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Market access for in-vitro diagnostic tests in Europe

A brief overview of the market access landscape for IVD tests in Europe: England, France, Germany, Italy and Spain (May 2024)


Market access for in-vitro diagnostic (IVD) testing is a challenging field. It includes co-existing frameworks of reimbursement (coding, payment mechanism tariffs), funding (post-reimbursement approval by payers), and health technology assessment (HTA). 

For most of the Med Tech companies, the starting point for understanding the European market is EU5 countries: England, France, Germany, Italy, and Spain.

Despite the single similarity of large populations, these countries are organized completely differently from the market access perspective.

On the reimbursement side, England and Spain use a global budget model, while France, Germany and Italy use a fee-for-service model. In both England and Spain, there are national coverage lists of genetic tests. HTA is part of the reimbursement process in France and Germany (partly) and it is a stand-alone process for IVD tests in England, Italy, and Spain. 

MTRC developed an analytical White Paper with a summary of key market access elements of EU5 countries, including stakeholders, payment mechanisms, innovative payment schemes, funding, and the role of HTA for in-vitro diagnostic tests.

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