Companion diagnostic (CDx) tests are in vitro diagnostics that support the safe and effective use of a specific medicinal product by identifying patients who are suitable or unsuitable for treatment.
Most European countries have no dedicated reimbursement framework for CDx tests. They are typically reimbursed via the same mechanisms as regular in-vitro diagnostic (IVD) tests. However, reimbursement models vary significantly across countries.
Our latest White Paper provides a comprehensive overview of the reimbursement landscape for CDx tests in five largest European countries: England, France, Germany, Italy, and Spain. It outlines payment mechanisms in both hospital and ambulatory care settings, the need for explicit approval by payers, the role of health technology assessments (HTA) in decision-making. An illustrative case study explores the reimbursement status of the Oncotype DX Breast Recurrence Score Test in five countries.
This publication is designed to support med tech professionals, particularly those in the IVD and pharmaceutical fields, in navigating the complex and evolving companion diagnostic reimbursement landscape across Europe and shaping effective market access strategies.
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