In-vitro diagnostic tests

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.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in July 2024. Nine recommendations were published concerning the registration of medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular, neurovascular, interventional radiology, nephrology and urology, orthopedic, endocrine devices, and in-vitro diagnostic tests, as well as medical aids.

In July 2024, SBRI (Small Business Research Initiative) Healthcare launched new funding competitions in four priority areas: antimicrobial resistance, women’s health, urgent & emergency care, and stroke. All types of innovations are eligible, including but not limited to medical devices, in-vitro diagnostics, digital health, and AI solutions.

On July 12, 2024, the UK National Screening Committee (UK NSC) announced a new task group for multi-cancer detection (MCD) tests. The group will review different methods for the evaluation of MCDs, from which UK NSC is expected to derive a position statement and develop a roadmap for a possible MCD screening program.

On July 16, 2024, the French Ministry of Labor, Health and Solidarity published the merged 2024 List of acts outside the nomenclature financed under MERRI G03.