In-vitro diagnostic tests

On September 2, 2024, the French Ministry of Health released further details on the renewed support for innovation in medical biology and anatomopathology procedures via the Repository of Innovative Services outside the Nomenclature of biology and anatomopathology (RIHN) 2.0 including criteria for application.

In September 2024, the Canary Islands Healthcare Evaluation Service (SESCS) is working on several HTAs, including evaluations in neuromodulation, IVD, and some other fields.

Molecular gene profile analysis (Oncotype DX) was evaluated within the "New Methods" framework starting in 2021. On August 26, 2024, the Decision Forum for "New Methods" recommended Oncotype DX to be introduced to predict the benefit of chemotherapy in postmenopausal patients with lymph node-positive, estrogen receptor-positive (ER+), human epidermal growth factor receptor-2 negative (HER2-) early-stage invasive breast cancer.

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 Sixteen topics were prioritized, twenty were not prioritized, and one was withdrawn.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).