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ResumenIntroducciónLas intervenciones públicas dirigidas a ayudar a los fumadores que desean cesar en el hábito tabáquico consisten principalmente en el consejo médico y la terapia de grupo. Actualmente, existen varios tratamientos farmacológicos que reducen la adicción al tabaco. Uno de ellos, el bupropión, tiene una destacada eficacia (30% en un año) en comparación con las terapias sustitutivas de nicotina (chicles [8%] y parches [17%] en un año). El objetivo de este estudio es analizar la eficiencia del empleo de farmacoterapias para la cesación en el consumo del tabaco.Material y métodosPara ello, partimos de la situación actual en España en cuanto a los métodos utilizados por los fumadores que desean dejar el hábito tabáquico, que consiste en una mezcla del consejo médico, la terapia de grupo y la fuerza de voluntad, combinada con el uso de fármacos en una proporción reducida. Dicha situación se compara con tres escenarios en los cuales, alternativamente, se amplía (hasta el 10%) el uso durante un año de las distintas farmacoterapias disponibles, realizando un análisis de coste-efectividad para calcular el coste por muerte evitada y por año de vida ganado en cada uno de ellos. Este análisis contempla un horizonte temporal de 20 años y se basa en una adaptación del modelo HECOS, promovido por WHO-Euro, que permite comparar distintas farmacoterapias. Los datos epidemiológicos empleados proceden de la Encuesta Nacional de Salud (1997) y del Instituto Nacional de Estadística (1999).ResultadosLa estrategia basada en el empleo de bupropión como método de cesación tiene una ratio coste-efectividad de 70.939 euros por muerte evitada y 37.305 euros por año de vida ganado, transcurridos 5 años. Cuando el horizonte temporal se amplía a 20 años, estos resultados se tornan en beneficios netos de 28.166 y 3.265 euros, respectivamente. Tanto los parches como los chicles de nicotina tienen unos cocientes de coste-efectividad superiores a la anterior estrategia: 171.834 euros por muerte evitada y 90.362 euros por año de vida ganado para los parches, y 513.004 euros por muerte evitada y 269.772 euros por año de vida ganado para los chicles, en el quinto año. Además, la intervención basada en el tratamiento con bupropión en un año evitaría un mayor número de muertes que las estrategias alternativas (alrededor de 3.000 muertes en un horizonte temporal de 20 años) debido al mayor descenso en el número de fumadores que produce.ConclusionesAlgunos métodos de cesación tienen bajos costes –como el consejo médico y la terapia de grupo– pero también una eficacia reducida. Los nuevos tratamientos farmacológicos incrementan tanto los costes como la ratio de eficacia. Cuando se evalúan las distintas intervenciones, la que incluye bupropión en una mayor proporción genera un ahorro neto en los costes sanitarios del tabaquismo.AbstractIntroductionPublic policies for smoking cessation are mainly based on advice from the primary care physician and group therapy. Several pharmacological treatments to reduce tobacco addiction are currently available. One of these treatments, bupropion, has remarkable efficacy (30% over 1 year) compared with nicotine replacement therapies (chewing gum 8%, patches 17% over 1 year). The objective of this study was to assess the efficiency of three smoking cessation strategies based on pharmacotherapies in Spain.Material and methodsThe current situation of methods for smoking cessation in Spain includes a mixture of primary care physician advice, group therapy and willpower, combined with the use of drugs in a small proportion of individuals. This situation was compared with three scenarios in which the use of the available pharmacotherapies was increased (by up to 10%) for 1 year. A cost-effectiveness evaluation was used to calculate the cost per death prevented and per year of life saved in each scenario. The analysis used a time horizon of 20 years and was based on an adaptation of the HECOS model, sponsored by WHO-Euro, which enables comparison of distinct pharmacotherapy interventions. Epidemiological data were based on the National Health Survey (1997) and the National Institute of Statistics (1999).ResultsThe cost-effectiveness ratio of bupropion at 5 years was 70,939 euros per death prevented and was 37,305 euros per year of life saved. When the time horizon was increased to 20 years, these figures became net savings of 28,166 and 3,265 euros, respectively. The cost-effectiveness ratios for both nicotine gums and patches were higher than that for bupropion: 171,834 euros per death prevented at 5 years and 90,362 euros per year of life saved for patches and 513,004 euros per death prevented and 269,772 euros per year of life saved at 5 years. Furthermore, bupropion treatment for 1 year would prevent a greater number of deaths than the alternative strategies (approximately 3,000 deaths in a time horizon of 20 years) due to the decrease in the number of smokers.ConclusionsThe cost of some tobacco cessation methods, such as primary care physician advice and group therapy, is low but their efficacy is also low. New drug treatments increase costs and also achieve higher efficacy rates. When assessing interventions and their costs economic evaluation shows that in the long run greater use of bupropion generates net savings in tobacco-related health costs.

Durante los ultimos anos, varios paises han incorporado la evaluacion economica de intervenciones sanitarias (EEIS) como criterio para establecer prioridades en salud. Desde su creacion en 1999, el modelo ingles del National Institute for Health and Clinical Excellence (NICE) se ha convertido en la principal referencia sobre como puede utilizarse el criterio de eficiencia en la seleccion de medicamentos y otras tecnologias. La idea de priorizar el uso de las nuevas intervenciones sanitarias en funcion de su eficiencia resulta enormemente atractiva, aunque no esta exenta de dificultades. Aparte del coste politico que supone racionar en funcion de criterios explicitos, se han senalado diversos problemas metodologicos y eticos, entre los que cabe destacar la determinacion del valor de los anos de vida ajustados por calidad (AVAC), el limite de eficiencia utilizado y si dicho limite deberia aplicarse o no de forma flexible. En la practica, la mayoria de los paises que utilizan la EEIS reconocen la existencia de diversos factores que influyen en las decisiones, tales como la gravedad de la enfermedad, la disponibilidad de otras alternativas, el impacto presupuestario, o la presencia de enfermedades que afectan a determinados colectivos. A pesar de estos problemas, cada vez existe mas consenso sobre las ventajas de utilizar el criterio de coste-efectividad si se pretende hacer un mejor uso de los recursos disponibles. Por ello, resulta sorprendente que, recientemente, varios paises hayan optando por priorizar en funcion de un criterio diferente, el de efectividad. En este trabajo se expondran algunos ejemplos que ilustran este cambio, sus posibles razones y algunos de los retos que plantea este nuevo sistema.

The EU Framework Programme for Research and Innovation (FP) Horizon 2020, for the period 2014–2020, represents a significant effort to support research activities. Almost 80 billion euros in current prices are going to be allocated to these activities over 7 years (versus the 50 billion budget of the 7th FP) which, under three major headings—Excellent Science, Industrial Leadership and Societal Challenges—have recently opened their calls for research projects. Health and biomedical research initiatives can be mostly channeled through the ‘‘Health, demographic change and wellbeing’’ chapter of the Societal Challenges heading, representing about 10 % of the total budget [1]. Furthermore, some other health related projects could also apply for funds under the ‘‘Food Security’’ and the ‘‘European Research Council’’ chapters, with the latter falling into the Excellent Science heading. In comparative terms with the last EU 7th FP, Horizon 2020 has notably increased the budget specifically dedicated to health research (from € 5.57 up to € 8.03 billion). In addition to this FP, the EU is currently running the 3rd Health Programme [2]; it is considered to be the main instrument for implementing the EU Health Strategy (funded with about € 450 million) and is complementary to the EU FP Horizon 2020. Among other goals, this programme specifically pursues research into public health, the efficiency and sustainability of health systems and human resources management. When such an important amount of public resources is spent (i.e. invested) to finance research, evaluation activities, ex ante and ex post, are crucial in the whole process. After identifying the potential research topics, a first evaluation (qualitative at this stage) must be performed to prioritize them under different criteria (health improvements for some target populations, integration of research networks, profitability for the industry, potential stakeholders for the innovation, and so on). The targets of the calls of the FPs usually reflect the interests of several stakeholders, represented by the Advisory Groups (AGs), the European Technology Platforms (ETPs) and the Programme Committees (PCs). The specific work-programmes are elaborated and reviewed by these three groups, with representatives of Member States in the PCs. Then, the call for proposals is issued and a second evaluation has to be carried out to select which ones are funded. The purpose of this evaluation is to reduce the uncertainties of allocating resources to some groups that may not perform the research as desired, and rather assign funds to those groups more likely to achieve the expected results. This evaluation considers several aspects, such the adequacy of the team and its critical mass for the projects, the fragmentation/integration of the research, the experience of the research team, the adequacy of means and planned activities of the project, the legality of the procedures, etc. This evaluation is carried out by panels of independent experts, organized by and under the supervision of the Directorate General Research and Innovation (DG R&I), and enhances the efficiency of the research process, although it does not directly perform an economic evaluation: that would be very difficult at this stage. Another evaluation—ex post—is implemented after the execution of the research process. Although this evaluation should theoretically assess the value of the research outcomes, in practical terms it mainly focuses on administrative aspects (control of invoices, payments, and the period between the authorization to run the research and & Fernando Antonanzas fernando.antonanzas@unirioja.es

Aims The objective of this study was to estimate the social cost of the consumption of illegal drugs in Spain. Design We performed a cost-of-illness study, using a prevalence approximation and a societal perspective. The estimation of costs and consequences referred to 1997. As direct costs we included health-care costs, prevention, continuing education, research, administrative costs, non-governmental organizations and crime-related costs. As indirect costs we included lost productivity associated with mortality and the hospitalization of patients. Estimation of intangible costs was not included. Findings The minimum cost of illegal drug consumption in Spain is 88 800 million pesetas (PTA) (467 million dollars). Seventy-seven per cent of the costs correspond to direct costs. Of those, crime-related costs represent 18%, while the largest part corresponds to the health-care costs (50% of direct costs). From the perspective of the health-care system, the minimum cost of illegal drug consumption is 44 000 million PTA (231 million dollars). The cost of illegal drug consumption represents 0.07% of the Spanish GDP. This gross figure compares with 2250 million PTA (12.5 million dollars) invested in prevention programmes during the same year, and with 12 300 million PTA (68.3 million dollars) spent on specific programmes and resources for the drug addict population. Conclusions Although there are limitations intrinsic in this type of study and the estimations obtained in the present analysis are likely to be an underestimate of the real cost of this condition, we estimate that illegal drug consumption costs the Spanish economy at least 0.2% of GDP.

Objetivo: Estimar el coste de la atención sanitaria al paciente diabético tipo 2, diferenciando el gasto derivado del control de la enfermedad, de la atención de sus complicaciones y de otros costes directos asociados. Métodos: Recogida retrospectiva del consumo de recursos a partir de la historia clínica y la entrevista personal en 29 centros de atención primaria de todo el territorio nacional de una muestra de pacientes seleccionados de forma aleatoria a partir del registro de diabéticos de cada centro. Resultados: Se evaluó a 1.004 pacientes (561 mujeres) con una media de edad de 67,42 años y una media de evolución de la enfermedad de 10,07 años. El 50,9% no presentaba complicaciones, el 17,7% sólo macrovasculares, el 19,5% sólo microvasculares y el 11,9% ambas. El coste anual sanitario por paciente fue de 1.305,15 euros. De este coste el 28,6% (373,27 euros) estaba relacionado directamente con el control de la diabetes, el 30,51% (398,20 euros) con sus complicaciones y el 40,89% (533,68 euros) no estaba relacionado. El coste medio de un paciente sin complicaciones fue de 883 euros frente a 1.403 de un paciente con complicaciones microvasculares, 2.022 cuando existían complicaciones macrovasculares y 2.133 cuando coexistían ambos tipos de complicaciones. Conclusiones: El elevado coste del tratamiento de la diabetes tipo 2 y sus complicaciones, sugiere la posibilidad de que la mejora del control de la enfermedad pueda no sólo mejorar la supervivencia y la calidad de vida, sino reducir los costes asociados con las complicaciones crónicas.

During the last decade we have witnessed a change in health care management. Predictive, personalized [1], individualized [2] or stratified [3] medicine are some of the terms that have been coined to describe a new approach to dealing with disease. In essence, the new paradigm is based on matching patients with the best treatments available according to each patient’s characteristics. Patients are classified through new tests, mainly genetic in nature, the growing proliferation of which is behind the extensive application of this new approach to managing disease. In parallel, new therapies, many based on new mechanisms of action and biological agents, allow ever narrower targets within the cell to be addressed. This combination of new diagnostic techniques and targeted therapies has improved the perspectives of managing some difficult conditions, such as some types of cancer, by controlling the progression of a disease and maintaining it rather as a chronic condition, even achieving a cure in some cases. This new paradigm is raising expectations for both patients and physicians. Health care systems are transforming the management of some diseases and re-writing treatment guidelines to incorporate the advantages of newly available therapies and approaches. However, notwithstanding the rapid development of these changes, there are some issues that should also be taken into account. Here, we highlight some elements that are frequently overlooked or taken for granted. Personalized medicine is frequently based on drug treatments that are more expensive than other, more traditional, therapies. These types of new drug generally target conditions that are more prevalent in developed countries, where a wide market in terms of potential patients and purchase capacity exists. To our knowledge, there is no experience of this kind of approach being used to address conditions whose prevalence is higher in less developed countries. It would be interesting to make personalized medicine accessible to lower income countries so that they could also benefit from the new advantages. A clear contribution of personalized medicine is that it aims to address the imperfect information related to diagnoses and effectiveness that generates uncertainties in healthcare. Personalized medicine reduces uncertainty by identifying more clearly those patients that will response better to treatment and by establishing new and more specific therapeutic targets. However, personalized medicine could also have the ‘‘side effect’’ of introducing undesirable effects into the system, in the sense that new diseases are seemingly created based on an identified gene mutation. Manufacturers intend to classify mutations of the general condition as potential new orphan diseases (prevalence lower than 50 cases per 100,000 persons), which, as a consequence, would attract a greater reward from health authorities in terms of higher prices for the new therapy, and probably better reimbursement policies. Of course, this process would imply higher costs for public health care systems. This is nothing new at this point, however, as this trade-off between improved health outcomes and higher health costs is already common practice. Within the last decade, new tests, mostly genetic, have gained access to the market. Currently, there are over 1,800 genetic tests that help define and classify new diseases and patients [4]. Some tests belong to the field of so-called companion tests, i.e., they must be applied to patients prior to the administration of a given drug to make sure that they are the right candidate to receive that medication. Other tests do not belong to this category and their link to drug F. Antonanzas (&) C. A. Juarez-Castello R. Rodriguez-Ibeas University of La Rioja, Logrono, Spain e-mail: fernando.antonanzas@unirioja.es

this research aims to understand if the consequences on drug expenditures and number of prescriptions of Royal Decree-Law 16/2012 as estimated by the Ministry of Health, Social Services and Equality (MHSSE) are similar to those found by using common statistical approaches. In addition, several models have been built to forecast the evolution of both variables for the period September 2013-December 2014.the Box-Jenkins methodology and the Box-Tiao intervention analysis were applied to data of the period 2003-13 to forecast the monthly values of the number of prescriptions and pharmaceutical expenditures. Forecasts were used in a counter-factual analysis to be compared to the actual values of prescriptions and drug expenditures. Moreover, forecasts for the period September 2013 to December 2014 were obtained to observe the impact of the policy in the future.the counterfactual analysis estimated a decrease in the number of prescriptions of 12.18% and 12.83% in the pharmaceutical expenditure; these figures were 12,75% and 14,03% respectively, when the intervention analysis was used.the estimated reduction in the number of prescriptions for the period June 2012-August 2013 was similar to the figure offered by the MHSSE, while the reduction in the drug expenditure series was smaller. The Box-Jenkins methodology generated low forecast errors (less than 3%) what makes this procedure useful to reliably anticipate future consumptions.

To contribute to the theoretical literature on personalized medicine, analyzing and integrating in an economic model, the decision a health authority faces when it must decide on the implementation of personalized medicine in a context of uncertainty. We carry out a stylized model to analyze the decision health authorities face when they do not have perfect information about the best treatment for a population of patients with a given disease. The health authorities decide whether to use a test to match patients with treatments (personalized medicine) to maximize health outcomes. Our model characterizes the situations under which personalized medicine dominates the alternative option of business-as-usual (treatment without previous test). We apply the model to the KRAS test for colorectal cancer, the PCA3 test for prostate cancer and the PCR test for the X-fragile syndrome, to illustrate how the parameters and variables of the model interact. Implementation of personalized medicine requires, as a necessary condition, having some tests with high discriminatory power. This is not a sufficient condition and expected health outcomes must be taken into account to make a decision. When the specificity and the sensitivity of the test are low, the health authority prefers to apply a treatment to all patients without using the test. When both characteristic of the test are high, the health authorities prefer to personalize the treatments when expected health outcomes are better than those under the standard treatment. When we applied the model to the three aforementioned tests, the results illustrate how decisions are adopted in real world. Although promising, the use of personalized medicine is still under scrutiny as there are important issues demanding a response. Personalized medicine may have an impact in the drug development processes, and contribute to the efficiency and effectiveness of health care delivery. Nevertheless, more accurate statistical and economic information related to tests results and treatment costs as well as additional medical information on the efficacy of the treatments are needed to adopt decisions that incorporate economic rationality.

Previous studies of smoking risk beliefs have focused almost exclusively on risks to the smoker. Using an original set of survey data from Spain, we examine the public's perceived risks from exposures to environmental tobacco smoke. The risk categories considered included lung cancer, heart disease, life expectancy loss, and low birth weight for children of smoking mothers. Risk beliefs were quite high, often dwarfing scientific estimates of the risk. The results are consistent with overestimation of risks from highly publicized, low probability events.

Using original survey data from Spain, this paper assesses the determinants of smoking behavior. This study examines the effect on smoking of the most diverse set of risk measures ever considered: lung cancer, relative lung cancer risks, lung disease, heart disease, relative heart disease risks, lost life expectancy to smokers, and various risk measures for passive smoking. Smoking measures include cigarette smoking, the number of cigarettes smoked, and pipe and cigar smoking. Primary smoking risks have a more consistent negative effect on smoking than perceived passive smoking risks.

Survey evidence for the Spanish population indicates that perceptions of lung cancer risk and life expectancy loss due to smoking are similar to estimates found in the United States. This paper also presents new evidence on the relative lung cancer risk for smokers, the perceived risk of lung disease for smokers, the heart disease risk for smokers, and the relative heart disease risk for smokers, all of which indicate substantial risk perceptions. Risk beliefs are particularly high for younger respondents, but are lower for better educated respondents.

In the context of budgetary difficulties, the estimation of non safety costs is an additional tool that may be useful in the decision making process of the health system as well as to improve the health care management. Until now there is no study that has estimated the costs of non safety in Spain in an integral way. The objective of this article is to show a first approach to the calculation of the costs of non safety referred to the year 2011.The study updated from the year 2005 an estimation of the costs of non safety affecting inpatients. Those costs referred to medication errors, to nosocomial infections and to surgical complications. The costs derived from the non safety related to outpatients are estimated from data obtained from the National Health Survey combined with other information of medication errors and their treatment costs that other authors calculated.Non safety costs were 2,474 million euros and 960 million euros for hospitalized and non hospitalized patients respectively.This first estimation shows that non safety costs are about 6% of total public health expenditure.

Background: This study aimed to assess the costs and clinical benefits of the 13-valent pneumococcal conjugate vaccine (PCV13) administered annually to the 65-year-old cohort in Spain versus the alternative of not vaccinating patients and treating them only when infected.Methods: Cases of pneumococcal disease avoided were calculated through a dynamic model based on the work of Anderson and May (1999). Sixty-six percent of the 65-year-old cohort was assumed to have been vaccinated with one PCV13 dose (304,492 subjects). Base-case estimated vaccine effectiveness and serotype coverage were 58% and 60%, respectively. Disease-related costs were calculated based on published data.Results: Over the 5-year period, a total of 125,906 cases of pneumococcal disease would be avoided. Net savings of 102 million would be obtained. The cost-saving distribution was not homogeneous, starting in the 2nd year and increasing through the 5th. To demonstrate model robustness, an additional scenario analysis was performed using extreme values of model parameters (vaccination programme coverage, vaccine effectiveness, discount rate and disease costs). Under those scenarios, net savings were always achieved.Conclusions: Based on the assumptions of the model, the 65-year-cohort pneumococcal vaccination campaign appears to be a cost-saving intervention in the Spanish population under different scenarios. © 2013 Pradas et al.; licensee BioMed Central Ltd.

INTRODUCTION:Re-purposing of established products (EPs) – defined as marketed for 8 years or more – may represent a high value for patients and society. It has been recognized by the European Commission as an important factor contributing to greater access to new therapies. Due to a lower development cost, it could also represent a cost-effective alternative and help to reduce pressure on healthcare budgets. However, it is perceived that no financial incentives exist for the pharmaceutical industry to invest in new indications for EPs. The objective of this research was to review current European regulations and propose strategies stimulating development in this field.METHODS:We performed a targeted literature review and held two international expert panel workshops to discuss current policies and their implications, and issue recommendations for changes.RESULTS:Within the current regulatory framework EPs face price cuts due to generic competition, reference pricing (RP), price re-negotiations or systematic price cuts, after a period of marketing presence. Extension of indications does not permit to increase or maintain the price. Generic substitution regardless of indication poses another challenge. Limited incentives in the form of an additional year of market protection exists only for new indication(s) registered within the first 8 years following initial approval. The expert panel proposed several strategies to stimulate development in this field, including: (i) extending the period in which registering a new indication results in additional market protection beyond 8 years and extending the duration of additional market protection; (ii) delaying inclusion in RP for EPs with a new value adding indication; (iii) establishing a differential pricing by indication; (iv) preventing temporarily generic substitution when an EP is prescribed for a new indication.CONCLUSIONS:Current regulations represent a serious disincentive to develop new indications for EPs. Regulatory and pricing policy changes are needed to stimulate development in this important field.

Health economics as a specialization area has rapidly grown during the last 4 decades. Researchers have selected the topics according to a variety of issues, such as general scientific interest, background knowledge, and perceived gaps in the field as well as the relevance of the topics to their jurisdictions, among others. On the part of the health authorities (managers and politicians), they have to cope with a variety of real-life types of problems that need to be addressed. In their daily practice, they have at their disposal instruments and information from the health economics literature to better manage their health systems. Nevertheless, some mismatches exist in the activities developed by these two groups. On the one hand, it is believed that health authorities disregard or do not use all the available information generated by researchers in their decision-making processes. This could be due to either the irrelevance of a given research for a specific health decision or because health authorities simply ignore it. On the other hand, researchers, for whatever the reason, do not address some topics that really matter to health managers and that would potentially improve the general efficiency of healthcare systems and increase social welfare. The interest in assessing the value of research activities in support of health systems policies was highlighted by Buxton and Hanney 2 decades ago [1]. The need to cope with the gap between research and health policy has also been previously acknowledged by some authors and institutions such as the WHO [2–4]. However, the number of studies and their scope have been quite limited (addressing particular health areas such as pain [5], focusing on single Member States’ research needs [6], being descriptive of some situations [7], and dealing with specific research venues—such as the economic evaluation of health technologies [8] and the value of information as a technique to establish research topics in economic evaluation [9]). More recently, Hunter and Brown [10] have reviewed research topics within the field of health management, and Debrand and Dourgnon [11] described the relationships between health economics research and health policies debated in a meeting of experts from several countries; they also emphasized the need for ‘‘using research evidence to produce pertinent and efficient tools for health policymaking.’’ In spite of these efforts, there is a lack of systematic analysis (follow-up or periodic reviews) on this topic so that health research can be channeled to the more useful areas of health policy making. Other authors have recently noted the necessity to fill the gap between health research and policy [12]. Interestingly, health economics scientific policy in most of the EU countries usually relies on public calls as the instruments to channel funds to research programs. However, these programs have vaguely defined goals and are commonly framed in rather general terms, either guided by some leading research teams or by politicians and bureaucrats in charge of the general scientific policy. Health authorities are not usually empowered to decide on or select the guiding principles of the general scientific policy (i.e., the goals of the calls for each program). In this environment, it is a common practice for each research group to participate in the calls by proposing its preferred topics, which usually find a niche that makes their proposal eligible to receive financial aid. One frequent evaluation criterion to evaluate the results of a research project ex-post is to look at the quality of the peer-reviewed F. Antonanzas (&) R. Rodriguez-Ibeas Department of Economics, University of La Rioja, 26004 Logrono, Spain e-mail: fernando.antonanzas@unirioja.es

Methadone programs have been organized in each Spanish region in a specific way. In spite of the regional interests to manage those programs in a more efficient way, so far the costs of the programs are unknown. As a previous step, it would be desirable to understand the activities related to these programs as well as their respective costs. This article aims to calculate the cost of the Methadone program in the autonomous community of La Rioja, and to understand those parameters which generate a greater cost to this programme.The study followed a similar structure as the research recently applied to the region of Murcia. The reference year for the study of the annual costs of the Methadone program was 2010. Data were obtained from different registries of several institutions involved in the regional program. Costs were classified according to different stages and dispensation centres which participated in this programme.Data analysis, for a concentration of 2 mg/ml of methadone, showed an approximate annual cost of 165.759 euros. Taking the total number of patients into consideration the individual cost was 412,34 euros.Dispensation is the stage which caused the largest cost to the programme, the highest per patient cost corresponded to the centre with less patients due to the fact that fixed costs are shared by a smaller group of persons; the biggest global cost of the programme came from Logroño's center but its average cost is lower.

In this paper, we characterise the risk-sharing contracts that health authorities can design when they face a regulatory decision on drug pricing and reimbursement in a context of uncertainty. We focus on two types of contracts. On the one hand, the health authority can reimburse the firm for each treated patient regardless of health outcomes (non risk-sharing). Alternatively, the health authority can pay for the drug only when the patient is cured (risk-sharing contract). The optimal contract depends on the trade-off between the monitoring costs, the marginal production cost and the utility derived from treatment. A non-risk-sharing agreement will be preferred by the health authority, if patients who should not be treated impose a relatively low cost to the health system. When this cost is high, the health authority would prefer a risk-sharing agreement for relatively low monitoring costs.

In this paper, we carry out a theoretical analysis of the strategic choice made by firms regarding the type of food they market when they face consumers who care about the healthy/unhealthy attributes of the product but incur in emotional/health costs when the food they consume has unhealthy attributes. We consider a two-stage game. In the first stage, one of the firms chooses the unhealthy content of its product. In the second stage, both firms simultaneously decide their prices. We find that, depending on the parameters of the model, product differentiation can be maximal or less than maximal. The firm that produces the unhealthy food charges a higher price and obtains a larger share of the market unless the emotional/health costs and the unhealthy food production costs are relatively high. We also find that educational campaigns will not always reduce the demand for the unhealthy food or the degree of the unhealthy attribute.JEL Classification:I10, I18, L11.

ResumenObjetivoLos modelos de Markov son el método estándar utilizado en los estudios de coste-efectividad para representar la historia natural de la enfermedad. El objetivo de este trabajo es mostrar los elementos clave en la construcción de modelos de Markov de tipo probabilístico.MétodosSe ha utilizado el ejemplo de un nuevo tratamiento para una enfermedad genérica. Para ello se ha construido un modelo de Markov con parámetros introducidos como distribuciones estadísticas para llevar a cabo el análisis de sensibilidad probabilístico mediante simulaciones de Monte Carlo. Los resultados se analizaron en forma de plano coste-efectividad y curva de aceptabilidad.ResultadosLa razón coste-efectividad incremental para el paciente medio es de 22.855€/año de vida ajustado por calidad (AVAC). En el análisis de sensibilidad probabilístico el resultado de todas las simulaciones se sitúa en el cuadrante nordeste, que corresponde a coste y efectividades positivas. El 67% de las simulaciones se sitúa por debajo del umbral de los 30.000€/AVAC.ConclusiónLa utilización de los modelos de Markov de tipo probabilístico requiere la integración de conceptos provenientes de la economía, la epidemiología, la estadística y la clínica. Algunas etapas del proceso, como la construcción y el procesamiento del modelo, la gestión de los riesgos absolutos y relativos, y el manejo de las distribuciones estadísticas, suelen plantear mayores dificultades, pero son necesarias para que el modelo reproduzca la enfermedad de forma válida.AbstractObjectiveMarkov models are the standard method used in cost-effectiveness studies to represent the natural history of disease. The objective of this study was to show the key elements in building probabilistic Markov models.MethodsWe used the example of a new treatment for a generic disease. A probabilistic Markov model was constructed using statistical distributions. Monte Carlo simulations were carried out to obtain the probabilistic sensitivity analysis. The results were analyzed in terms of the cost-effectiveness plane and acceptability curve.ResultsThe incremental cost-effectiveness rate for the average patient was €22,855/quality adjusted life years (QALY). In the probabilistic sensitivity analysis, the results from all simulations were located in the northeast quadrant, corresponding to positive cost and effectiveness. However, 67% of the simulations were below the threshold of €30,000/QALY.ConclusionThe use of probabilistic Markov models requires the integration of concepts from economics, epidemiology, statistics, and the clinical setting. Some stages of the process, such as the construction and processing of these models, the management of absolute and relative risks and of statistical distributions, often pose major difficulties but are key steps required to reproduce the disease with validity.

Obesity and overweight (body mass index (BMI) [30 and BMI between 25 and 30, respectively, calculated as the ratio between weight in kilograms and the square of height measured in centimetres) are considered by many epidemiologists as the new pandemic in developed countries. At the EU, this pandemic has a prevalence of around 50% for those aged 50 and older, being in the range 20–30% for total population in most of the member states (MS). Further, children’s prevalence has grown during the last 20 years being also in a similar range to the figures of the adults. The trends are positive in almost all the MS with the exception of the Scandinavian countries where the trends are more stable and the prevalence rates are lower than in the other countries. Life-styles, mainly, sedentary and high intake of calories derived from products containing intense doses of energy-dense elements such as fats and sugar together with the greater amount of food intake are the major responsible for the obesity positive trends. Genetics are believed to only account for a marginal 1% of the cases [1, 2]. Health consequences of obesity have also been fre

The economic evaluation of health technologies has become a major tool in health policy in Europe for prioritizing the allocation of health resources and the approval of new technologies. The objective of this proposal was to develop guidelines for the economic evaluation of health technologies in Spain. A group of researchers specialized in economic evaluation of health technologies developed the document reported here, following the initiative of other countries in this framework, to provide recommendations for the standardization of methodology applicable to economic evaluation of health technologies in Spain. Recommendations appear under 17 headings or sections. In each case, the recommended requirements to be satisfied by economic evaluation of health technologies are provided. Each recommendation is followed by a commentary providing justification and compares and contrasts the proposals with other available alternatives. The economic evaluation of health technologies should have a role in assessing health technologies, providing useful information for decision making regarding their adoption, and they should be transparent and based on scientific evidence.

Markov models are the standard method used in cost-effectiveness studies to represent the natural history of disease. The objective of this study was to show the key elements in building probabilistic Markov models.We used the example of a new treatment for a generic disease. A probabilistic Markov model was constructed using statistical distributions. Monte Carlo simulations were carried out to obtain the probabilistic sensitivity analysis. The results were analyzed in terms of the cost-effectiveness plane and acceptability curve.The incremental cost-effectiveness rate for the average patient was 22,855 euro/quality adjusted life years (QALY). In the probabilistic sensitivity analysis, the results from all simulations were located in the northeast quadrant, corresponding to positive cost and effectiveness. However, 67% of the simulations were below the threshold of 30,000 euro/QALY.The use of probabilistic Markov models requires the integration of concepts from economics, epidemiology, statistics, and the clinical setting. Some stages of the process, such as the construction and processing of these models, the management of absolute and relative risks and of statistical distributions, often pose major difficulties but are key steps required to reproduce the disease with validity.

Over the last few years, economic evaluation of health technologies has become a major tool used by European health policy decision-makers to create strategies for prioritizing the allocation of health resources and the approval of new technologies. Spain was a pioneer in proposing the standardization of methodology applicable to economic evaluation studies. However, because health policy decision-makers refused to support the initiative, the methodology was never put into practice. In the medium term, evidence of the economic value of new health technologies financed by the national health system will probably be increasingly required. At that time, stakeholders and decision-makers will have to agree upon a clear and concise set of rules on the technical and methodological issues that must be followed by economic evaluations of health technologies. Consequently, we have provided guidelines and recommendations for producing first-rate economic evaluations. The recommendations appear under seventeen headings or sections. In each case, the recommended requirements to be satisfied by an economic evaluation of health technologies are provided and each recommendation is followed by a commentary, providing a justification and comparing and contrasting the proposal with other available alternatives.

Economic evaluation of health care technologies (EEHT) has become a basic tool in the decision-making process in health. The continuous development of methods and their direct application to reality have placed EEHT as a key item on the agenda of health policy makers across countries. The present article introduces the aims of EEHT and describes the experience of several European countries where economic evaluation studies are currently used to select the health technologies to be implemented. The role played by EEHT in Spain at the present time is then discussed. Finally, pressing tasks are identified and recommendations are made for the consolidation of EEHT as a basic element in the decision-making process of health care technologies.

The joint utilization of both decision trees and epidemiological models based on differential equations is an appropriate method for the economic evaluation of preventative interventions applied to infectious diseases. These models can combine the dynamic pattern of the disease together with health resource consumption. To illustrate this type of model, we adjusted a dynamic system of differential equations to the epidemic behavior of influenza in Spain, with a view to projecting the epidemiologic impact of influenza vaccination. The results of the epidemic model are implemented in a diagram with the structure of a decision tree so that health resource consumption and the economic implications can be calculated.

In this paper, we have elaborated an index in two phases to measure the degree of transferability of the results of the economic evaluation of health technologies. In the first phase, we have considered the objective factors (critical and non-critical) to derive a general transferability index, which can be used to measure this internal property of the studies of economic evaluation applied to health technologies. In the second phase, with a more specific index, we have measured the degree of applicability of the results of a given study to a different setting. Both indices have been combined (arithmetic and geometric mean) to obtain a global transferability index. We have applied the global index to a sample of 27 Spanish studies on infectious diseases. We have obtained an average value for the index of 0.54, quite far from the maximum theoretical value of 1. We also found that 11 studies lacked some critical factor and were directly deemed as not transferable. Copyright © 2008 John Wiley & Sons, Ltd.

Alcohol consumption in the EU is the highest in the world with 1 1 L of pure alcohol per adult per year. The average consumption rises to 15 L when abstainers (55 million adults or 15%) are excluded. Almost half the consumption is beer (44%), the rest being wine (34%) and liquors (22%). The people in the northern EU countries prefer beer, while the people in the southern countries opt for wine, Spain being an exception to this rule because of its higher beer consumption. Men drink on average more than women, roughly double, and about 58 million adults consume more than 40 g of alcohol per day. Alcohol is also an addictive drug. It is estimated that, in any year, over 23 million EU citizens suffer from alcohol dependence [1]. Alcohol consumption provides pleasant moments to individuals, it is linked to social events and belongs to the ancestral European culture. Bacchus was the Roman divinity for wine, and Greeks used to gather daily for an informal meeting "symposium", literally, those who drink together around a wine recipient as is frequently represented in their famous orange and black pottery. However, alcohol consumption increases the risk of many social problems, and it is the cause of as many as 60 illnesses and medical conditions. The risk of illness

E l objetivo de este articulo es revisar algunos conceptos sobre la relacion entre el coste-efectividad de una tecnologia sanitaria, su impacto presupuestario y las decisiones que se pueden tomar a partir de una evaluaci ...

To describe self-perceived health status and health-related quality of life (HRQoL) in healthy individuals of working age, to measure changes due to influenza infection, and to evaluate the effect of influenza infection on HRQoL in monetary terms.We performed a descriptive observational study through questionnaires administered to 50 patients of working age infected with the influenza virus during the epidemiologic year 2004-2005 and living in private homes of the city of Logroño (Spain). The patients completed the questionnaires twice: with and without influenza. The dimensions and HRQoL indicators of the European Quality of Life-5 Dimensions (EQ-5D) questionnaire were evaluated. HRQoL utility indices were used to calculate lost quality-adjusted life years (QALYs).On average, the reduction in the HRQoL utility index caused by influenza infection was between 0.37 and 0.65, on a scale from 0 (death) to 1 (perfect health). An influenza epidemic in 100,000 individuals could imply a loss of 137 QALYs, which in monetary terms could represent 2,722,609euro.The EQ-5D dimension most negatively affected by influenza wasdaily activitieswhile the least affected dimension wasanxiety/depression. Influenza causes substantial losses in HRQoL among the population of working age. The results of the sensitivity analysis of the monetary effects of influenza infection yielded intervals showing a range of more than 5 times the mean value.

To analyze the revenue-generating potential of a new retail sales tax on tobacco and its effects on public health if the tax revenues were allocated to finance smoking cessation programs.We provide an extensive review of the legislation on the authority of autonomous communities to order the levy and collection of special taxes and describe the new tobacco retail sales tax. We calculated collected tax revenues with a simulation model of indirect taxation -the SINDIEF (Simulador de Imposición Indirecta del Instituto de Estudios Fiscales) model- and determined the potential number of smokers who would quit smoking. Epidemiological and clinical variables from existing pharmacological therapies were used to obtain the results.For the highest tax rate (20 eurocents per pack), we found that 1,078,000 smokers yearly would give up smoking, suggesting that the new tax could be considered as a way to promote pharmacotherapy in smoking behavior.Fiscal corresponsability to finance smoking cessation programs could be based on a tobacco retailing sales tax, similar to that levied on hydrocarbons. Simulations for different tax rates show the huge potential of the tax to yield revenues, as the tax is levied yearly on 4.6 billion cigarette packs each year.

In this article, we provide readers with a summary of the main economic features of the recently approved Spanish law regarding pharmaceutical preparations entitled the Law of Guarantees and Rational Use of Pharmaceuticals and Health Products (Law 29/2006 of July 26th). We review information on pricing, reference pricing, promotion of generic drugs, public reimbursement, patients’ contributions, and penalties. Other aspects of minor economic relevance such as the information on prices shown in the packs and the transparency on the results of clinical trials irrespective of whether these are positive or not, are not addressed in this paper. We conclude with some observations on the new horizons opened up by this new legal framework. We have not included any detailed references to the new law; we merely wish to comment on certain aspects of its application.

This article examines the cost impact associated with the utilization of the Taxus drug eluting stent versus a conventional bare-metal stent for percutaneous coronary interventions in a Spanish hospital setting.A decision analysis model has been developed to compare the intervention and re-hospitalization costs at 12 and 24 months post-intervention. The analysis considers the general patient population and a high-risk subpopulation (diabetes, small vessel, long lesion). The analysis simulates the results of the TAXUS-IV clinical trial, in a population with similar risks, with appropriate costs, and including budget impact analyses with alternative utilization scenarios.The expected average per patient hospital cost at 12 months was 6934 euros with Taxus and 6756 euros with bare-metal stent (and increase of 2.6%). At 24 months, per patient hospital cost was 6,991 euros for Taxus and 6887 euros for bare-metal stent (an increase of 1.5%). In the high-risk subpopulation, Taxus was overall cost saving as compared to bare-metal stent both at 12 months (decrease of 3.0%) and 24 months (decrease of 4.7%).Use of Taxus in the overall population slightly raises treatment costs, while in patients with greater risk of restenosis the treatment cost is reduced. Given the decrease in the number of repeat revascularizations with this stent, the cost-effectiveness relationship could be acceptable in the general patient population and is dominant in the high-risk subpopulation.

Several clinical trials have demonstrated the efficacy and safety of the NMDA antagonist memantine in moderately severe to severe Alzheimer's disease (AD) patients. A 28-week pharmacoeconomic study conducted in the US also showed a reduction of total healthcare costs and informal care compared to placebo. Long-term implications of memantine treatment were modelled in the UK and Finland and revealed reductions in dependency, institutionalization and costs. However, these conclusions were not directly applicable to the Spanish setting where patients are mainly treated within the community. The objective of this study was to estimate the long-term implications in terms of costs and health benefits of memantine therapy compared to standard care using a Spanish adaptation of previous models over a 2-year time horizon. As in previous adaptations, Markov health states were defined as a combination of severity (mild-moderate, moderately severe, severe) and dependency plus death as the absorbing state. Spain-specific data (costs, mortality and epidemiological data) were obtained from local and recently published cohorts of AD patients. Data on the effectiveness of memantine were derived from a randomized double-blind placebo-controlled clinical trial of 252 moderately severe to severe AD patients. Effectiveness was measured as the time spent in a non-dependent health state. The evaluation was conducted over 2 years, while the efficacy of memantine was applied for 1 year only in order to ensure a conservative approach. The robustness of the model was tested by conducting stochastic analyses and various sensitivity analyses on the key assumptions. Patients receiving standard care were estimated to spend 6 months in a non-dependent state and to incur average total costs of Euro 24,700 over 2 years. The memantine strategy was associated with an additional 2.5 months in a non-dependent state and a Euro 700 cost reduction. Monte-Carlo simulations and sensitivity analyses supported these findings. Memantine appears to be cost-effective compared with standard care in moderately severe to severe AD patients in a Spanish setting. The prolonged independence provided by memantine treatment translated into cost reductions which offset drug costs and resulted in overall cost-savings.

Clinical journals often publish economic evaluation studies of health technologies and programs. To improve the peer review process and, hence, the quality and validity of published studies, the British Medical Journal (BMJ) established publication guidelines for the publication of economic evaluations aimed at authors, reviewers and editors. The present article analyzes the opportunity of adopting the BMJ's or similar guidelines by Medicina Clínica and the probable effectiveness of this measure. The article concludes that although this initiative would probably improve the review process and the quality of the papers published, it might be worthwhile to review, up-date and adapt the BMJ guidelines to the Spanish context by means of a consensus-forming process. Finally, this article discusses the limitations of the peer review process in improving the quality and validity of economic evaluations and suggests some complementary measures, drawing on lessons and experiences from the field of clinical research.

To evaluate the cost-effectiveness of samarium [153Sm-EDTMP] (Quadramet) compared to conventional therapy in the treatment of pain in patients with prostate cancer and bone metastases.A decision tree model for the treatment of bone pain due to metastases was adapted to the Spanish context. The model represents the standard treatment patterns in Spain for the study population. The time-course of the model is 4 months and it computes an estimate for the cost of pain control per patient. The effectiveness data for the model derive from a randomised trial. The current treatment patterns have been established according to the consensus opinions of a group of medical experts.The cost of pain control per patient is euro 12,515.39 for conventional therapy and euro 5,595.52 for samarium-153 (Quadramet) therapy. The incremental cost-effectiveness analysis shows that samarium-153 (Quadramet) is a dominant therapy. It presents lower costs and higher efficacy than the conventional strategy. The sensitivity analyses showed these results to be robust.Samarium-153 (Quadramet) is cost-effective in treating pain in patients with prostate cancer and bone metastases.

To characterize the peculiar economic nature of the pharmaceutical market in the EU, to study potential groupings of countries based on several pharmaceutical variables, to analyze some recent regulations designed to create the single market, and to present some thoughts on the decision making process in public health from the perspective of current public health budgets.We performed an economic analysis of health and pharmaceutical macrovariables, cluster analysis, review of EU pharmaceutical and industrial regulations and review of pharmaceutical budgeting legislation in the member states.The pharmaceutical market of the EU was characterized and EU countries were classified into two principal groups according to 5 selected variables. EU regulations tend to promote R + D and drug production and thus the EU industrial sector is backed up. National regulations differ in terms of pricing and drugs reimbursement.The creation of a single market for drugs in the EU should take this regulatory diversity into account and seek equilibrium between economic factors and public health. This single market may be a dangerous strategy if it becomes a general dogma and even more so if deadlines are fixed and short.

ResumenObjetivosCaracterizar la naturaleza económica singular del mercado de medicamentos en la Unión Europea, estudiar las posibles agrupaciones de países en función de ciertas variables farmacéuticas, analizar algunas normas reguladoras recientes dirigidas a la creación del mercado único y presentar algunas reflexiones sobre la toma de decisiones en materia de salud pública desde la perspectiva de la situación actual de los presupuestos públicos sanitarios.Métodoanálisis económico de macromagnitudes sanitarias y farmacéuticas, análisis de agrupamiento de datos («cluster »), revisión de la legislación farmacéutica e industrial comunitaria, así como de las formas de presupuestación farmacéutica de los estados miembros.ResultadosSe ha caracterizado el mercado de medicamentos en la Unión Europea y se han clasificado los países a partir de 5 variables en torno a 2 grupos principales. Las medidas legislativas comunitarias tienden a fomentar la I+D y la producción de fármacos, de modo que se consolide el sector industrial. Las regulaciones nacionales son diferentes en materias de reembolso y establecimiento de precios.ConclusionesLa creación del mercado único del medicamento en la Unión Europea debe contemplar esta diversidad reguladora y buscar un equilibrio entre los aspectos económicos y de salud pública. El mercado único farmacéutico puede ser una estrategia peligrosa si se convierte en dogma general y más si se determinan plazos fijos y breves.AbstractObjectivesTo characterize the peculiar economic nature of the pharmaceutical market in the EU, to study potential groupings of countries based on several pharmaceutical variables, to analyze some recent regulations designed to create the single market, and to present some thoughts on the decision making process in public health from the perspective of current public health budgets.MethodWe performed an economic analysis of health and pharmaceutical macrovariables, cluster analysis, review of EU pharmaceutical and industrial regulations and review of pharmaceutical budgeting legislation in the member states.ResultsThe pharmaceutical market of the EU was characterized and EU countries were classified into two principal groups according to 5 selected variables. EU regulations tend to promote R + D and drug production and thus the EU industrial sector is backed up. National regulations differ in terms of pricing and drugs reimbursement.ConclusionsThe creation of a single market for drugs in the EU should take this regulatory diversity into account and seek equilibrium between economic factors and public health. This single market may be a dangerous strategy if it becomes a general dogma and even more so if deadlines are fixed and short.