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Market access for medical technologies in Spain

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in Spain

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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. 

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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 SNS (CISNS), composed of the 17 Health Regional Ministers.

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 on Benefits, Insurance and Financing and the (mandatory) technical advice of the Spanish Network of Agencies for the Evaluation of Health Technologies and Benefits.

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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 Instituto de Salud Carlos III.

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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 National Catalog of Genomic and Genetic tests.

MTRC has experience with more than 90 projects in Spain

News and insights

09 Feb 2024

New national catalog for genetic tests released in Spain

On January 23, 2024, the Ministry of Health introduced a new national catalog, which guarantees the Spanish population's genetic tests nationwide. Currently, the catalog includes 672 tests in eight disease areas, including adult and pediatric oncohematology, pharmacogenomics, hereditary metabolic and mitochondrial diseases, and others. Twelve more disease areas are expected to be added in 2024.
23 Nov 2023

36 cardiovascular projects funded in Spain

In November 2023, the Agency for Health Quality and Assessment of Catalonia (AQuAS) informed that the La Marató Foundation selected 36 cardiovascular projects together with eight other projects in a ranked reservation list to be funded.
20 Nov 2023

Adaptation for Digital Health Technology Assessment Framework in Spain

On November 13, 2023, the Agency for Health Quality and Assessment of Catalonia released a user guide on the health technology assessment framework: adaptation for digital health technology (DHT) assessment. The guidelines described can be equally useful for HTA agencies, researchers, and developers of DHT, decision-makers, and regulators.

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