In-vitro diagnostic tests

On March 31, 2024, the Ministry of Labor, Health, and Solidarity published a Decree in the Official Journal of the French Republic relating to the conditions of coverage of innovative IVD tests within the RIHN framework, which should facilitate the transition from the RIHN framework to regular reimbursement via the NABM Nomenclature.

In March 2024, the English government endorsed the UK National Screening Committee's recommendation to introduce newborn screening for hereditary tyrosinaemia type 1 (HT1). Testing for HT1 will be added to the NHS Newborn Blood Spot Screening Programme in England.

On March 23, 2024, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system and associated tariffs to be implemented no later than May 1, 2024. A total of 107 new codes were added, 92 codes were amended, and two codes were terminated.

In March 2024, the Health Sciences Institute in Aragon (IACS) is working on several HTAs, including evaluations in diagnostic imaging, IVD, as well as clinical guidelines in endocrine, orthopedics, nephrology and urology, and some other fields.

On March 1, 2024, the updated Benefit Order was published in the Official Journal of the French Republic. Notable updates encompass modifications to existing emergency care supplements and the addition of new ones for non-hospitalized emergency care services, such as laboratory tests, imaging, specialist consultations, out-of-hours care, and specific provisions based on patient condition and age.

In March 2024, several ongoing mini-HTA assessments for diagnostic imaging, e-health, endoscopic procedures, IVD, neuromodulation, peripheral vascular, and some other fields are evaluated as a part of a framework for the managed introduction of innovations "New Methods in Norway.

On February 15, 2024, the new version of the Nomenclature of Medical Biology Acts was released in France. Various changes were implemented, including the introduction of five new codes and modification of the existing codes and titles. The newly introduced codes concern microbiological and biochemical tests.

In February 2024, the Basque Office for Health Technology Assessment (OSTEBA) is working on several HTAs, including evaluations in the cardiovascular, e-health, ENT, IVD, and some other fields.

On January 26, 2024, NHS England announced the third round of the Innovation Open Call, funded by the NHS Cancer Programme. All types of late-stage innovations aimed at early detection and diagnosis of cancer are eligible, including medical devices, in-vitro diagnostics, digital health solutions, and AI. Awarded projects will be 100% funded up to the total value of £4 million to produce and evaluate evidence in a real-world setting, supporting adoption and spread by providers, commissioners, and regulators. The application submission will be open on April 8, 2024.

On January 23, 2024, the Ministry of Health introduced a new national catalog, which guarantees the Spanish population's genetic tests nationwide. Currently, the catalog includes 672 tests in eight disease areas, including adult and pediatric oncohematology, pharmacogenomics, hereditary metabolic and mitochondrial diseases, and others. Twelve more disease areas are expected to be added in 2024.

The LEA catalog was brought in 2017, but the tariffs were approved in 2023. The new tariffs for outpatient specialist care were supposed to enter into force on January 1, 2024, but the adoption of new tariffs was postponed to April 1, 2024, due to the technical inability of the Regions to implement the change in time.

On December 18, 2023, the updated version of the laboratory test nomenclature was published by the Finnish Institute for Health and Welfare (THL) to come into force on January 1, 2024. Sixty new codes were introduced concerning in-vitro diagnostics and functional diagnostic tests in the cardiology, pulmonology, and gastroenterology fields.