Skip to main content

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

fghgfv

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. 

hbvc

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.

hgfv

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.

1111

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

2024 RedETS working plan published in Spain

On May 23, 2024, the 2024 working plan was published by the Spanish Network of HTA Agencies (RedETS). Topics in cardiovascular, diagnostic imaging, e-health, endoscopy, ENT, extracorporeal treatments, ICU/OR, in-vitro diagnostics, interventional radiology, men’s health, neurology and neurosurgery, neuromodulation, obstetrics and gynecology, orthopedics, peripheral vascular, pulmonary and airways, radiology, radiotherapy, robotic surgery, spine, surgical procedures, and some other fields are included in the plan.

Spanish Common Package of Benefits to be updated soon

The Draft Order amending the Common Package of Benefits of the National Health System was published in spring 2024. The proposed changes mostly concern screening, primary and community care, eHealth, cardiovascular, and medical aids fields.

Ongoing HTAs by IACS in Spain in March 2024

In March 2024, the Health Sciences Institute in Aragon (IACS) is working on several HTAs, including evaluations in diagnostic imaging, IVD, as well as clinical guidelines in endocrine, orthopedics, nephrology and urology, and some other fields.

Get in touch

Contact us to discuss your needs and learn about our services