The future of HTA: new regulation and market access

Jorge Mestre-Ferrándiz, Ana Becerro de Bengoa, Paloma González y Carme Pinyol, ISPOR Spanish Chapter

ISPOR Spain Chapter, in order to act as a training and informative resource at national level for professionals interested in pharmacoeconomics and health outcomes research, will periodically organize training on Wednesdays under the name of “ISPOR Wednesdays”. They will consist of training sessions throughout the year on relevant topics in this field, taught by experts in this field, with a duration of two hours.

The first presentation that has been done during the session of “the Wednesdays of the chapter” Iñaki Gutiérrez Ibarluzea, director of Organizational Innovation and Management of the BIOEF (Basque Foundation for Health Innovation and Research), was about the HTA regulation story, its light-dark, will reflect on the adequacy or not of the HTA regulation mechanism (the so-called HTA regulation) and its consequences at the Spanish national level, on the task of EUnetHTA21 going forward and how it will impact individual countries and on medical device and diagnostic testing regulations. As a final reflection, the audience discussed who should benefit and how from these activities, initiatives and policies in health.

A brief summary of the presentation is:
The role that Health Technology Assessment (HTA) should play in decision-making at European level and in the formation of a pan-European health system has been subject to discussions since the 90s, when the first experiences of evaluation units were implemented in countries such as Spain, the United Kingdom and Scandinavian countries. In fact, the Spanish National Health System and its service providers were among the first to include HTA as a decision-making tool.

More recently, a joint effort by the International Society of ETS (HTAi) and the International Network of Public ETS Agencies (INAHTA) has developed a new definition of Health Technology Assessment as: A multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its life cycle. The purpose is to inform decision-making to promote an equitable, efficient and high-quality health system. This new definition that slightly qualifies the previous ones is aligned with the universal coverage objectives of the World Health Organization, which define that access to safe, effective, quality and affordable essential medicines and vaccines must be ensured for all.
And that, to ensure that goal, the design of the essential benefits package must be based on data and evidence.

On this basis and in systems in general that ensure universal or near-universal coverage in Europe, why is the role of ETS in this regard still being discussed? The first reason that can explain it would be to know in which countries of the European Union the STD is deployed and what role it plays in them. In fact, although it seems impossible at this point in the game, there are still countries in the union that do not have ETS or similar mechanisms implemented to support the processes of defining and updating the portfolio of services. This is especially relevant in the case of Eastern European countries, but also occurs at the national level in other countries with previous experiences in ETS. The second reason relates to the difference in service delivery systems and the lack of a common idea of health in Europe. Since the beginning of the twentieth century, the commission and the EU have asked different experts and committees to advise on how to do this and from there emerged reports and initiatives such as EUR-ASSESS, ECHTA-ECAHI, the EUnetHTA project and the subsequent JA1, JA2 and JA3 joint actions. More recently, an extension called EUnetHTA21 has been proposed. In this state of affairs, several actions have taken place and one of them that has changed the landscape has been the decision of the EU appropriate or not to promote a regulation, on the other hand, the promoters of an HTA network in Europe have generated in parallel an organization called Head of Agencies Group (HAG) that has emerged as the successor of the initial EUnetHTA project.