Economic and budgetary impact of drug evaluation reports. Practical guidelines associated to the MADRE 4.0. program. November 2016
Practical guidelines (PDF)
Model of the 2017 report (update of the economic section) (Word file)
Excel® tool (beta version). March 2018
Annex: Sources of information and literature searches for the economic section of the MADRE program (January 2017)
The updating the economic section of the MADRE 4.0 report was undertaken thanks to a SEFH grant. The first step was an analysis of the main areas for improvement in the economic section and a review of the existing literature. Later on, the RAND/UCLA methodology was followed to hold an electronic brainstorming session, which was attended by professionals with practical experience in the preparation of evaluation reports. Based on the contributions and proposals of the participants, a draft document was put together, which contained 152 detailed scenarios, classified into the sections defined in the GENESIS report model. Such scenarios were classified by a 14-strong group of experts in drug evaluation, health economics and scientific methodology. Scores were assigned during two consultation rounds, one held face-to-face and the other remotely. During these rounds, the scores of the scenarios where significant differences existed were discussed and an attempt was made to reach a consensus. Lastly, drawing on the ideas generated in the previous phases, the research team drafted the present set of guidelines.
These practical guidelines are an up-to-date tool meant to support professionals with drafting the economic section of the MADRE 4.0. program by providing recommendations for addressing key aspects such as costs, the critical evaluation of past economic evaluations, selection of the most appropriate type of economic evaluation, sustainability and the calculation of budgetary impacts, target populations and population-based health outcomes. Moreover, the guidelines contain a proposal for a cost-effectiveness threshold to be applied in the reports and defines a series of therapeutic positioning criteria based on incremental cost-effectiveness and budgetary impact ratios.
The copyright for these guidelines is protected and has been transferred to Spanish Society of Hospital Pharmacists.
The reference for the guidelines is as follows: Ortega Eslava A, Marín Gil R, Fraga Fuentes MD, López-Briz E, Puigventós Latorre F (GENESIS-SEFH). Guía de evaluación económica e impacto presupuestario en los informes de evaluación de medicamentos. Guía práctica asociada al programa MADRE v 4.0. Madrid: SEFH (ed.), 2017. ISBN: 978-84-617-6757-1. Available at: http://gruposdetrabajo.sefh.es/genesis.
As a byproduct of the guidelines, a series of support excel® sheets have been developed to facilitate the calculations required in the different section of the guidelines. The guidelines are currently available as a beta version.
Please feel free to send us any proposal or suggestion to the following e-mail address: This email address is being protected from spambots. You need JavaScript enabled to view it..
MADRE 2012 Program
MADRE PROGRAM models
Version 4.0
December 2012
MADRE program (PDF file)
MADRE program. Download compressed file (ZIP)
Instructions for downloading the compressed version of the MADRE program (ZIP)
MADRE 4.0 web application (beta version)
"The project to update the MADRE program was undertaken using the RAND-UCLA methodology, which combines available evidence with expert judgement. The 4-0 version of the MADRE program incorporates the latest drug evaluation methodologies: indirect comparisons, budgetary impact analyses and equivalent therapeutic alternatives. It also incorporates specific sections for describing specific health problems and analyzing study endpoints."
The copyright for this project is protected and has been transferred to Spanish Society of Hospital Pharmacists.
The reference for this document is as follows: Marín R, Puigventós F, Fraga MD, Ortega A, López-Briz E, Arocas V, Santos B. Grupo de Evaluación de Novedades y Estandarización e Investigación en Selección de Medicamentos (GENESIS) de la Sociedad Española de Farmacia Hospitalaria (SEFH). Método de Ayuda para la toma de Decisiones y la Realización de Evaluaciones de medicamentos (MADRE). Versión 4.0. Madrid: SEFH (ed.), 2013. ISBN: 978-84-695-7629-8. Available at: https://gruposdetrabajo.sefh.es/genesis/en/methodological-rationale/madre-program
Please feel free to send us any proposal or suggestion to the following e-mail address: This email address is being protected from spambots. You need JavaScript enabled to view it.
MADRE Program
MADRE PROGRAM models
Version 3.0
September 2005
Handbook of procedures under the MADRE program (PDF file)
MADRE program. Download compressed file (ZIP)
Instructions for downloading the compressed version of the MADRE program (ZIP)
The MADRE program has been developed to help practitioners draft reports for the assessment of new drugs.
Physicians are free to adapt the basic model provided to the characteristics of each drug and each hospital.
The purpose is to make it easier to prepare well-organized reports that present the most significant aspect of the evaluation performed in a systematic way.