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In-Vitro Diagnostic Tests

A general overview of the market access landscape for in-vitro diagnostic tests in European countries.

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Reimbursement landscape 

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. 
 

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Policy considerations

Approval by payers or national decision-makers is required for the inclusion of a novel expensive test in the national lists of reimbursable services in many countries. For example, in England, expensive genomic tests used in rare diseases and oncology are covered in the National Genomic Test Directory by NHS England; in Norway, innovative IVD tests can obtain coverage decisions by payers within the “New Methods” framework; in Spain, genomic tests guaranteed for the population are listed in the Common Catalog of Genetic and Genomic Tests of the NHS.

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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)

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Role of innovation funding

Innovative payment schemes play an important role in market access for IVD tests in Europe: around 52% of the innovative payment schemes can cover in-vitro diagnostics (Medtech Funding Mandate in England; Government-co-sponsored studies according to the §137e of the German Social Code Book V in Germany; small-scale experiments for introduction of innovations in the Netherlands). Some of the innovative schemes allow for direct application by the industry (Innovative Devices Access Pathway (IDAP) in England, Article 51 of the Social Security Financing Act in France).

France offers a unique and unparalleled opportunity to gain early access to the market through the development of clinical and economic evidence using seven Innovative Payment Schemes, including the List of innovative medical biology procedures outside the Nomenclature (LAHN) – the key innovative scheme for IVD tests in France. Funding via the LAHN means an additional budget for laboratories that comes from the research and innovation (MERRI) budget distributed by the Ministry of Health and Access to Care. 
 

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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.

MTRC has experience with more than 85 projects related to IVD tests in Europe 

News and insights

Projects awarded under the 2025 round of the Appropriate Care Framework in the Netherlands

In August 2025, the Dutch Organization for Health Research and Development (ZonMw) awarded seventeen projects under the subsidy round “Preparatory implementation activities Round 1” of the Appropriate Care Framework program. Awarded projects include e-health, men’s health, in-vitro diagnostic, and other fields.

Med Tech-related health technology assessments in Wales in June-July 2025

In June-July 2025, Health Technology Wales (HTW) accomplished one full appraisal on implantable tibial neuromodulation devices for urinary incontinence. In addition, seven Med Tech-related Topic Exploration Reports were published in the e-health, diagnostic imaging, in-vitro diagnostics, neurology, and radiotherapy fields.

The 2025 List of Innovative Procedures Outside the Nomenclature (LAHN) was published in France

On August 5, 2025, the Ministry of Labor, Health, Solidarity, and Families published the 2025 version of the List of Innovative Procedures Outside the Nomenclature (LAHN), which specifies tests funded under the innovative payment scheme for in-vitro diagnostics (RIHN). Tariffs for tests included in the LAHN were expected to decrease by 20% annually from January 1, 2025, except for those with a positive evaluation by the French National Authority for Health (HAS) in defined clinical indications. However, unlike previous edition, the 2025 LAHN does not specify tariffs. It introduces 14 new codes, which duplicate existing generic codes but are restricted to the clinical indications positively assessed by HAS. These new codes will be exempt from the annual tariff reduction.

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