Spain

On May 13, 2025, the Common Package of Benefits of the Spanish National Health System (NHS) was amended. The med tech-related updates mostly concerned in-vitro diagnostics, gastrointestinal, e-Health, cardiovascular, ENT, ophthalmology, oral health, and neurology fields.

In March 2025, the Draft Order amending the Common Package of Benefits of the National Health System and some other related legislative orders were released for public consultation. The Draft Order focuses on updating public health and primary care services, expanding neonatal and cancer screenings, improving equity in access to in-vitro fertilization, refining rehabilitation definitions, including patients in genetic advisory bodies, and modifying the system for ortho-prosthetic products.

In March 2025, the Health Sciences Institute in Aragon released a document that provides guidance on incorporating real-world data into health technology assessment, focusing on the preadoption phase for evaluating new technologies in the Spanish Network of HTA Agencies (RedETS) framework. It outlines a workflow aligning with RedETS practices, identifying key milestones where RWD adds value and offering methods and tools to integrate RWD into decision models.

In February and March 2025, the Common Catalog of Genetic and Genomic Tests of the National Health System was updated in Spain. A new section, “Hepatic diseases,” was added, including 24 tests for multiple hepatic diseases.

In January 2025, the General Directorate of the Common Package of Benefits of the National Health and Pharmacy System released a Resolution regarding the participation of patients in the working groups dependent on the Commission of Benefits, Insurance, and Financing (CPAF). This Resolution officially endorses patient involvement in CPAF working groups to enhance the legitimacy and inclusivity of healthcare policy decisions.

In January 2025, the Spanish Minister of Health participated in a meeting to establish the “Green Anesthesia” working group. The group’s goal is to further advance the sustainability of the healthcare system and develop a set of best practices and solutions to achieve “better anesthesia for patients and for the planet”.

In January 2025, it was announced that two Benchmark centers, departments, and units of the Spanish National Health System (CSURs) were designated, and two CSURs were redesignated for previously approved pathologies and procedures in the cardiovascular field.

In January 2025, the Common Catalog of Genetic and Genomic Tests of the National Health System was updated in Spain. A new section, “Respiratory medicine,” was added, including 29 tests for multiple respiratory diseases.

In November 2024, the Galician Agency for Health Technology Assessment (AVALIA-T) is working on several HTAs, including in cardiovascular, e-health, ICU/OR, in-vitro diagnostics, neurology and neurosurgery, neuromodulation, orthopedics, pulmonary and airways, radiotherapy, surgical procedures, and some other fields.

In October 2024, the Agreements on new pathologies and procedures for the care of which it is necessary to designate Benchmark centers, departments, and units of the National Health System (CSURs) were approved in the cardiovascular, endoscopy, gastrointestinal, nephrology, and urology, obstetrics and gynecology, surgical procedures, neuromodulation, and peripheral vascular fields. In addition, several CSURs were designated or redesignated for previously approved pathologies and procedures.

In September 2024, the Canary Islands Healthcare Evaluation Service (SESCS) is working on several HTAs, including evaluations in neuromodulation, IVD, and some other fields.

On June 19, 2024, the Order SND/606/2024, of June 13, came into force. This Order, among other things, creates the Advisory Committee for the Common Package of Benefits in the Area of Genetics.