). La mediana del periodo de incubacionfue de 39,0 h (maximo de 62 y minimo de 3 h). La proporcion de sintomas fue: fiebre17,6% (3/17), diarrea 57,9% (11/19), vomitos 84,2% (16/19), nauseas 89,5% (17/19) y dolorabdominal 89,5% (17/19). En el analisis estratificado, mientras las ostras mantuvieron su relacion (RRM-H = 3,3; IC del 95%: 1,1-8,7), los caracoles de mar presentaron una reduccion del valor de la RRM-H resultando no significativo (RRM-H = 2,8; IC del 95%: 0,9-41, 1). El consumo de ostras presento una prueba dosis-respuesta estadisticamente significativa (p = 0,005). El examen por microscopia electronica detecto particulas virales de pequeno tamano compatibles con virus Norwalk-like. La implicacion de las ostras se comunico a las autoridades sanitarias. Conclusiones Esta investigacion demuestra la utilidad del analisis dosis-respuesta para aportarevidencias epidemiologicas, la implicacion potencial del consumo de ostras en las toxiinfeccionespor virus Norwalk-like y la necesidad de la investigacion de los centros de produccion parala prevencion y control.

Fundamento Investigar las caracteristicas epidemiologicas y la etiologia de un brote de to-xiinfeccion alimentaria. Pacientes y metodo Se realizo un estudio de cohortes historicas sobre el consumo de 21 alimentos, sintomas clinicos y se determino por PCR-RT la presencia del ARN del virus Norwalk-like en heces de 5 enfermos y de tres manipuladores. La implicacion de cada alimento se determino con el riesgo relativo (RR) y el intervalo de confianza (IC) del 95%. Resultados La tasa de ataque fue del 70,0% (7/10), la mediana del periodo de incubacion de 35,0 h y los principales sintomas: vomitos (85,7%; 6/7), fiebre (85,7%; 6/7) y diarrea (71,4%; 5/7). Cuatro alimentos resultaron implicados: pescado a la marinera (RR=1,7; IC del 95%, 0,9–3,3); entremeses (RR=1,6; IC del 95%, 0,9–2,7); yogur (RR=1,5; IC del 95%, 1,0–2,4) y cordero (RR=1,3; IC del 95%, 0,6–3,0). Tres muestras de heces resultaron positivas para el virus Norwalk-like genogrupo II. Se detec-taron defectos de manipulacion de alimentos. Conclusiones La tecnica de PCR permitio con-firmar la etiologia del brote como virus Nor-walk genogrupo II. A pesar de que los enfer-mos se recuperan rapido, estos brotes tienen gran repercusion social.

Our goal was to investigate the epidemiological characteristics and etiology of an outbreak of food-borne disease caused by Norwalk-like viruses, genogroup II.We performed a historical cohort study on the consumption of 21 food items and clinical symptoms. We assessed RNA Norwalk-like viruses by RT- PCR in stool samples from 5 patients and 2 food-handlers. The potential involvement of each food item was assessed by relative risk at 95% confidence intervals (CI).The overall attack rate was 70.0% (7/10). The median incubation period was 35.0 hours. Symptoms included: vomits 85.7% (6/7), fever 85.7% (6/7) and diarrhoea 71.4% (5/7). Four food items were involved [fish (RR = 1.7; CI 95% 0.9-3.3); 'selection of cold meats' (RR = 1.6; CI 95% 0.9-2.7); yoghurt (RR = 1.5; CI 95% 1.0-2.4) and lamb (RR = 1.3; CI 95% 0.6-3.0)]. Three stool sample gave positive results for Norwalk-like viruses genogroup II. Important oversights in food-handlers' work were detected.RT-PCR enabled us to confirm the etiology of this outbreak as Norwalk-like viruses genogroup II. Although patients recovered quickly, the outbreak caused considerable public alarm.

Registre de pacients; Medicaments hospitalaris; Dades clíniques Patient registration; Hospital medicines; Clinical data Registro de pacientes; Medicamentos hospitalarios; Datos clínicos Durante el año 2011 se diseñó el actual Registro de Pacientes y Tratamientos MHDA (RPT-MHDA), un único registro específico y centralizado para todos los hospitales del SISCAT, con el objetivo de recoger, de forma sistemática, información sobre utilización, efectividad y seguridad de los MHDA en condiciones de práctica clínica habitual, así como el grado de adherencia a los criterios definidos por el PHF.