First state framework for health technology assessment in the Spanish National Health System

On May 26, 2026, the Spanish Ministry of Health announced approval of the first national HTA framework for the Spanish National Health System. The Royal Decree 415/2026 regulates national HTA activities intended to inform decisions by the competent authorities on the incorporation, financing, pricing, reimbursement, modification of conditions of use, or disinvestment in health technologies. The Decree also aligns Spain’s HTA system with Regulation (EU) 2021/2282 (HTAR) and establishes common national rules, methodologies, and coordination mechanisms.

The new HTA framework applies to medicines and non-pharmacological health technologies, including medical devices, in vitro diagnostics, procedures, digital technologies, and organizational models. Medical devices may be assessed either as a general technology with available comparators or, where appropriate, as specific devices.

Assessments will include clinical aspects, such as the health problem, current alternatives, technical characteristics, safety, and clinical efficacy, as well as non-clinical aspects, including costs, resource use, efficiency, budget impact, and ethical, organizational, social, legal, and environmental considerations.

Clinical evaluations must not duplicate assessments already conducted at the EU level under the HTAR framework. Where an EU joint clinical assessment is available, it should serve as the basis for the Spanish clinical evaluation, which may be supplemented by a national categorization of the technology’s added clinical value.

The new framework will include an HTA Council and two independent HTA Offices: one for medicines and one for non-pharmacological technologies within the Spanish Network of HTA Agencies (RedETS). The HTA Council will provide strategic direction, approve work programs, and methodological guidelines. The Offices will prepare comparative clinical and non-clinical assessments, coordinate scientific consultations, support the detection of emerging technologies, and manage activities linked to EU joint clinical assessments and scientific advice.

Assessments will be based primarily on dossiers submitted by health technology developers, supported by other sources of evidence specified in methodological guidelines. Failure to submit or correct the required dossier may suspend the evaluation.

HTA reports will be submitted through the Health Technology Adoption Group, which will issue a final assessment of the relative positioning of the technology. For non-pharmacological technologies, clinical and non-clinical assessment reports must generally be completed within 140 days, with possible extensions where additional information is required. HTA reports will be non-binding and will inform, but not replace, decisions by the competent authorities. 

Implementation of the new framework will be phased, with the first regulatory instructions and methodological guidelines to be approved within one year.

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