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Market access for medical technologies in Belgium

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in Belgium

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Key topics

There is only one key theme describing market access for medical technologies in Belgium: 

  • Reimbursement: payment via composite model, including physician fees for procedures (INAMI Nomenclature or DRG system), ward stay, and individual implants and invasive non-implantable materials

There are no separate funding (approval by the payer) or health technology assessment challenges in Belgium. Elements of HTA are integrated into reimbursement decision-making. 

Belgium has one innovative payment scheme for medical technologies (Restricted Clinical Application for invasive medical devices and implants, Application Clinique Limitée). 

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Reimbursement

Belgium has one of the most complicated reimbursement systems in Europe. It is mainly based on the mixed model of per diem, per procedure (fee for service), and per material used payment:

  • Per diem payment: for hospital ward stays
  • Fee for service: for all services performed (interventional procedures, laboratory and imaging services, etc.)
  • Material fees: for implantable devices, non-implantable consumables, pharmaceuticals

The overall payment made to the hospital is based on the sum of these individual fees, which are incurred during the period of admission.

Reimbursed procedures are listed in the INAMI Nomenclature. Each procedure has associated codes and physician fees for ambulatory and hospital use. 

Invasive non-implantable devices and implants are reimbursed via reimbursement lists, maintained by INAMI. There are eight different models of how pricing is determined within the “List of benefits,” ranging from free pricing to price registered per brand via Nominative Lists.

Since 2019, several low-cost and simple (low-variability) procedures are reimbursed not via individual INAMI codes but via APR-DRGs. The APR-DRG tariff covers only the procedural component (physician fees which are otherwise covered by the INAMI Nomencalture). 

Ward stay and pharmaceuticals are paid separately in the system.

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Specifics for IVD tests

Reimbursement of laboratory testing includes several components:

  • Fee for individual tests performed using INAMI Nomenclature (usually reimbursed at 25% of the tariff)
  • Lump-sum payment per day of stay (in hospitals)
  • Lump-sum payment per admission (in hospitals)
  • Lump-sum payment per prescription (in out-patient settings)
  • Copayment per test by patients
  • Specific reimbursement projects by INAMI (NGS, gene expression profiling tests; companion diagnostic tests)

Reimbursement tariff is covered by insurance companies at the 25% level for the majority of the IVD tests. The remaining amount is recovered by laboratories via lump sum payments and copayments (depending on the type of settings, e.g., using lump-sum payment per day of stay and per admission in hospital settings.

In order to be reimbursed, IVD tests shall be included in INAMI Nomenclature and/or be part of the specific agreements with INAMI (for specific projects, e.g., on NGS or gene expression profiling tests for early-stage breast cancer).

MTRC has experience with more than 151 projects in Belgium

News and insights

Permanent reimbursement for next-generation sequencing (NGS) in oncology launched in Belgium

On July 1, 2024, the National Institute for Health and Disability Insurance (INAMI/RIZIV) introduced a new agreement (Convention), which allows permanent reimbursement for molecular biology tests by next-generation sequencing (NGS) in oncology and hemato-oncology. The tests were reimbursed temporarily in the context of the pilot Convention from 2019. Fifty-one new pseudo-nomenclature codes with tariffs were introduced. The pseudocode descriptions specify the indication, while certain biomarkers and reimbursement conditions are mentioned as notes to the code.

The status of ongoing reform of the Belgian Nomenclature and planned next steps

On June 18, 2024, the Belgian National Institute for Health and Disability Insurance (INAMI/RIZIV) updated the information about the status of the ongoing structural reform of the Nomenclature started in 2019. INAMI/RIZIV reported on activities already completed as of June 2024 and announced further steps.

New procedure codes were added to Belgian Nomenclature in May 2024

On May 1, 2024, the Belgian National Institute for Health and Disability Insurance (INAMI/RIZIV) updated several articles of the Nomenclature. New procedure codes were introduced in pulmonary, endoscopy, and in-vitro diagnostic fields.

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