Reimbursement Landscape in Europe
We provide a comprehensive understanding of the current European reimbursement environment relevant for your specific medical device:
- Clarify national coding systems and guidelines applicable for your device or comparable products across each European country.
- Assess the reimbursement status in catalogs of supplementary health insurance providers and regional health agencies.
- Locate specific existing reimbursement mechanisms or recommend the development of new pathways where gaps exist.
- Identify main decision makers and lay out the typical path toward national, regional, or local reimbursement.
Reimbursement Planning for European Decision Makers
We devise the evidence-generation plan required for European decision makers, including national payer organizations, HTA entities, and Ministries of Health:
- Value Story: Developing clinical and economic claims tailored to the specific expectations of European stakeholders.
- Economic Model: Highlighting economic benefits from the perspective of European payers to support pricing and coverage.
- Clinical Data Assessment: Recommending adjustments to clinical studies to ensure the generation of reimbursement-related evidence.
- Stakeholder Feedback: Conducting interviews with local clinicians and payer representatives using Mediclever's extensive European network.
Implementation & Market Access Execution
We execute the strategy by securing the necessary mechanisms for long-term commercial success in Europe:
- Billing Guides: Instructions for healthcare providers on how to correctly obtain reimbursement for your device.
- Reimbursement Applications: Applying for add-on funding, DRG inclusions, or national innovation programs in collaboration with medical societies.
- Pilot Projects: Initiating data-generation projects with regional public and private health insurance companies.
- Interim Funding: Navigating interim reimbursement mechanisms, grants, and charity funds to accelerate initial market entry.
Frequently Asked Questions: EU Reimbursement
How long does it take to get reimbursement in Europe?
Timelines vary significantly by country. While some local pathways can be accessed in 6-9 months, national inclusion in catalogs like the German DiGA or French LPPR typically takes 12-24 months, depending on the clinical evidence available.
Does CE Marking under MDR guarantee reimbursement?
No. CE Marking (MDR) focus on safety and performance, while payers focus on "clinical added value" and cost-effectiveness. A device can be legal to sell but have no mechanism for payment without a dedicated reimbursement strategy.
What is an HTA assessment?
Health Technology Assessment (HTA) is a formal process used by bodies like HAS (France) or G-BA (Germany) to determine the clinical benefit of a new device compared to the current standard of care.