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Evidence gap analysis

Strategic analysis of the sufficiency of evidence to obtain reimbursement and HTA approval in Europe and recommendations about evidence generation

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Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
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Belgium updated reimbursement agreement for next-generation sequencing (NGS) in oncology

Since July 1, 2024, molecular biology tests based on next-generation sequencing (NGS) in oncology and hemato-oncology have been reimbursed in Belgium under a dedicated agreement (Convention) between healthcare providers (laboratories) and the National Institute for Health and Disability Insurance (INAMI/RIZIV). Providers wishing to join the Convention submit a request to INAMI/RIZIV. 

The Convention enables reimbursement of NGS testing and RNA sequencing (RNA-seq) through specific reimbursement categories referred to as Pseudocodes. Each Pseudocode defines a clinical indication, while the associated reimbursement conditions specify the sample type and the minimum set of biomarkers to be analyzed.

The applicable Pseudocodes and reimbursement conditions are listed in two separate Annexes to the Convention: Annex 1 for solid tumors and Annex 2 for malignant hematological diseases. A reimbursement fee is assigned to each Pseudocode. In practice, however, the applicable fees are updated annually through Circulars issued by the National Medical-Mutual Commission, whereas the Annexes continue to reference the initial fees established in 2024.

In May 2026, INAMI/RIZIV published an updated version of the Convention and its Annexes, with implementation scheduled for July 1, 2026.

Multiple changes were introduced in Annex 1 ”Solid tumors”, including:

  • Four new Pseudocodes covering additional clinical indications; 
  • Two new Pseudocodes introducing a €400 supplement for performing NGS or RNA-seq on liquid biopsy samples in selected indications. 

The example of a new supplement is provided below.

  • 536115-536126 “Supplement for performing NGS on a liquid biopsy sample in patients with solid tumors”. The supplement applies to the following indications: Non-squamous lung carcinoma (presence of an adenocarcinoma [ADC] component or poorly differentiated carcinoma in which an ADC cannot be excluded); Squamous lung carcinoma in a patient who has never or rarely smoked; Lung carcinoma with progression within one year under targeted therapy; Metastatic breast carcinoma, ER-positive and HER2-negative; Metastatic castration-resistant prostate carcinoma; Intrahepatic cholangiocarcinoma.

In Annex 2 ”Malignant hematological diseases”, three new Pseudocodes covering additional clinical indications were introduced.

Other amendments across both Annexes included updates to reimbursement conditions (diagnostic rules), revisions to the list of biomarkers and genes for several existing Pseudocodes, and minor textual clarifications and corrections.

See the full details in French here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.