In-vitro diagnostic tests have a specific reimbursement framework compared with medical devices.

In most of the European countries, IVD tests, that are performed at hospitals are included in DRG tariff, and laboratories are funded using a global budget principle.

However, in out-patient settings, many countries have specific reimbursement frameworks for IVD tests, most commonly using a fee-for-service payment model.

In this report, we summarized reimbursement decisions for IVD tests in 2018, 2019, and 2020 (thee consecutive years) in the countries, where an explicit reimbursement framework exists (Belgium, France, Germany, Netherlands, Switzerland). 

Why this report can be of interest to IVD industry?

• First, it can indicate the level of activity of reimbursement authorities in different European countries. Knowledge, about how often new tests are added to reimbursement nomenclatures can support planning of reimbursement activities. Should you consider Belgium or Germany for market entry, or is it better to focus on France? Our report can help find answers to these questions
• Second, knowledge of what tests were added to the reimbursement nomenclature can support decision-making about evidence requirements for reimbursement registration

Belgium: IVD tests included into INAMI Nomenclature (all relevant chapters)

France: IVD tests included into NABM and RIHN (innovative tests) Nomenclatures, changes in the Supplementary List

Germany: IVD tests included into EBM nomenclature

Netherlands: IVD tests included into reimbursement list of Dutch Health Care Authority (NZa) (tests reimbursed when ordered by GPs)

Switzerland: IVD tests included into List of Analyses (Annex 3 of the KLV List)