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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 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).

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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 Health Institute Carlos III (ISCIII).

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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 Common Catalog of Genetic and Genomic Tests of the NHS.

MTRC has experience with more than 105 projects in Spain

News and insights

Designation of Benchmark centers of the Spanish National Health System in October 2024

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.

Ongoing HTAs by SESCS in Spain in September 2024

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

Creation of the Advisory Committee in the genetics field in Spain

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.

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