General Market Access Landscape for Companion Diagnostic Tests in Europe

Current reimbursement landscape for companion diagnostic tests as a part of hospital or outpatient care

Many countries lack a specific framework or unified approach to reimbursement for companion diagnostic (CDx) tests. Reimbursement for CDx tests follows the same principles as the framework for regular in-vitro diagnostic tests.

In most European countries (Germany, Italy, Spain, and countries of the Nordic region), CDx 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 CDx tests during hospital admission is used only in Belgium and in private for-profit hospitals in France. 

In some European countries (England, the Netherlands), CDx tests attract additional (top-up) reimbursement, which is paid in addition to the DRG tariff. For example, in England since 2020, all cancer molecular diagnostic tests (including CDx tests) are on the High Cost Device List and are paid on top of the basic payment mechanism (HRG tariff for elective procedures or global budget for emergency procedures) by NHS England (using the National Genomic Test Directory).

In outpatient settings, CDx tests are generally covered by the same reimbursement framework as other IVD tests. For example, in Germany, CDx tests should be included in the EBM catalog to receive reimbursement within the statutory health insurance system. In Italy, CDx tests are reimbursed using the same reimbursement framework as regular IVD tests, which includes two components: reimbursement of the tests and reimbursement tariff setting at the national level in the Essential Levels of Care (LEA) and introduction of individual tests, which are not yet reimbursed at the national level, at the regional level. In Spain, CDx tests are funded using the same principle as other care (via global budget allocation to hospitals).

In many European countries, the CDx tests do not have specific reimbursement codes; generic codes with broad descriptions of test methods or tumor types are used. For example, in Germany, the CDx tests can be described via generic EBM codes for high-throughput sequencing to analyze genetic alterations in solid malignant neoplasms, which differ depending on the lengths of analyzed nucleic acid molecules (measured in kilobases). The absence of specific codes creates administrative challenges and hinders tracking and funding.

In France, regular reimbursement for CDx tests is available via the NABM Nomenclature, the permanent, main reimbursement catalog for coverage within statutory health insurance, and CCAM Classification of Medical Procedures, used in France for pathology services. There is a limited number of NABM codes specifying the targeted gene and the type of cancer (e.g., EGFR mutation detection test in non-small cell lung cancer for targeted therapy).

In Italy, reimbursement decisions are often made at regional or local levels, resulting in variability in access to CDx tests. 

Role of HTA

Due to their high cost and novelty, CDx tests are often the subject of HTA in different European countries. 

For example, in 2024, seven HTAs of CDx tests were published in Spain, including an assessment of CDx tests in breast, lung, and colorectal cancers.

In the Netherlands, the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) uses HTA to determine whether services are covered under Basic Health Insurance. In October 2023, the ZIN published the Position “Gene expression testing in women over 50 years and early-stage breast cancer”, which concluded that MammaPrint® and Oncotype DX® can be reimbursed from the basic health insurance package in a small group of women aged 50 and over with early-stage breast cancer, for whom there is doubt whether they will benefit from additional chemotherapy. 

While NICE assessments played a certain role in evaluating companion diagnostic tests in the past, they are no longer relevant, as decision-making has been moved to the central level, with NHS England taking the lead.

Future challenges 

Future challenges in the market access landscape for CDx tests include a fragmented reimbursement decision-making process between local or regional levels, leading to inconsistent access; linking reimbursement for CDx tests to the associated drug; insufficient funding when budget allocations for diagnostics are often underprioritized compared to therapies.