ABSTRACT
OBJETIVO: Describir las características de los informes de posicionamiento terapéutico (IPT) publicados en España en el periodo 2013-2019. Diseño y fuente de datos: Revisión sistemática de todos los IPT publicados en la página web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Selección de estudios: Se incluyeron todos los IPT realizados desde mayo de 2013, hasta marzo de 2019. Extracción de datos: Las principales variables recogidas fueron los grupos terapéuticos evaluados, el número de IPT, el tiempo de elaboración, la existencia de restricciones a las indicaciones autorizadas y la información sobre la eficiencia. RESULTADOS: En el periodo evaluado se realizaron 214 IPT, con un tiempo medio de elaboración de 8,8 meses, casi tres veces el objetivo de 3 meses planteado inicialmente. El 57% de los IPT establecieron restricciones de uso respecto a las indicaciones de sus fichas técnicas. El 26% de los IPT hicieron referencia a la existencia de datos económicos, aunque ninguno incluyó detalles sobre la eficiencia. Se actualizaron el 10% de los IPT. CONCLUSIONES: Para que los IPT puedan cumplir su objetivo de mejorar la eficiencia del proceso de evaluación y la coherencia en las decisiones sobre precio, reembolso y financiación de medicamentos por parte del SNS es preciso que se cumplan los plazos establecidos para su publicación, se incorpore sistemáticamente información sobre la eficiencia de los fármacos y se actualicen los informes con la nueva información generada
OBJECTIVE: Describe the characteristics of the therapeutic positioning reports (TPRs) published in Spain in the period 2013-2019. Design and data source: Systematic review of all TPRs published in the website of the Spanish Agency of Medicines and Health Products (AEMPS). Selection of studies: All TPRs published since May 2013, until March 2019 Data extraction: The main variables collected were the therapeutic groups assessed, the number of TPRs, the time of elaboration, the existence of restrictions versus the authorized indications and the information on the efficiency of medicines. RESULTS: During the period under review, 214 TPRs were carried out, with an average production time of 8.8 months, almost three times the objective of 3-month initially set. 57% of the TPRs established restrictions of use with respect to the approved indications. 26% of TPRs referred to the existence of economic data, although none included details on the efficiency. 10% of TPRs were updated. CONCLUSIONS: For TPRs to meet their objective of improving the efficiency of the assessment process and the consistency in the decisions on price, reimbursement and financing of medicines by the SNS, the deadlines established for publication must be met, incorporating systematically information on the efficiency of the drugs and including periodic updates with the new information generated
Subject(s)
Humans , Drug Monitoring/standards , Drug Information Services/standards , Time Factors , Drug Monitoring/statistics & numerical data , Drug Information Services/statistics & numerical data , Government Agencies , SpainABSTRACT
OBJECTIVE: Describe the characteristics of the therapeutic positioning reports (TPRs) published in Spain in the period 2013-2019. DESIGN AND DATA SOURCE: Systematic review of all TPRs published in the website of the Spanish Agency of Medicines and Health Products (AEMPS). SELECTION OF STUDIES: All TPRs published since May 2013, until March 2019 DATA EXTRACTION: The main variables collected were the therapeutic groups assessed, the number of TPRs, the time of elaboration, the existence of restrictions versus the authorized indications and the information on the efficiency of medicines. RESULTS: During the period under review, 214 TPRs were carried out, with an average production time of 8.8 months, almost three times the objective of 3-month initially set. 57% of the TPRs established restrictions of use with respect to the approved indications. 26% of TPRs referred to the existence of economic data, although none included details on the efficiency. 10% of TPRs were updated. CONCLUSIONS: For TPRs to meet their objective of improving the efficiency of the assessment process and the consistency in the decisions on price, reimbursement and financing of medicines by the SNS, the deadlines established for publication must be met, incorporating systematically information on the efficiency of the drugs and including periodic updates with the new information generated.
