Burden of disease attributed to acute respiratory infections in South America.

INTRODUCTION: Respiratory diseases (RD) are an important public health problem. Their burden has not been comprehensively evaluated in South America (SA). This study describes the burden of acute respiratory infections (ARIs) in SA in 2019. METHODOLOGY: This is an exploratory, population-based study with a quantitative approach to incidence, mortality, and Disability-adjusted life years (DALYs) by standardized age group among the 12 countries. Measurements were captured through the Institute for Health Metrics and Evaluation (IHME) website. It used the Burden Study Global Disease, Injury and Risk Factors (GBD) 2019 assessment. Correlation analyses were performed. RESULTS: The age-standardized incidence rate per 1,00,000 people for lower respiratory infections (LRIs) is lowest in Chile (3,902) and highest in Peru (9,997). For upper respiratory infections (URIs), Bolivia (2,25,826) had the lowest rates, while Brazil (3,16,667) and Colombia (3,06,302) had the highest. Standardized mortality rates for LRI were lowest in Colombia (15.10) and highest in Bolivia (80.53). Bolivia had the highest standardized DALY rate (2,083), while Uruguay had the lowest (468). Upper ARI had lower incidence rates than lower ARI. The lowest DALY rates were in Suriname (82) and the highest were in Brazil (111). There is a correlation between sociodemographic and economic health indicators and the standardized rates of incidence and DALY in the upper ARIs. CONCLUSIONS: The present paper provides comprehensive ARI burden estimates for the region. The substantial incidence and considerable mortality and DALYs are noteworthy and lead to reflections on preventive measures such as rational use of antibiotics and deeper epidemiological investigations.

Health-Economic Analyses of Diagnostics: Guidance on Design and Reporting.

Cost-effectiveness analyses (CEAs) can be used to assess the value of diagnostics in clinical practice. Due to the introduction of the European in vitro diagnostic and medical devices regulations, more clinical data on new diagnostics may become available, which may improve the interest and feasibility of performing CEAs. We present eight recommendations on the reporting and design of CEAs of diagnostics. The symptoms patients experience, the clinical setting, locations of test sampling and analysis, and diagnostic algorithms should be clearly reported. The used time horizon should reflect the time horizon used to model the treatment after the diagnostic pathway. Quality-adjusted life-years (QALYs) or disability-adjusted life-years (DALYs) should be used as the clinical outcomes but may be combined with other relevant outcomes, such as real options value. If the number of tests using the same equipment can vary, the economy of scale should be considered. An understandable graphical representation of the various diagnostic algorithms should be provided to understand the results, such as an efficiency frontier. Finally, the budget impact and affordability should be considered. These recommendations can be used in addition to other, more general, recommendations, such as the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) or the reference case for economic evaluation by the international decision support initiative.

Effects of economic and health policies on the consumption of antibiotics in a Spanish region.

OBJECTIVES: Inappropriate and indiscriminate use of antibiotics is one of the main factors contributing to the increasing bacterial resistance. Surveillance of antibiotic consumption is fundamental for assessing the effects of rational use-oriented measures introduced under economic or health policies. This study quantifies and assesses the introduction of a pharmaceutical co-payment and implementation of campaigns to increase awareness about and rational use in the consumption of antibiotics (volume and expenditure). METHODS: Monthly official dispensations recorded by a health authority (La Rioja, Spain) between January 2009 and December 2017 (108 observations). Total and disaggregated (by active principle and patient's income level) time series for a number of packages and expenditure were studied using intervention and counterfactual analyses (Box-Jenkins methodology). RESULTS: Co-payment reduced the total antibiotic consumption (number of packages -8.52% and expenditure -8.61%) and the difference was greater for the highest-priced antibiotics. Only two of the four campaigns had a significant effect, which lasted 6 months. Counterfactual analysis estimated the savings. CONCLUSION: Economic and health policies helped to reduce antibiotic consumption. Each policy has different effects, co-payment reduces overall drug consumption through a price effect (loss of purchasing power), awareness campaigns depend on other elements for their success (media, scope and patient income).

[Risk sharing contracts in the national health care system: Perceptions of health care professionals]. / Los contratos de riesgo compartido en el sistema nacional de salud: Percepciones de los profesionales sanitarios.

OBJECTIVE: Risk-sharing contracts (RSC) present a novel management tool, which link the payment to the pharmaceutical company to health outcomes. The objective of this work was to know the perception of health professionals about the utility of these agreements in the Spanish National Health System. METHODS: A questionnaire was designed to conduct a series of semi-structured interviews with hospital pharmacy, laboratory and oncology professionals from Spanish hospitals in Madrid, Aragón, Castilla-La Mancha, Castilla y León, Cataluña, La Rioja, País Vasco and Navarra. The selection criteria was for convenience. The interview period was from April to November 2017. A qualitative analysis was performed based on the responses from 14 interviews. RESULTS: All the surveyed affirmed that the CRCs allow to improve the economic and administrative management of the hospital, emphasizing as main advantages the budgetary control, the obtaining of funding and the savings possibilities. CRCs are perceived (13 of 14 respondents) as agreements with positive health implications because they increased the portfolio of treatments and had greater efficacy. The need for CRCs to register patients, involved monitoring and control, also contributed to the improvement of their health. In addition, CRCs were believed (8 out of 14 respondents) to facilitate the introduction of personalized medicine (MP) as both depend on diagnostic tests, one for screening reasons (MP) and the other for obtain clinical evidences that improve economic outcomes (CRC). However, it was considered that signing the CRCs entails the need to modify certain regulations (5 out of 14 respondents) as well as to increase the number of staff to handle bureaucratic tasks and to increase laboratory tests, which can complicate health management. CONCLUSIONS: Qualitative social research techniques have proven to be useful for gathering information on a new topic and understanding the perception of the advantages and disadvantages of CRCs, as well as their association with the MP. In addition, synergies were detected between the CRCs and the MP. Respondents had positive opinions on CRCs about its application, although work must be done in order to improve the normative and organizational context so that the additional complexity that they incorporate does not constitute an obstacle to extend its use.

OBJETIVO: Los contratos de riesgo compartido (CRC) presentan un novedoso instrumento de gestión sanitaria que condiciona el pago a la compañía farmacéutica dependiendi de si el paciente tratado con su fármaco es curado con éxito. El objetivo de este trabajo fue conocer la percepción de los profesionales sanitarios acerca de la utilidad de dichos acuerdos en el Sistema Nacional de Salud español. METODOS: Se diseñó un cuestionario para realizar una serie de entrevistas semiestructuradas con profesionales de farmacia hospitalaria, laboratorio y oncología de hospitales españoles de Madrid, Aragón, Castilla-La Mancha, Castilla y León, Cataluña, La Rioja, País Vasco y Navarra. El criterio de selección fue de conveniencia. El periodo de realización de las entrevistas fue de abril a noviembre de 2017. Se efectuó un análisis cualitativo a partir de las respuestas de 14 entrevistas. RESULTADOS: Todos los encuestados afirmaron que los CRC permiten mejorar la gestión económica y administrativa del hospital, destacando el control presupuestario, la obtención de financiación y la posibilidad de ahorro como ventajas principales. Los CRC son percibidos (13 de 14 entrevistados) como acuerdos con implicaciones positivas para la salud porque aumentaban el portfolio de tratamientos disponibles y porque los tratamientos introducidos contaban con una mayor eficacia. La necesidad de los CRC de registrar a los pacientes implicaba un seguimiento y control que también se entendió contribuía a la mejora de su salud. Además, los CRC se creyó (8 de 14 entrevistados) que favorecían la introducción de la medicina personalizada (MP) ya que tanto la MP como los CRC dependen e impulsan la elaboración de pruebas diagnósticas, ya sea por motivos de cribado (MP) o de aumentar las evidencias clínicas para mejorar los resultados económicos (CRC). No obstante, se consideró que la firma de los CRC conlleva la necesidad de modificar ciertas normativas (5 de 14 entrevistados), de aumentar las plantillas para encargarse de tareas burocráticas, como la elaboración de registros, y también de incrementar las pruebas de laboratorio, lo cual puede complicar la gestión sanitaria. CONCLUSIONES: En general, los CRC contaron con opiniones positivas acerca de su aplicación aunque deba trabajarse para mejorar el contexto normativo y organizativo de modo que la complejidad adicional que incorporan no constituya una traba para extender su uso. Además, se detectaron sinergias entre los CRC y la MP.

Unlocking the potential of established products: toward new incentives rewarding innovation in Europe.

Background: Many established products (EPs - marketed for eight years or more) are widely used off-label despite little evidence on benefit-risk ratio. This exposes patients to risks related to safety and lack of efficacy, and healthcare providers to liability. Introducing new indications for EPs may represent a high societal value; however, manufacturers rarely invest in R&D for EPs. The objective of this research was to describe incentives and disincentives for developing new indications for EPs in Europe and to investigate consequences of current policies. Methods: Targeted literature search and expert panel meetings. Results: Within the current European-level and national-level regulatory framework there are limited incentives for development of new indications with EPs. Extension of indication normally does not allow the price to be increased or maintained, the market protection period to be extended, or exclusion from a reference price system. New indication frequently triggers re-evaluation, resulting in price erosion, regardless of the level of added value with the new indication. In consequence, manufacturers are more prone to undertake R&D efforts at early to mid-stage of product life cycle rather than with EPs, or to invest in new chemical entities, even in therapeutic areas with broad off-label use. This represents a potentially missed opportunity as developing new indications for EPs offers an alternative to off-label use or lengthy and expensive R&D for new therapies, opens new opportunities for potentially cost-effective treatment alternatives, as well as greater equity in patients' access to treatment options. Conclusion: There are potential benefits from the development of new indications for EPs that are currently not being realized due to a lack of regulatory and pricing incentives in Europe. Incentives for orphan or paediatric drugs have proven to be effective in promoting R&D. Similarly, incentives to promote R&D in EPs should be developed, for the benefit of patients and healthcare systems.

[A Dynamic Model to Estimate the Budget Impact of a Pneumococcal Vaccination Program in a 65 Year-old immunocompetent Spanish Cohort with 13-Valent Pneumococcal Conjugate Vaccine]. / La vacunación anti-neumocócica con la vacuna conjugada 13-valente en población inmunocompetente de 65 años: análisis del impacto presupuestario en España aplicando un modelo de transmisión dinámica.

OBJECTIVE: To estimate the 5-year clinical and economic impact of a pneumococcal vaccination program on immunocompetent population aged 65-year-old in Spain. METHODS: A 5 year dynamic model based on differential equations was built for the conceptualization of the burden of pneumococcal disease (PD) on a 65 year-old cohort. A 36.5% of the cohort was vaccinated with an expected efficacy rate of 52.5% as observed in the CAPITA study. The serotype vaccination coverage used was 63.4% (CAPA study), the incidence of pneumococcal disease was 162.2 per 100,000 cases per year (CMBD 2010-2013) and a rate of vaccinated subjects previously from the start of the model of 0.99%. The study used the perspective of The National Health System, and included the costs associated to PD and the conjugate vaccine laboratory selling price. RESULTS: In a 5 years-period, the vaccination with 13-valent pneumococcal conjugate vaccine is expected to avoid 10,360 cases of pneumococcal disease (7,411 in-patient pneumonias) and 699 deaths (14,736 Life Years Gained) in the 65 year old cohort. Vaccination costs of 36.5 million euros would be completely offset by medical cost reduction of 41.5 million euros, yielding to a net saving of 3.8 million constant euros (4.9 million undiscounted). CONCLUSIONS: PCV13 vaccination targeting the cohort of 65 year-old immunocompetent Spanish adults is expected to result in net savings for the National Health System, while decreasing disease burden and averting a substantial number of related deaths.

OBJETIVO: Analizar el impacto económico y sanitario en 5 años de la vacunación de la cohorte española de 65 años inmunocompetente con la vacuna antineumocócica conjugada 13-valente. METODOS: Mediante un modelo de transmisión dinámica basado en ecuaciones diferenciales se analizó la carga de la enfermedad neumocócica (EN) en sujetos de 65 años en 5 años, siendo vacunada anualmente el 36,5% de la cohorte. Se aplicó la eficacia de la vacuna del 52,5% observada en el estudio CAPITA en pacientes de 65 años inmunocompetentes, cobertura de serotipos vacunales del 63,4% (estudio CAPA), incidencia de infección neumocócica de 162,2/100.000 casos año (CMBD 2010-2013) y proporción de vacunados previamente al arranque del modelo del 0,99%. La perspectiva fue la del Sistema Nacional de Salud (SNS). Costes de casos de EN según CMBD y precio de venta de laboratorio de la vacuna conjugada. RESULTADOS: En 5 años la vacunación con vacuna conjugada 13-valente espera evitar 10.360 casos de EN (7.411 hospitalizaciones por neumonías) y 699 muertes (14.736 años de vida ganados -AVG-), en una cohorte de 65 a 69 años de edad. El coste de vacunación esperado de 36,5 millones de euros se compensaría completamente por la reducción de 41,5 millones de costes médicos evitados, con un ahorro neto acumulado de 3,8 millones de euros a precios constantes (4,9 a precios corrientes). CONCLUSIONES: La vacunación con vacuna conjugada 13-valente en adultos de 65 años inmunocompetentes resulta eficiente para el Sistema Nacional de Salud, reduciendo la carga de enfermedad y evitando un número importante de muertes.

Cost-effectiveness analysis of levobupivacaine 0.5 %, a local anesthetic, infusion in the surgical wound after modified radical mastectomy.

BACKGROUND AND OBJECTIVE: Effective treatment of postoperative pain contributes to decreasing the rate of complications as well as the total cost of the operated patients. The aim of this study was to analyze the costs and the efficiency of use of continuous infusion of levobupivacaine 0.5 % with the help of an infusion pump in modified radical mastectomy. METHODS: A cost calculation of the analgesic procedures (continuous infusion of levobupivacaine 0.5 % [levobupivacaine group (LG)] or saline [saline group (SG)] (2 ml/h 48 h) has been carried out based on the data of a previous clinical trial (double-blind randomized study) of patients who underwent modified radical mastectomy surgery. The measure of the effectiveness was the point reduction of pain derived from the verbal numeric rating scale (VNRS). The usual incremental cost-effectiveness ratio (ICER) was performed. RESULTS: Considering only the intravenous analgesia, overall costs were lower in LG, as less analgesia was used (EUR14.06 ± 7.89 vs. 27.47 ± 14.79; p < 0.001). In this study the costs of the infusion pump were not calculated as it was used by both groups and they offset each other. However, if the infusion pump costs were included, costs would be higher in the LG, (EUR91.89 ± 7.89 vs. 27.47 ± 14.79; p < 0.001) and then the ICER was -8.51, meaning that for every extra point of decrease in the pain verbal numerical rating score over the 2-day period, the cost increased by EUR8.51. CONCLUSION: Infiltration of local anesthetics is an effective technique for controlling postoperative pain and the associated added costs are relatively low in relation to the total cost of mastectomy, therefore providing patients with a higher quality of care in the prevention of pain. CLINICAL TRIALS REGISTRATION: clinicaltrials.gov: reference number NCT01389934. http://clinicaltrials.gov/show/NCT01389934

Postoperative analgesia by infusion of local anesthetic into the surgical wound after modified radical mastectomy: a randomized clinical trial.

BACKGROUND: There is no consensus on the efficacy of postoperative infusion of local anesthetics after radical mastectomy. METHODS: A randomized, double-blind, placebo-controlled, parallel-groups clinical trial was conducted in a tertiary hospital. Eighty consecutive women with operable breast cancer with indications for modified radical mastectomy without breast reconstruction were assigned randomly to receive infusion of levobupivacaine (0.5%) or saline at 2 ml/hour for 48 hours through a wound catheter. Seventy-three women finished the study (intervention group, n = 34; control group, n = 39). During surgery, all patients received 0.25% levobupivacaine (30 ml). RESULTS: The levobupivacaine group reported less pain (p < 0.001) than controls in the postanesthesia care unit (1.6 ± 1.3 versus 6.7 ± 1.8) and on the ward at 24 (0.8 ± 0.9 versus 4.2 ± 1.9) and 48 (0.4 ± 0.7 versus 3.3 ± 2.3) hours. In the postanesthesia care unit, the levobupivacaine group consumed less metamizole (0.4 ± 0.5 versus 0.8 ± 0.4; p < 0.001) and dexketoprofen (0.1 ± 0.3 versus 0.7 ± 0.4; p < 0.001), with differences in paracetamol use being insignificant (0.8 ± 0.4 versus 0.9 ± 0.3; p = 0.140). On the ward, the levobupivacaine group used significantly less paracetamol (0.5 ± 0.7 versus 2.0 ± 2.0; p < 0.001) and metamizole (0.2 ± 0.4 versus 1.2 ± 1.4; p < 0.001), but differences in dexketoprofen were not significant (0.03 ± 0.2 versus 0.2 ± 0.6; p = 0.074). In the postanesthesia care unit, the levobupivacaine and control groups consumed 0 ± 0 and 0.7 ± 1.2 doses of opioids (p = 0.001), respectively. The authors observed no differences in nausea and vomiting at any stage in the postanesthesia care unit (0.2 ± 0.4 versus 0.4 ± 0.5; p = 0.081) or on the ward (0.3 ± 0.5 versus 0.4 ± 0.5; p = 0.563). All participants reported high levels of satisfaction. CONCLUSION: Continuous infusion of local anesthetic reduces pain and analgesic consumption, with high satisfaction, but does not affect rates of nausea and vomiting.

[Impact of the Royal Decree-Law 16/2012 on the number of prescriptions and pharmaceutical expenditures]. / Impacto del Real Decreto-Ley 16/2012 sobre el copago farmacéutico en el número de recetas y en el gasto farmacéutico.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

[Non safety costs in the Spanish health care system]. / Aproximación a los costes de la no seguridad en el Sistema Nacional de Salud.

BACKGROUND: 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. METHOD: 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. RESULTS: Non safety costs were 2,474 million euros and 960 million euros for hospitalized and non hospitalized patients respectively. CONCLUSIONS: This first estimation shows that non safety costs are about 6% of total public health expenditure.

[Costs-analysis of methadone program in the autonomous community La Rioja, Spain]. / Análisis de costes del programa de metadona en la Comunidad Autónoma de La Rioja.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Dynamic modelling of infectious diseases: an application to the economic evaluation of influenza vaccination.

OBJECTIVE: To evaluate the economic efficiency of influenza vaccination using both dynamic and static modelling approaches. SETTING: The Spanish National Health System. DESIGN AND METHODS: We modelled the progress of an influenza epidemic in Spain according to the epidemiological pattern of susceptible-->infective-->resistant, employing a non-linear system of ordinary differential equations that enables the measurement of epidemiological effects of an anti-influenza vaccination. We used a decision tree to represent the repercussion on healthcare resources use and on financial resources. The same analyses were conducted using a static approach, and the results were compared. Healthcare costs were valued in euro, year 2005 values. RESULTS: For the base case, the impact of the healthcare intervention (vaccination) was not efficient from the perspective of the healthcare payer when using a static approach (return rate 0.28 per euro invested in vaccination). Nevertheless, it was efficient when employing a dynamic approach (return rate 1.22 per euro). Furthermore, a considerable freeing of healthcare resources would have been produced over the entire influenza season. CONCLUSIONS: The indirect effect of vaccination on the non-vaccinated individuals (the 'herd immunity effect') can be greater than the direct effect on individuals vaccinated. This implies that the herd immunity effect needs to be taken into consideration in the economic evaluations of prophylactic measures employed against infectious diseases.

Healthcare rationing in Spain: framework, descriptive analysis and consequences.

This paper describes the main healthcare rationing policies implemented in Spain over the last 2 decades, and analyses the consequences of these policies on the healthcare system, patients, healthcare practitioners, the pharmaceutical industry and policymakers. The primary explicit healthcare rationing policies utilised in Spain include a catalogue that defines the healthcare rights of citizens. However, the existing system may lead to inequity between regions, and is not structured to direct resources towards the most cost-effective options. Health technology assessment requires further work before it can be utilised widely for the development of rationing strategies. Selective reimbursement of drugs and drug co-payments provide only short-term results and appear to have little long-term impact on expenditure. Implicit rationing instruments, especially waiting lists, have had a significant effect on healthcare quality and the welfare of citizens, and have contributed to keeping the Spanish healthcare budget under control. Newer regulations should integrate some form of economic evaluation within the policy-making processes associated with healthcare. Further research is needed to identify those efficient and equitable rationing instruments that are most likely to improve health interventions for an aging society that is increasingly demanding of health services.

[Use of a retail sales tax on tobacco to fund drug therapy for smoking cessation]. / Utilización de un impuesto sobre ventas de tabaco en la fase minorista destinado a la financiación de la farmacoterapia para la deshabituación tabáquica.

OBJECTIVES: 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. METHODS: 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. 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. CONCLUSIONS: 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.

[Cost-effectiveness analysis of samario-153 (Quadramet) for the treatment of patients with prostate cancer and bone metastases]. / Análisis coste-efectividad de samario-153 (Quadramet) en el tratamiento del dolor en pacientes con cáncer de próstata y metástasis óseas.

OBJECTIVE: 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. METHOD: 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. RESULTS: 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. CONCLUSION: Samarium-153 (Quadramet) is cost-effective in treating pain in patients with prostate cancer and bone metastases.

[Economic evaluation studies in health]. / Estudios de evaluación económica en salud.

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.