Medical Device Reimbursement in Spain

Medical Device Reimbursement Landscape in Spain

The purpose of this step is to understand the current reimbursement environment in Spain, relevant for your medical device, and how it aligns with broader medical device reimbursement strategy and European market access planning. To do so, we will:

• Clarify the relevant type of coding systems and guidelines, applicable for the specific device or to any comparable products, issued on a national level or by each of the 17 Autonomous Communities (Comunidades Autónomas). Clarify the reimbursement status in the reimbursement catalogs of supplementary health insurance providers.
• Locate any specific reimbursement mechanisms that could be utilized by the device, as-is, or recommend on whether new mechanisms will have to be developed and if so, which mechanisms.
• Identify the main decision makers, lay out the typical path towards obtaining national, regional or local reimbursement, including milestones and typical timelines and provide an initial reimbursement strategy for the device in Spain.

Reimbursement Planning for Decision Makers in Spain

According to the conclusions in the Reimbursement Landscape, we devise the plan for developing the required evidence for Spanish decision makers, such as the Ministry of Health, Social Services and Equality (MSSSI), the Interregional Council of the National Health System (CISNS) or regional Health Technology Assessment (HTA) entities. This includes the development of:

• Value Story: Puts forward the claims for clinical and economic benefits associated with the use of the new device in the eyes of the relevant decision makers and would serve as the basis for the Economic Model.
• Economic Model: Highlights the economic benefits of the new device from the perspective of decision makers in Spain. May identify specific outcomes data that should be added to future clinical study protocols.
• Clinical Data: Recommendations for adjustments and modifications of any planned clinical studies in order to generate the required reimbursement-related evidence for decision makers.
• Decision Makers’ Feedback: Conduct interviews with the identified decision makers in Spain, utilizing Mediclever’s network of local clinicians, payer representatives and other stakeholders, to obtain their feedback regarding the developed value story, the economic model and the reimbursement aspects of the planned clinical study.

Implementation

Depending upon the existence, or the lack of, applicable reimbursement mechanisms (as identified in the Reimbursement Landscape step), we will conduct the following activities:

• Billing Guide: Develop a set of instructions guiding physicians and other healthcare providers how to obtain reimbursement following the use of the new device.
• Reimbursement Applications: Work with the relevant medical societies and university hospitals to apply for new reimbursement mechanisms, such as add-on funding on top of DRG rates or allocated fixed budgets for specific technologies/devices.
• Pilot Projects: Initiate pilot projects with regional health departments of different Autonomous Communities.

Key Questions About Medical Device Reimbursement in Spain

How long does medical device reimbursement take in Spain?

Timelines vary depending on whether national, regional, or hospital-level funding mechanisms are required. Reimbursement processes may take several months to more than a year, particularly when regional evaluation by Autonomous Communities is needed.

Which reimbursement pathways exist for medical devices in Spain?

Devices may obtain funding through inclusion in national or regional reimbursement catalogs, hospital DRG-based payments, add-on funding mechanisms, or regionally allocated budgets managed by the Autonomous Communities.

What coding systems are relevant for reimbursement in Spain?

Reimbursement relies on procedure coding, Spanish DRGs, and regional coding frameworks, with variations across Autonomous Communities and hospital systems.

Who are the key decision makers for reimbursement in Spain?

Decision makers include the Ministry of Health, the Interregional Council of the National Health System (CISNS), regional health authorities, hospital management, and regional HTA bodies.

Can reimbursement planning begin before regulatory approval?

Yes. Early reimbursement planning can inform evidence generation, pricing strategy, and regional access planning, although formal reimbursement decisions require regulatory approval.

View all medical device reimbursement and market access FAQs, or explore our medical device reimbursement consulting services.

Why Mediclever for Medical Device Reimbursement in Spain?

Mediclever is a specialized medical device reimbursement consultancy supporting manufacturers seeking access to the Spanish healthcare system. We combine local expertise with structured reimbursement strategy development across national, regional, and hospital levels.

Our team supports medical device companies with reimbursement landscape assessments, evidence generation strategies, coding and DRG analyses, to facilitate medical device market access and reimbursement strategy development in Spain across national, regional, and hospital decision-making levels.

Mediclever has supported reimbursement and market access projects involving national and regional Spanish stakeholders, including hospital-based decision makers and regional health authorities.