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.
Get insights from MTRC free analytical reports
Gain in-depth insights into market access challenges and evidence requirements for medical technologies in Spain with free MTRC analytical reports and white papers
Explore MTRC research papers:
- Market access for medical devices in Europe: England, France, Germany, Italy and Spain (Report #1)
- Market access for in-vitro diagnostic tests in Europe: England, France, Germany, Italy and Spain (Report #8)
- Reimbursement Pathways for Companion Diagnostic (CDx) Tests in Europe (Report #21)
- Case study: Market Size Analysis for Mechanical Intracranial Thrombectomy in Europe (Report #28)
- Evidence requirements for AI-based technologies in Europe (Report #29)
MTRC has experience with more than 126 projects in Spain
How can MTRC help?
Development of reimbursement analysis (procedure coding, payment mechanism, reimbursement tariffs, policy and HTA considerations)
Development of market access 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
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