IMPACT OF HEALTH TECHNOLOGY ASSESSMENT IN LITIGATION CONCERNING ACCESS TO HIGH-COST DRUGS.

OBJECTIVES: The impact of health technology assessment (HTA) in the judicialization of the right of health has not been deeply studied in Latin American countries. The purpose of this study is to review the process of judicialization of the access to high cost drugs in Uruguay and assess the impact HTAs have had on this process. METHODS: The methodology used for this study included a comprehensive literature search in electronic databases, local journals, internal documents developed in the Ministry of Health, as well as conducting interviews with key informants. RESULTS: Judicialization of the access of high cost drugs has been increasing since 2010. The strategy of the Ministry of Health of Uruguay to decrease this problem included the organization of roundtables with judges and other stakeholders on the basis of HTA, the training of defense lawyers in the use and interpretation of HTA, and the participation of a professional who develops HTA in the preparation of the defense arguments. A year after the implementation of this strategy, 25 percent of writs of protection were won by the Ministry of Health. CONCLUSIONS: Even though the strategy implemented was effective in reducing the loss of litigations, it was not effective in reducing the growing number of writs of protection. It is essential to address this problem in a broad debate and to promote understanding between the parties.

INFLUENCE OF HEALTH TECHNOLOGY ASSESSMENT AND ITS MEASUREMENT.

OBJECTIVES: The aim of this study was to obtain information on methods used to measure health technology assessment (HTA) influence, decisions that were influenced, and outcomes linked to HTA. METHODS: Electronic databases were used to locate studies in which HTA influence had been demonstrated. Inclusion criteria were studies that reliably reported consideration by decision makers of HTA findings; comparative studies of technology use before and after HTA; and details of changes in policy, health outcomes, or research that could be credibly linked to an HTA. RESULTS: Fifty-one studies were selected for review. Settings were national (24), regional (12), both national and regional (3) hospitals (9), and multinational (3). The most common approach to appraisal of influence was review of policy or administrative decisions following HTA recommendations (51 percent). Eighteen studies (35 percent) reported interview or survey findings, thirteen (26 percent) reviewed administrative data, and six considered the influence of primary studies. Of 142 decisions informed by HTA, the most common types were on routine clinical practice (67 percent of studies), coverage (63 percent), and program operation (37 percent). The most frequent indications of HTA influence were on decisions related to resource allocation (59 percent), change in practice pattern (31 percent), and incorporation of HTA details in reference material (18 percent). Few publications assessed the contribution of HTA to changing patient outcomes. CONCLUSIONS: The literature on HTA influence remains limited, with little on longer term effects on practice and outcomes. The reviewed publications indicated how HTA is being used in different settings and approaches to measuring its influence that might be more widely applied, such as surveys and monitoring administrative data.

Cáncer de mama: costo-efectividad de la determinación de receptores hormonales y tratamiento adyuvante con tamoxifeno en estadios I y II / Breast cancer: cost-effectiveness analysis in determining hormone receptors and adjuvant treatment with tamoxifen in stages I and II

Introducción: El objetivo del presente trabajo fue estimar los costos de la determinación de receptores hormonales en cáncer de mama en estadios I y II en relación a los beneficios clínicos y riesgo del tratamiento con tamoxifeno en mujeres con tumores positivos para receptores estrogénicos (RE+). Metodología: Se estimaron los efectos del tratamiento adyuvante con tamoxifeno en mujeres con cáncer mamario RE+ a partir de los meta-análisis publicados en la última década. Se estimaron los costos de la determinación de RE, de hormonoterapia, quimioterapia, así como el costo promedio del tratamiento de recurrencias, a partir de los datos obtenidos del CASMU. Se compararon los efectos del tratamiento y los costos con el escenario hipotético en que el tamoxifeno no sea utilizado como adyuvante. Resultados: Se estimó que de cada 200 mujeres diagnosticadas con cáncer de mama en estadio I o II, la terapia con tamoxifeno durante cinco años (20mg/día) evitaría la aparición de 21 recurrencias en cinco años, comparando con el no uso de tamoxifeno como adyuvante

Evaluación de tecnologías de salud / Health technologies evaluation

La evaluación de tecnologías en salud registra un desarrollo creciente a nivel de los sistemas de salud. El presente trabajo de revisión busca sistematizar tanto los aspectos conceptuales, como la base metodológica utilizada, los diferentes componentes que incluye el área, y las principales tendencias observadas. El objetivo principal es contribuir a la comprensión del alcance y la utilidad del resultado del proceso de evaluación en los distintos niveles de toma de decisión en salud: definición de políticas, gestión de servicios de salud y para el ejercicio de la práctica médica.Puede afirmarse que la evaluación de tecnologías se ha convertido en una verdadera especialidad en el área de la salud. El objeto de la evaluación tiende cada vez más a la integralidad, abarcando no solamente medicamentos y equipos médicos, sino también acciones preventivas, procedimientos de mediana y alta complejidad e inclusive modos de organización en salud. El proceso de evaluación de tecnologías de salud se refiere tanto a las nuevas tecnologías como a las ya existentes, debido a la incertidumbre sobre su efectividad o en casos menos frecuentes por la demostración de efectos adversos que superan a los beneficios