Crónica de la Jornada Técnica de AES: “Nueva normativa de evaluación de tecnologías sanitarias: ¿aterrizando o despegando?”

On the afternoon of March 6, 2025 we gave the departure pistol of the activities of the XLIV Health Economics Days Madrid 2025. As the tradition sends, this active act consisted of the celebration of a technical day on a fear topic. Undoubtedly, one of the most discussed tempas in health economics in the last season is that of the new

The technical day was entitled «New regulations for the evaluation of health technologies: landing or taking off?» and was held at the Madrid Athenaeum. Go ahead of our gratitude to Chiesi, sponsor of the day, and the Madrid Athenaeum, 190, for hosts in a place as inspiring as Importa in the dissemination of culture, the arts and knowledge in the container Viedoololo.

Since last January the application of the new regulation of evaluation of health technologies has begun. While at the moment it only applies to oncological medicines and advanced therapies, we must adapt to it, I know that Paulatinamete will incorporate over the next few years, in its two configurations: RECTIVALS TO MEDICAL ASPILS. In Spain, the development of these regulations was led by the cancellation of the Consolidation Plan for therapeutic positioning reports (IPT) by the National Court, what d. price and financing. From this confluence arises the Royal Decree of the STD, real in parliamentary process. This Royal Decree established a procedure that includes different governance bodies, with different commissions and groups with key functions in the Evaluation and Position Procurement, highlighting the configuration of the configuration of two out of two of the two of the evaluation of the evaluation of the evaluation of the evaluation of the evaluation of the evaluation of the evaluation of the evaluation evaluation. Health technologies, one for medications and one for health products and other technologies. These offices would perform both clinical and non -clinical evaluations.

Like any new standard, it is necessary to know both the background and the form of this. For this we celebrate this technical day, to dialogue with the most actors and that is that innovations in health technologies really important for society. These innovations suppose scientific and knowledge advances, and after a stage of industrial development, purpose, they can lead to an improvement in health results for patients and society. However, this improvement in population health – dedicated to innovations – must be sustainable from the financial point of view.

The technical day was inaugurated by Anna García-Altés (president of the Board of Directors of AES) and by me, Manuel García Goñi (president of the Organizing Committee of the XLIV AES Days). The program of the day was divided into two round tables. The first table was dedicated to the takeoff of the standard, its background, its objectives and its challenges. The second was dedicated to its landing, that is, how this new norm will be applied.

In the first round table we have exceptional import speakers for the development of the Royal Decree of Evaluation of Health Technologies, under the moderation of Néboa Zozaya (Member of the Board of AES and the Weber Foundation). First our rapporteur was César Hernández (General Director of Common Portfolio of Services of the National Health and Pharmacy System of the Ministry of Health), which presented an institutional panoramic view of the new regulations, counting the novelties of the approach. It influenced the separation between the clinical evaluation, more technical and that has more to do with authorization, and the procurement of decision -making, more focused on financing and reimbursement of these innovations, whether they are medications. In fact, when I arrive, the new law of medicines and health products will deal with the background regulatory of both fields, while the real decrees, ETS, on the one hand, and financing and price of medicines, poro) will carry out a decision to carry out these.

Our second rapporteur, María Jesús Lamas (director of the Spanish Agency for Medicines and Health Products, AEMPS), began commenting on how the take -off of European regulation, which provides an integrated system in Europe of the evaluation of health technologies, with the landing of a definitive ETS design in Spain, and with the still operational, although partially and improved, in a partially and improved way, and in a partially and improvement, with the previously and with the still operational, and with the still operational. He accentuated the fact that with the new one who is going to analyze, always avoiding any value judgment that could affect decision making, which must be independent. Pedro Luis Sánchez (Director of the Farenaindustria Studies) continued, addressing the main objectives that the evaluation of health technologies must be met from the point of view of the pharmaceutical industry. He highlighted the enormous importance that the structure of the evaluation that provides the new regulations is for industry. He explained how these regulations should be useful for decision -making, be a reference at international and local to avoid unnecessary duplications in the evaluation of being eagle, balance and light: all aspects of the aspects of the aspects of Sebesitan, considered clinical view, but also the times so as not to harm access to innovation must be entitled.

Our fourth speaker on the table was Paula Echeverria (technique of political incidence and rights defense of the patient organizations platform), which emphasized the thin importation of the reduction of the innovos. This should occur to an exercise of transparency in the procurement of evaluation and seizure, using real life data and in which they should effectively participate, patients. Therefore, it is necessary to ensure the financial financial for a correct implementation of the new regulations. Finally, the last rapporteur of thesea was Eduardo López Briz (coordinator of the Genesis Group (Spanish Society of Hospital Pharmacy, SEFH) and Chief of Pharmacy Section of the FEE Hospital), Quera Abb Abbon the regulations from the value of the hospital of Valuado de Valúa de Valúa de Valuu Value Valúa Valúa Valúa Valúa de Valúa de Valúa de Valuado de Valuado de Medicina, and present a comparison of the use of resources from National Institute of Excellence in Health and Care (Nice), in the United Kingdom, with the very scarce resources that at the moment it seems that they will be used in the evaluation of health technology in Spain. It accentuated the import that transparency has in the structure of the evaluation, the process, and the results; As well as the importance of participation in the evaluation of the agents of the different, such as, for example, the expert patient or health professionals with experiment enterts.

The second table, moderated by Javier Colás (director of the Cluster Citt-Bio-Medicina of the Community of Madrid), revolved around the landing of the new normacive, addressing the practic of the evaluation, with a particular focus on the sanitary operative. He had the intervention of five experiences that gave their vision from the point of view of the evaluation agencies. First, Lidia García (Economist of the Health of the Evaluation Service of the Canarian Health Service (SESCS) in representation of the Spanish Network of Evaluation of Health Technologies and Profits of the System Nacian Health System (REDETS) Expliciol Cesals. of the REDETs. Processes and steps to be guided in joint clinical evaluations.

Next, María Alaez (Technical and Quality Director of the Spanish Federation of Health Technology Companies, FENIN) contributed the vision of the health device industry, and presented the desire to participate as an interlocutor of the industry in the evaluations of health technologies, and especially with -Te ETS agencies, as well as in the forums and reference meetings, so that the industry is present in all the industry. Following Elena Casous (Chief of Divisió of the Advanced Therapies Unit in the Ministry of Health of the Community of Madrid), who represented the perspective of the Ministry of Health, providing data superior acts on the Evalus Evalusa are carrying out today. The end and access of this type of therapies, which, in many cases, is based on the design of an explehovo monitoring to apply payments for resulting. Finally, Sonia García de San José (Vice President of the Spanish Society of Health Directors (Sedisa) and manager of the Gregorio Gregorio Mario Hospital) contributed the vision of health management, which au a au a better management of resources and access to Newevas Technologies for patients to receive efficient provision.

In short, a very intense and huge technical day, with relevant speakers, and necessary for tempting where we are and where we are going, in relation to the new regulations in evaluation of health technologies. It should be noted the great reception that he had, so much that we had to change the room of the Athenaeum in the last minute to a greater capacity. This technical day serves as a regulation to continue discussing this and other relevant issues during the XLIV Days of Health Economics, which will pestle in the faculty of Economic and Business Sciences of the Cacurse University of Madrid, Delogio. Where we are located that we see all those interested in health economy. The program, already available on the AES website, of course, deserves it.