In-vitro diagnostic tests

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.

In January 2024, eight NHS Genomic Networks of Excellence were launched within the NHS Genomic Medicine Service (GMS). NHS England is funding these innovative networks to develop the evidence and model of adoption for cutting-edge genomic advances and technology applications and inform commissioning decisions.

In January 2024, NHS England issued an updated version of the National Genomic Test Directory for 2024/2025, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. Six new codes (test-indication combinations) were introduced in the Test Directory for cancer, and four new codes in the Test Directory for rare and inherited diseases.

In December 2023, the reimbursement scheme for outpatient pathology services was updated for 2024. This scheme has been gradually introduced in Norway since 2022. It comprises fee-for-service reimbursement by the Norwegian Health Economics Administration (Helfo) using Pathology Activity Codes (APAT). Fourteen new reimbursement codes were introduced.

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.