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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

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.

Updates in the Spanish Common Package of Benefits

On June 19, 2024, the Order SND/606/2024, of June 13, came into force. This Order, among other things, amends Annexes I, II, III, VI, and VII of Royal Decree 1030/2006, of September 15, which establishes the Common Package of Benefits of the National Health System and the procedure for its update. The changes mostly concern in-vitro diagnostics, ENT, pulmonary and airways, cardiovascular, and some other fields.

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