On the Draft Royal Decree regulating Health Technology Assessment in Spain
Health Technology Assessment (HTA) allows authorities to decide on the incorporation, funding, pricing, reimbursement, or disinvestment of these technologies to ensure an equitable and efficient healthcare system.
Health Technologies include medicines, medical procedures, medical devices, in vitro diagnostic tests, and other health-related technologies.
The text includes the participation of patients and healthcare professionals in the evaluation processes of health technologies before their incorporation into the benefits of the National Health System.
The Draft Royal Decree is open for public consultation from Monday, August 12. Interested organizations or citizens can submit their contributions via the designated email address until September 20.
The Ministry of Health has published the Draft Royal Decree regulating Health Technology Assessment (HTA). This Draft Royal Decree, which initiates the public consultation process, regulates the evaluation of Health Technologies, including medicines, medical procedures, medical devices, in vitro diagnostic tests, and other health-related technologies.
The assessment is a scientific process that allows authorities to decide on the incorporation, funding, pricing, reimbursement, or disinvestment of these technologies to ensure an equitable and efficient healthcare system. It is important to emphasize that although the evaluation is essential to inform decisions, it is not the decision itself.
In Spain and Europe, the assessment of medicines, medical devices, or other types of Health Technologies has followed different paths due to specific characteristics and regulations. Although the conceptual framework for assessment is similar, the demand and pace of incorporation into the National Health System vary depending on the type of technology. To adapt to these differences, a common evaluation structure has been established for all technologies, but with separate configurations for medicines and medical devices on one hand, and other types of technologies on the other.
This separation has been maintained in Spain with the participation of the Spanish Agency of Medicines and Medical Devices and the Spanish Network of Agencies for Health Technology Assessment and National Health System Benefits. Both institutions have conducted their assessments following different methodologies, although serving the same purpose of informing decisions related to the benefits portfolio and public funding.
To develop this regulation, nine assessment areas have been identified, four clinical and five non-clinical. The four clinical areas are: the identification of a health problem and the current Health Technology, the analysis of the technical characteristics of the new health technology, its relative safety, and its relative clinical efficacy. The five non-clinical assessment areas relate to the cost and economic evaluation of a technology and its ethical, organizational, social, and legal aspects.
Furthermore, the procedure for public funding of medicines and medical devices for their inclusion in pharmaceutical benefits must consider criteria such as the “therapeutic and social value of the medicine and its incremental clinical benefit considering its cost-effectiveness ratio” or the “social value of the medical device and its incremental clinical benefit considering its cost-effectiveness ratio.”
This Royal Decree must align with the EU regulation establishing a joint assessment model for the four domains belonging to the clinical area for medicines and medical devices. The objective is to ensure a common denominator of equity within the EU while respecting the competencies and management capacities of the Member States.
Therefore, the main objective of the project is to establish a regulation that facilitates the implementation of HTA in Spain, aiming to improve health outcomes, ensure equitable access to technologies, optimize efficiency and sustainability in their adoption, and promote technological development and industrial manufacturing in our country.
Additionally, it consolidates a transparent and independent model, grounded in the best available scientific knowledge, consistent with the timelines for the incorporation of technologies, adaptable to the type of technology evaluated, and with participation. In fact, the project formalizes the participation of patients and healthcare professionals in the evaluation processes of health technologies before their inclusion in the benefits of the National Health System.
Regarding the public consultation of this Draft Royal Decree on Health Technology Assessment, the Secretary General of Health, Javier Padilla, highlighted the following points:
1- Purpose
Evaluating technologies, procedures, and products is crucial to determine their value for the system and inform funding/disinvestment decisions. In other words, assessment is a source of research, innovation, and knowledge for action.
2- This Draft Royal Decree divides the assessment into two levels:
Clinical assessment (including relative efficacy and safety)
Non-clinical assessment (including, among others, economic evaluation).
3- One of the key elements of this Draft Royal Decree is to advance in the transparency and predictability of the evaluation processes, the criteria considered, and the elements to be evaluated.
4- Another key element is to ensure the independence of the different levels of the assessment system. On the one hand, to ensure that evaluation decisions are independent of funding definitions.
5- Formal independence (also free from conflicts of interest) is complemented by ensuring that the evaluation information directly impacts funding decisions. The governing bodies of the system will work towards this. In other words, Health Technology Assessment informs decision-making but does not constitute the decision itself. The Draft Royal Decree clearly identifies both areas of work, evaluation, and decision-making, with their respective structures, competencies, and responsibilities.
6- The Draft Royal Decree incorporates the participation of patients and healthcare professionals in the evaluation processes of health technologies before their inclusion in the benefits of the National Health System.
This is a much-anticipated change in various fields.
7- Transparency operates in several directions, so developers will be required to provide accurate production, research, and development costs of their products, as well as sources of public and private funding.
8- The Draft Royal Decree incorporates elements related to the detection of emerging technologies and the incorporation of real-world evidence to reduce uncertainty in evaluation processes. In other words, steps forward so as not to fall behind.
9- The Draft Royal Decree seeks to standardize and streamline evaluation processes, integrating the European health technology assessment regulation in a harmonized and coordinated manner. Avoiding duplications and leveraging other evaluations to make better decisions.
10- This Draft Royal Decree moves towards a transparent, independent system, based on the best state of scientific knowledge, consistent with the timelines for the incorporation of technologies, adapted to the type of technology evaluated, and with participation.
Source: Ministry of Health. Government of Spain. Monday, August 12.
Other publications by Jose A. Vidal on Health Technology Assessment (HTA): ES & EN versions
