Companion diagnostic tests

On May 18, 2026, the Decision Forum for “New Methods” updated its coverage decision for molecular gene profile analysis using Oncotype DX. The test, which has been covered since 2024 for postmenopausal patients with lymph node-positive HR-positive, HER2-negative, early-stage invasive breast cancer, will now also be covered for patients with lymph node-negative breast cancer.

In May 2026, the Belgian National Institute for Health and Disability Insurance (INAMI/RIZIV) published an updated reimbursement agreement (Convention) for next-generation sequencing (NGS) in oncology and hemato-oncology. Multiple changes were introduced, including seven new reimbursement categories (Pseudocodes) covering additional clinical indications and new supplements for performing NGS or RNA sequencing (RNA-seq) on liquid biopsy samples in limited solid tumor indications. The updated Convention will enter into force on July 1, 2026.

On April 1, 2026, the revised EBM (German Uniform Evaluation Standard) catalog for the second quarter of 2026 came into force. The EBM catalog is used to reimburse day case and outpatient services under the fee-for-service model. The key changes include the introduction of new EBM codes for the reimbursement of lung cancer screening, monitoring progress, and evaluating the digital health application, as well as several IVD tests

In January 2026, nine new topics were added to the Implementation Agenda of the Care Evaluation and Appropriate Use (ZE&GG) program, requiring healthcare providers to implement these evidence-based practices in daily care and to demonstrate results within two years. The topics concerned the in-vitro diagnostic, gastrointestinal, and ENT fields. Additionally, 16 topics were removed from the agenda, as most had been sufficiently implemented and others were no longer relevant.

On December 3, 2025, the Swiss Federal Office of Public Health published updates to the Healthcare Benefit Ordinance (KLV/OPre), which determines coverage of medical services in Switzerland. The changes will take effect on January 1, 2026, and relate to prophylactic vaccinations, cost containment measures, and other matters. The updates are also implemented in KLV Annexes, including the List of explicitly evaluated services (Annex 1), the outpatient-before-inpatient mandate (Annex 1a), the List of Medical Aids (Annex 2, MiGeL), and the List of Analyses (Annex 3, AL).

In October 2025, the National Institute for Health and Care Research (NIHR) in England released four Med Tech-related assessments in its HTA Journal, which concerned tumor profiling tests in early breast cancer, remote monitoring of heart failure in people with cardiac implantable electronic devices, microstructural scaffolds in symptomatic defects of the knee, as well as rapid tests for antifungal stewardship in the ICU.

In September 2025, the Belgian National Institute for Health and Disability Insurance (INAMI/RIZIV) updated the list of reimbursable companion diagnostics. A new clinical indication, urothelial carcinoma, was introduced, with two new predictive biomarker tests included in the List.

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.

On July 17, 2025, the Federal Joint Committee (G-BA) decided that the use of the Oncotype DX Breast Recurrence Score® test as the sole test for deciding for or against adjuvant systemic chemotherapy will be reimbursed for patients with primary hormone receptor-positive, HER2-negative breast cancer involving one to three lymph nodes. Previously, reimbursement was limited to patients without lymph node involvement.

In July 2025, the Belgian National Institute for Health and Disability Insurance (INAMI/RIZIV) updated the list of reimbursable companion diagnostics to be used from August 1, 2025. One new predictive biomarker – analysis of BRAF V600 mutation status in glioma – was added to the list.

In the first and second quarters of 2025, the Dutch Healthcare Institute (ZIN) published three coverage positions concerning the ENT, gastrointestinal, and in-vitro diagnostic fields. Two of the three decisions (Internal nasal valve correction for airway blockage and molecular diagnostics of the NTRK gene fusion in cancer patients) received favorable recommendations for coverage under basic health insurance.

In March-April 2025, Health Technology Wales (HTW) accomplished one full appraisal of permanent implant brachytherapy devices for unresectable pancreatic cancer. Five Med Tech-related Topic Exploration Reports were published (on superior rectal artery embolization, glucose monitoring systems in neonates, gender-affirming surgery, telemetric intracranial pressure monitoring, tumor-profiling tests to guide bisphosphonate treatment in cancer).