OBJECTIVES: Novel in vitro diagnostic tests offer valuable prognostic or predictive information to patients and clinicians. Developers of such tests face challenges to obtain reimbursement through national coverage systems. This study aims to identify hurdles and provide possible solutions by comparing reimbursement criteria and pathways of national coverage systems in Europe specifically for in vitro diagnostic test services.

METHODS: A literature study was conducted on reimbursement pathways and criteria for in vitro diagnostics in several European countries including: England, France, Germany, Italy, Spain, Belgium, the Netherlands, Austria and Switzerland. Complementary to the literature study, semi-structured interviews were carried out with national experts from either industry, academia or national coverage agencies.

RESULTS: We identified three reimbursement pathways resulting in either permanent or temporary reimbursement for in vitro diagnostic testing services across countries: general reimbursement pathways for medical services, co-dependent technologies pathways and Innovation funding pathways CONCLUSIONS: Lack of transparency in reimbursement criteria and budgetary issues are considerable factors that hinder in vitro diagnostic companies seeking reimbursement for diagnostic tests. Cross-country harmonization, transparency of reimbursement criteria and informed budget management are possible solutions in ensuring novel diagnostic tests to reach patients through national coverage systems.