Mediclever Home Page

Medical Device Reimbursement in Spain.

Identification of comparable products in the national benefits package and Spanish DRGs, applications for reimbursement or add-on funding by the Autonomous Communities (Comunidades Autónomas).

Reimbursement Landscape in Spain

The purpose of this step is to understand the current reimbursement environment in Spain, relevant for your medical device. 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 Spain 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.


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 department of different Autonomous Communities.

Flat fees, concrete timelines, and support through your entire reimbursement process

Local Presence and Experience in:

  • Sweden
  • Austria
  • Denmark
  • Other
  • Australia
  • Israel