General Market Access Landscape for In-Vitro Diagnostic Tests in Europe

Current reimbursement landscape for in-vitro diagnostics as a part of hospital or outpatient care

In most European countries, IVD tests performed during inpatient stays are included in the payment for hospital admission (DRG-based payment or global budget). Laboratories are funded using a global budget principle without a specific reimbursement framework. In general, laboratories introduce tests that are necessary from the clinical perspective. The fee-for-service model for IVD during hospital admission is used only in Belgium and in private for-profit hospitals in France.

Many countries have specific reimbursement frameworks for IVD tests provided as a part of outpatient specialist care, most commonly using a fee-for-service payment model. In most countries, IVD tests are a part of the national list for reimbursable outpatient specialist services (e.g., EBM catalog in Germany, LEA catalog in Italy). In other countries, there are specific national nomenclatures intended for IVD tests (Nomenclature of Medical Biology Procedures (NABM) or Norwegian Laboratory Code (NLK) system). 

The name of codes in the national lists used for reimbursement of IVD tests can include a detailed description of an analyte and/or the test method (for example, EBM code 32150 “Immunological detection of Troponin I and/or Troponin T on a prefabricated reagent carrier in the case of the acute coronary syndrome (ACS), if necessary, including quantitative evaluation using apparatus”) or provide a generic high-level description of a test method making the code applicable for multiple tests (for example, code G1.01 “Mutational analysis of disease that requires only one gene for diagnosis” in Italian LEA catalog). 

The national nomenclatures typically define the tariffs (LEA catalog in Italy) or point values (NABM in France or EBM catalog in Germany) and conditions for reimbursement for individual tests. Additional regulation can determine the monetary caps for the use of certain tests (Germany).
In some countries, there is no reimbursement system for in-vitro diagnostic tests; their cost is included in the basic payment mechanism for medical care (e.g., the NHS Payment Scheme in England or the global hospital budget in Spain).

The framework (evidence requirements, timelines) for the creation of novel IVD reimbursement codes in the national lists varies between countries; however, in most countries, it can be triggered by manufacturers. 
 

Role of HTA

Health Technology Assessment is an important factor influencing the adoption of IVD tests, apart from reimbursement and acceptance by payers / national decision-makers. In most countries, HTA is incorporated into reimbursement decision-making (INAMI/RIZIV in Belgium, HAS in France, New Methods” framework in Norway). However, in some countries, there are stand-alone HTA organizations whose recommendations can support the adoption of the new IVD tests by healthcare providers (NICE in England or AGENAS in Italy)

Future challenges 

Future challenges in the market access landscape for IVD tests include adjusting existing payment models to accommodate novel tests, creating new reimbursement or funding frameworks for expensive tests, and developing a reimbursement framework for point-of-care tests.