In-vitro diagnostic tests

On July 29, 2025, the French National Authority for Health (HAS) issued positive opinions on including targeted next-generation sequencing-based panels in certain clinical indications for patients with aminoacidopathy and acute leukaemia in the NABM Nomenclature for regular reimbursement. Currently, these tests are temporarily reimbursed within the innovative payment scheme (RIHN). These HAS assessments are performed by HAS as a part of the RIHN reform and ‘cleaning up’ the List of temporary covered tests.

In July 2025, the National Institute for Health and Care Research (NIHR) in England released seven Med Tech-related assessments in its HTA Journal, which concerned nephrology and urology, pulmonology, gynecology, in-vitro diagnostics and e-Health 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.

On July 9, 2025, the NHS Cancer Programme granted £14.4 million to seven projects through the third Innovation Open Call. The projects aimed to fast-track the implementation of proven, late-stage innovations for the early detection and diagnosis of cancer.

In July 2025, the Common Catalog of Genetic and Genomic Tests of Spain’s National Health System was updated. Two sections with a total of 25 new genetic tests were introduced for ENT diseases and non-hepatic gastrointestinal diseases.

Since January 2025, three MedTech-related mini-HTAs were initiated in the areas of men’s health, in-vitro diagnostics, and diagnostic imaging as a part of a framework for the managed introduction of innovations "New Methods" in Norway. Furthermore, 11 mini-HTAs were published in this period, including cardiovascular, e-health, gastrointestinal, men’s health, and spine areas.

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 June 2025, the Skåne University Hospital (HTA South) is working on health technology assessments in several areas, including diagnostic imaging, e-health, in-vitro diagnostics, men’s health and neurology.

On June 18, 2025, a new version of the Nomenclature of Medical Biology Procedures (NABM 98) was released. Seven new codes were introduced.

On June 10, 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 July 1, 2025, and relate to colorectal cancer screening with the increase in the number of reimbursed colonoscopies, cancer treatment, men’s health, medical aids, and other medical services.

On June 5, 2025, the French National Authority for Health (HAS) published its favorable opinion on the coverage of AI-assisted digitalized urine cytology using VisioCyt Bladder, an in-vitro diagnostic medical device, under the renewed Repository of Innovative Procedures outside the Nomenclature of Biology and Anatomocytopathology (RIHN) 2.0.