OBJECTIVES:

European Medicines Agency (EMA) defines companion diagnostics (CDx) as a “device which is essential for the safe and effective use of a corresponding medicinal product”, frequently used to identify patients likely to gain benefits or be at risk from the corresponding medical product. Pharmaceutical companies frequently participate in the development and marketing of CDx products.

The research aim is to identify and compare assessment and funding models for CDx in United Kingdom (UK), France and Germany (EU3).

METHODS:

EMA guidelines and EU3 national recommendations on CDx were reviewed to identify assessment pathways. Funding models were then evaluated, followed by comparison of EU3 CDx funding based on a basket of products. The research findings were used to develop a typology of the various access models, specific to CDx in EU3.

RESULTS:

No common assessment has yet been defined by the EMA. However, a framework defining limits of CDx within in-vitro diagnostics (IVDs) is available, classifying them as “at least a class C” i.e. as at high risk(on a scale from A, lowest risk to D, highest risk for patients).

To be launched in EU3, any CDx needs to go through national health technology assessment (HTA) after receiving a European conformity (CE) mark. The clinical utility needs to be demonstrated in France; while a more pragmatic approach is used in the UK (clinical studies results or systematic literature review can be accepted as evidence). Funding variations between patient settings exists; for instance in Germany inclusion in the Einheitlicher Bemessungsmassstab (EBM) list and diagnosis-related groups (DRGs) are required to achieve outpatient and inpatient reimbursement respectively.

CONCLUSIONS:

Three different assessment models of CDx were identified in EU3. Each model can lead to a national health insurance funding for use with or without the targeted-drug, to identify relevant patients.