In a recent post on this blog, we outlined the concept of Health Technology Assessment (HTA). It seeks to answer the question: do the additional health gains provided by new technology justify the price we have to pay for it? Fundación de las Cajas de Ahorros (Funcas) has released three technical notes on HTA in Spain, authored by Juan Oliva, Professor of Economics at the University of Castilla la Mancha; José Vida, Associate Professor of Administrative Law at the University Carlos III of Madrid, and the undersigned. The first of these notes examines the barriers hindering the systematic and comprehensive implementation of HTA in our country, its inadequate regulation, its level of development in practice, and the latest trends.
Since the 1990s, numerous developed countries have progressively established HTA, while it has not been solidly and systematically developed in Spain. Why? Some healthcare sector stakeholders have identified administrative, methodological, and practical application barriers. We emphasize the importance of political barriers (such as the controversial nature of decisions on the allocation of scarce resources and the fear of losing control), the absence of models from other sectors, as well as historical and cultural factors (such as a traditionally very generous pharmaceutical provision). Political determination to overcome these barriers has been lacking, although we are not the only country facing difficulties in adopting efficiency criteria.
Regarding the legal framework, while the general constitutional and legal framework undoubtedly requires compliance with the principle of efficiency in resource allocation, the specific regulations of the sector (the 2015 Law on Guarantees and Rational Use of Medicines, the 2003 Law on Cohesion and Guarantees of the National Health System, and Royal Decree-Law 9/2011) are inadequate. They separately regulate and organize HTA for medicines and other healthcare technologies, which is not optimal. Regulation of the latter is relatively satisfactory, while that of medicines lacks specificity and regulatory and methodological development, making it fragmented, unsystematic, discontinuous, partial, and insufficient.
The practical implementation of HTA studies in Spain is increasing, although their quantity remains modest. In particular, the development of specific economic evaluation studies of medicines to support specific Administration decisions regarding their therapeutic positioning, public financing, and prices has been very limited, and their quality offers room for improvement. The most active public actors are the Health Technology Assessment Network (RedETS); the Joint Committee for the Evaluation of New Drugs formed by six Autonomous Communities; the Comissió d’Avaluació Econòmica i d’Impacte Pressupostari (CAEIP) of the Catalan Health Service (CatSalut), until its disappearance in 2019, and the Canary Islands Health Service. In the private sector, authors include professional and scientific societies (GENESIS, SEFH, AES), the pharmaceutical and healthcare products industry, consulting firms, and university researchers.
In recent years, there has been political will to advance HTA, manifested in planning initiatives (Plan for Therapeutic Positioning Reports (IPT); organization (REvalMED…); information systems (Valtermed), budget allocation, and training, although some, lacking a legal basis, have been annulled by the courts (Judgment of the Contentious-Administrative Chamber of the National Court of June 26, 2023). Regulation (EU) 2021/2282 of the European Parliament and of the Council of December 15, 2021, on the assessment of health technologies, establishes a common framework that will be an essential reference point and has already prompted the initiation of the processing of a draft Royal Decree regulating these matters.
The conclusions of the report are clear. HTA has not been fully and systematically implemented in Spain, especially concerning medicines. The legal framework and the practice of Public Administrations should have consolidated it long ago as an aid for decision-making. The full development of standards, organizational structures, and procedures that underpin decisions on the financing and pricing of medicines and other technologies, incorporating the efficiency dimension, with technical-scientific quality, transparency, accountability, and participation, is one of the pending subjects of our National Health System. Recent and ongoing reforms point to a hopeful change. However, the road ahead is long and requires far-reaching actions, including legislative developments at the highest level. Political determination, as well as appropriate incentives, coordination, and leadership, are required.