Genetic tests

On December 31, 2025, the Ministry of Health, Family, Autonomy, and People with Disabilities published a Decree, amending the conditions of temporary coverage for innovative IVD tests via the RIHN framework (included in the List of Innovative Procedures Outside the Nomenclature, LAHN). Changes include extending the maximum duration of transitional coverage from five to nine years and lowering the annual tariff reductions from 20% to 10%. The LAHN 2026 was also released, reflecting the changes introduced by a Decree.

In December 2025, the National Institute for Health and Care Research (NIHR) in England released three Med Tech-related assessments in its HTA Journal, which concerned endoscopic treatments for obesity, whole-genome sequencing for rare diseases in newborn screening, and a tele-ophthalmology-enabled and artificial intelligence-ready referral pathway for community optometry referrals of retinal disease.

On October 21, 2025, the French National Authority for Health (HAS) issued positive opinions on the inclusion of targeted next-generation sequencing-based panels for patients with multiple myeloma and lung cancer in the NABM Nomenclature for regular reimbursement. Currently, these tests are temporarily reimbursed within the innovative payment scheme (RIHN). These HAS assessments are performed as a part of the RIHN reform and ‘cleaning up’ the List of temporarily covered tests.

On September 5, 2025, the Ministry of Health opened a public consultation on a Draft Ministerial Order to update the Common Package of Benefits of the National Health System. The key planned changes are expected in diagnostic imaging, endocrine, gastrointestinal, in-vitro diagnostics, neurology and neurosurgery, and obstetrics and gynecology fields. Input can be submitted via email until September 26, 2025.

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.

On August 5, 2025, the Ministry of Labor, Health, Solidarity, and Families published the 2025 version of the List of Innovative Procedures Outside the Nomenclature (LAHN), which specifies tests funded under the innovative payment scheme for in-vitro diagnostics (RIHN). Tariffs for tests included in the LAHN were expected to decrease by 20% annually from January 1, 2025, except for those with a positive evaluation by the French National Authority for Health (HAS) in defined clinical indications. However, unlike previous edition, the 2025 LAHN does not specify tariffs. It introduces 14 new codes, which duplicate existing generic codes but are restricted to the clinical indications positively assessed by HAS. These new codes will be exempt from the annual tariff reduction.

In August 2025, the Common Catalog of Genetic and Genomic Tests of the National Health System in Spain was updated. Two sections with a total of 140 new genetic tests were introduced: one for bone diseases, including craniofacial anomalies, and another for kidney diseases and urogenital disorders. Furthermore, six new tests were added in pediatric oncohematology. Other changes concerned adult oncohaematology, hereditary metabolic, and mitochondrial diseases.

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 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 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.

On May 12, 2025, the updated version of the Finnish Laboratory Tests Nomenclature was published by the Finnish Institute for Health and Welfare (THL) to come into force on June 1, 2025. Twenty-one new codes were introduced.

On May 6, 2025, NHS England issued an updated version of the National Genomic Test Directory for 2025/26, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. One new code (test-indication combination) was introduced in the Test Directory for cancer, and one for rare and inherited diseases.