September 2025 update of the reimbursable companion diagnostics list in Belgium

In Belgium, there is a “coupled reimbursement” framework for companion diagnostics, maintained and updated by the Belgian National Institute for Health and Disability Insurance (INAMI/RIZIV), which includes:

• Generic codes (INAMI/RIZIV Nomenclature Article 33ter) for molecular tests, with fees depending on the level of complexity (1 for the lowest, 3 for the highest);
• A list of reimbursable predictive biomarkers (Chapter VIIIc of the reimbursable pharmaceuticals), each linked to a specific pseudocode and an Article 33ter code;
• A list of associated personalized medicines (Chapter VIIIb of the reimbursable pharmaceuticals) with defined reimbursement conditions and prices.

In September 2025, the list of reimbursable predictive biomarkers (Chapter VIIIc) was updated. A new clinical indication, urothelial carcinoma, was introduced with two new predictive biomarker tests:

• Detection of FGFR3 gene fusion in unresectable or metastatic urothelial carcinoma;
• Analysis of an FGFR3 mutation in unresectable or metastatic urothelial carcinoma.

Both tests are classified as level 3 of complexity.

See full details in French here.

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