Market access for medical technologies in Spain

Key topics

There are two key themes describing market access for medical technologies in Spain:

Funding: explicit inclusion of service or implant into the package of benefits provided within the NHS
Health technology assessment: HTAs by national and regional organizations

There is no reimbursement, but only funding framework in Spain. Hospitals receive funding through a global budget, although the responsibility for the allocation of hospital budgets is assigned to the health authority of the Autonomous Communities.

Funding

One of the key aspects of market access in Spain is the explicit inclusion of service or implant into the package of benefits provided within the NHS. The package of benefits is defined by the Interterritorial Council of the NHS (CISNS), composed of the Health Regional Ministers and the Health Minister of Spain.

The Common Package of Benefits of the National Health System is the set of techniques, technologies or procedures, understood as each of the methods, activities and resources based on scientific knowledge and experimentation, through which health benefits are made effective («BOE» num. 222, 16/09/2006). The Common Package of Benefits is common for all regions of Spain, and each Autonomous Community has its complementary package.

The decision to include new technologies in the package of benefits is made by the Interterritorial Council of the NHS upon the proposals submitted by the Commission of Benefits, Insurance and Financing and the (mandatory) technical advice of the Spanish Network of HTA Agencies (RedETS).

Health technology assessment

HTAs are performed at the regional level by seven HTA bodies (in Andalusia, Aragon, Basque Country, Canary Islands, Catalonia, Galicia, and Madrid) and at the national level by the Health Institute Carlos III (ISCIII).

Specifics for IVD tests

There is no specific reimbursement framework for in-vitro diagnostic tests. Most IVD tests are funded using a global budget principle as part of the funding of the labs.

Genomic and genetic tests that are guaranteed nationwide are included in the Common Catalog of Genetic and Genomic Tests of the NHS.

MTRC has experience with more than 105 projects in Spain

How can MTRC help?

Development of reimbursement analysis (procedure coding, payment mechanism, reimbursement tariffs, policy and HTA considerations)

Development of reimbursement strategy

Development of the health economic model in the Spanish settings

Adaptation of the global health economic model to the Spanish settings

Access to an educational seminar on the Spanish reimbursement system

News and insights

14 Apr 2025

Draft Order amending the Common Package of Benefits of the Spanish National Health System

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.

25 Mar 2025

Guidance for the use of real-world data in health technology assessment in Spain

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.

19 Mar 2025

Tests for hepatic diseases introduced in the Spanish Catalog of Genetic and Genomic Tests

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.

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