In-vitro diagnostic tests

NICE recently introduced a new centralized approach to prioritizing topics for its guidance and a decision-making body - a prioritization board. In July 2024, the decisions of the prioritization board were first published by NICE. Sixteen topics were prioritized, twenty were not prioritized, and one was withdrawn.

On August 8, 2024, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 197 and 093 with changes to be implemented no later than October 4, 2024. Thirteen new procedure codes related to cardiovascular, endoscopy, gastrointestinal, interventional radiology, neurology, gynecology, orthopedics, spine, and robotic surgery areas, and four new diagnostic codes were introduced.

On August 3, 2024, the Ministry of Labor, Health, and Solidarity published an Order in the Official Journal of the French Republic modifying the national neonatal screening program using laboratory examinations. Starting November 1, 2024, all newborns will be screened for sickle cell disease. Other modifications include organizational changes and modifications related to the timing of blood sample collection.

In July 2024, NHS England issued an updated version of the 2024/25 National Genomic Test Directory, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. A total of 58 new codes (test-indication combinations) were introduced in the Test Directory for cancer, and ten new codes in the Test Directory for rare and inherited diseases.

In July 2024, the National Institute for Health and Care Research (NIHR) in England released five MedTech-related assessments in its Health Technology Assessment (HTA) Journal, which concerned cloud-based device (CaRi-Heart) for predicting cardiac risk, remote continuous monitoring of Parkinson's disease, home-monitoring for neovascular age-related macular degeneration, treatment of pilonidal sinus disease, and cystatin C in glomerular filtration rate-estimating. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and informs National Institute for Health and Care Excellence (NICE) guidance.

In July 2024, the National Institute for Health and Care Excellence (NICE) released a report on proposed approaches to the economic evaluation of multi-indication health technologies (MIHTs) developed by the HTA Lab. Examples of MIHTs include circulating tumor DNA tests, polygenic risk scores, and virtual ward platform technologies, which can be used across multiple disease areas or multiple indications. This report proposes approaches that NICE could adopt for future economic evaluations of MIHTs and provides recommendations for implementing the approaches on pilot topics.

On August 2, 2024, the French National Authority for Health (HAS) published a report presenting the program for evaluating targeted high-throughput sequencing procedures. The program defined indications for which the technology will be evaluated with a view to its transitioning to regular reimbursement under the Statutory Health

In July 2024, the National Institute for Health and Care Excellence (NICE) published one new Diagnostics Guidance (CYP2C19 genotype testing to guide clopidogrel use after ischaemic stroke or transient ischaemic attack) and one Technology Appraisal Guidance (Selective internal radiation therapy with QuiremSpheres for treating unresectable advanced hepatocellular carcinoma).

On August 2, 2024, the HAS published positive opinions on the inclusion of targeted high-throughput sequencing of gene panels in the medical management of lung cancer, gastrointestinal stromal tumors, and chronic lymphocytic leukemia in the NABM Nomenclature. This is a consequence of the efforts to disburden the innovation funding budget and clean the List of IVD tests outside the Nomenclature (Liste des actes hors nomenclatures, AHN, i.e., the merged 2023 RIHN List and the Supplementary List funded outside Statutory Health Insurance via the research and innovation budget).

On July 1, 2024, the National Institute for Health and Disability Insurance (INAMI/RIZIV) introduced a new agreement (Convention), which allows permanent reimbursement for molecular biology tests by next-generation sequencing (NGS) in oncology and hemato-oncology. The tests were reimbursed temporarily in the context of the pilot Convention from 2019. Fifty-one new pseudo-nomenclature codes with tariffs were introduced. The pseudocode descriptions specify the indication, while certain biomarkers and reimbursement conditions are mentioned as notes to the code.

In July 2024, the UK National Screening Committee (UK NSC) released an annual report from April 1, 2023 to March 31, 2024. The report provides a summary of the Committee’s ongoing work and accomplishments, including recommendations regarding the introduction of national population screening programs.

At the end of July 2024, the French Ministry of Health released a document on the RIHN reform process, including the description on the new RIHN application and evaluation process, but also how the HAS will evaluate tests currently covered in the RIHN Nomenclature, with the purpose of of deciding whether these tests will be granted permanent reimbursement, or will be excluded from coverage within the statutory health insurance. Cleaning the current AHN List will allow for the financing of truly innovative tests patients need.